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A STUDY OF A HOME EXERCISE
PROGRAMME FOR
COMMUNITY DWELLING PEOPLE
WITH LATE-STAGE STROKE
GILLIAN BAER
A thesis submitted in partial fulfilment of the
requirements for the degree of
Doctor of Philosophy
QUEEN MARGARET UNIVERSITY
2011
i
ABSTRACT
BACKGROUND
Many people living with chronic stroke are not involved in any form of ongoing
rehabilitation, despite having ongoing impairments and limitations in activity and
participation. The approach to structuring practice of functional tasks, as part of
ongoing rehabilitation, can incorporate diverse techniques. Current texts advocate
that physiotherapists construct stroke rehabilitation programmes that incorporate
Motor Learning principles, however the evidence to support this is limited. No
evidence related to stroke exists as to whether functional tasks should be practised
in their entirety (whole practice) or in component parts (part practice). The primary
aim of the work reported in this thesis was to investigate the effects of a home
exercise programme based on Motor Learning principles of part practice (PP) or
whole practice (WP) of selected functional tasks for people at least six months after
a stroke.
METHODOLOGY
A single blind, randomised controlled trial was undertaken, with participants
allocated to either a part practice experimental group (PP), a whole practice
experimental group (WP) or a control (Con) group. Both experimental groups
followed a four week exercise intervention programme of functional tasks based on
PP or WP. Outcome measures were undertaken at baseline, at the end of a four
week intervention (wk 4), at short-term follow-up (wk 4.5) and at long-term follow-up
(wk 16). Outcome measures utilised were the Barthel Index (BI), Motor Assessment
Scale (MAS), Timed Up and Go over 2 metres (TUG2m), Step Test, Frenchay Arm
Test (FAT), Hospital Anxiety and Depression Scale (HADS), Frenchay Activities
Index (FAI)and the Stroke Impact Scale (SIS). Differences between the groups at
each measurement point were examined using a Kruskal Wallis test. Differences
within each group over time were analysed using a Friedman’s Anova, followed up
by a Wilcoxon’s Signed Ranks test using a Bonferroni correction where a significant
difference was found.
RESULTS
Sixty four people with late-stage stroke were recruited and provided informed
consent. Data were available for analysis for 60 participants (median time since
stroke 21 months). No statistically significant differences were found between the
three groups at any point for any of the dependent outcome variables. A number of
statistically significant within group changes were found in all groups. Most
statistically significant changes were demonstrated by PP including on the BI from
baseline to wk 4.5; on the MAS from baseline to weeks 4, 4.5 and 16; on the Step
Test from baseline to weeks 4, 4.5 and 16 and on the FAT from baseline to week 4.
On more global measures the PP group reported statistically significant
improvements on the SIS in the domains of strength, mood and mobility from
baseline to wk 4; and in the SIS participation domain from baseline to wk 16; as well
as a statistically significant within group improvements on FAI from baseline to wk 4.
CONCLUSIONS
People with late-stage stroke demonstrated capacity for improvements in a number
of measures of impairment, activity, participation and mood. The PP group
demonstrated improvements, over time, in more of the outcome measures relating
to physical ability than either WP or Con groups. Implications for clinical practice
and further research are discussed.
i
ACKNOWLEDGEMENTS
It has been a long journey and there are many people to thank for their support
along the way.
I would like to thank Prof Brian Durward for his support, advice and wisdom
throughout the study.
His knowledge and willingness to debate were much
appreciated.
I am also extremely grateful to Prof David Weller for his enthusiasm and his help
and generosity in sharing his considerable expertise relating to community based
research.
My heartfelt thanks also to Prof Marie Donaghy, who stepped in as Director of
Studies towards the final stages of this process.
Her enthusiasm, support and
feedback were highly valued.
For statistical advice, my thanks go to Dr Rob Elton from Edinburgh University for
his interest in the project and extremely helpful and thought provoking planning
meetings. I am also highly appreciative of the advice and assistance provided by Dr
Robert Rush from Queen Margaret University.
I am indebted to the Chief Scientist Office of the Scottish Executive without whose
financial support by means of a Primary Care Research Fund grant, this project
would not have been viable.
During the planning phase of the project, meetings with many members of the
Lothian Primary Care Research Network provided thought-provoking challenges. I
am particularly grateful to Dr Brian McKinstry and Dr Lucy McLoughan for their
interest and support.
My thanks are extended to all the GP practice staff who supported the study and
gave of their valuable time.
I am also grateful to all the physiotherapists and
rehabilitation staff who supported this study and referred potential participants.
Particular mention must go to Jane Shiels for her help in arranging access to
patients and space in an extremely busy gym to enable the pilot phases of the work.
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My thanks go to Richard Wilson for his considerable technical know-how, his
assistance with providing some of the equipment for the practice regime and his
ability to ensure there was always at least one working activPAL.
I am grateful to Sasha Baggaley and Kirsteen Roscoe for their support and
organisation when working on the study.
Without them and their enthusiasm,
recruitment would have been much harder.
To all staff in the Department of Physiotherapy, I would like to record my thanks for
their unfailing support and good humour.
I am extremely grateful to all the people with stroke and their carers who participated
in this study, for their interest, their feedback and all the cups of coffee.
Lastly for love and support, above and beyond, I must record my deep appreciation
to:
mum
- for always being there
dad
- for encouraging, amongst other things, a sceptical attitude (I think you
would have enjoyed debating the merits of this work)
the girls - for your support, encouragement, humour and even childcare to enable
me to keep going
Finally, a massive thank you to the two most important people - Brendan and Joe you’ve got your mum back.
ii
TABLE OF CONTENTS
1
INTRODUCTION
1
1.1
Scene setting …………………………………………………………
1
1.2
Guidelines and Policies for Ongoing Stroke Rehabilitation in the
Community ……………………………………………………………
2
1.3
Stroke Services in the Community…………………………………..
3
1.4
The impetus for this study……………………………………………
4
1.5
Structure of the thesis ……………………………………………….
5
2
STROKE
7
2.1
Introduction ……………………………………………………………
7
2.2
Definitions………………………………………………………………
7
2.3
Aetiology of Stroke ……………………………………………………
8
2.3.1 Biophysical mechanisms of stroke ………………………………….
10
Epidemiology of Stroke ………………………………………………
12
2.4
2.4.1
Incidence …………………………………………………………
13
2.4.2
Prevalence ……………………………………………………...
16
2.5
Stroke Recovery ……………………………………………………..
17
2.5.1
Neurobiological Evidence of Stroke Recovery …………………
18
2.5.2
Prognostic Indicators of Recovery ……………………………
22
2.6
Functional Recovery Profiles ………………………………………..
24
2.7
Summary ……………………………………………………………..
26
3
STROKE REHABILITATION
28
3.1
Introduction ……………………………………………………………..
28
3.2
Physiotherapy Intervention in Acute Stroke Management ………….
30
3.3
Acute and Sub-Acute rehabilitation ……………………………………
31
3.4
Evidence to Support Physiotherapy in Late-Stage Stroke
Rehabilitation …………………………………………………………..
38
3.4.1
Studies of Mobility in Late-stage stroke ……………………………
39
3.4.2
Studies of Strengthening in Chronic Stroke ………………………
44
3.4.3
Studies of mixed strengthening, conditioning and mobility in
late-stage stroke ………………………………………………..
47
iii
3.4.4
Studies of upper limb rehabilitation in late-stage stroke ……..
56
3.5.5
Summary points from studies of later stage stroke rehabilitation
59
3.5
Services available to people with stroke following cessation of
formal rehabilitation …………………………………………………..
3.6
Summary ……………………………………………………………..
69
70
4
MOTOR LEARNING THEORY AND REHABILITATION
71
4.1
Introduction ……………………………………………………………..
71
4.2
Types of Motor Skill to be relearnt ……………………………………
73
4.2.1
Open and Closed Loop Motor Skills ……………………………….
74
4.2.2
Discrete, Serial and Continuous Skills ……………………………
74
4.2.3
Gentile’s Two-Dimensional Taxonomy of Tasks ………………..
75
Theories of Motor Learning …………………………………………..
78
4.3.1
Temporal Stages of Motor Learning …………………………….
78
4.3.2
Structural Theories of Motor Learning ……………………………..
81
4.3
How to Structure Practice ……………………………………………
86
4.4.1
Massed or Distributed Practice ………………………………….
87
4.4.2
Blocked or Random Practice …………………………………….
90
4.4.3
Variable or Constant Practice …………………………………… .
92
4.4.4
Whole or Part Practice …………………………………………….
94
4.4.5
Attentional Focus during practice …………………………………
96
4.4
Feedback ………………………………………………………………
97
4.5.1
Intrinsic Feedback …………………………………………………
98
4.5.2
Extrinsic Feedback …………………………………………………..
98
Neurophysiological Evidence relating to Motor Learning ……………
104
4.5
4.6
4.6.1
The Cerebellum and Motor Learning ……………………………..
105
4.6.2
Structural changes associated with Motor Learning …………….
109
4.7
Summary ………………………………………………………………
110
5
RATIONALE FOR STUDY
112
5.1
Introduction ……………………………………………………………..
112
5.2
Research Aims …………………………………………………………
114
5.2.1 Hypotheses ……………………………………………………………..
115
iv
6
117
6.1
DEVELOPMENT OF THE METHODOLOGY FOR A
RANDOMISED CONTROLLED TRIAL OF PHYSIOTHERAPY
FOR LATE-STAGE STROKE
Introduction …………………………………………………………….
6.2
Development of the Exercise Intervention ………………………….
117
6.2.1
6.2.2
Sample and Recruitment Procedures for the development of the 119
Exercise Intervention ………………………………………………….
Selecting and Refining the exercises …………………………………. 119
6.2.3
Pilot Exercise Procedure – in Hospital ……………………………….
120
6.2.4
Analysis of pilot exercises in hospital and impact on final pilot
protocol ………………………………………………………………….
122
6.3
117
Determining Screening Tests and Outcome Measures to be used in
the final protocol ………………………………………………………..
124
6.3.1
The Mini Mental State Examination ………………………………
124
6.3.2
The Functional Reach Test ………………………………………..
126
6.3.3
Mixed Measures of Impairment and Activity Limitation ………….
128
6.3.3.1
The Rivermead Motor Assessment ………………………………
128
6.3.3.2
The Motor Assessment Scale ……………………………………
129
6.3.3.3
Piloting the Rivermead Motor Assessment and the Motor
Assessment Scale …………………………………………………
132
6.3.3.4
The Frenchay Arm Test ……………………………………………
132
6.3.4
Global Measures of Activity Limitation …………………………….
133
6.3.4.1
The Barthel Index …………………………………………………….
133
6.3.4.2
Piloting the Barthel Index……………………………………………
135
6.3.4.3
The Frenchay Activites Index ………………………………………
136
6.3.5
Measuring Aspects of Mobility and Balance ………………………
138
6.3.5.1
The Timed Up and Go ……………………………………………….
138
6.3.5.2
Familiarisation with timing the Timed Up and Go
139
6.3.5.3
The Step Test ………………………………………………………
139
Measuring Aspects of Mood
141
The Hospital Anxiety and Depression Scale ……………………
141
Measuring Quality of Life ………………………………………….
142
6.3.7.1
The Stroke Impact Scale ……………………………………………
143
6.3.7.2
The Stroke Specific Quality of Life Scale ……………………….
144
6.3.6
6.3.7
v
6.3.7.3
Comparisions between the Stroke Impact Scale and the Stroke 145
Specific Quality of Life Scale ………………………………………
6.3.7.4
6.3.8
Piloting the Stroke Impact Scale and the Stroke Specific Quality
of Life Scale ………………………………………………………..
146
The final Selection of Outcome Measures ……………………….
147
6.4
Pilot of Exercise Intervention and Outcome Measures in the
Community ………………………………………………………………. 148
6.4.1
Methodology of Community pilot of exercise intervention ……..
149
6.4.2
Results of community pilot exercise intervention ……………….
151
6.4.2.1
Number of repetitions for each exercise …………………………
152
6.4.2.2
Baseline to end of intervention outcome measure data ………..
155
6.4.3
Summary of key findings from community pilot …………………..
160
Testing the ActivPAL ……………………………………………………
163
6.5
6.5.1
Methodology for establishing the agreement of activPAL and
video data at different walking speeds ……………………………. 166
6.5.2
Results for agreement between activPAL and video data at
different walking speeds …………………………………………..
6.6
6.6.1
167
Establishing Concurrent Validity of a modified Timed Up and Go
test over two metres ……………………………………………………
169
Methodology of a pilot study investigating concurrent validity of
a modified Timed Up and Go test over two metres …………….
170
6.6.2
Results of the pilot of the Timed Up and Go …………………….
171
6.6.3
Summary of findings from Timed Up and Go pilot ………………
176
6.7
Summary ……………………………………………………………….
177
7.0
METHODOLOGY
179
7.1
Introduction ………………………………………………………………
179
7.2
Trial Design Overview ………………………………………………….
179
7.3
Subject Populations …………………………………………………….
181
7.3.1
Inclusion Criteria ……………………………………………………
182
7.3.2.
Exclusion criteria ……………………………………………………
182
7.4
Recruitment ……………………………………………………………
182
7.4.1
Initial recruitment strategy …………………………………………
184
7.4.2
Recruitment Strategy v2 ……………………………………………
188
7.4.3
Recruitment strategy v3 …………………………………………..
189
vi
7.4.4
Recruitment strategy v4 ………………………………………….
190
7.4.5
Consent ……………………………………………………………
191
7.5
Outcome Measure procedures ………………………………………
191
7.6
Randomisation ………………………………………………………..
195
7.7
Procedures …………………………………………………………….
195
7.7.1
Baseline Outcome Measures visits ………………………………..
196
7.7.2.
Intervention Visit 1 ………………………………………………..
197
7.7.3
Intervention Visit 2 ………………………………………………….
198
7.7.4
Intervention Visits 3 and 4 …………………………………………
199
7.8
Data Analysis …………………………………………………………..
199
8.0
RESULTS
202
8.1
Introduction ……………………………………………………………..
202
8.2.
Subject characteristics …………………………………………………
202
8.3
Drop Outs and Missing Data ………………………………………….
204
8.3.1.
Drop Outs …………………………………………………………..
205
8.3.2
Missing Data ………………………………………………………..
206
Global Measures of Impairment, Activity and Participation ………..
207
8.4
8.4.1
The Barthel Index (BI) – descriptive data ……………………....
207
8.4.2
Frenchay Activity Index (FAI) …………………………………....
211
8.4.3
Motor Assessment Scale (MAS) ……………………………………
215
Measures of Mobility ……………………………………………………
219
8.5.1
Timed Up and GO over 2 metres (TUG2m) ………………………
219
8.5.2
The Step Test ……………………………………………………..
225
8.5
8.6.
8.6.1
8.7
8.7.1
8.8
Measures of arm and hand function ………………………………….
230
The Frenchay Arm Test (FAT) ……………………………………
230
Measures of Mood ……………………………………………………..
234
The Hospital Anxiety and Depression Scale (HADS) ……………
Measure of Health Status ……………………………………………..
234
238
8.8.1
The Stroke Impact Scale descriptive data ………………………..
238
8.8.2
The Stroke Impact Scale – Strength (SIS-str) …………………….
239
8.8.3
The Stroke Impact Scale – Memory (SIS-mem) …………………
241
8.8.4
The Stroke Impact Scale – Mood (SIS-mood) …………………..
243
8.8.5
The Stroke Impact Scale – Communication (SIS-comm) ………
246
vii
8.8.6
The Stroke Impact Scale – Activities of Daily Living (SIS-ADL) ...
248
8.8.7
The Stroke Impact Scale – Mobility (SIS-mob) ………………….
250
8.8.8
The Stroke Impact Scale – Hand (SIS-hnd) …………………….
252
8.8.9
The Stroke Impact Scale – Participation (SIS-partic) …………….
254
8.8.10
The Stroke Impact Scale – Recovery visual analogue scale
(SIS-VAS) ……………………………………………………………
257
8.9
Exercise Repetitions …………………………………………………..
260
8.10
Monitoring Activity ………………………………………………………..
262
8.11
Summary of Findings ……………………………………………………
265
9.0
DISCUSSION
269
9.1
Introduction ……………………………………………………………..
269
9.2
Sample Characteristics ………………………………………………..
271
9.3
Discussion of Global Measures of Impairment, Activity, Participation
273
9.3.1
Barthel Index ………………………………………………………….
273
9.3.2
The Motor Assessment Scale ………………………………………
276
9.3.3
The Frenchay Activity Index ……………………………………….
279
Discussion of Mobility Outcomes ……………………………………..
280
9.4.1
The Timed Up and Go over 2 metres ……………………………
280
9.4.2
Gait Speed ………………………………………………………….
281
9.4.3
Stepping Up …………………………………………………………
283
9.4.4
Rising to Stand ……………………………………………………..
284
Measures of Arm Function …………………………………………….
285
The Frenchay Arm Test ……………………………………………
285
Discussion of Measurement of Mood …………………………………
286
The Hospital Anxiety and Depression Scale ……………………..
286
Discussion of Health Status ……………………………………………
288
The Stroke Impact Scale Domains ………………………………..
288
9.4
9.5
9.5.1
9.6
9.6.1
9.7
9.7.1
9.8
The Practice Regime …………………………………………………..
291
9.9
Sample Measurement of Activity ………………………………………
294
9.10
Possible explanations for changes in outcomes ……………………
296
9.11
Limitations and Sources of Error ……………………………………..
298
9.11.1
Study Design………………………………………………………..
299
9.11.2
Recruitment Strategy ………………………………………………
301
viii
9.11.3
The Sample …………………………………………………………
302
9.11.4
The Intervention ……………………………………………………
303
9.11.5
Outcome Measurement ……………………………………………
306
9.12
Clinical Implications ……………………………………………………
309
9.13
Future Research ………………………………………………………
311
9.14
Conclusions ……………………………………………………………
316
REFERENCES ………………………………………………………..
320
APPENDICES
355
I
Pilot information sheet and Pilot Consent form
II
Pilot exercise sheets ……………………………
III
Prompts for Barthel Index ……………………..
IV
Raw data for TUG pilot ………………………..
V
Data for pilot Outcome measures: …………….

TUG

Motor Assessment Scale

The Step Test

Frenchay Arm Test

Barthel Index
VI
ActivPAL guide and example data …………….
VII
Pilot exercise repetitions ………………………..
VIII
Final RCT Information sheet and ……………..
Final RCT consent form
IX
Randomisation list ……………………………….
ix
X
DATA
Xa

Barthel Index
Xb

Frenchay Activities Index
Xc

Xd

Timed Up and Go
Xe

Step Test
Xf

Frenchay Arm Test
Xg

Hospital Anxiety and Depression
Xh

Stroke Impact Scale
Xi

Exercise Repetitions
Xj

ActivPAL data
XI
x
LIST OF FIGURES
Figure 2.1
Age specific stroke incidence rates per 100,000 population
from three centres in Europe ……………………………………
14
Figure 2.2
Stroke Incidence in Scotland 2000-2009……………………….
16
Figure 3.1
Notional Stroke Rehabilitation matrix …………………………
29
Figure 4.1
General structural organisation of cerebellum ……………….
106
Figure 4.2
Synaptic organisation of cerebellar circuitry showing
excitatory and inhibitory circuits …………………………….
Figure 6.1
Flow diagram of the stages of development ……………….
Figure 6.2
Line graph of weekly total Rise to stand repetitions by pilot
participants ………………………………………………………
Figure 6.3
Figure 6.4
Figure 6.5
Line graph of weekly total Stepping Up with the unaffected
leg repetitions by pilot participants ……………………………
Line graph of weekly total of Cuppa time exercise repetitions
by pilot participants ……………………………………………..
Line graph of weekly total of TipTap exercise repetitions by
pilot participants ……………………………………………..
107
118
152
153
154
155
Figure 6.6
Pilot Motor Assessment Scale pre- post intervention scores
156
Figure 6.7
Pilot Timed Up and Go pre- post intervention scores
157
Figure 6.8
Pilot Rise to stand time pre- post intervention scores
158
Figure 6.9
Pilot Step Test data - stepping up with the unaffected leg prepost intervention scores …………………………………………
159
Figure 6.10
Pilot Frenchay Arm Test data pre- post intervention scores
159
Figure 6.11
Placement of ActivPAL ………………………………………..
164
Figure 6.12
Bland and Altman plot of agreement between step counts
xi
recorded by activPAL and video at 2.5km/h ………………
Figure 6.13
Figure 6.14
Figure 6.15
Figure 6.16
Figure 6.17
recorded by activPAL and video at 5km/h ………………
recorded by activPAL and video at 7.5km/h ………………
Bland and Altman plot of gait velocity for Timed Up and Go
performed over 2metres (TUG2m) or 3 metres (TUG 3m)…
Bland and Altman plot of turn times for Timed Up and Go
performed over 2metres (TUG2m) or 3 metres (TUG 3m)…
168
168
169
173
174
Bland and Altman plot of the number of steps taken during
turning for Timed Up and Go performed over 2metres
(TUG2m) or 3 metres (TUG 3m)…………………………….
175
Figure 7.1:
Map of North East Edinburgh LHCC ………………………..
185
Figure 7.2
Flow Diagram of Trial Design ……………………………….
194
Figure 8.1
Consort Diagram ……………………………………………..
195
Figure 8.2
Box plot of scores on Barthel Index ……………………….
209
Figure 8.3
Box plot of Frenchay Activity Index scores ……………….
213
Figure 8.4
Box plot of Motor Assessment Scale total scores ………
216
Figure 8.5a
Box plot of Timed Up and Go 2m total time ……………….
221
Figure 8.5b
Box plot of Timed Up and Go 2m gait speed ……………….
222
Figure 8.5c
Box plot of Rise to Stand time during TUG2m ……………….
222
Figure 8.6a
Box plot of Step Test - number of steps onto block with
unaffected leg ……………………………….……………….
Figure 8.6b
Box plot of Step Test - number of steps onto block with
affected leg ……………………………….……………….
xii
227
228
Figure 8.7
Box plot of Frenchay Arm Test scores ……………………….
Figure 8.8a
Box plot of Hospital Anxiety and Depression Scale - Anxiety
subscale ………………………………………. ……………….
Figure 8.8b
Box plot of Hospital Anxiety and Depression Scale Depression subscale …………………………… ……………….
232
235
236
Figure 8.9
Boxplot for Stroke Impact Scale - strength domain …………..
240
Figure 8.10
Boxplot for Stroke Impact Scale - memory domain ………….
242
Figure 8.11
Boxplot for Stroke Impact Scale - mood domain …………..
244
Figure 8.12
Boxplot for Stroke Impact Scale - communication domain
247
Figure 8.13
Boxplot for Stroke Impact Scale - ADL domain …………..
249
Figure 8.14
Boxplot for Stroke Impact Scale - mobility domain …………..
251
Figure 8.15
Boxplot for Stroke Impact Scale - hand domain …………..
254
Figure 8.16
Boxplot for Stroke Impact Scale - participation domain …
256
Figure 8.17
Boxplot for Stroke Impact Scale - Recovery VAS…………
259
Figure 8.18
Percentage of time spent in specific position or activity………
263
Figure 8.19
Number of sit to stand transitions undertaken during a single
day…………………………………………………………….…
Figure 8.20
Number of steps undertaken during a single day………
xiii
264
264
LIST OF TABLES
Table 3.1
Summary of studies of community based exercise
programmes for people with late-stage stroke ………………… 62
Table 4.1
Gentile's taxonomy of skills ………………………………………
77
Table 6.1
Exercises attempted during development of the intervention ..
121
Table 6.2
Screening tests and outcome measures to be used in the
definitive trial ……………………………………………………..
148
Table 6.3
Characteristics of Community pilot participants ……………….
149
Table 6.4
Timed Up and Go pilot study - subject characteristics ………..
171
Table 6.5
Timed Up and go pilot study - summary of gait parameters
and components of Timed Up and Go ………………………….
172
Table 6.6
Test - retest relaibility of TUG2m over one week …………
176
Table 7.1.
Schedule of outcome measure visits
193
Table 8.1
Subject characteristics …………………………………………..
202
Table 8.2
Reasons for drop out following recruitment to the study ……..
204
Table 8.3
Summary of valid and missing data points for all outcome
measures at eacn measurement timepoint ………………….
206
Table 8.4
Descriptive data for Barthel index scores ……………………
208
Table 8.5
Descriptive data for Frenchay Activity index scores ………
212
Table 8.6
Descriptive data for the Motor Assessment Scale total scores
215
Table 8.7
Descriptive data for Timed Up and Go 2m components ……
220
Table 8.8
Medians and interquartile ranges for number of steps on The
Step Test ………………………………………………...
226
Table 8.9
Descriptive data for the Frenchay Arm Test …………………..
231
Table 8.10
Descriptive data for the Hospital Anxiety and Depression
Scale ………………………………………………………………
235
Medians and interquartile ranges for the Stroke Impact Scale
- strength domain ………………………………………...
239
- memory domain ………………………………………...
242
- mood domain ………………………………………...
244
- communication domain ………………………………………...
246
- ADL domain ………………………………………...
248
Table 8.11
Table 8.12
Table 8.13
Table 8.14
Table 8.15
Table 8.16
xiv
-mobility domain ………………………………………...
251
- hand domain ………………………………………...
253
- participation domain ………………………………………...
255
- VAS of recovery.. ………………………………………...
258
Table 8.20
Summary of Exercise Repetitions undertaken by participants
261
Table 8.21
Summary of descriptive data of activity undertaken during a
single day ………………………………………………………..
262
Table 8.17
Table 8.18
Table 8.19
xv
1. INTRODUCTION
1.1
Scene setting
“The impact of a stroke may continue for as long as the person who has had
the stroke lives, which means that services may need to be available for the
whole of their life”. (Department of Health, 2007 p38).
Every year 15 million people in the world suffer a stroke (Mackay and Mensah
2004). The burden of stroke is considerable, it is reported as the third highest cause
of death in the Western world (EUSI 2003) and the leading cause of adult disability
(Khaw, 1996: Warlow 1998, Mackay and Mensah, 2004).
Stroke is generally
considered a disease of older people although it can occur at any age. In Scotland,
there has been a reduction in stroke related mortality over the decade 1999 – 2008
(ISD 2009). With an increasingly aging population however, it is likely that the
prevalence of people living with chronic stroke related disability will increase
(Truelsen et al 2006).
Due to the on-going nature of post-stroke disability, the
condition of stroke requires extensive resources for management and treatment. It
has been reported that stroke accounts for around 4-6% of the annual National
Health Service (NHS) budget, which equates to an estimated direct cost of £2.8
billion (National Audit Office, 2005). It has been recognised that while in-patient
stroke services have improved markedly over the recent past, services in the
community setting to support people with stroke need to be reviewed and improved
(Outpatient Services Trialists, 2004; The Stroke Association, 2010). Furthermore,
once an individual returns to the community setting there can sometimes be a
deterioration in functional ability as the challenges to the individual can be
multifaceted and complex compared to the relatively safe and controlled
environment within the hospital setting (Outpatient Services Trialists, 2004).
In the first four weeks following stroke, approximately 20% of people will die, around
30% will make a full recovery, leaving around 50% of stroke survivors with residual
1
Chapter 1
Introduction
significant disability (Langton Hewer et al 1993; Hacke et al, 2000; Hardie et al,
2004). The nature and extent of symptoms following stroke depend on the location
and size of the area of brain affected by the stroke event, with the result that people
with stroke can present with a vast array of symptoms. The most common sequalae
include impairments of motor and sensory functions associated with hemiplegia,
cognitive and perceptual disturbance, bladder and bowel dysfunction and disorders
of communication and mood. For comprehensive consideration of these issues the
reader is referred to relevant texts such as Carr and Shepherd (2003); Stokes
(2004), and Barnes et al (2005). The rehabilitation of people with stroke is therefore
challenging as any of the symptoms can have an ongoing and extensive impact on
broad domains of functioning such as work, leisure and social integration.
The management of neurological disability places much reliance on rehabilitation.
The therapist has a multitude of therapeutic techniques available for reducing
impairment (Ward 2005). Many therapeutic interventions however, are poorly
defined and do not necessarily have an explicit theoretical underpinning. In order to
advance practice therefore, physiotherapists working in stroke rehabilitation are
currently faced by the challenges of defining and undertaking evaluation of complex
interventions (Pomeroy and Tallis 2002).
1.2
Guidelines and Policies for Ongoing Stroke Rehabilitation in the
Community
In the past decade, a number of guidelines and strategies have been developed in the
UK in order to improve stroke care.
For people with late-stage stroke, recent
recommendations from guideline development bodies in England and Scotland identify
2
Chapter 1
Introduction
the need for ongoing access to specialist services. The most recent guidelines from
the Scottish Intercollegiate Guidelines Network (SIGN) state:
“Stroke patients in the community should have access to specialist therapybased rehabilitation services.” (SIGN 2010, p52).
A recent survey of stroke survivors found that 21% felt they required further
community based physiotherapy but were not able to access this service from the
NHS (Stroke Association, 2010). While the National Stroke Strategy (Department of
Health 2007) recommended that people with stroke should be able to access skilled
stroke services for “as long as they need it”, resources are not finite. This means
that physiotherapists working in stroke rehabilitation need to consider how to provide
ongoing practice and rehabilitation to enable people with late-stage stroke to
maintain improvements in function. One method of providing ongoing practice that
has demonstrated effectiveness is the use of exercise classes (Marigold et al 2005;
Mead et al, 2007). Not all people with stroke however are able to access class
based activities, therefore physiotherapists also need to consider how to develop
effective methods of self practice strategies of functional tasks in other community
settings such as the home environment.
1.3
Stroke Services in the Community
One of the major aims for the physiotherapist working in stroke rehabilitation is to
provide an environment in which the person with stroke can undertake exercise to
maximise their potential physical ability and functional independence.
It is well
documented that better stroke outcomes are associated with more rehabilitation
(Langhorne et al, 1996; Kwakkel, 2006).
During the in-patient phase of stroke
rehabilitation however, it has been well documented that people with stroke spend
much of their day alone and inactive, with less than 15% of waking hours being
3
Chapter 1
Introduction
engaged in rehabilitation or physical practice of functional activities (Newall et al
1997; Bernhardt et al 2004). It is not clear how active people with stroke are once
living in the community.
In England and Wales, access to specialist stroke rehabilitation provision for longer
term management in the community is available for 55% of people with stroke
(Intercollegiate Stroke Working Party, 2010).
62% of people with stroke may
however, wait more than two weeks to access these services (The Stroke
Association 2010). In 2010 there is recognition of the pressing need to improve
stroke services in the community in the United Kingdom (UK) (The Stroke
Association 2010). At the time of planning the study reported in this thesis however,
the need to provide ongoing management and services for people with late-stage
stroke did not appear to be a high priority.
1.4
The impetus for this study
Since the 1990’s there has been a growing interest, and growing body of evidence,
relating to the effectiveness of “task specific practice” in neurological rehabilitation
(for example Dean and Shepherd, 1997; Page, 2003; Sullivan et al, 2007). It is not
clear exactly what is meant by task specific practice – but in its’ simplest terms it
refers to training specifically for a task. Carr and Shepherd (1998) have stated that
when considering whether to structure exercise training as whole or part practice
that:
“the action should be practised in its entirety, particularly when one part of
the action is to a large part dependent on the performance of a preceding
part” (Carr and Shepherd 1998, p37).
In subsequent work, reference to whole practice is made as analogous to task
specific practice (Carr and Shepherd 2003).
Conversely, Shumway Cook and
4
Chapter 1
Introduction
Woollacott (2001) suggested that part-practice can be an effective way to retrain
some tasks. From experience of neurological rehabilitation, physiotherapists often
structure practice sessions so that component parts of a movement that are difficult
for an individual are practised repetitively but separately to the whole movement.
Referring to Motor Learning texts to gain a definitive answer as to whether to
structure exercise sessions for people with stroke as whole or part
practice, it
became apparent that the recommendations to adopt whole practice or part practice
was derived from healthy populations, not from people with neurological
impairments.
The focus of this thesis is on how to structure practice to re-learn functional tasks for
community dwelling people with late-stage stroke. The aspiration at the start of this
research journey was to add, in a small way, to the body of knowledge in this area.
1.5
Structure of the thesis
This thesis reports the findings from a randomised controlled trial (RCT) of a homebased exercise programme for people with late-stage stroke.
The exercise
programme was based on Motor Learning principles for how to structure task
practice.
The literature review in the ensuing chapters provides consideration of three areas
of literature. Firstly, in chapter two, an overview of the nature of stroke and poststroke recovery mechanisms is presented.
An exploration of the process of Stroke Rehabilitation is presented in chapter three.
A longitudinal perspective is used to consider the management focus at various
time-points after stroke.
The main focus of chapter three however is a critical
5
Chapter 1
Introduction
consideration of the evidence surrounding physiotherapy rehabilitation strategies for
people late after stroke.
This review is limited to interventions conducted for
community dwelling individuals with late-stage stroke. Furthermore consideration of
evidence was restricted to interventions that did not require extensive technical
support or expensive equipment, such as Treadmill Training, as this was not felt to
be a viable rehabilitation option within the home setting.
Chapter four considers literature surrounding Motor Learning and the reacquisition
of skill following stroke. As will be seen, the majority of the theory underpinning
learning of motor skills was developed by sports scientists, exercise scientists and
psychologists. Therapists, psychologists and movement scientists working in
neurological rehabilitation have applied the recommendations from the Motor
Learning literature to the rehabilitation process and a consideration of the relevance
of this has been provided.
The rationale for the study and the aims are put forward in chapter five to
contextualise the work presented in chapter six.
The development of the
methodology for the definitive trial is reported in chapter six.
This work was
exploratory in nature and consisted of pilot work undertaken in an out-patient setting
as well as a small pilot of the potential methodology carried out in the community.
Findings from the development phase informed the definitive RCT.
The
methodology for the RCT is reported in chapter seven and the results are presented
in chapter eight. The final chapter critically considers the findings from the RCT,
relates these findings to previous work, critiques the limitations of the RCT and
considers how the current study fits with Motor Learning theory. Finally suggestions
for how the work can be taken forward are presented.
6
Chapter 1
Introduction
2. STROKE
2.1 Introduction
This chapter provides definitions and an overview of the nature of stroke, providing a
summary of epidemiology and aetiology. A more in-depth consideration of stroke
recovery and management will be provided with an emphasis on sub-acute and
chronic stroke.
2.2 Definitions
The World Health Organisation (WHO) defines stroke as:
“a clinical syndrome characterised by rapidly developing clinical symptoms
and / or signs of focal and at times global … loss of cerebral function with
symptoms lasting more than 24 hours or leading to death, with no other
apparent cause other than that of vascular origin”
(Aho et al 1980).
Stroke was traditionally considered as distinct from a threatened stroke or Transient
Ischaemic Attack (TIA), with TIA being considered as a cerebral ischaemic event of
less than 24 hours duration (Hankey et al 1993). The definition of a TIA has recently
been updated as: “a transient episode of neurological dysfunction caused by focal
brain, spinal cord, or retinal ischemia, without acute infarction.” (Easton et al, 2009 p
2276). It has been highlighted that TIA should be considered as part of the
continuum of stroke, with both conditions being indicative of disturbances to cerebral
circulation and increased risk of disability and morbidity (Easton et al, 2009). A
further manifestation of cerebrovascular attack, again not recorded as stroke, is
Reversible Ischaemic Neurological Deficit (RIND) whereby symptoms resolve
completely within 21 days (Warlow et al 2001).
7
Chapter 2
Stroke
Stroke is a recovering neurological condition. In the initial hours following the acute
event, the severity of symptoms will become apparent. In the aftermath of stroke,
recovery will occur to some extent, although around 50% of stroke survivors are left
with varying degrees of disability (Langton Hewer et al 1993; Hacke et al, 2000).
Stroke is not a homogeneous entity, discrete signs and symptoms are apparent
depending on the site and size of lesion and this is discussed further in 2.3.
2.3 Aetiology of Stroke
The term “stroke” covers a broad diagnostic range and refers to dysfunction in the
blood supply to an area of the brain (Effective Health Care 1992; SIGN 2010).
Normal brain function requires an adequate supply of arterial blood to provide
nutrition and oxygen as well as an efficient venous system to remove cellular waste
products (Siegel and Sapru, 2006). The site and extent of the brain damage caused
by a stroke contribute to the subsequent neurological deficits. Depending on the
severity of the disruption to the cerebral blood supply, the person with stroke will
experience a variety of impairments or loss of brain function, which may result in
permanent impairment of function, restricted ability to conduct every day activities,
and in severe cases, death.
There are a number of different causes of stroke.
The most well documented
mechanisms of stroke are of either an occlusion within the cranial blood supply
(ischaemic stroke – either due to embolus or thrombus) or due to a rupture of blood
vessels (haemorrhagic stoke). Ischaemia is reported to account for approximately
80% of Stroke cases (Sudlow & Warlow 1997; Syme et al 2005). The most common
cause of ischaemic stroke is occlusion of one of the major cerebral arteries; in
8
Chapter 2
Stroke
descending order of frequency these are Middle Cerebral Artery (MCA), Posterior
Cerebral Artery (PCA), or Anterior Cerebral Artery (ACA) respectively. The main artery
is not always affected, other common sites are their smaller perforating branches to
deeper parts of the brain. Brainstem strokes, arising from disease in the vertebral and
basilar arteries, are less common.
Approximately a further 10% of strokes are
reported to be due to Primary Intracerebral Haemorrhage (PICH), 5% due to Subarachnoid Haemorrhage (SAH) and in a further 5% of cases, the cause is uncertain
(Sudlow & Warlow 1997).
Primary Intracerebral Haemorrhage into the deeper parts of the brain usually occurs
in older, hypertensive people. PICH is often associated with a particular type of
degeneration, known as lipohyalinosis or fibrohyalinosis, which results in necrotic
lesions in the small penetrating arteries of the brain. The arterial walls weaken, are
replaced by collagen, the wall thickens and the lumen narrows and it is thought that
microaneurysms develop. These may rupture and lead to lacunar infarcts or small
deep haemorrhages. The resultant haematoma may spread by splitting planes of
white matter to form a substantial mass lesion. Haematomas usually occur in the
deeper parts of the brain, often involving the thalamus, lentiform nucleus and
external capsule, and less often, the cerebellum and the pons.
Sub-Arachnoid Haemorrhage (SAH) involves bleeding into the subarachnoid space,
usually arising from rupture of an aneurysm situated at or near the circle of Willis.
The most common site is in the region of the anterior communicating artery, with
PCA and MCA locations almost as frequent. Congenital factors play some part in
the aetiology of berry aneurysms in a younger population, but SAH is not
9
Chapter 2
Stroke
predominantly a disease of the young. Hypertension and vascular disease lead to
an increase in aneurysm size and subsequent rupture.
In a small number of patients, stroke may occur due to general medical disorders which
affects either the arteries or the blood going through them e.g. arteritis, the collagen
vascular diseases such as systemic lupus erythematosus and polyarteritis nodosa,
bacterial endocarditis, mitral valve prolapse and haematological diseases such as
thrombocythaemia and sickle cell disease have all been reported as causes of
stroke (Baer and Durward 2004).
2.3.1
Biophysical mechanisms of stroke
Hademenos and Massoud (1997) have reported the biophysical mechanisms of
stroke, stating that there are six distinct processes as identified below:
Atherosclerosis
Calcified fatty deposits or plaques are laid down circumferentially on the
intimal layer of blood vessel walls. As the process advances, blood vessel
walls become thicker, irregular, fibrosed and calcified leading to a reduced
and more turbulent blood flow.
Atherosclerotic processes promote
thrombosis, partly due to flow obstruction and partly to high shear stresses
on the vessel walls. Atherosclerotic blood vessels are at risk of displacement
of small plaques which subsequently may lodge in smaller blood vessels
resulting
in
ischaemia.
Atherosclerotic
thrombosis
accounts
for
approximately 33% of all stroke cases (Hademenos and Massoud, 1997).
Embolus
10
Chapter 2
Stroke
An embolus is a foreign body such as a blood clot, a bubble of oxygen or a fragment
of tissue that circulates through the blood stream until it gets lodged in a blood
vessel. Emboli can originate from blood vessels themselves as well as organs such
as the heart or lungs. In this condition, small particles of gas or solid matter become
“travelling clots” e.g. a collection of platelets dislodged from an atherosclerotic
lesion. The embolus circulates until reaching a smaller blood vessel that it blocks
with ensuing ischaemia. Emboli are thought to be responsible for approximately
31% of all strokes (Hademenos and Massoud, 1997).
Thrombus
A thrombus is a fibrinous clot formed due to atherosclerosis or blood vessel
damage. Blood vessel injury and disruption to the intimal lining of the vessels are
thought to be aggravating factors in thrombus formation. Approximately 33% of
ischaemic strokes are caused by thrombus (Hademenos and Massoud, 1997).
Reduced Systemic Pressure
In the three mechanisms described above, it is thought that the heart functions
under normal systemic pressure. In cases of cardiovascular disease such as atrial
fibrillation, cardiac muscle becomes weakened, abnormal heartbeats can occur
resulting in reduced systemic pressure and ischaemia (Hademenos and Massoud,
1997).
Haemorrhage
During haemorrhagic stroke events, cerebral blood vessels rupture resulting in blood
seeping into surrounding brain tissue and ultimately increasing the pressure on
surrounding tissue, reduced vessel diameter and a reduction in blood flow through
the vessel. The two main causes of haemorrhage are aneurysm (ballooning of the
blood vessel wall) which may rupture to cause a bleed, and arteriovenous
malformations (AVM) which is a congenital lesion due to inappropriate capillary
11
Chapter 2
Stroke
development, resulting in a tangled mass of weakened blood vessels between
arterial and venous systems (Hademenos and Massoud, 1997).
Vasospasm
Cerebral vasospasm occurs in arteries in the subarachnoid space following a
subarachnoid haemorrhage (SAH). Vasospasm can last for hours to days,
causes reduced blood flow and subsequent cerebral ischaemia. Vasospasm
is maximal between five and ten days after SAH, but the damage to
surrounding tissue may be minimised with judicious use of vasodilators
(Hademenos and Massoud, 1997).
The biophysical mechanisms briefly described above may contribute solely or in
combination to the cause of stroke.
Recent advances in the medical and
pharmaceutical treatment of stroke are, in part, based on an increasing
understanding of the underlying biophysical mechanisms.
2.4 Epidemiology of Stroke
There have been many epidemiological studies in stroke throughout the world, with
an increasing number of published studies in the past 25 years as medical interest
in the management of stroke gains more attention. Epidemiological studies may
access data regarding incidence, prevalence and mortality in a number of ways.
The validity of some forms of data provision has been questioned, for example
mortality rates may vary regionally depending on disease coding practices
(Thorvaldsen et al, 1995). The use of Stroke Registers has improved the validity of
data available, improving consensus on disease coding and a more systematic
manner of recording stroke events (Thorvaldsen et al, 1995). Criteria for recording
12
Chapter 2
Stroke
incidence and mortality include using standard definitions of stroke with at least 80%
of cases verified by scan, standard methods for data collection and standard
methods for reporting (Feigin and vander Hoorn 2004). These quality criteria should
result in improved validity of stroke epidemiological data in the twenty first century.
2.4.1
Incidence
Incidence of stroke can be defined as the first-ever cases of stroke occurring in a
given population over a defined time period (Warlow et al 2001).
There can be
difficulties in identifying all patients with stroke as most stroke registers tend to be
hospital based (Bamford et al, 1988) and yet not all stroke patients are admitted or
referred to hospital. Studies in the United Kingdom towards the end of the 20 th
century estimated that hospital admission varied from 55% (Bamford et al, 1988) to
78% (Wolfe et al, 1993). In Scotland, in the 12 months up to end of March 2009,
there were around 16,700 hospital admissions for stroke (ISD, 2009).
The Oxford Community Stroke Project (OCSP) was the first comprehensive,
prospective epidemiological study conducted in the 1980’s (Bamford et al 1988). A
population of over 105,000 attending 49 General Practices were meticulously
followed by the study team, if stroke was suspected, during a four year period.
Stroke was confirmed by computer tomographic scan (CT scan) and clinical
assessment. 675 first ever strokes were recorded during this time, equating to an
incidence of 200:100,000. The OCSP highlighted an increasing incidence of stroke
with increasing age (Bamford et al 1988) and this finding has been replicated by
many other studies (for example Sudlow and Warlow, 1997; Wolfe et al, 2000) with
13
Chapter 2
Stroke
reports of a relatively low incidence up until the age of around mid 50’s followed by a
sharp increase in the 65-74 year age groups and beyond.
Age
Wolfe, C. D.A. et al. Stroke 2000;31:2074-2079
Figure 2.1 Age specific stroke incidence rates per 100,000 population from
three centres in Europe
In the Western World, in the latter part of the twentieth century, incidence rates for
stroke were generally cited at around 2:1,000 (Bamford 1988). There are variations
in worldwide reported incidence of stroke. The MONICA (Monitoring Trends and
Determinants in Cardiovascular Disease) study followed populations in 16 European
and two Asian populations between 1985 and 1987. 13,597 stroke events were
14
Chapter 2
Stroke
registered in a total background population of 2.9 million people aged 35 to 64
years, which is towards the younger end of the stroke population. Age-standardised
stroke incidence rates were reported as between 1–2.85:1,000 in men and from 0.5–
1.98: 1,000 in women. The MONICA study also found a higher incidence of stroke in
eastern European populations compared to western Europeans (Thorvaldsen et al
1995).
More recently, Wolfe et al (2000) gathered incidence figures over a three
year period from Dijon, France; Erlangen in Germany and London UK and found
that Dijon had the lowest age-standardised incidence rates at 100.4:100,000,
followed by London 123.9:100,000 and Erlangen 136.4:100,000.
Statistically
significant differences in survival rates were also reported with a 35% fatality rate
overall, which was more discretely reported as 27% Dijon, 34% Erlangen, and 41%
London, (p<0.001).
With improved acute medical management of stroke and more systematic gathering
of incidence data however, the incidence of stroke is declining. In Oxford, in 2004,
the age-specific incidence of stroke had fallen 40%, compared to 1988 data, to an
incidence of 0.71: 1,000 (Rothwell et al, 2004).
In Scotland, a community based
study of incidence rates for the population of the Scottish Borders region between
1998-2000 reported an incidence rate for first ever Cerebral Infarctions of 1.97:1,000
and first ever Cerebral Haemmorhage of 0.24:1,000. (Syme et al, 2005). This was
comparable to national data at the time, however incidence rates are declining with
2008-09 reports of an average incidence rate in Scotland of
100,00 (ISD, 2009).
just under 169.1:
The National Scottish Stroke Audit claims estimates of
approximately 15,000 people in Scotland suffer a stroke each year. Hospital care
for Stroke patients accounts for 7% of all NHS beds and 5% of the entire NHS
budget (ISD, 2010).
15
Chapter 2
Stroke
Age-Sex Standardised (European Standard Population) Incidence rate per 100,000 population
300
250
200
150
100
50
0
2000
2001
2002
2003
2004
2005
Males
2006
Females
2007
2008
2009
Both Sexes
(Information Services Division, 2009)
Figure 2.2 Stroke Incidence in Scotland 2000 – 2009.
In conclusion, while it is apparent that there is a reduction in the incidence of stroke,
the incidence of stroke remains high in older people. The most recent figures in
Scotland indicate an incidence rate of 1,761: 100,000 population in people aged
over 75 years (ISD, 2009). With stroke being the major cause of disability in adults,
the implications of these data, are that it is likely that more people with stroke will be
living in the community as the demographic trend of an increasingly aging
population is fulfilled.
2.4.2
Prevalence
Prevalence refers to the number of people with a defined condition and who are
alive within a set population at a certain point in time. It can be argued that
16
Chapter 2
Stroke
prevalence data are more important in planning long-term services for stroke than
incidence data (Hare et al, 2006), although this argument has been disputed by
Warlow et al (2001) who point out that both the co-existing degree of activity
limitation and participation restriction as well as pre-morbid conditions impact more
realistically on the need for on-going long-term services.
Further problems with using stroke prevalence data includes the fact that severely
disabled people who die soon after their stroke may not be represented (despite
representing a considerable burden to services) and retrospective studies may be
confounded by mortality statistics obtained from death certificates that may not cite
stroke as a condition or cause of death.
One relatively recent study that has been
conducted in a robust manner is the Copenhagen study which cites prevalence
rates of 3-6:1,000 (Jørgenson et al 1995).
To put these data into perspective,
approximately 18 – 36 people with stroke would be registered in an average General
Practitioner (GP) practice of around 6,000 people.
In 1999 - 2000, in Scotland, at
the time of planning the study, prevalence data were very similar to those cited by
Jørgenson et al (1995) with prevalence rates for all ages cited as 4.8 : 1,000 for men
and 4.7 : 1,000 for women (ISD 2000). When considering the older population,
prevalence rates rose to 37 : 1,000 for men and 26.7 : 1,000 for women aged over
75.
2.5 Stroke Recovery
Outcome following stroke is highly variable and influenced by many factors. For
many subjects, there will be some degree of spontaneous recovery. Severity of the
initial post-stroke deficit is a key predictor of outcome, however the amount of final
17
Chapter 2
Stroke
recovery is not predictable (Chen et al, 2002). Within the first four weeks outcomes
are grossly reported as death in approximately 20% of first strokes, full recovery in
30% and residual disability in 40-50% (Langton Hewer, 1993; Warlow, 1998; Hacke
et al, 2002). In Scotland, the 30 day mortality rate for hospitalised patients is higher
than this and is reported at 28% (Lewsey et al, 2009).
Stroke recurrence has
recently been reported as declining (Lewsey et al, 2010). In Scotland, in the 15
years preceding 2001 approximately 1 in 10 people hospitalised for stroke were
hospitalised for a further stroke incident within five years (Lewsey et al, 2010). With
the risk of second strokes being more disabling, this has further implications for
rehabilitation services (Rothwell et al, 2004; Lewsey et al, 2010).
Over the past 20 years, evidence from basic science and clinical research has
started to provide evidence that the brain is capable of recovery following stroke,
provided that relevant treatment is applied at an appropriate dosage and at an
appropriate timepoint. Functional recovery during the first three to four weeks poststroke is known to occur with resolution of local factors such as oedema, absorption
of necrotic matter and the establishment of collateral circulation in the peri-lesional
area (Rossini and Forno 2004; Dobkin and Carmichael, 2005). Evidence has also
emerged to demonstrate that even long after perceived recovery has plateaued,
cortical reorganisation of the human brain may occur with an associated change in
motor function (Nudo, 2003; Nudo 2006).
2.5.1
Neurobiological Evidence of Stroke Recovery
In the first few days post-stroke, recovery is mainly due to reperfusion of ischaemic
penumbra and resolution of oedema (Chen et al, 2002) and restitution of non-
18
Chapter 2
Stroke
infarcted penumbra (Kwakkel et al 2004b, Kreisel et al 2007). Emerging evidence
from neurobiological research and neuroimaging studies have shown that the
human brain is capable of extensive functional and structural plasticity for weeks to
months following stroke (Green 2003; Nudo 2003). In addition to plastic changes,
functional training as well as compensatory movement strategies may further impact
on movement recovery. A summary of the emerging evidence from animal and
human studies is presented in this section.
Plasticity has been defined as “any enduring change in the cortical properties either
morphological or functional” (Donoghue et al 1996; Schallert et al, 2003; Butefisch
2004 (p163). Evidence suggests that the brain is primed for change post-stroke
(Teasell & Kalra 2005) and that repeated use of the affected limbs post-stroke is a
major influencing factor on potential plastic changes. Evidence from animal studies
and brain mapping research indicate that a number of different processes contribute
to neuroplasticity, and that these processes occur at different chronological
timepoints post-stroke (Schaecter 2004; Kwakkel et al 2004b; Kreisel et al, 2007).
Anatomical and tissue repair
The unmasking of pre-existing but latent connections, has been suggested as one
key mechanism by which cerebral cortex reorganisation is mediated early after
stroke (Kwakkel et al 2004b). It has been suggested that the process of unmasking
latent synapses occurs within the hyper-acute phase post-stroke – i.e. within
minutes.
19
Chapter 2
Stroke
A mechanism responsible for synaptic plasticity and cortical reorganisation is the
presence of horizontal cortical connections within the motor cortex.
The motor
cortex has many overlapping motor representations, and within the cortex there is a
profound
network
of
horizontal
interconnections
mainly
within
discrete
representations but also a less dense network between areas (Butefisch 2004).
Longer-term changes within the brain have been attributed to processes of axonal
regeneration and axonal sprouting as well as synaptogenesis in the peri-infarct area.
In rats, it has been demonstrated that peri-infarct axonal sprouting may occur
between 3 – 14 days after cortical infarction and that up to 60 days post infarct there
are signs of synaptogenesis (Stroemer et al 1995 cited in Nudo 2006). Further, it
has been suggested that specific patterns of gene expression early after infarct are
responsible for growth promotion associated with sprouting processes and
contribute to the repair mechanisms of brain tissue (Nudo 2006).
Cortical Reorganisation
It is well documented that people with stroke show varying degrees of recovery
within days or weeks after the acute event (Bonita and Beaglehole, 1988; Kwakkel
et al, 2004b). One of the early explanations for recovery has been that normal brain
tissue facilitated a process of reorganisation (Sterr, 2004). This hypothesis has
been confirmed on both animals and humans, however it has been found that
reorganisation may confer both positive but also negative phenomena. In a study of
squirrel monkeys where small lesions were made in part of the distal forelimb
representation of the primary motor cortex (M1) and the animals left to recover with
no training (Nudo et al, 1996), the intact area reduced in size
20
Chapter 2
Stroke
The excitability of the motor cortex has been studied using Functional Magnetic
Resonance Imaging (fMRI), Transcranial Magnetic Stimulation (TMS) and Positron,
Emission Tomography (PET) scanning. Investigation of normal brain activity show
activation of the contralateral hemisphere during a motor task. In a study of hand
muscle activation in patients within two weeks of stroke, Turton et al (1996)
demonstrated a reduced excitability of the ipsilesional motor cortex compared to the
contralatesional cortex, however this was shown to improve towards normal patterns
as hand motor recovery occurred over a one year period.
Liepert et al (2000) used transcranial magnetic stimulation (TMS) to investigate the
effects of a 12 day programme of Constraint Induced Therapy (CIT) on 13 people
with chronic stroke (mean 4.9 years post-event). Immediately after intervention the
use of the affected hand in daily activities had significantly improved and the cortical
representation of the affected hand muscles was found to be enlarged significantly,
accompanied by a shift in the central position of the motor map which implied a
recruitment of adjacent brain areas. At six months post intervention, eight subjects
were followed up and demonstrated that high activity levels had been retained,
although the cortical area representation of the affected cortex had returned to
normal size indicating a return to normal balance of motor neurone excitability.
Negative cortical reorganisation has been reported in sub-acute stroke patients
approximately eight – 16 weeks post-stroke and no longer undertaking rehabilitation.
In addition to a reduction in ipsilesional motor cortex excitability, a reduction in the
21
Chapter 2
Stroke
cortical representation of affected muscles was also noted, which has been
postulated as being related to either neuronal damage or associated with disuse
(Traversa et al 1997 in Liepert et al 2000).
Feydy et al (2002) undertook a
longitudinal study of cortical reorganisation in 14 stroke patients between one and
six months port stroke. fMRI was used to monitor cortical reorganisation related to
recovery.
Two reorganisation patterns were found. Nine patients demonstrated
“focusing” whereby initial patterns of ipsilateral and contralateral activation
developed towards a normal activation of the contralateral sensorimotor cortex.
Five patients showed “persistent recruitment” associated with a lesion of the M1
primary motor cortex, with a perseveration of ipsilateral activation.
The studies considered above generally have investigated people within the first
year after stroke. The fact that there still exists a potential for recovery, or changes
in activity, at months or even years after stroke is less well understood and thought
to be mostly due to compensations and behavioural change (Kriesel et al, 2007).
Processes related to therapy driven cortical hyperexcitability (Liepert et al, 2000)
and motor cortex enlargement in subjects following intense training of limbs, such as
that shown following Constraint Induced Therapy (Levy et al, 2001; Wolf et al, 2002)
identify a potential for change.
2.5.2
Prognostic indicators of recovery
Post-stroke recovery is influenced by various factors such as age, lesion
characteristics and pre-morbid status (Duncan et al, 1992b). Interactions between
these factors may also play a part in the capacity for recovery. Most evidence
relating to physical recovery indicators in stroke arises from medical literature,
22
Chapter 2
Stroke
although a recent systematic review (Meijer et al 2003) urges careful interpretation
of some findings due to the use of variable methodologies.
Age
Although stroke can occur at any age, the incidence rises sharply past the age of 65
(Wolfe et al 2000b; ISD 2009). Severity of stroke is not related to age, however age
can influence outcomes. With increasing age there is an association with poorer
outcomes in basic activities of daily living (ADL) and greater levels of residual
disability (Nakayama et al 1994; Kelly Hayes et al 2003).
Early recovery of movement:
A recent study by Hashimoto and colleagues (2007) used a new five point ordinal
rating scale, the Ability of Basic Movement Scale (ABMS) to assess the ability to
perform basic movements at the bedside at set times after stroke and relate this to
functional ability at discharge. While elements of reliability of the ABMS have been
established by the investigatory team, validity is less clearly developed and the 5
activities in the ABMS do not have clear operational definitions, which makes
generalised use of this scale problematic. Data on 142 subjects indicated that the
“ability to turn over from supine”, “remain sitting” and “sit up” at 10 days post-stroke
were “strong” predictors of “functional ability” at discharge..
Sub-acute predictors
Within the past 10 years, two systematic reviews of literature have been undertaken
to ascertain the evidence-based predictors of functional recovery at six and 12
months post-stroke in a sub-acute stroke population (Kwakkel et al1996; Meijer et al
2003).
23
Chapter 2
Stroke
While Kwakkel at al (1996), identified studies up until 1995, Meijer et al (2003)
included studies up until 2002, and it is notable that during that additional time
period, there has been an increased interest in stroke rehabilitation research. While
criticisms have been levelled at the methodology employed in many of the studies,
some interesting conclusions can still be drawn. Several studies with internal and
statistical validity have identified factors linked with a poorer prognosis.
These
factors include : the loss of consciousness persisting for 48 hours post-stroke (Wade
and Langton Hewer, 1987, Taub et al, 1994); the presence of urinary incontinence
at one week post-stroke (Thomessen et al, 1999; Meijer et al, 2003); a lower initial
Barthel Index score
within the first two weeks post-stroke (Wade and Langton
Hewer 1987; Taub et al 1994) and severe limb paresis or paralysis (Taub et al,
1994). Other potential predictors included swallowing problems (Taub et al 1994);
apraxia and visuo-spatial problems (Sveen et al 1996) and poor sitting balance
(Wade and Langton Hewer 1987).
2.6 Functional Recovery profiles
Epidemiological studies of stroke recovery and papers reporting stroke rehabilitation
research have repeatedly stated that the most rapid and the majority of physical
recovery is seen in the first three months following stroke (Wade and LangtonHewer 1987; Kreisel et al, 2007). It is important to remember that while stroke is
not a homogeneous entity and that individual recovery patterns may be diverse,
there is still a general regularity to recovery profiles within the first six months
irrespective of rehabilitation input (Kwakkel et al 2004b). Most of the early papers
describing physical recovery were limited to capturing data within the first three
24
Chapter 2
Stroke
months post-stroke (Wade et al, 1985; Wade and Langton Hewer, 1987; Heller et al,
1987) and therefore more is known about that period.
Gowland was one of the first physiotherapists to report observations of physical
recovery post-stroke in a systematic manner (Gowland 1982). Two hundred and
twenty nine people in the sub-acute phase of stroke (median time since onset seven
weeks) were included in her work. Measures of physical function were relatively
crude, however she was able to report that by the end of the rehabilitation period,
while only 5% had functional upper limb recovery, 70% of patients were able to walk
independently (Gowland, 1982).
Partridge et al (1993) collected data on 348 people with stroke undertaking basic
functional activities, relating to bed mobility and gait, over a six week period poststroke. On admission, approximately 29% could move from lying to sitting, 29%
could stand up independently and 11% could walk indoors. At six weeks these data
had improved to 74%, 73% and 56% respectively.
In a large study of 947 people with stroke, data on functional recovery was collected
for six months after the initial stroke event (Jørgenson et al, 1995). Data were
collected on crude indices of recovery such as the Barthel Index, and on considering
the recovery profiles, patients were stratified by initial severity of stroke.
The
findings in this study demonstrated that for 80% of the stroke population, optimal
activities of daily living scores were achieved within eight weeks after stroke onset
and that even at 20 weeks the most severely affected patients had achieved their
25
Chapter 2
Stroke
best recovery (Jørgenson et al, 1995). However, while claims are made that no
more recovery should be expected after the six month post-stroke period, it appears
from the study that patients stopped receiving therapy when the team felt that more
improvement was ”unlikely”, therefore not capturing any later possible improvement.
Partridge et al (1993) reported detailed profiles of basic mobility recovery within the
first six weeks of recruitment to their study, however they failed to look at recovery
profiles of upper limb function, or to extend the study into the later stages of stroke.
The gross measures that have been reported by Gowland (1982) and Jørgenson et
al, (1995) may reflect compensatory activity by the unaffected side rather than
resolution of motor deficits, or the effects of whether therapy was still being
received. These studies do however allow physiotherapists to start to build a picture
of functional recovery, which at this point in time requires extension into longitudinal
studies to allow a picture of the natural recovery of people with late-stage stroke to
be built up.
2.7 Summary
This chapter has provided an overview of Stroke epidemiology, aetiology and
recovery mechanisms. Stroke is a recovering neurological condition, however the
stroke population are heterogeneous and therefore there are variations in the rate
and extent of recovery. Incidence rates of stroke are declining, in part this is due to
improved healthcare and improved management in the acute phase of stroke.
Stroke incidence in older people, however is relatively high and recent prevalence
rates in Scotland indicated almost a ten fold increase in stroke prevalence for people
aged 75 and over, than compared to stroke prevalence for the adult population as a
26
Chapter 2
Stroke
whole (ISD, 2000). With more people expected to survive stroke, with increasing
levels of disability, it is clear that a substantial body of evidence is required, so that
appropriate interventions are available for stroke survivors, at all stages of the poststroke period.
In the following chapters a review of the evidence underpinning Stroke
Rehabilitation will be presented, this will have a particular emphasis on rehabilitation
in later stage stroke as it pertains to this study.
The theory supporting Motor
Learning will be presented and a discussion of how this theory is applied to healthy
subjects as well as to people with a neurological impairment. Ultimately this review
of the literature will contextualise the aims, rationale and hypotheses of the work
reported in this thesis.
27
Chapter 2
Stroke
3. STROKE REHABILITATION
3.1 Introduction
The process of Stroke Rehabilitation has received considerable interest in the past
two decades and there now exists a vast amount of literature in the area. This
chapter will commence with a brief overview of what constitutes Stroke
Rehabilitation. Following this, the process of Stroke Rehabilitation will be discussed
from two perspectives. Firstly, a brief overview of the whole journey of the stroke
patient, from stroke onset, is presented in order to put the rehabilitation of people
with late-stage stroke into context. This is followed in section 3.4 by a focus on
Physiotherapy approaches for Stroke with an emphasis on interventions for people
with later-stage stroke and the evidence for Stroke Rehabilitation in the community
setting as these two factors are of most relevance for this thesis.
Rehabilitation has been defined as:
“an active and dynamic process through which a disabled person is helped to
acquire knowledge and skills in order to maximise their physical,
psychological, and social functioning” (Barnes 2003, p iv4).
Stroke rehabilitation covers a substantial period of time and could be considered as
the time since stroke until the end of life.
Langhorne and Legg (2003) have
commented on the false division of ‘early’ or ‘acute’ from ‘later’ rehabilitation when
considering the evidence for Stroke Rehabilitation, as the available evidence does
not necessarily fall neatly into such precise era. In terms of considering where to
focus critique of the volume of papers investigating physiotherapy focused stroke
rehabilitation, it was considered useful to consider the continuum of Stroke
Rehabilitation as a matrix (see figure 3.1). This matrix indicates “notional stages” of
rehabilitation and within this thesis summary evidence will be presented for all
28
Chapter 3
Stroke Rehabilitation
stages with an in-depth critique on late-stage and community-based interventions.
It is accepted that other authors, in considering a similar matrix, may identify
different treatment intensities, different stages or apply alternative labels for each
stage.
Late-stage /
Chronic
6 months+
Ongoing
rehab
4-6 months
post-stroke
Sub-acute
1-3 months
post-stroke
Time since stroke
Acute
rehabilitation
8 – 28 days
post-stroke
Acute
management
0-7 days
post-stroke
Daily (7 days) Daily (5 days) Daily (5 days)
in-patient
in-patient
out-patient or
treatment
rehab
community
rehab
Physiotherapy
frequency
Figure 3.1.
setting
and
2 – 3 days
per week
out-patient /
community
1-2 days
per month
out-patient /
community
indicative
Monitor
<1x month
No formal
treatment
rehabilitation
Notional Stroke Rehabilitation matrix
Indicating representative stroke patient – physiotherapist contact
29
Chapter 3
It is not simple to summarise Stroke Rehabilitation within a single definition. It has
been noted however, that
“a clear consensus exists that the purpose of rehabilitation is to limit the impact
of stroke related brain damage on daily life by using a mixture of therapeutic
and problem solving approaches” (Young and Forster 2007 p86).
Principal members of the stroke rehabilitation team, in addition to the medical
practitioner, are rehabilitation nurses, physiotherapists, occupational therapists,
speech and language therapists and clinical psychologists. In an integrated team,
this should allow problems affecting upper and lower limb movements, balance,
mobility, activities of daily living (such as bathing and dressing), communication and
swallowing problems and disorders of mood and emotions to be addressed (EUSI
2003; Baer and Durward 2004; SIGN 2010;). A key recommendation of recent
Stroke rehabilitation guidelines in Scotland states
“The core multidisciplinary team should include appropriate levels of nursing,
medical, physiotherapy, occupational therapy, speech and language therapy,
and social work staff”. (SIGN 2010 p5)
In Stroke Rehabilitation, physiotherapists are not only instrumental in the treatment
of movement disorders, but also in prevention of secondary complications such as
chest infection, soft tissue contracture and pressure sores (Ryerson and Levit 1997;
Carr and Shepherd 1998; Edwards 2002; SIGN 2010). An indication of the role of
the physiotherapist at various stages in the matrix of the stroke patient journey will
be outlined in the following sections.
3.2
Physiotherapy Intervention in Acute Stroke Management during the first
seven days post-stroke
This section summarises non-pharmacological and non-surgical roles of the
physiotherapist in Acute Stroke Rehabilitation.
It is recommended that a
30
Chapter 3
physiotherapy assessment of the stroke patient is undertaken within the first 72
hours post-stroke (RCP 2008). The specific aims of acute management relevant to
Physiotherapy include:
 Positioning of the stroke patient to maintain joint range of motion and muscle
length of two joint muscles (Carr and Kenney 1992; Chatterton et al 2001; Carr
and Shepherd 2003), to reduce the development of abnormal muscle tone
(Bobath 1990, Bhakta 2000; Edwards 2002), and to maintain body alignment
(Lynch and Grisogono 1991; Carr and Kenney 1996; Chatterton 2001)
 In the acute post-stroke days, stroke patients may have reduced ventilatory
function which may enhance the likelihood of hypoxaemia and atelectasis (Brott
and Reed 1989; EUSI 2003).
There is some evidence, from small scale
studies, that if upright positioning is tolerated by the patient, this may be
beneficial for maintaining respiratory function and preventing some respiratory
complications such as infection or atelectasis (Chatterton et al 2000; Rowat et
al 2001; Tyson and Nightingale 2004; SIGN 2010). Further, if the patient is
able to tolerate mobilisation such as sitting out of bed or taking short assisted
walks this also has been shown to have an effect on reducing respiratory
complications (Indredravik et al 1999)
 There is an accumulation of evidence from research undertaken in Europe and
Australia to indicate that early mobilisation, commenced within 24 hours of
stroke onset and often on the day of admission has a beneficial effect in
preventing some of the complications with prolonged immobility and in
facilitating an improved physiological outcome, with better control of blood
pressure, dehydration, pyrexia and glucose levels (Indredravik et al 1999;
Langhorne and Pollock 2002; Bernhardt et al 2008).
31
Chapter 3
 In addition, assessment of and intervention strategies to address physical
impairments as well as impairments of sensation, perception and cognition are
recommended to be commenced at this point. (Ryerson and Levit 1997; SIGN
2010; RCP 2008).
3.3
Acute and Sub-acute rehabilitation
As indicated at the start of this chapter, the “stages” of stroke rehabilitation identified
in figure 3.1 are notional, therefore this section will consider the “acute” and “subacute” stages following stroke as a continuum. Many of the interventions will be
similar or progressions of initial management strategies and, depending on the
clinical picture presented by the patient, changes in the rehabilitation process will be
indicated – such as cessation of respiratory management.
During the first months post-stroke, physiotherapists will continue with many of the
aims from the acute management stage in the first week. There will be long-term
aims of maintaining joint range of motion and postural alignment, (Edwards 2002;
Carr and Shepherd 2003; Herbert 2005; Bobath 1990) and avoiding soft tissue
complications (Edwards 2002; Carr and Shepherd 2003; Ada and Canning 2005).
Depending on the treatment philosophy being followed, physiotherapists may place
an emphasis on maintaining or promoting normal muscle tone as a pre-cursor to
movement re-education (Edwards et al 2002; Bobath 1990) or may encourage the
patient to move through synergistic reflex movement patterns with subsequent
encouragement of active movements (Brunnstrom 1970).
Re-education of
movement and functional tasks in relation to daily activity will continue from the
acute management stage or will commence in the acute rehabilitation stage.
32
Chapter 3
Similarly, ongoing cognisance of and, where appropriate, rehabilitation of or
adaptation of rehabilitation to account for impairments of cognition, memory,
sensation, pain or speech may be indicated (Ryerson and Levit 1997; Carr and
Shepherd 2003; Edwards 2002; Baer and Durward 2004;).
As time since stroke progresses, people who have sustained a mild stroke may no
longer
be
receiving
rehabilitation
for
physical
impairments
involving
the
physiotherapist. However, many stroke patients will still require rehabilitation and
may receive this either on either an in-patient basis or as an out-patient.
In the past 20 years, strong evidence has emerged that people with stroke managed
in a dedicated stroke unit tend to have better outcomes not only in reducing
mortality, but also in improved functional outcomes than those managed in general
medical wards or elderly care wards (for example Langhorne et al 1993; Hankey et
al 1999; Seenan et al 2007). While Stroke Units may operate in a variety of ways
depending on local requirements, a number of common strategies appear to be
associated with successful outcomes of Stroke Unit rehabilitation. These strategies
are complex and often inter-related but include early, integrated assessment of
medical, nursing and therapy requirements, the instigation of early management
strategies such as early mobilisation (Indredavik et al 1999; Langhorne and Pollock
2002). or prevention or treatment of complications such as infection (Indredavik et al
1999; Evans et al 2001; Langhorne and Pollock 2002), planned and co-ordinated
multidisciplinary rehabilitation procedures which include early planning for discharge
and specialist staff (Jørgensen et al 1995; Indredavik et al 1999; Evans et al 2001;
Langhorne and Pollock 2002).
33
Chapter 3
There is evidence that sub-acute stroke rehabilitation in the home setting can be
beneficial (Young and Forster 1991; Gladman et al 1993; Baskett et al 1999). The
Bradford Community Stroke trial explored the effects of eight weeks of rehabilitation
received either in the home environment or in a day hospital (Young and Forster
1991). 58% of the cohort were less than 12 weeks post-stroke at time of discharge
from hospital and 107 of an initial 124 participants were available for follow-up at the
end of the intervention. Participants in both groups demonstrated small functional
improvements on the Barthel Index and the Motor Club Assessment, but there were
no significant differences between the groups except for stair climbing ability and
social activity for participants receiving therapy at home (Young and Forster 1991).
Similar findings were reported from a trial of 100 people with sub-acute stroke in
New Zealand by Baskett et al (1999). In this study, people with stroke sustained at
a mean time of five weeks prior to recruitment were randomised to either a control
group who received therapist contact in a day hospital environment approximately
two or three times a week, or an experimental group who received individualised
functional exercises in the home environment. Exercises were recorded in a diary
and progressed as deemed relevant by the therapist and the experimental group
were visited weekly for up to three months. While both groups showed a trend
towards improvement in gait speed and some outcomes such as the Motor
Assessment Scale and the Barthel Index, there were no statistically significant
differences in functional outcomes between the groups (Baskett et al, 1999).
In a large study of 327 people with sub-acute stroke (within 3 months of stroke
onset), Gladman et al (1993) found virtually no differences in outcomes between
those receiving input from therapists in a new domiciliary rehabilitation service or a
traditional hospital out-patients service following discharge from hospital. Despite
stratifying for initial hospital admission location (Health Care of the Elderly ward,
34
Chapter 3
Stroke Unit or General Medical ward), there were no significant differences in
outcome in Barthel Index scores at three or six months post discharge, and only a
significant improvement in extended ADL scores for the Stroke Unit sub-stratum
group receiving domicillary rehabilitation for their home and leisure activities
Extended ADL scores.
While the findings from these three studies suggest that there were no major
statistically significant differences in outcomes between groups, the studies
demonstrated that it was feasible to deliver on-going sub-acute stroke rehabilitation
in the home setting (Young and Forster 1991; Gladman et al 1993; Baskett et al
1999). It was also suggested that rehabilitation provided in the home environment
may be preferred by the patient, may be more easily tailored to the needs of an
individual and can be more cost effective than on-going rehabilitation delivered in a
day hospital setting (Young and Forster 1991).
Ongoing Rehabilitation (4 – 6 months post-stroke)
Ongoing rehabilitation may take place in the hospital or home environment.
Depending on the needs of the patient, the rehabilitation input received may be
similar to that outlined in the sub-acute stages, or it may reduce to a level where
monitoring or maintenance is the prime focus (SIGN 2010; RCP2008). In Scotland,
a recommendation based on a recent Cochrane review of home-based therapy
services for people with stroke (Outpatients Service Triallists 2003), states:
“Stroke patients in the community should have access to specialist therapybased rehabilitation services” (SIGN 2010, p52).
Similarly, in England, specific recommendations are made regarding “the whole
stroke pathway” including the provision of “later rehabilitation in the community”
35
Chapter 3
(RCP 2008, p22).
These recommendations indicate that the importance of
continuing appropriate stroke rehabilitation, following discharge from hospital, as
part of on-going rehabilitation is starting to be recognised. Evidence relating to the
effectiveness of physiotherapy for people late after stroke will now be reviewed.
3.4 Evidence to support Physiotherapy in Late-Stage Stroke Rehabilitation
The evidence to support the effectiveness of Physiotherapy for people with acute
and sub-acute stroke has been emerging over the past two decades. However it
was not until the last ten years or so that interest in the potential for rehabilitation for
chronic stroke has received sustained attention.
A recent Cochrane Review
investigated the benefits of “therapy-based” rehabilitation services at more than a
year post-stroke (Aziz et al, 2009). It was reported that analysis of the five trials that
were included in the review resulted in an indication of a trend towards improvement
but that there was insufficient evidence to make definitive conclusions (Aziz et al,
2009). Only two out of the five studies included in the above review were relevant to
the work reported in this thesis and are critiqued in this chapter (Green et al, 2002;
Wade et al, 1992), the other trials provided mixed Occupational Therapy (OT) and
physiotherapy with limited focus on exercise (Mulder et al, 1989; Werner et al, 1996)
or provided only OT (Sackley et al 2006). A number of trials that were excluded
from the Cochrane Review of therapy-based rehabilitation at more than a year poststroke are included in this chapter (See table 3.1), as the findings have implications
for the work reported in this thesis.
Recently, Combs et al (2010) claimed that traditional therapy models have been
“refocused” to investigate high intensity, task specific, short programmes of training.
36
Chapter 3
While this high intensity, task specific practice could be considered to incorporate
specific approaches aimed at retraining specific areas of the body, such as
Constraint Induced Therapy (CIT) (Wolf et al 1989, Taub et al 2000; Wolf et al 2006)
and Treadmill Training (TT) (Hesse et al 1994; Moseley et al 2003, Moore et al,
2010), a small number of investigators have studied the potential for change in
community dwelling people with chronic stroke receiving therapy at home or in a
community setting. A recent Cochrane review considered the effect of Repetitive
task training (RTT) for improving functional ability after stroke and included studies
of people with stroke along the continuum of stroke rehabilitation and in both home
and hospital settings (French et al, 2009). A number of the studies included in that
Cochrane review, relevant to the work in this thesis, have been considered in this
chapter (e.g. Dean et al, 2000; McLellan and Ada 2004; Salbach et al 2004).
Overall, the Cochrane review indicated a “modest” but not a sustained improvement
in lower limb function following RTT, an associated positive impact on some aspects
of ADL but no improvement in arm function (French et al, 2009).
It is beyond the scope of this thesis to consider the novel, highly specific
interventions such as CIT or TT as these interventions can only be provided for a
limited population and may require intense resource support and are often only
feasible in the hospital environment. In part, the limitations are due to the intensive
delivery – daily or twice daily, and with CIT often requiring up to six hours daily of
intensive task practice (Miltner et al 1999; Smith et al 2000; Sullivan et al 2002; Wolf
et al 2006). These high resource demands are inconsistent with interventions aimed
at more general and ongoing rehabilitation for people with chronic stroke. Studies
included in this section therefore, are limited to considering the evidence supporting
37
Chapter 3
community-based and low technology approaches to rehabilitation, more details are
included in table 3.1.
Search Strategy To identify relevant studies to support the work reported in this
thesis, a search for English language papers was undertaken. Databases searched
were Medline, CINAHL (the Cumulative Index to Nursing and Allied Health
Literature), the Cochrane Central Register of Controlled Trials, the Cochrane
Database of Systematic Reviews, Web of Science and PEDro (the Physiotherapy
Evidence Database). Keywords included in the search strategy were combinations
of stroke, cerebrovascular accident, CVA, hemiplegia hemiparesis, late-stage or
chronic and combinations of physiotherapy, physical therapy, therapy, rehabilitation,
home, home-based, domicillary, community, and combinations of exercise, exercise
therapy, training, function, strength, activity, gait, balance, and upper extremity..
Dam et al (1993) undertook one of the earliest studies of stroke rehabilitation that
indicated the capacity for positive change over two years for people with relatively
severe stroke.
The included sample had been discharged from rehabilitation,
however the participants entered the study at around three months post- stroke and
therefore, would not be regarded as being the chronic phase. The aim was to see if
different manifestations or severity of stroke had potential for functional
improvement over two years. Fifty one people who had sustained severe strokes,
were not yet ambulant and were at least three months post-stroke were recruited.
The two year study design was complex, the intervention consisted of providing up
to seven bouts of rehabilitation - lasting one to three months, with at least one month
rest between each treatment bout. Details of intervention were not clearly reported
38
Chapter 3
but stated to be between 60 – 120 minutes of physiotherapy, five days a week.
Outcomes were taken every three months during the first year and every six months
during the second year using the Barthel Index and the gait, motor and total domain
scores of the Hemiplegic Stroke Scale (HSS). Interestingly, the HSS was designed
with 16 people with acute stroke (Adams et al 1987) and does not appear to have
been established with more chronic stroke which may raise questions about the
validity of some of the findings. Dam et al (1993) reported that after 12 months, all
subjects had improved their neurological status and ability to perform basic ADL, but
no further changes were demonstrated in the second year. There was no difference
in improvements depending on side of stroke or whether the subjects had suffered
an ischaemic or haemorrhagic stroke.
While the work by Dam et al (1993) was quite innovative in that it was one of the first
to study people with stroke for a prolonged period and demonstrate that recovery
was measurable beyond the initial three month period post-stroke. The trial would
be difficult to replicate however, as details of the intervention were not clear, the
bouts of intervention were lengthy and resource intensive and probably not viable in
an environment other than a research situation.
The following sections (3.4.1 – 3.4.4.) will consider the evidence relating to
community rehabilitation of people with late-stage stroke.
On reviewing the
literature in this area, the environment in which rehabilitation was conducted varied
between the home, community settings such as a gym or community centre, or outpatient facilities. It is therefore difficult to make comparisons between studies based
on the effect of environment.
Trials in out-patient facilities that required
39
Chapter 3
considerable amounts of highly technical equipment (such as isokinetic machines)
that would not be transferable to the home setting have not been included. Trials
that included a circuit of simple exercises that could be performed in the home
environment (e.g. rising from a chair, heel raises, reaching exercises) have been
included. The constant feature of the participants included in the studies that have
been reviewed, is that all participants had been discharged from in-patient
rehabilitation and were community dwelling. At the end of this section, summary
findings will be identified and an indication of how the definitive trial reported in
chapters seven and eight fits with the current literature will be proposed.
3.4.1. Studies of Mobility in Late-stage Stroke
The studies included in this section predominantly investigated the effects of
physiotherapy on mobility outcomes in late-stage stroke.
Wall and Turnbull (1987) reported an early, small scale, non-randomised pre-post
intervention study of gait re-education for people at least 18 months post-stroke.
Twenty participants were allocated to one of four groups that practiced the same
exercises either as two hours of out-patient physiotherapy weekly, two hours of
home physiotherapy weekly, a mixed group with one hour each of out-patient and
home physiotherapy or a control group. The intervention phase lasted six months.
Gait parameters were measured monthly over a 10 month period. No statistically
significant differences were found between any of the groups for any measurement
point, although isolated points of improved gait speed were apparent within the outpatient group on one occasion and the mixed group on two occasions. The overall
conclusion from this study was that the exercise programme was ineffective at
40
Chapter 3
improving gait, however the small sample size and carefully selected sample may
have affected the findings, or the intensity of intervention was insufficient.
Wade et al (1992) investigated whether home-based physiotherapy intervention late
after stroke was effective in improving mobility for people with chronic stroke. This
study was novel in that the intervention consisted primarily of advice, goal setting
and unsupervised exercise with an emphasis on self management and problem
solving. A randomised cross over design was adopted with subjects either receiving
early intervention (EI) following two baseline assessments or late intervention (LI),
three months after baselines. A whole battery of outcome measures were recorded
at baselines and then at three, six and nine months with a focus on mobility, ADL as
well as a measure of manual dexterity to ensure that if changes in stroke impairment
were found these were not generalised to upper limb function as well as mobility.
On the 10m walk test both groups showed a reduction in walking time immediately
after their intervention phase, which was not sustained at follow-up, but there were
no statistically significant differences between the groups over time. More clinically
relevant was that during the intervention phase seven subjects started walking
outside.
No significant changes were noted in non-mobility related outcomes.
Weaknesses of this study were that the intervention therapist was known to be
highly experienced in neurological rehabilitation and it may be that the findings
would not be replicated by another individual, also there was a lack of follow up for a
number of subjects so findings need to be viewed cautiously. However this was one
of the first low intensity, home based rehabilitation studies to show positive
outcomes and the potential for functional improvements for people with chronic
stroke.
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Chapter 3
Green et al (2002) undertook a large RCT of “community physiotherapy” in 170
people with chronic stroke and residual mobility problems, this work had been
influenced by the work of Wade et al (1992) and aimed to overcome some of the
weaknesses such as ensuring the study was adequately powered and intervention
was delivered by an established service. Subjects were randomised to either a
(maximum) 13 week “community physiotherapy” intervention or were allocated to
the control group. All participants were followed up at three, six and nine months
after randomisation.
A small but significant improvement in Rivermead Mobility
Index score was found for the Intervention group at three months, but this did not
persist. No significant changes were found for the other measures: Barthel Index,
Frenchay Activity Index or Hospital Anxiety and Depression Score. Overall, the
effects were small and transitory and may have been attributable to insufficient
intensity of treatment or a lack of focus on treatment for non-mobility related
problems.
McClellan and Ada (2004) undertook a small RCT in Australia investigating the
effect of a six week home-based mobility exercise programme for people with stroke
who had been discharged from physiotherapy.
An innovative feature of their
programme was that unlike previous studies that had looked at providing home
based physiotherapy for people with chronic stroke, they made the argument that
resources are not finite and therefore it was valid to investigate the efficacy of
providing limited physiotherapy input (three contacts over six weeks). 26 subjects
were randomised to receive either mobility exercises or “sham mobility” upper limb
exercises. The authors noted that therapists might have reservations about leaving
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patients to undertake unsupervised exercise in that they may practice incorrectly, be
unsafe or there may be compliance issues, however strategies were developed to
overcome these potential issues by drawing from a pre-determined list of
standardised exercises for each individual, and videotaping correct performance of
the exercise (McCLellan and Ada 2004). It was found that on average, participants
practised exercises 75% of the time, but that after the intervention had ceased 87%
of the subjects continued to practice.
By the end of the intervention phase, a
statistically significant increase in Functional Reach (which requires loading of the
lower limbs and good balance) was found in the intervention group and this was
maintained at 14 week follow up. No significant improvements between the groups
were found in either walking performance or quality of life. This was a rigorously
designed study, which included features that may be relevant to adopt within the UK
National Health Service. The lack of statistical significance may be attributed to the
fact that the measures were not sensitive enough to show change, that the
intervention phase was too short or that the study was underpowered.
Similar work investigating an experimental group undertaking a six week task
oriented gait training intervention compared to a control group undertaking seated
upper extremity work was reported by Salbach et al (2004). Participants with a
mean time since stroke of over seven months were recruited over 33 months, which
might indicate a problem with engaging interest of potential participants.
The
exercise programme was designed to strengthen the legs, improve balance and
increase walking capacity. While positive effects for the intervention group were
found on measures of balance and mobility, these were not found to be statistically
significant compared to the control group.
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Chapter 3
An interesting small-scale study investigated the effects of a four week dual exercise
programme on walking ability in 25 people with a reported mean time since stroke of
over four years (Yang et al, 2007). The 13 subjects in the experimental group
undertook 12 sessions of gait training with dual task demands of carrying, bouncing,
manipulating or kicking balls of various diameters (up to 95cm) while the control
group received no intervention.
Statistically significant improvements for the
experimental group for gait speed, cadence and stride length and time were
reported, with walking speeds post intervention cited as within low – normal values
of 0.85 – 1.15 m/s, (Yang et al, 2007). While the sample in this study were relatively
young (mean age 59 years) and had a relatively high level of recovery with a degree
of functional use of the hemiplegic upper extremity, this work continues to add to the
body of evidence relating to the potential for improvement late after stroke, although
no long-term follow-up was reported.
Overall, with the exception of the work by Wall and Turnbull (1982), the studies that
have investigated interventions to target mobility function in people with chronic
stroke in the community setting, have found small and sometimes, sustained
improvements in mobility or mobility related characteristics.
3.4.2. Studies of Strengthening in Chronic Stroke
Until recently, many therapists subscribed to the view that resistance training and
strengthening was detrimental to people with stroke (Bobath 1990; Davies 1985),
however this view has been challenged by a number of authors (Saunders et al
44
Chapter 3
2004; Ada et al 2005; Carr and Shepherd 2003). In a systematic review of studies
of strengthening interventions for people with both acute and chronic stroke, Ada et
al (2005) concluded that strengthening was feasible for people with stroke without a
detrimental effect on spasticity, although positive outcomes were more likely early
after stroke than in chronic stroke. Further, by pooling data from similar studies they
identified that an increase in strength could be accompanied by an improvement in
activity levels. An overview of studies designed to investigate strengthening for
people with chronic stroke are discussed below.
In a small randomised trial of a class-based, four week circuit training for people with
chronic stroke ( x 1.3 years), nine participants completed the study, the numbers
were therefore low and the experimental group comprised only five people (Dean et
al 2000). The experimental intervention comprised a circuit of 10 stations designed
to improve lower limb strength and walking ability, while the control participants
undertook upper limb tasks. Outcomes were taken at the end of intervention and at
two month follow-up. The authors identified statistically significant improvements in
a number of measures relating to gait speed and in force generation during standing
up for the experimental group, but no changes in upper limb function for either the
experimental or control groups. Although this was a small study, an interesting
finding was that the positive changes found in the experimental group at the end of
the four week programme for gait endurance, gait speed and the number of step ups
on the Step Test, were maintained at two month follow-up. This finding indicates
that the programme was successful in affecting learning.
A small pre- post design study followed six chronic stroke patients all of whom had
sustained a stroke at least 12 months prior to the study (Monger et al 2002). The
45
Chapter 3
subjects in this study received a three week home-based exercise programme
where a physiotherapist visited three times weekly and prescribed and progressed
task specific training of step ups and sit to stand transitions designed to strengthen
lower limb muscles. Subjects were also asked to exercise themselves on the days
when they did not receive therapy. This study demonstrated an improvement on the
Motor Assessment Scale (MAS) for five out of the six subjects and an improvement
in walking speed for all subjects. Additional biomechanical analysis showed that the
mean peak vertical ground reaction force during rising to stand occurred closer to
the point of thighs off which was a shift towards more normal performance. The
findings related to the improvements in sit to stand score on the MAS must be
viewed with some caution, not only due to the small sample size but also it is
unclear whether the training undertaken by the six subjects consisted of practising
the precise criteria that are measured with the MAS.
A small study of a community based, low intensity strengthening programme for
people with chronic stroke has been reported recently (Cramp et al, 2010). Using
an A-B-A design, 18 people with a mean time of seven months post-stroke, were
recruited to attend a twice weekly, 60-90 minute exercise programme at a leisure
centre for a maximum of 14 weeks. Simple strengthening exercises using everyday
equipment such as chairs, steps and theraband formed part of the programme. To
be included in analysis, participants had to complete a minimum of 16 sessions out
of a possible 28 sessions (Cramp et al, 2010). Key findings from this work were that
in addition to improvements in gait velocity, Berg Balance scores and ADL,
statistically significant gains in strength in hip extensors, hip abductors, knee
extensors and ankle dorsi and plantar- flexors were evident after training.
Interestingly it was reported that the positive effect had been gained after eight
46
Chapter 3
sessions of training and for the majority of measures, no further statistically
significant gains were found after a further eight training sessions. While this study
demonstrated the feasibility of an exercise programme within a leisure centre setting
and positive results in relation to lower limb strength gains, the results need to be
viewed cautiously given the small sample size, marked variability in the amount of
training undertaken and a relatively recent mean time since stroke meaning that
some participants were in a “natural” phase of recovery.
Studies that have predominantly investigated strength training in chronic stroke have
been limited by low numbers and often a lack of associated task training to
maximise any functional gains, which could explain some of the equivocal findings.
The work by Monger et al (2002) was relatively resource intensive and the findings
would need to be replicated to lend any support to this approach. At this point
therefore, while it is clear that strengthening is not detrimental to people with chronic
stroke, there is no strong, generalisable evidence that strengthening programmes
result in significant positive changes for people with chronic stroke.
3.4.3. Studies of mixed strengthening, conditioning and mobility in latestage stroke
A number of studies have investigated the effects of community based rehabilitation
programmes which have tended to have a dual focus of improving strength and
conditioning or strength and mobility. Texiera –Salmera et al (1999) undertook a
small scale, randomised crossover trial recruiting 13 people at least nine months
post stroke. Six people received immediate and seven people received a delayed
10 week programme of strengthening and physical conditioning. Participants in this
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Chapter 3
study had relatively mild residual impairments in that they had to be able to
ambulate for at least 15 minutes, and undertake activity for 45 minutes with rests.
Supervised graded exercises included incremental walking, plus stepping or cycling
and lower limb strength training. It is not clear if data were normally distributed,
however parametric statistics were used throughout which may mean results should
be interpreted with caution. Key findings showed some impressive and statistically
significant improvements following the 10 week intervention programme. Gait speed
improved from 0.77m/s to 0.99m/s (+ 28%), stair climbing rate from 51 to 68 stairs
per minute (+37%), an increase in combined lower limb muscle strength in the
hemiplegic leg from 192 Nm to 240 Nm (+42%) and a reduction in the Nottingham
Health Profile Score from just under 10 to 3 (+78%). There were no significant
changes noted in lower limb spasticity.
The authors attributed these positive
findings, in part, to the combination of strengthening with functional endurance
training.
Another small scale study recruited 19 people with chronic stroke (mean time 44 or
49 months) into a crossover trial with participants receiving either an immediate or a
delayed 10 week low intensity exercise programme (Kim et al, 2004). An individual
10 week programme focusing on posture, gait, movement and ADL function was
provided, although precise details of the intervention were not clear. It appears that
a physiotherapist visited once a week for up to 60 minutes with participants
expected to practice independently, although strategies to ensure this were not
reported.
Following the intervention phase, a non statistically significant trend
towards improvement on the lower extremity component of the STREAM (Stroke
Rehabilitation Assessment of Movement) scale was noted. With the lack of detail
provided for this study it is not clear whether lack of significance was attributed to
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Chapter 3
the lack of power, low intensity intervention, compliance factors or a combination of
these issues.
Combs et al (2010) reported a series of A-B-A-A case studies on nine people with
chronic stroke of more than six months duration, with immediate (within a week) and
retention (five months post intervention) testing. The subjects were all fairly high
functioning stroke survivors, mobile at “unlimited household walker” level and able to
partially elevate the affected arm as well as grasp and release a cloth. Within these
case studies, participants followed a highly intensive two week programme of at
least three hours a day practice of walking, functional activities and strengthening
over five days each week.
The results demonstrated only small mean
improvements in activity based outcomes, but larger mean improvements in
participation measures of the Stroke Impact Scale (SIS) domains of perceived
recovery, physical ability and participation.
Subjects in this study were also
classified as high or low functioning depending on their Wolf Motor Function scores
and it was found that those subjects classified as low functioning made greatest
improvements.
In a slightly larger study, Hartman-Maier et al (2007) investigated the effects of an
intensive community group rehabilitation programme in 27 people at least 6 months
post-stroke and compared post-intervention data with 56 controls.
The authors
concluded that while the level of disability did not improve in the Intervention group,
the programme was beneficial in terms of increasing leisure activity and life
satisfaction, although these data should be viewed with caution as detail for the
community rehabilitation programme was not provided, so it is unclear what was
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undertaken and some variables (Stroke Impact Scale) were only reported for the
Intervention group.
In a single blinded RCT, 48 people at least a year post-stroke and discharged from
formal rehabilitation were recruited to either an experimental group (n=24) receiving
a four week programme (12 sessions) of a simple 30 minute circuit class or a control
group with no intervention (Yang et al, 2006). The circuit lasted for 30 minutes at
each session and consisted of six work stations using everyday equipment (such as
a chair) to allow participants to practice movements to improve lower limb strength.
Muscle strength was assessed using a handheld dynamometer and demonstrated
statistically significant differences between the groups with increases in all lower
extremity groups tested in the intervention group. A similar finding was reported for
measures of gait, a step test and the Timed Up and Go test (Yang et al, 2006).
Interestingly, the gains in strength were associated with functional improvements.
No information was available about long-term effects of the intervention however.
Furthermore, there are some areas of uncertainty about aspects of this study, for
example while it was noted that exercises were progressed and encouragement was
provided, it is not clear whether this was standardised and the experience of the
assessor in using the dynamometer was not reported which may affect the reliability
of the findings.
A similar intensity of intervention of 12 thirty minute circuit sessions over four weeks
was conducted in an RCT with 58 people at least six months post-stroke (median
3.9 years) in New Zealand (Mudge et al 2009). The intervention group (n=31) again
undertook simple exercises designed to improve gait, balance and strength while
50
Chapter 3
the control group (n=27) undertook group educational or social sessions. Measures
of gait, step count and activity were taken at the end of intervention and at a three
month follow-up. Small statistically significant improvements in gait endurance were
found at the end of intervention for the intervention group and for gait speed and self
reported gait ability at the end of the follow-up period. These findings however were
measured in the clinic setting and improvements did not translate to an increase in
reported community ambulation or step count. While the work was conducted in a
private rehabilitation clinic, the input was such that it could be relocated to a home
setting and it was noted that the participants wanted to continue with the exercise
circuit following cessation of the trial (Mudge et al, 2009).
A non-blind, randomised controlled trial (RCT) investigated the effects of a ten week
supervised out-patient exercise programme versus an unsupervised home
programme (one week of supervised exercise followed by nine weeks of
unsupervised) aimed at improving strength and conditioning in 72 ambulant, chronic
stroke survivors (Olney et al 2006).
This study found modest improvements in
walking speed for both groups but no gains in muscle strength. Interestingly, while
no short term physical effects were found in the unsupervised group, at one year
follow-up a significant improvement in the Human Activity Profile was demonstrated,
which may suggest that undertaking unsupervised exercise had positively impacted
on activity levels.
Stuart et al (2009) undertook a pragmatic, non-blinded trial of community based
exercise with people with chronic stroke. Participants were recruited from three
geographical regions in Italy, with those from one region receiving intervention
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Chapter 3
(n=49) and those from the two other regions acting as controls and receiving “usual
care”. The intervention group received a 13 week programme of three times weekly
exercise classes concentrating on strength, balance and walking rehabilitation, with
a progressive increase in walking time from six to 15 minutes during the course of
the study. Mean change scores were reported. between baseline and six month
follow-up and showed that
the participants in the intervention group showed
statistically significant improvement on all measures of gait, balance and ADL over
the six month period, while the control group showed a slight deterioration in many
of the measures including gait velocity, Berg Balance Scale, Short Physical
Performance Battery (SPPB) scores and self-rated participation on the SIS.
Between groups there was a significant difference, in favour of the intervention
group, for many of the mobility and balance outcomes but not ADL (Barthel) or the
self-rated domain of mobility on the Stroke Impact Scale. While these changes are
noted, the findings must be viewed with caution due to the non-randomised nature
of the trial and the fact that the outcome assessor was not blinded to group
allocation which may well have confounded findings. Furthermore, some of the
changes such as gait velocity, were very small e.g. 0.07m/s gain in gait speed over
six months, which clinically may not manifest in any noticeable change in
performance.
In a rigorously designed RCT the effect of a 12 week programme of exercise or
relaxation classes on 66 people with stroke was investigated (Mead et al; 2007).
Although the median time since stroke to starting the intervention was six months,
some subjects were recruited at less than three months post-stroke, so the sample
was a mix of sub-acute and chronic stroke, albeit all were no longer receiving
rehabilitation. The intervention consisted of a one hour mixed exercise class, with
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exercises progressed every two to four weeks, or a relaxation class for control
subjects as well as a “tea and chat” social component at the end of each class for all
subjects. Measures of impairment, activity and participation were taken at baseline,
end of intervention and at a four month follow up.
Data were transformed to allow
parametric analysis by Analysis of Covariance (ANCOVA) which allowed
comparison of performance between groups at end of intervention and follow-up
controlling for baseline levels.
While both groups improved on a number of
measures within their group over time, there was only a difference between the
groups for Timed Up and Go, walking velocity and the physical domain of the SF36
at the end of intervention in favour of the exercise group, with only the SF36 score
improvement being retained at the four month follow up. While there are a number
of strengths to this study including the clearly described interventions and attention
to progression as well as accounting for confounders such as social interaction,
there were some limitations – most notably that many of the participants may have
been considered to be in the “natural” improvement six month window following
stroke as well as the high functional level (eg independently ambulant) of the
participants.
In an investigation of the effects of two different community based exercise
programmes, Marigold et al (2005) measured balance, mobility and number of falls
in 61 people with chronic stroke. The subjects in this study were functioning at a
relatively high level as they not only had to travel to a setting outwith the home, but
also had to tolerate activity for an hour. There was however, about 20% drop out
with only 48 subjects completing post-intervention assessments and 42 available for
one month follow up measures.
The study was well controlled with subjects
randomised either to receive a 10 week programme of three times weekly one hour
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exercise classes either focussing on stretching and weight shift exercises such as
tai chi movements or reaching tasks, or on increasingly demanding balance and
mobility tasks such as altering the base of support, increasing the height of
obstacles. In addition to a battery of outcome measures, subjects kept a falls diary
over a 12 month period from recruitment into the study. It was found that subjects
adhered well to the exercise programme with over 92% attendance for both groups.
Both groups showed improvements in step reactions times, lower limb muscle
activation, timed up and go, reduction in number of falls over 12 months and the
Nottingham Health Profile, however only step reaction time, muscle activation and
number of falls were significantly improved in the agility compared to the stretching
group. The effect of the group, as well as the content of intervention, may well have
had an impact on the findings in this study.
A number of smaller scale case studies or pre-post design studies have been
undertaken which, while they can be perceived as less robust in terms of being able
to generalise findings, may show some interesting information that may inform future
work.
Twenty years ago, Tangeman et al (1990) reported a pre- post trial of
rehabilitation aimed at improving balance and function. Forty subjects with chronic
stroke recruited to this study underwent four weeks of intensive (two hours daily)
rehabilitation aimed at improving function and balance. The detail of the intervention
is not fully described but does identify that the rehabilitation consisted of one hour
each of Physiotherapy and Occupational Therapy. Disappointingly, given the time
at which this work was undertaken, results were measured using non-validated,
non-standardised measures of balance, weight shift and activities of daily living.
Therefore, while the authors reported that there were significant improvements in
weight shift ability, balance and ADL between the start and end of the programme,
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any claims have to be viewed with caution as the measures did not have established
reliability or validity. Additionally this work can not be compared rigorously to any
other published studies with a similar focus on balance and functional ability in
chronic stroke.
In a small pre- post design study, six people at least one year post-stroke undertook
a three week programme of task specific exercises at home (Monger et al 2002).
Participants practised 30 repetitions of rising to stand (RTS) and step ups daily and
received nine visits from a therapist. Measures of rise to stand and walking speed
showed statistically significant improvements at post testing. The improvement in
RTS was impressive with gains of two or more points on the Motor Assessement
Scale RTS item for all but one subject. However, the lack of a retention test does
not allow comment to be made as to whether the changes were transient or
sustained as learnt behaviour over a longer term.
While findings from small scale studies can not be generalised to the wider stroke
population, these studies can be useful in determining whether further work might be
appropriate.
Useful information can also be gleaned in relation to trial design,
composition of interventions and relevant outcomes to be used for future studies. A
body of evidence relating to small gains in selected gait paramenters and muscle
strength is becoming apparent following short, four week, interventions of simple
mixed programmes of strengthening, balance and gait training for people with
chronic stroke.
Interestingly, it appears that the duration of intervention of an
appropriate input, does not require to be protracted in order to show some positive
impact for people with chronic stroke.
Many of the studies however, failed to
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consider the long-term effects of the intervention and this is an area that requires to
be included in rehabilitation for people with chronic stroke.
3.4.4
Studies of upper limb rehabilitation in late-stage stroke
It is estimated that around 80% of people who have a stroke have some degree of
upper extremity impairment (Nakayama et al 1994; Parker et al 1986).
In
comparison to recovery of lower limb function and mobility, functional recovery of
the arm is often incomplete or completely absent and this feature will often have a
negative impact on the ability to undertake activities of daily living (ADL) (Wade et al
1983; Parker et al 1986; Heller et al 1987, Feys et al 1998). Interventions such as
Constraint Induced Therapy (CIT) or Functional Electrical Stimulation (FES) will not
be considered in this section, as the focus of this review will continue to be on nontechnological interventions that are suitable for undertaking in the community
setting. Some studies of mixed UL and LL interventions have been considered in
section 3.3, therefore this section includes only studies focusing on community
based UL interventions.
A 19 week group exercise programme concentrating on either upper limb (UL) or
lower limb (LL) exercises was reported by Pang et al (2006). The group nature of
the programme was advocated as a means of increasing accessibility to ongoing
rehabilitation. 63 community dwelling people with late stage stroke of more than
one year were matched, by gender, prior to randomisation. The study had originally
been designed to investigate a lower limb groups exercise programme on
cardiovascular fitness (with the UL group presumably acting as control subjects) and
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therefore participants in this study were required to be at a relatively high level of
function as they were required to pedal a cycle ergometer at 60rpm.
The UL
intervention consisted of shoulder exercises using theraband of increasing
resistance; hand and arm strengthening, hand and arm mobilising, hand and arm
weight bearing and UL functional activities. Measures of functional activity, arm
recovery, grip strength and arm use were taken at baseline and at the end of the 19
week intervention. Three of the original participants dropped out of the study – two
because of the time commitment and one who found the exercises too fatiguing.
Analaysis of Covariance (ANCOVA) showed statistically significant improvements in
the UL group on the Wolf Motor Function Test and the UL section of the FMA
compared to the LL group. There were no statistically significant differences in grip
strength or Motor Activity Log scores. While limited detail of the intervention was
provided in the paper, an exercise log book was completed for each patient. This
log book may have had a motivating effect on the cohort which may have influenced
findings. One of the key weaknesses of the study is that the inclusion criteria were
heavily weighted towards fitness levels and lower limb ability (cycle ergometer). If
the study had required as stringent UL inclusion criteria, there may have been
further improvements, for example 10 of the subjects were classified as “severe” UL
paresis, and some participants (number not stated) required electrical stimulation to
activate wrist extension which potentially impacted on the ability to grip the
dynamometer required for measuring grip strength.
Furthermore, no long-term
follow up data were given, therefore it is not clear whether any of the changes in
performance were sustained.
Another large study of 91 people with late-stage stroke was reported by Higgins et al
(2006).
Participants were randomised to receive arm or mobility training and
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attended eighteen 90 minute treatment sessions over six weeks. The intervention
was tailored to the individual, and the UL group used everyday objects while the
mobility group concentrated on balance and speed during walking. All participants
undertook a supplementary home exercise programme. Results were reported for
UL measures and while there were some clinical improvements, with an increase for
the number of blocks moved, no statistically significant changes were found on any
outcomes despite the intensive and individualised training. It could be argued that
the intervention may have been too individualised and that intensive practice on
tasks with a high degree of standardisation could be more applicable for an RCT
where a proportion of the participants had severe UL impairments.
In a study of task specific training undertaken in the participant’s home, Michaelsen
et al (2006) recruited 30 people between six months and four years after stroke.
Randomisation ensured that equal numbers of participants with mild or moderatesevere UL impairment were allocated to each group.
A therapist supervised a
programme of reach and grasp, task specific exercises, undertaken for one hour,
three times a week over five weeks. Both intervention and control groups undertook
the same exercises, with the intervention group being restrained by a “seat-belt”
during the task to prevent concurrent trunk movements. Practice followed motor
learning principles and included functionally relevant, repetitive practice of reach to
grasp movements with target objects of varying size, shape and weight. Functional
UL outcomes and kinematic measurements of the trunk and elbow during reaching
were taken at baseline, end of intervention and at a one month follow up. It was
found that both groups improved their function and demonstrated reduced UL
impairment, however this improvement was only statistically significant for the
intervention group.
There were no significant differences in trunk displacement
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during reaching, the intervention group however showed a significant increase in
elbow extension during reaching compared to the control group. Further analysis
showed that the mildly impaired control subjects made the least improvements and
that for mildly impaired intervention subjects, trunk restraint provided no additional
benefits . While this study might be considered peripheral to the community based
home exercise interventions that may inform the current study, it did demonstrate
the capacity for improvement in UL function in people at least six months after
stroke.
However, it required considerable therapist contact, and artificially
restrained a movement component which detracts from the general uptake of this
type of intervention.
In a small study of 12 people at least five months post-stroke, Thielman et al
(2004) investigated the relative merits of task specific training compared to
resistance training of reaching. Participants were classed as “low” or “high” level
of arm function depending on upper limb scores on the Motor Assessment
Scale. All participants practiced movements to similar targets. Approximately
150 – 180 repetitions of each exercise was undertaken in each exercise session
A kinematic analysis demonstrated some modest improvements in upper limb
trajectories during reaching, including improvements in participants classified as
low level. It is not clear whether improvements were sustained as no follow-up
was undertaken. Once again, this small study demonstrates the capacity for
improvement late after stroke, even in people with poor function at start of the
study.
3.4.5
Summary points from studies of late-stage stroke rehabilitation
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Many of the studies reviewed in this chapter indicate the potential for improvements
for people with chronic stroke following rehabilitation. However, improvements were
often small (e.g. Higgins et al 2006) and sometimes transitory (e.g. Olney et al
2006). Furthermore, in some of the studies changes were not necessarily limited to
the intervention group which raised the question of a Hawthorne effect.
Many different methodologies were employed and this makes cross study
comparison difficult.
Sample sizes were highly variable and ranged from six
(Monger et al 2002) to 170 (Green et al 2002), with five studies reporting group
sizes of <20, which would limit generalisation. The interventions were often not well
defined and therefore would make replication difficult. Furthermore, the amount of
intervention was highly variable and low intensity interventions may have
confounded the possibility of demonstrating positive effects.
In table 3.1. the myriad of outcome measures used in studies of community-based
interventions for people with late-stage stroke are identified.
This makes
comparisons between studies difficult. To further compound this issue, there were
no standardised outcome measurement schedules. One of the biggest weaknesses
was the lack of retention measures. This meant that any changes identified at one
time point, may have been either a reflection of permanent change in ability as a
result of learning, or it could have been a transient change in performance that
would not be sustained. The number of times that outcome measurements were
taken also varied, from two in pre-post designs (such as Texeira-Salmela et al
1999), to ten repeated monthly outcome measures (Wall and Turnbull 1987). One
of the dangers of many repeated outcome measures is that changes could be due to
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a practice effect on the measure (improving performance on the measure) rather
than an improvement in the characteristic of interest.
At the time of planning the current study (1999 and 2000) only limited evidence
relating to the efficacy of later-stage stroke rehabilitation was available (Wade et al
1992, Dam et al 1993, and Texeira-Salmela et al 1999). Thus the evidence at that
time indicated large gaps in the literature and therefore great potential for
investigating further the impact of a clearly defined physiotherapy exercise
programme for people with chronic stroke.
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Table 3.1 Summary of Community based exercise programmes for people with late-stage stroke
EVIDENCE FOR LONG-TERM REHABILITATION
Authors
Design
Sample
Age (yrs)
Time since
stroke
Intervention
Main findings
Wall &
Turnbull 1987
n = 20 allocated
to 4 groups
range 45-70
Range
1.5 – 10 years
x
65.6 (+
10.9)
x
3.1 yrs (+
3.9)
Wade
1992
Randomised
cross over
Chronic (>12
months poststroke)
n = 40
Indep ambulant
Chronic (> 1 yr
post-stroke)
Early int n =49
Late int n = 45
6 months Ix
A - 2 hrs per week OP exs
B – 2 hrs week home exs
C – 1 hr home /1 hr OP exs
D - control
4 week treatment = 2
hrs/day x 4 days /wk
(focused on balance and
functional activities)
No difference between groups on gait parameters
Tangeman
1990
Nonrandomised
Repeated
measures
pre-post
Pre-post
design
EI: x 72.3 (+
9.7)
EI: x 53.1
mth (+29.5)
10mwt(s) EI -3.9s; +6.5s; -1.4s
LI +6.4s; -3.9s; +2.6s
LI: x 72.0 (+
10.6)
LI: x 59.6
mth (+35.3)
Both groups received 6 wks
physiotherapy (between 1 -6
visits) either after baseline
assessments (EI) or after a
3 month delay (LI).
Followup at 9 months
Complex – up to 7
consecutive “bouts” of daily
therapy lasting 1 – 3 months
every 3 months, with at
least 1 month between
“treatment bouts”
Both groups: 10 wk
programme (3x / wk) of
graded strength and
physical conditioning
I: immed
C: delayed 10 wks
Dam
1993
Nonrandomised
Sub-acute /
chronic.
Non-ambulant >3
mths post-stroke
n=51
x
66.8
(+ 10.1)
> 3 months
TeixeiraSalmela
1999
Randomised
pre- post test
trial
with delayed
intervention
for C group
Chronic (>9
months poststroke)
I: n= 6
C: n=7
I: x 65.9 (+
10.2)
C: x 69.4 (+
8.9)
I: x 9.2 (+
12.7)
C: x 6.4 yrs
(+ 6.2)
2 baselines (1 mth apart), end intervention, 3 month follow-up
Non-validated measures of weight shift, balance and ADL
At 12 months
BI -  by 65% with two thirds attaining good level of ADL (BI >
70)
HSS – total  by 25%
HSS – gait  by 42%
HSS – motor  by 13%
Statistically significant improvements (p>0.007) in
 gait speed by 28%
 adjusted activity score 39.2%
 rate of stair climbing 37.4%
 NHP of 77.8%
 affected leg strength 42.3%
62
Chapter 3
Authors
Design
Sample
Age (yrs)
Time since
stroke
Intervention
Main findings
Dean
2000
Matched
pairs
randomised
design
I x : 66.2
(+ 7.7)
C x : 62.3 (+
6.6)
I x : 2.3 yrs (+
0.7)
C x : 1.3 yrs
(+ 0.9)
RCT
I x : 71.5 (+
8.7)
C x : 73.5 (+
8.3)
I: >12 mths
C: >12 mths
I = 1 hr circuit class ( ↑
functional performance and
endurance of LE tasks) over
4 weeks
C = 1 hr circuit class ( ↑
functional performance and
endurance of UE tasks) 3x
week over 4 weeks
I: max 13 weeks with min 3
contacts by community
physiotherapist at home or
as OP
C: no intervention
At end of intervention and two month follow up
Experimental group demonstrated
Gait speed 
Gait endurance 
Force production through affected LL when standing up
Step Test 
Green
2002
Sub-acute /
chronic.
Convenience
sample n=12 >3
months poststroke no longer
receiving
rehabilitation
Chronic >12 mths
170
I: n= 85
C: n=85
Monger
2002
Pre-post
design
Chronic >12 mths
n=6
x
65 (+ 5
x
3.6 yrs (+
2.9)
3 week task specific training
of step-ups and sit-to-stand
transitions
Kim 2004
Randomised
crossover
design
I 1 x : 61.4
(+ 11.2)
I2 x : 62.8 (+
9.4)
I 1 x : 44mth
(+ 29.6)
I2 x : 49.2 (+
31.6)
10 weeks of once weekly 60
min home programme of
posture, gait, ADL and
motor exs
McClellan
and Ada
2004
RCT to
improve
mobility;
home ex with
minimal
supervision
N = 19
I1 (n=9) = immed
home PT
I2 (n=10)=
delayed home PT
I n=13;
C n=10
I: x 69 (+
13)
C: x 72 (+
9)
I median
6.5mth (IQR
5.5mth)
C median
4.5mth (IQR
3mth)
I: 6 weeks home practice of
mobility exs taught in
hospital environment
C: 6 weeks home practice of
UL exs
No changes in control group
Outcomes at baseline, 3, 6 and 9 months
RMI
Gait speed over 10m
BI
FAI
HADS
Pre- post- intervention
MAS (standing up)  in 5 /6 participants
10mwt: in walking speed in all subjects
Grip strength: no change
Both groups showed significant in STREAM LE after
intervention phase
Baseline, end intervention (6 wk), 2 month follow up (14wk)
FRT: significantly more in I at both 8 and 14 wks follow up
MAS (walking):  in both gps, no difference
SA-SIP30: no significant changes over time in either group
63
Chapter 3
Authors
Design
Sample
Age (yrs)
Salbach 2004
RCT stratified
by initial
walking
speed
I: n = 44
C: n = 47
I:
Thielman
2004
Matched
pairs, prepost-design
Chronic ( > 5
mths)
N = 12
Marigold
2005
RCT of agility
exs vs
stretching/
weight
shifting
RCT
Higgins
2006
Michaelsen
2006
Randomised
pre-post
design
Time since
stroke
Intervention
Main findings
I: x 7.9 mth
(+ 2.9)
C: x 7.2 mth
(+ 2.4)
I: 6 weeks (3x / week) circuit
of balance, leg strength and
gait exs
C: seated arm exs
At end of intervention
6mwt - 40m (I) compared to 5m (C)
Gait speed 0.14m/s (I)compared to 0.03m/s (C)
TUG 1.2 s (I) compared to 1.7s (C)
Range 54 –
83
5 – 19 months
Smoothing of trajectory of arm kinematics
Improved trunk movement during reaching
Chronic>12mths
post-stroke
n=61
I(agility) n= 30
I(stretch) n=31
activity tolerance
@ 60 mins
I(agility) x :
68.1 (+9.0)
I(stretch) x :
67.5 (+ 7.2)
I(agility)
4 weeks of 35 mins
intervention
3x weekly
Task Training vs Strengthen
10 week group exercises,
3x weekly for 1 hour per
class
Agility: progressively difficult
balance tasks
Stretch: slow, low impact tai
chi and reaching exercises
Late-stage
N = 91
I(upper limb)
I (mobility)
Chronic between
6-48 months post
I n= 15
C n = 15
I(UL)
x : 73
I(mob) x : 71
I(UL)
3x week over 6 weeks
90 minutes each session
Individual functional task
practice
5 weeks = 1 hour, 3x per
week
Task specific reach and
grasp exercises with (Int) or
without (con) trunk restraint
in number of blocks moved on Box and block test
No significant findings
C:
x
x
71 (+ 12)
73 (+ 8)
x : 3.6 yrs
(+1.0)
I(stretch)
x : 3.8 yrs (+
2.4)
x : 7mths
I(mob) x : 8
mths
x 68.9 (+
10.3 years)
x 16.7 (+ 9.1)
mths
Outcomes at baseline, end intervention and 1 month retention
BBS - no significant difference between groups
TUG – trend towards improvement in agility group
Step reaction time – significant improvement in agility group
No. of falls – reduced by half in the agility group
Outcomes at baseline, end intervention and one month follow
up.
I - TEMPA Functional improvement
I - FMA reduced impairment
I - Kinematic reduced compensatory trunk movement and
improved elbow extension during reach
64
Chapter 3
Authors
Design
Sample
Age (yrs)
Time since
stroke
Intervention
Main findings
Yang 2006
RCT of
strengthening
circuit vs no
intervention
Non-blind
RCT:
supervised
vs nonsupervised
ex
Single blind
RCT
UL vs LL
(control)
training
Comparison
of I data to
an preexisting data
set (C)
Chronic
I: n=24
C: n=24
I
x : 56.8
C x : 60
I:
x 64.4mths
C: x 62.7mths
I: Gait speed ,  6mwt, TUG
I: strength hip, knee and ankle flex and extensors
Chronic
Sup ex: n=37
Non-sup n=37
Sup x 63.5 (+
12)
NSup ẋ65.8
(+11.6)
ẋ4.1yrs (+ 4.4)
ẋ3.4yrs (+3.9)
Chronic
I: n = 27
C: n=56
I
x : 61.59
C x : 57.7
I: 35.2mths
C: 11.7mths
I = 4 weeks (12 sessions) 30
minute circuit of 6 LE
strength exs
C = no intervention reported
Sup= 1.5hrs sessions, 3x
weekly over 10 wks
NSup = same as S wk1
followed by 9 wks
Exs include stretches,
aerobic ex and strength
Group programme 3x week
1 hr exercise over 19 weeks
UL gp – exs for UL, strength
and UL functional tasks
LL gp exs for mob and bal
I= group community
rehabilitation 2-4days a
week (not stated how long)
C = no group rehab
RCT with
blinded
outcome
assessor
Chronic
I: n=13
C: n = 12
I: x 59.5 (+ 11.8)
I:
Olney
2006
Pang
2006
HartmanMaier
(2007)
Yang 2007
Chronic
UL gp n=30
LL gp n=30
UL
LL
C:
x =64.9
x =66
x
59.2 (+ 12)
UL
LL
x =5.1
x =5.2
x 4.1 (+ 3.1)
C: x 4.7 yr (+
7.4)
I: 12 x 30 minutes sessions
over 4 weeks of ball
manipulation, bouncing and
kicking
C: no intervention
Overall modest physical gains
6minwt: Both S and NS signif at post, 6 mths and 1 year
HAP: cont  in NSup gp to be signif at 1 yr, non sigat 10
wks but then decline
No change in strength over time in either gp
PCI: Sig in NSup gp only at 1 yr.
Overall UL group – stat significant ↑ in UL functional ability :
WMFT
FMA
FIM – Both groups dependent I worse than C (P=0.004)
L-ADL – no significant difference between groups
ACS – only reported for I group significant activity pre-post
intervention, but C group more active at baseline
LSQ – significantly more satisfaction with life as a whole and
leisure for I group.
SIS – only administered to I group
At end intervention statistically significant  in,
gait speed by 0.3m/s, cadence, stride time and stride length
for I group.
65
Chapter 3
Authors
Design
Sample
Age (yrs)
Time since
stroke
Intervention
Main findings
Mead
2007
RCT of
exercise vs.
relaxation
Sub-acute /
Chronic
I: n= 32
C: n= 34
I:
x 72 (+ 10.4)
C: x 71.7 (+
9.6)
I: median 178
days (IQR 86 –
307)
C: median 161.5
days (IQR 91.8 –
242.8)
12 weeks group intervention
3x wk in rehabilitation
hospital
I: ex group including
endurance and prog
resistance training
C: group relaxation
Mudge
2009
RCT with
blinded
outcome
assessor
Chronic
I: n = 31
C n = 27
I: median 76
C: median 71
I : median 3.3 yrs
C: median 5.8 yrs
I: 12 x 30 minutes circuit
over 4 weeks, circuit 15
stations – targeting strength,
balance and walking
C: social and educational
sessions
Outcomes at baseline, end of intervention (3 months) and
long term retention (7 months)
I (3 months): on SF36; STS time; TUG; HADS; bilateral leg
extensor strength; FRT and walking economy
I (7 months):  maintained in leg strength, HADS and
STStime.
C (3months) walking speed; SF36 (mental health domain),
extensor strength of unaffected leg. These were maintained
at C (7months)
Gait endurance - statistically significant  at end intervention
for Intervention group,
Gait speed statistically significant  at 3 month follow up for
I group.
RMI statistically significant  at 3 month follow up for I
group.
Stuart
2009
Nonrandomised
trial
Chronic (>9
months poststroke) with mild
to mod gait
impairment
I: n=49
C: n=44
I:
x 66.8 (+ 1.4)
C: x 70 (+ 1.7)
I:
x 4.2yrs (+ 0.8)
C: x 3.5 yrs (+
I: 3x week 1 hr exercise
(walk, strength, balance) for
13 weeks
C: “usual care”
Nb non-blind
outcome
assessor
0.5)
Overall small physical gains in I group but also some gains
for C subjects over study period
Gait velocity over 6minwt I:  by -0.07m/s; C:↓ by 0.05m/s
MI (0-100) I:  by 7.4; C: ↓ by -2.1
SPPB (0-12) I: by 1.58; C: ↓ by -0.84
BBS (0-54) : I:  by 5.1; C: ↓ -1.5
BI (0-100) : I:  by 3.9; C: ↑ by 0.7
I = Various  in SIS communication, SIS mobility and
SIS participation and for control in same domains
66
Chapter 3
Authors
Design
Sample
Age (yrs)
Time since
stroke
Intervention
Main findings
Combs
(2010)
9 case
Studies
Ambulant; able
to pick up
flannel with
affected hand
x 58.1
(+ 12.5)
x 6.5 yrs (+
5.8yrs)
Small mean  in activity measures WMF, BBS, TUG, 6minwt
with small effect sizes.
mean  in participation measures SIS and COPM with 5
subjects reporting minimal clinically important differences
(10-15 points) on SIS
Cramp
2010
Repeated
measure
A–B–A
design
N = 18
Sub-acute to
chronic
(between 3 – 12
months post –
stroke)
x
x
A1-B-A2-A3 design
(A1: pre; A2: 1 wk post; A3:
5mths post)
3 hrs daily, 5 days per week
over 2 weeks,
- 7 exercises daily from
bank of over 50 individual
exs
plus 30mins home ex
A1 – 4 weeks
B - 14 weeks, twice weekly
exs (60-90mins); low
intensity, no special
equipment
A2 – 5-10wk follow-up
Table 3.1
65 (+ 2)
time 7 months
Outcomes after 8 interventions (n=17) and after 16 (n=15)
 in LE strength after 8 and 16 interventions
 in Gait velocity, after 8 interventions
 6mwt after 16 interventions
 Berg balance after 16 interventions
 in Nottingham ADL after 16 interventions
Summary of studies of community based exercise programmes for people with late-stage stroke (arranged chronologically)
67
Chapter 3
Key for table 3.1
Abbreviation Name of Outcome Measure
ABC Scale
ACS
BI
BBS
COPM
FAI
FIM
FIM motor
FRT
HADS
HAP
HSS
Lawton IADL
LLFDI
LSQ
MAS
MI
NHP
PCI
RMI
SA-SIP30
SF36
SPPB
SIS
Strength
STS time
TEMPA
TUG
WMFT
6mwt
10mwt
Activities-Specific Balance Scale
Activity Card Sort
Barthel Index
Berg Balance Scale
Canadian Occupational Performance Measure
Frenchay Activity Index
Functional Independence Measure
FIM Motor (for Basic ADL)
Functional Reach Test
Hospital Anxiety and Depression Scale
Human Activity Profile
Hemiplegic Stroke Scale (Graded Neurological Scale)
Lawton Instrumental Activities of Daily Living
Later Life Function and Disability Instrument
Life Satisfaction Questionnaire
Motricity Index
Nottingham Health Profile
Physiological Cost Index
Rivermead mobility Index
Stroke Adapted Sickness Impact Profile
Short Form 36
Short Physical Performance battery
Stroke Impact Scale
Muscle Strength
Time to stand Up
Test of Upper Extremity Performance
Timed Up and Go
Wolf Motor Function
Six min walk
10 metre walk test
Possible Score
0-100
0-20 or 0-100
0 - 54
0 - 45
18 - 126
(pos score 13-91)
distance
0 - 21
0-23
0-48
0 - 100
1 - 15
0 - 100
0 - 12
0 - 100
Nm
Timed
0-39
Timed
Timed
Timed or gait speed
68
Chapter 3
3.5 Services available to people with stroke following cessation of formal
Rehabilitation
This section considers services available to people with chronic stroke once
discharged from hospital rehabilitation services. In large part, this is dependent on
geographical location and healthcare funding, however there is no doubt that with
increasing healthcare costs and reduction in healthcare budgets and resources,
services will be reduced.
Guidelines for stroke rehabilitation and ongoing care exist in the United Kingdom
(SIGN 2010; RCP 2008). While these guidelines are not directives, they indicate
best available evidence-based practice and have been developed, in part, to
improve what has been reported as insufficient and poorly coordinated services
(Pound et al 1994; Pound et al, 1995; LeWinter and Mikkelsen 1995). Tyson and
Turner (2000), conducted an audit to assess the services available to people with
stroke, six weeks after hospital discharge, as well as a survey of how these services
were viewed by the patients. While most people received a home visit, this was
limited to assessment of basic care and more intricate tasks (such as using the
telephone) were not tackled, the survey of patients also revealed frustration with
promised services that did not materialise (such as respite care, ongoing therapy or
meals on wheels). In relation to ongoing therapy, while around half of the sample
was referred on for continuing rehabilitation, not all of them received this service. A
tension was identified between patients who were dissatisfied at the lack of available
therapy and the rehabilitation staff who felt that not only was there a lack of
resources to provide ongoing rehabilitation, but also a lack of belief in the benefits of
ongoing rehabilitation.
69
Chapter 3
Green et al (1999) looked more specifically at community physiotherapy provision
for people at least a year post-stroke in Bradford, UK. Over a one year period, 83
referrals for physiotherapy were received which represented just 3% of the service
referrals for that period and treatments mostly focussed on mobility, balance and
“exercise therapy”. The number of treatment interventions was limited with modal
contacts being one session. Questions were raised by the authors as to whether
the low referral rate reflected genuine need or a reflection of opportunistic referral,
however the relatively low workload for community staff was highlighted.
3.6 Summary
This chapter has considered evidence relating to physiotherapy and stroke
rehabilitation with an emphasis on the evidence to support physiotherapy and latestage stroke. It is clear that there is potential for improvement in functional status for
community dwelling people with late-stage stroke, however it is not clear what input
will lead to the most effective outcomes.
Further research into the long-term
effectiveness of physiotherapy in large, well controlled, randomised trials outwith the
hospital environment is clearly required.
70
Chapter 3
4. MOTOR LEARNING THEORY AND REHABILITATION
4.1
Introduction
In this chapter, consideration will be given to learning of different types of motor
skills, theories of motor learning, and how practice sessions can be structured.
Much of the formative work in the field of Motor Learning derives from psychologists,
sport and exercise scientists, developing practice situations in which a new skill can
be best learnt (e.g. factory line assembly tasks) or how to refine an existing skill in
order to improve sporting performance. Therefore, much of the evidence derives
from work undertaken with subjects with an intact neurological system, in particular
young college students.
In physiotherapy the findings from the field of motor
learning have been applied, with little or no empirical testing to rehabilitation practice
in people with neurological impairments. Throughout this chapter, the background
from which evidence has been developed will be made clear.
Motor Learning focuses on understanding how movement is acquired and how
movement is modified (Shumway Cook and Woollacott 2007).
This description
differentiates Motor Learning from the concept of Motor Control which is concerned
with the ability to regulate movement. Clearly Motor Control and Motor Learning are
intricately linked as it is not possible to acquire movement without learning how to
regulate it.
Motor Learning can not be observed but may be inferred from
performance. Some key terms require definition from the outset and these terms
are identified below. Motor Learning has been defined as:
“a set of processes associated with practice or experience leading to
relatively permanent changes in the capability for producing skilled action”
(Schmidt and Lee 2005 p302; Shumway Cook and Woollacott 2007 p22)
71
Chapter 4
Motor Learning
This definition identifies that important elements to consider in Motor Learning are
practice or experience of movement and the resultant ability to generate skilled
action. One critical issue when considering Motor Learning is the importance of
distinguishing between the potentially transient features of performance of a skill,
with the longer lasting or relatively permanent changes associated with learning.
Performance is generally considered as undertaking a specific skill, in a specific
context at a specific time. As performance improves, then variability of action when
undertaking the skill will reduce as performance becomes refined (Magill 2001;
Schmidt and Lee 2005). Learning, on the other hand, is considered a relatively
permanent change in the ability of an individual to perform a skill (Schmidt and Lee
2005; Shumway Cook and Woolacott 2007). If therefore, a physiotherapist works
with a stroke patient to improve their ability to stand up and by the end of the
treatment session the patient is able to stand up independently that can be
considered a change in performance. If the patient then maintains that ability to
consistently stand up independently the next day and the next week, then this
consistent performance will be indicative that learning has occurred.
In terms of rehabilitation for people with stroke who were previously able to perform
skilled actions, the learning of a “lost” or “impaired” motor skill has been described
variously as “motor relearning” (Carr and Shepherd 1980) or “recovery of function”
or
“reacquisition
of
movement”
Hochstenbach and Mulder 1999).
(Shumway
Cook
and
Woollacott
2007;
Studies of motor learning have generally been
designed with two phases – an initial practice or “acquisition” phase to ascertain
performance and a subsequent retention phase or test. The purpose of taking a
retention test is to ensure the diffusion of any performance enhancing factors (such
72
Chapter 4
Motor Learning
as feedback) or performance degrading factors (such as fatigue) that may have
impacted on the learning situation.
A general aim in stroke rehabilitation is to promote as optimal a return to function as
possible. For people with stroke therefore, there is a need to practice movement
skills in relation to everyday tasks.
Stroke patients need to practice both with
supervision as in therapy and without supervision which is highly applicable to later
stages post-stroke. There is a tension here however, while chapter three identified
the emerging literature to identify the potential for people with chronic stroke to
make positive improvement in motor functions with some targeted rehabilitation
interventions, little cognisance has been given to the optimal practice regimes for
relearning motor skills.
This chapter therefore aims to summarise current
knowledge and understanding of Motor Learning.
4.2
Types of Motor Skill to be relearnt
A motor skill has been defined as “an activity or task that has a specific purpose or
goal to achieve” (Magill 2007 p 5). In the motor learning literature, the terms “skills”,
“motor skills”, “actions” and “movement” can be used interchangeably (Magill 2007).
While it has been argued that “movement” can be argued to represent specific
“behavioural characteristics” of body parts that are the component parts of a motor
skill, (Magill 2007), the terms will be used interchangeably throughout the chapter.
Motor skills have been classified in a number of different ways in order to enhance
communication about the demands of each task, to structure rehabilitation and to
enhance research. These classifications are briefly considered below.
73
Chapter 4
Motor Learning
4.2.1 Open and Closed Motor Skills
When looking at a skill in an environmental context, skills have been classified on a
continuum from being performed in a relatively stable and highly predictable
environment – a “closed skill” - to those performed in an unstable environment with
random factors that may affect performance – an “open skill” (Carr and Shepherd
2003; Magill 2007; Schmidt and Wrisberg 2008).
Most motor skills lie somewhere
inbetween the two extreme endpoints. It may well be that in stroke rehabilitation,
the initial focus of motor skill relearning may be on closed skills such as standing up
from a standard height chair in a gym setting with no time pressures and minimal or
no environmental distractions with the aim to progress a patient with a high level of
recovery to performing the skill in a less predictable, unstable environment such as
standing up from a bus seat on a moving bus.
4.2.2 Discrete, Serial and Continuous Skills
When learning a new skill, or re-learning skills as in rehabilitation, the trainer or
therapist needs to consider the demands of the task.
For example a key
characteristic might be the ability to generate rapid force production (a long jump
take-off) or to coordinate the movement of forward trunk flexion with extensor force
production in the lower limbs when rising to stand. The demands of the task, and
the ability to structure practice to train for the task are key elements that the
physiotherapist needs to take cognisance of.
A “discrete skill” is considered one with a distinct start and end point (Schmidt and
Lee 2005). A discrete skill may be kicking a ball, standing up or writing one’s name,
the end of the movement is clearly defined and not random. While discrete tasks
74
Chapter 4
Motor Learning
requiring less cognitive input, may be performed rapidly, some discrete tasks with
greater cognitive involvement, such as writing, may take some time to complete.
Research into discrete task skill acquisition has often taken the form of button press
in response to a stimulus or the learning of a specific pattern of dextrous
movements.
A “Serial task” is considered as a task that consists of a set of individual movements
(Schmidt and Lee 2005). Serial tasks may be considered as a sequence of discrete
tasks that are performed in succession, for example brushing ones teeth or getting
out of bed. While many elements of a serial task may have a discrete start and end
point, it has been argued that the longer time to perform serial tasks and the
effortless way in which a skilled performer accomplishes the many different
elements of the task enables a separate classification to be recognised (Schmidt
and Wrisberg 2005).
A “continuous skill” has no clearly defined start and end point, therefore they often
tend to be cyclical or fluid (Schmidt and Lee 2005).
In a continuous task the
movement can continue for a prolonged time and the end point would be considered
arbitrary.
Continuous tasks are often rhythmical such as walking, or require
constant adaptation and tracking such as steering a car.
4.2.3 Gentile’s Two-Dimensional Taxonomy of tasks
While the above classifications of tasks and skills provide some description of the
complexity of the task, they fail to give a more comprehensive overview of task
75
Chapter 4
Motor Learning
demands that physiotherapists may require to take into consideration when
undertaking rehabilitation and developing appropriate interventions.
In an attempt to overcome this, Gentile (1978) proposed a two-dimensional
classification system, specifically for physiotherapists, that took into account both
the environmental demands as well as the actions required by the learner in order to
complete the task (see table 4.1).
The required actions are then further classified
depending not only on required movements of the body, but also manipulation of
external objects.
The environmental demands take into account whether the
environment is stationary or mobile and whether the “regulatory conditions” under
which the task is performed are static or variable. As can be seen from table 4.1,
the complexity and demands of the task increase as one moves through the
classification from top left to bottom right.
This classification has been widely acknowledged as having wider application in
teaching motor skills in a variety of settings (Magill 2007; Schmidt and Wrisberg
2005).
It also provides an excellent basis upon which to structure practice in
rehabilitation, giving clear guidance as to how to manipulate tasks to increase or
decrease task demands. Many of the tasks physiotherapists set for their patients to
practice are towards the top/left of the matrix (e.g. less demanding).
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Table 4.1.
Closed skills
Open skills
ENVIRONMENTAL CONDITIONS
ACTION REQUIREMENTS
Stationary
Regulatory
Conditions and
No intertribal
variability
Stationary
Regulatory
Conditions and
Intertribal
variability
Moving
Regulatory
Conditions No
intertribal
variability
Moving
Regulatory
Conditions and
Intertribal
variability
STABILITY
No body transport
and No object
manipulation
Maintain standing
balance alone in a
room
Maintain standing
balance – brushing
teeth
BODY TRANSPORT
Body transport with
no object
manipulation
Sit to stand transfer –
same chair same
supporting surface
Maintain standing
balance on different
floor surfaces (carpet,
wood, gravel)
Maintain standing
balance while
unloading crockery
from dishwasher
Sit to stand transfer
from different height
chairs, different
supporting surfaces
Climbing different height
stairs with variable weight
/ shape bags
Maintain standing
balance on moving
escalator (constant
speed)
Maintain standing
balance on escalator,
reading a newspaper
Walking on an
escalator
Walking on an escalator
carrying a bag of
shopping
Maintain standing
balance on moving bus
(variable acceleration)
Maintain standing
balance on moving bus,
carrying bag of
shopping
Walking on an
escalator, negotiating
other people
Walking on an escalator,
negotiating other people,
holding a bag of shopping
No body transport.
Object manipulation
Body transport and
object manipulation
Climbing stairs – holding
a handbag
Gentile’s taxonomy of skills
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4.3
Theories of Motor Learning
Motor Learning is the study of achieving motor skills as well as the study of
modifying these skills. For simplicity, this section discusses conceptual models of
Motor Learning that are commonly presented in Motor Learning and Skill Acquisition
texts. Both temporal and structural theories exist.
4.3.1 Temporal Stages of Motor Skill Learning
The phases within temporal stages of Motor Learning are not meant to be perceived
as discrete, but rather blend into one another as the learner moves along a
continuum from early learning to later refinement of a motor skill. However artifical
stages have been described by various originators of theories in order to allow the
observers of Motor Skill learning to identify key stages of learning.
4.3.1.1 The Three Stage model of Fitts and Posner
The model proposed by Fitts and Posner in 1967 depicts three proposed main
stages of learning a motor skill and is acknowledged as a “classic” theory (Magill
2001).
Within this classical model, the initial stage of motor skill learning has been termed
the Cognitive Stage of learning. This occurs as the novice tries to understand the
nature and complexities of the new task and develops a number of potential
movement strategies to enable them to achieve the task. This stage requires the
learner to attend to the demands of the task and to focus on cognitively oriented
problems such as how much force should be exerted to pick up that glass of juice.
A number of strategies may be trialled, performance of the task is often inconsistent
and a large number of errors may be demonstrated during task attempts in this initial
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stage (Fitts and Posner 1973, Schmidt and Lee 2005; Shumway Cook and
Woollacott 2007).
In the second stage of motor skill learning, or the Associative stage of learning, the
demands of the skill have been understood and set indicators are associated with
successful performance of the task. The time in this stage is spent refining the best
motor strategies to achieve the task, there is a reduction in the variability of
performance and the learner starts to problem solve and identify performance errors
such as ‘insufficient force was generated when attempting to grip and lift the glass,
that’s why it slipped and spilt’.
As the learner moves into the third or Autonomous stage, the skill has been learnt
and is conducted with a large degree of automaticity and little conscious thought. In
this stage, the learner can undertake repeated skilled movements, problem solve
and make any adjustments required as well as dual task, such as lifting the glass of
juice and talk to a friend on the phone at the same time.
Schmidt and Wrisberg (2008) have labelled the three stages as “trial and error”
(Cognitive), “honing in” (Associative) and “free and easy” (Autonomous), which is a
simple and clear description of the Three Stage model. As indicated previously, the
stages are theoretical, and the execution of the task being learnt gradually becomes
more refined as the learner moves towards the autonomous phase.
4.3.1.2 The Two Stage model of Gentile
Just a few years after the publication of Fitts and Posners Three Stage model,
Antoinette Gentile, a movement science researcher proposed a two stage model of
learning that focused on the goal of the learner (Gentile 1978).
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In the “Initial” stage, Gentile argued that learners trial a number of movement
strategies to become accustomed to the demands of the movement and to achieve
the movement goal. In this initial stage, it was proposed that the learner also takes
cognisance of certain relevant environmental cues to ensure appropriate
organisation of movements, for example in reaching to a box in a cupboard, the
learner concentrates on developing appropriate movements of flexion with elevation
at the shoulder as well as appropriate extension movements of the wrist and fingers
in order to raise the arm to an appropriate height and to prepare the hand to grasp
the box. In this early stage, it is argued that the learner also learns to discriminate
between environmental cues that do not influence the movement to be performed,
for example the decoration on the box has no bearing on the task to be performed,
(a “non-regulatory cue”), whereas the weight of the box does (a “regulatory” cue).
Gentile proposed that the learner uses trial and error to formulate appropriate
movement features that allow successful achievement of the goal. During this initial
stage the learner has to actively problem solve when a movement is not fully
successful and therefore there is a large cognitive component.
As the learner
moves towards the second stage of learning in this model, Gentile suggests that
there is “a general concept of an effective approach …The action goal is not
achieved consistently and [sic] lacks efficiency.” (Gentile 2000 in Carr and
Shepherd).
In the second stage or “Fixation” or “Diversification” stage, movement skills are
refined. The learner develops the capacity to adapt the movement, for example
reaching to a smaller box in a higher cupboard.
Additionally, this stage is
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characterised by the movement being achieved successfully in a more consistent
manner and with more economy of effort.
The term “fixation” relates to the
capability to successfully carry out Closed Skills where basic movement patterns are
refined (fixated) to ensure consistency of successful achievement in this stage, for
example putting a key in a lock. “Diversification” refers to the ability to adapt the
acquired skill in situations where the performance of the skill is not undertaken in
stable conditions, these open skills are often described as types of skills required in
sporting activities such as having several options for where to pass the ball in
hockey with the unpredictable nature of where the opposing team may be. Time to
prepare the movement will be extremely limited and so the learner has to be able to
anticipate environmental cues and adapt their movement quickly.
The models of Fitts and Posner and of Gentile are theoretical and should not be
considered as concrete entities. Learning takes place along a continuum, therefore
“stages” will blur. Atlhough Gentile proposes a two stage model, there remains
elements of cognition, refining the task elements and developing automaticity
proficiency.
4.3.2 Structural Theories of Motor Learning
A number of theories regarding the processes involved in motor learning have been
proposed since the 1970’s. Emerging knowledge has led to revisions to theories
and the development of functional imaging techniques is adding substantially to the
body of knowledge.
A summary of the two most commonly cited theories is
presented.
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Adams was the first person to propose a theory of motor learning– the Closed Loop
Theory (Adams 1971). His theory was based on a hierarchical understanding of
movement control (e.g. the work of Sherrington in the early twentieth century) and
the body’s response to sensory input. Adams described a closed loop feedback
process for motor control, in which during the execution of a movement or action,
feedback regarding the success or otherwise of the movement was compared
against an existing memory of the movement stored in the nervous system. Adams
suggested a memory trace was used to select and initiate a desired movement and
that through a period of practice a perceptual trace of the correct movement was
constructed and strengthened over time. During activity, it was hypothesised that
the correctness of a movement was compared to the perceptual trace, which worked
to modulate and correct errors (Adams 1971; Shumway Cook and Woollacott 2007).
Adams Closed Loop theory indicated that a person undergoing rehabilitation would
be required to undertake repeated and precise practice of specific tasks in order to
develop and strengthen the perceptual trace. Errors were deemed to be detrimental
to learning as they would promote an incorrect perceptual trace (Shumway Cook
and Woollacott 2007).
The idea of errorless learning has been shown to be
incorrect (see section 4.6), with emerging evidence that variability of tasks improves
movement performance (Schmidt and Lee 2005).
Further weaknesses in this
Closed Loop theory have been identified, for example the theory can not explain
how novel movements can be carried out, nor can it explain how movement can be
carried out in the absence of sensory feedback (Magill 2007; Shumway Cook and
Woollacott 2007).
While the Closed Loop theory can now be argued as being
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redundant for explaining motor learning in humans, it laid the groundwork against
which other theories could be proposed.
4.3.2.1 Schmidts Schema Theory
A more robust theory, that still holds an influential place in explaining Motor Learning
is the Schema Theory proposed by Richard Schmidt (1975). This theory, based on
open loop control, was developed to provide an alternative explanation and
overcome some of the weaknesses identified with the Closed Loop Theory
(Shumway Cook and Woollacott 2007).
Schema Theory emphasises that when
learning a new motor programme related to movement, the person learns a general
set of rules which are open to adaptation and application to various situations.
Important conceptual features of this theory were that of generalised motor
programs and schema.
Schmidt proposed that a Generalised Motor Program (GMP) contains the rules for a
class of movements, rather than a single movement, and allows the production of
flexible and skilled actions (Schmidt 1975; Shumway Cook and Woollacott 2007). A
GMP has been defined as:
“a motor program that defines a pattern of movement rather than a
specific movement; this flexibility allows performers to adapt the
generalized program to produce variations of the pattern that meets
various environmental demands” (Schmidt and Wrisberg 2008 p124).
Within Schema Theory it is suggested that one GMP controls movements with a set
of defined characteristics. Therefore, if in the task of rising to stand, characteristics
such as relative sequencing of movement components, movement amplitudes,
relative timing and muscle force production remain constant, then whether rising
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from a stool or a dining chair, the same GMP will be utilised to control the
movement. Alternatively, if there was a change in one of the characteristics then a
different GMP would control the movement.
Within Schema Theory, it is also suggested that memory plays an important role.
Schema have been defined as “a set of rules relating the various outcomes of an
individual’s actions … to the parameters that the person sets to produce those
outcomes” (Schmidt and Wrisberg 2008 p272). It has been proposed that motor
memory or recall schema are responsible for selecting an appropriate response
and that sensory memory or recognition schema appraises the response.
Thus
when making repeated attempts at a movement, it is proposed that knowledge of
the initial conditions and the specifics of the required movement response to create
the recall schema. Memory of the success of the movement and the parameters of
the movement requirements (e.g. amount of force) create an association within the
nervous system.
The recall schema is available prior to the movement being
attempted and does not rely on feedback during the movement. With respect to
recognition schema, it is suggested this schema is responsible for evaluating prior
sensory outcomes with the expected sensory consequences and provide ongoing
comparisons with the actual movement.
In this way, recognition schema are
considered to be responsible for evaluating responses and identifying any
anomalies between expected and actual sensory feedback. On completion of the
movement, information is fed back into the schema to enable modification of the
existing schema. The greater the number of repetitions of the movement results in
more data available to refine the rule for that movement, the rule is then retained in
the recall schema.
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Schema theory would suggest that motor learning is dependent on continual
revision and renewal of recognition and recall schema with each attempted
movement. With this repeated practice, refinement of the rules of the generalised
motor programme occurs, thus reducing error with subsequent movement attempts.
Central to Schema Theory is the hypothesis that increasing variability of practice, for
example changing parameters such as the chair height to stand up from, or the
supporting surface for the feet, will improve learning by creating stronger
generalised motor programmes (Schmidt 1975; Shumway Cook and Woollacott
2007; Schmidt and Lee 2005)
While much has been written in support of Schema Theory, as with all theories,
there are problematic issues that have not yet been fully addressed. One question
that may be asked is how this theory addresses the issue of how a new movement
can be learnt. This conundrum, the “novelty problem” (Schmidt and Wrisberg 2008,
p123), is sometimes explained in relation to sports, whereby an innovative tennis
shot is accounted for by the notion that a “novel” movement relies on following rules
for selecting potentially appropriate parameters that have previously been applied in
similar movements.
While this explanation assists with understanding original
movement production it fails to address how a first generalised motor programme or
schema can be created in a child that has not experienced movement.
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4.4
How to structure practice
Textbooks on Motor Learning are predominantly aimed at sports and physical
activity coaching and derive from work undertaken with young healthy adults
(Schmidt and Wrisberg 2008; Schmidt and Lee 2005). While the recommendations
may be appropriate for people with neurological impairments, this has received
scant attention in the neurological field.
There is therefore, a challenge for
therapists to consider how best to structure rehabilitation sessions to optimise skill
acquisition. There is a need to consider the type of task to be practised and balance
pragmatic organisational issues when setting up practice sessions to ensure the
tasks can be undertaken successfully. Therapists working in rehabilitation will also
be concerned to ensure changes in performance relate to learning with long-term
retention of any gains. Furthermore, transferability of skill from one environment to
another is a critical feature of learning (Shumway Cook and Woollacott 2007; Carr
and Shepherd 1998).
It is recognised that in order to acquire a skill, regular and extensive practice of the
skill is required (Carr and Shepherd 1998; Shumway Cook and Wollacott). In the
stroke rehabilitation setting, many patients receive only a limited amount of therapy
(Bernhardt et al 2004; de Wit et al 2005; Tinson 1989) and opportunities for skill
practice may be inadequate. The amount of practice required to regain a skill for
people with impairments of motor control is not known, however it has been
suggested that thousands of repetitions are required (Bach-y-Rita and Baillet 1987)
and that intensive practice is probably required during the initial rehabilitation phase
(Carr and Shepherd 1998; Winstein et al 1999). Some authors have recommended
that short practice periods interspersed with rest periods similar to circuit training
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may be beneficial in later stages or when trying to promote unsupervised practice
(Carr and Shepherd 1998).
Physiotherapy in stroke rehabilitation is intricately linked with practice of movement.
While it is often stated that the more practice that a person undertakes the more
learning takes place (Shumway Cook and Woollacott 2007; Scmidt and Lee 2005;
Marley et al 2000), the number of practice repetitions required to acquire a new skill
or relearn a previously skilled movement have not been articulated. There may well
be inter-individual variation in the need to practice as each individual will have their
own set of experiences on which movements can be learnt or refined. There are
several means of structuring practice that need to be considered when developing
an optimal practice regime. In terms of stroke rehabilitation, how to structure each
limited rehabilitation session is of clear importance, in order to make the best use of
time and resources. In addition to the amount and type of practice, cognisance also
requires to be taken of the effects of fatigue.
4.4.1
Massed or Distributed Practice
Massed practice has been defined as when the amount of practice within an
exercise schedule exceeds the amount of rest time between trials, whereas
distributed practice is when there is a greater amount of rest time than actual
practice time. If the same amount of exercise is to be undertaken, then following a
massed practice schedule will achieve the same amount of practice in a shorter time
than if it is undertaken in a distributed practice schedule (Shumway Cook and
Woollacott 2007; Magill 2007).
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The vast majority of work in this area has been undertaken with young healthy
subjects, with a focus on investigating the practice to rest relationship within practice
sessions (Schmidt and Wrisberg 2005).
Most authors agree that distributing
practice is more beneficial to learning, although potentially detrimental in terms of
immediate performance (Lee and Genovese 1988; Magill 2007; Schmidt and
Wrisberg 2005; Shumway Cook and Woollacott 2007).
An important early study investigated whether it was more beneficial to undertake
fewer lengthy practice sessions or a greater number of shorter sessions to improve
keyboard skills in postal workers learning to operate a mail sort machine. Total
training parameters of 60 hours, with practice occurring over five days each week
were set. Participants received either one daily session of one or two hours, or two
daily sessions of one or two hours. The group that had the most distributed practice
(an hour daily) were found to achieve a target typing speed with least practice (55
hours), all the other groups took over 60 hours to achieve the target and the most
intensely massed practice group (two sessions of two hours daily) did not achieve
the target. On retention tests at one, three and nine months there was no difference
between the three groups that had achieved target speed (Baddely and Longman
1978).
In a small study, with more resonance to rehabilitation practice, Shea et al
(2000) investigated the learning of a continuous balance task on a balance
“stabilometer” with 14 young university students. They found that two sessions of
seven trials of a 90 second practice on the stabilometer, conducted over one
(massed) or two (distributed) days resulted in better learning for the distributed
practice group and that this learning effect was retained at a 24 hour retention test.
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Little work in this area has been conducted with people with neurological
impairments. Two recent studies investigating a verbal information recall task and a
visual route finding ability with populations of people with Multiple Sclerosis (MS)
(Goverover et al 2008) or Traumatic Brain Injury (TBI) (Goverover et al 2009) have
been carried out. In both studies sample sizes were small (n=20 and n=10) and
only three acquisition trials were undertaken. Trials were consecutive in the massed
practice condition and with five minutes rest in the distributed practice group, with
retention tested at 30 minutes (Goverover et al 2009a; Goverover et al 2009b).
Dsitributed practice was found to be beneficial for both tasks in the TBI population
(Goverover 2009a) but only for the verbal task in the MS population (Goverover
2009b). While inferences were made to support the use of distributed practice in
learning functional tasks in these populations, there is, currently, insufficient
evidence from empirical studies of physical tasks such as a sit to stand transfer.
In relation to stroke, recent authors have deemed Constraint-Induced Movement
Therapy (CIMT) as massed practice (Vearrier et al 2004; Marklund and Klässbo
2006; Massie et al 2009; Taub et al 2000).
In CIMT, the unaffected limb is
constrained for prolonged periods (up to 90% of the waking day) to force movement
of the affected limb, which is trained for six to seven hours daily (Taub et al 2000).
This intensive intervention, while broadly fitting the description of “massed” practice,
includes markedly different characteristics (for example constraint and intense
prolonged exercise) to the massed nature of practice within a regular one hour
treatment or practice session and therefore findings from CIMT research will not be
considered further.
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It is unclear why distributed practice is more beneficial for learning, however some
explanations have been proposed.
Massed practice while improving immediate
performance, is more likely to elicit fatigue which may negatively impact on learning
(Magill 2007). Alternatively, less cognitive effort may be used with massed practice,
as the schedule may induce boredom due to constant repetition, this reduction of
cognitive engagement may result in reduced learning.
In terms of consolidation of
memory, massed practice may not allow sufficient time for the neurobiochemical
processes necessary for transformation of the memory trace into a relatively
permanent representation (Magill 2007)
4.4.2
Blocked or Random Practice
In stroke rehabilitation, the therapist will attempt to improve a number of different
skills in a single treatment session, and generally one task will be practised for a
number of times before moving on to the next task (e.g. sitting balance then sit-tostand transfer then reaching).
Blocked practice is undertaken within a session
when task A is practiced repeatedly before task B and so on, whereas random
practice occurs when a number of different tasks are practiced non-consecutively
and in no particular order within the session. In conditions of blocked practice,
performance has been shown to improve during the acquisition or practice phase
whereas performance on a retention test which indicates actual learning generally
tends to degrade, the reverse has been shown to be true for random practice (Shea
and Morgan 1979; Magill and Hall 1990).
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Intuitively it may make sense to structure a rehabilitation session to follow a
programme of uninterrupted task performance and organisationally it may be easier
to structure a practice session with tasks undertaken in blocks.
However, the
evidence for blocked practice is weak in terms of learning, although some authors
have suggested that during the early stage of skill acquisition, blocked practice may
enable the learner to gain the fundamentals of the movement to be learnt.
There is now a body of evidence derived from laboratory experiments with young
normal subjects that supports the superiority of random practice to engender
learning. Shea and Morgan (1979) were the first to investigate random or blocked
practice. Their sample of college students were required to practice three different
patterns of arm movement to knock down barriers as fast as possible.
All
participants practised 18 repetitions of each movement, but one group did all task A,
then B then C, while the other group practised in a random order. While the blocked
group performed slightly better by the end of the acquisition phase of six practice
sessions, retention tests conducted 10 minutes and 10 days after the acquisition
phase showed superior learning for the group who had initially undertaken random
practice.
These findings have been replicated by other investigators studying
relatively simple tasks (e.g. Wilde et al 2005; Wulf and Lee 1993).
Few studies investigating random or blocked practice in people post stroke have
been conducted. Hanlon (1996) was the first to report in this area. Twenty four
participants at least six months post-stroke were randomly assigned to either a
“block” or “random” group practising 10 trials daily of a five step upper limb task until
task achievement was completed. A separate “control” group received no practice.
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All subjects undertook the same retention tests at two and seven days after
cessation of the intervention. The random practice group showed significantly better
learning of the task than the blocked practice group and control groups on both
retention tests. While these findings lend some cautious support to the findings of
studies undertaken with young healthy adult participants, the work by Hanlon can be
criticised due to the small sample size (n = 24) with only eight subjects in each
group.
Additionally, there was lack of clarity of randomisation procedures and
supplementary non-specific upper limb tasks that were part of the random practice
group schedule which might have biased findings due to the extra practice. It was
however, the first study undertaken in people with stroke to demonstrate agreement
with findings from studies undertaken on young healthy subjects.
In a slightly larger study, Pohl et al (2006) investigated the ability of 37 people within
45 days of stroke onset (22 classified as moderate and 15 classified as mild) and 32
age matched controls to acquire a target sequence using a switch box. Participants
undertook both random and blocked practice with a total number of 480 repetitions
in a single test session. In this study all participants improved their performance as
measured by faster reaction time and reduced variability of performance, however a
significantly slower time and more variable performance was found for participants
deemed as moderate stroke. While this study demonstrated improved performance,
no retention test was reported so long term learning could not be assessed.
Furthermore, the task (a serial reaction time task) was not analogous to functional
daily activities so generalisations can not be made. Despite the weaknesses of the
study, the findings are interesting and may indicate that practice may need to be
structured differently for people with different severity of stroke.
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4.4.3
Variable or Constant Practice
When practising a task, another feature that needs to be considered is whether to
structure the session so that the learner undertakes variable or constant practice.
Variable practice allows practice of the same basic movement pattern but with
variations of some characteristic, for example when practising sit to stand transfer,
altering the seat height or foot base width could be introduced. In constant practice
all the task demands would remain static. Variable practice has been shown to be
more beneficial to learning than constant practice (Schmidt and Lee 2005), although
it can be difficult to schedule in an environment other than a research laboratory or
clinic.
It has been suggested that variable practice may strengthen the schema
resulting in more effective learning of the task rules (Schmidt and Lee 2005).
An investigation of the ability to correctly produce a criterion force under conditions
of constant or variable practice was undertaken with 24 young healthy adults (Shea
and Kohl 1990 experiment 1). The variable practice group undertook a total number
of 289 repetitions (17 blocks of 17 trials), of which 85 trials were at the criterion
force, whereas the constant practice group undertook 85 trials at the criterion force.
Feedback was provided by computerised error information. While no significant
difference between the groups was found during acquisition, at a 24 hour retention
test, the variable practice group performed with significantly more accuracy (Shea
and Kohl 1990 experiment 1).
This study allowed the variable practice group a
greater intensity of practice than the constant specific practice group and it may be
that this greater practice allowed development of more refined schema. In a followup study the same methodology was followed with the addition of another constant
specific group that undertook 289 trials at the criterion force (Shea and Kohl 1990
experiment 2).
This second experiment showed that at the retention test, the
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variable group again performed significantly more accurately than either of the
specific constant groups. Furthermore the specific constant group undertaking 289
acquisition trials showed poor ability to reproduce the criterion force with the authors
hypothesising that either they had insufficient time to process error feedback during
acquisition trials, or that they may have failed to attend to the task requirements due
to the repetitive nature of the constant task (Shea and Kohl 1990 experiment 2).
4.4.4
Whole or Part Practice
When teaching a new skill or when reacquiring previously skilled movements during
rehabilitation, it is common practice to break down a complex movement into
component parts or part practice (PP) rather than whole practice (WP) of the task in
its entirety. In neurological rehabilitation, PP is often encouraged intuitively by the
therapist who may have assessed, for example, that a stroke patient does not have
sufficient dynamic balance capability to walk unaided, but may be able to practice
weight transfer in standing.
While this may make intuitive sense, it has been
suggested that stripping away other demands of the task may result in an alteration
of the motor programme so that the part task is no longer the same as it is when
undertaken in the whole task context (Fontana et al 2009; Schmidt and Lee 2005).
Some rehabilitation texts have advocated that movements should be practised in
their entirety (Carr and Shepherd 2003), although other authors have recommended
different strategies for different types of movement. For complex tasks, where
practise of discrete components can be structured easily, it has been suggested that
PP is preferable. Whole Practice has been recommended for a discrete task of
short duration, or for longer duration, cyclical, continuous tasks such as walking
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(Fontana et al 2009; Marley et al 2000).
Recommendations for serial tasks
however are varied. While Marley et al 2000 recommended serial tasks to be
practised under PP conditions, counter-claims have been made in favour of WP of
serial movements where parts of the task depend on preceding successful actions
(Schmidt and Lee 2005).
Hansen et al (2009) found that all 36 of their young
healthy adult participants demonstrated improvement on a four component serial
aiming task whether undertaking part or whole practice. Practice was structured
either as WP or PP of different components with some overlap (eg components 1,2
and 3 or components 2,3 and 4).
The improvement in performance after 40
acquisition trials which was maintained on testing learning one day later, was put
down to PP participants being able to learn transitions between movement
components. It is interesting that learning is said to have occurred after one day as
experience with people with stroke is that retention for 24 hours is not necessarily a
good indicator that a skill has been relearnt.
No studies relating to PP or WP were found for people with stroke. In a small
crossover study of 20 elderly participants performing either part practice of a
signature task by separating the movement into three components (PP) or
performing the whole task in its’ entirety (WP), it was found that during the WP
conditions movement times were faster and kinematic variables smoother (Ma and
Trombly 2001). These results are similar to findings favouring WP from studies on
less functionally complex tasks such as computer games (Fabiani et al 1989;).
From the paucity of literature in this area relating to complex functional tasks that
are often serial or continuous in nature, it is clear that empirical research in this area
is required to add to the body of knowledge contained in texts on Motor Learning.
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4.4.5
Attentional Focus during practice
The ability to attend to tasks and the environment is critical in the relearning of motor
skills (Hochstenbach and Mulder 1999). However, many people post-stroke may
have impairments in the ability to selectively attend to tasks and the ability to
maintain attention, therefore the manner in which a person with stroke is requested
to practice skills is important. In providing practice opportunities for learning or
relearning a task, the instructor or therapist needs to determine what instructions to
provide to facilitate the learner in undertaking the desired movement. In addition to
any physical demonstration of the motor skill to be learnt, such as how to grip an
object, instruction can either have an internal focus on the body movements
required (for example elbow, wrist and hand position) or an external focus on
remote features (such as keeping a mug level).
A recent review which included studies relating to focus of attention for motor
learning has shown that having an external focus of attention for movement
outcomes is more beneficial for motor learning than an internal focus concentrating
on movement of body parts (Wulf et al 2010). It is known that an internal focus,
attending to particular movements of the body, when undertaking an automated
motor skill can be detrimental to performance (McNevin et al 2000; Schmidt and
Wrisberg 2008). Despite these findings, observational evidence would assert that
physiotherapists often instruct people undergoing rehabilitation to move their body in
a certain way, inherently utilising an internal attentional focus (“bend your knee”, “lift
your toes”).
However, this manner of instruction is counter to research that
demonstrates having an external focus of attention is more beneficial to motor skill
learning than an internal focus (Wulf and Weigelt 1997).
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It has even been shown that in some skills, at times, no instruction can be more
beneficial than early instruction. Wulf and Weigelt (1997), undertook a study where
healthy subjects were either instructed on the desired movement pattern on a ski
simulator at the start of the study, or received no instruction. The subjects in the “no
instruction” group demonstrated better performance during acquisition and at a
retention test.
A possible explanation for this is that they had to problem solve for
themselves how to improve performance.
It is not clear why an external focus of attention is more beneficial to learning a skill
than an internal focus, although it has been suggested that consciously trying to
control automatic movements may interfere with “normal” motor control processes
(McNevin et al 2000). It has also been suggested that focusing on the outcome of a
movement rather than the actual movement itself are also pertinent for the focus of
feedback (Shea and Wulf 1990).
These findings have implications for designing
practice to be undertaken without supervision. Optimal strategies may be to provide
external cues to focus on – for example moving an object manually and focussing
on the object rather than the hand moving it.
4.5
Feedback
Feedback is of key importance when learning movement skills in order to gauge
success, or otherwise, of performance.
Feedback has received considerable
attention in Motor Learning research and is important in providing information and
motivation for the learner (Shumway Cook and Woollacott 2007; Schmidt and
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Wrisberg 2008; Schmidt and Lee 2005).
Feedback has been described as
“information produced from the various sensors as a consequence of moving”
(Schmidt and Wrisberg 2008 p 69). This definition however limits consideration of
feedback to internal processes and a complimentary definition taking cognisance of
external processes could be “augmented error information provided to the performer
about goal achievement” (Winstein 1991a p66).
4.5.1
Intrinsic Feedback
Intrinsic feedback is feedback that is provided from the learner’s own sensory
system as a consequence of movement (Shumway Cook and Woollacott 2007).
Intrinsic feedback includes sensations such as touch, pressure and joint position
sense of the moving limbs as well as visual and auditory information.
4.5.2
Extrinsic Feedback
Extrinsic feedback refers to information provided to the learner externally to
supplement intrinsic feedback, this externally derived feedback is also referred to as
augmented feedback. In stroke rehabilitation, extrinsic feedback may be supplied
by the therapist in a variety of ways using verbal, auditory and material cues.
4.5.2.1
Knowledge of Results
Knowledge of Results (KR) is provided to the learner on completion of the
movement and supplies information relating to the success of the movement
outcome in relation to the goal (Shumway Cook and Woollacott 2007; Schmidt & lee
2005). KR is considered extrinsic as it is often provided verbally, however the result
of a movement will also generate intrinsic information, therefore KR can be
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considered to be augmented by intrinsic feedback. It has been hypothesised that
timing feedback to allow active problem solving may be most beneficial for motor
learning (Winstein et al 1996).
Bilodeau and Bilodeau (1958) were the first to investigate the effect of frequency of
KR. In their work 273 airforce personnel undertook 40 trials to learn a lever pull task
with either 100%, 33%, 25% or 10% KR.
All groups demonstrated improved
performance when acquiring the skill, however no retention test to identify learning
was undertaken in this early work, therefore it was not clear what the optimum KR
schedule would be.
Since the early work of Bilodeau and Bilodeau (1958), various studies have been
carried out to determine how best to provide KR to learners. In a study of 36 healthy
young adults undertaking a investigating barrier knock-down task, feedback was
provided either in a known blocked KR (regarding a specific movement parameter)
or random KR (Lee and Carnahan 1990). Following 60 acquisition trials (ten blocks
of six trials), it was found that while all groups improved their performance, the
blocked KR group acquired the skill more quickly than the random KR group. At a
retention test (two blocks of six trials with no feedback) undertaken ten minutes after
the acquisition phase there was no difference between the groups at the first block,
although the random KR group performed better at the second block (Lee and
Carnahan 1990). Although this task was a serial mechanistic pattern of movement,
unrelated to complex functional tasks, it does provide an indication that delivery of
feedback may need to be structured in a similar way to structuring practice.
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KR can be provided at various frequencies. KR provided after every movement trial
is termed “100% KR”, however it may also be provided by fading the frequency (for
example after every second trial - 50% KR).
Findings from work in this area
generally indicates that less frequent KR may not be beneficial for immediate
performance (during acquisition) although it may be beneficial for learning as
indicated on retention tests.
More recently, Winstein et al (1996) studied a group of 60 young healthy adults (
age 26 years) learning a partial weight bearing task, with 80 repetitions of the task
during the acquisition phase and a delayed retention tested at 48 hours. It was
found that during acquisition, a group receiving concurrent feedback (during
performance) were more accurate (mean accuracy 1.4%) and consistent (mean
normalised variable error 1.2%) with the task than groups receiving either 100%KR
or 20%KR (mean accuracy 6.4% and 8.2%; mean normalised variance error 5% and
5.3%). During retention however, all groups were less accurate, but the concurrent
feedback group performed with the largest error (11.2%).
These findings lend
credence to the suggestion that while performance may improve transiently with
concurrent feedback, this mode of providing information is not beneficial for motor
learning.
Of the limited studies that have been conducted on people with Stroke, limited
support for the findings on studies conducted with young healthy adults has been
demonstrated. Winstein et al (1999) investigated 40 people with chronic stroke
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(median time since onset 24 months) and 40 age-matched controls 57 years)
undertaking a rapid elbow flexion and extension movement by moving a lever.
Participants were “pseudo-randomised” to receive either 100% feedback for 99 trials
or 67% faded feedback for 99 trials. Feedback was provided on a computer screen.
A retention test of 18 trials (two blocks of nine movements) with and without
feedback was undertaken one day later. This study showed no difference between
feedback groups on accuracy and consistency of performance of the task during
either the acquisition or retention phases.
There was however a difference in
movement pattern between the control group and people with stroke, with the latter
group being less accurate and more variable in their performance at all phases.
While this study demonstrated the capacity for motor learning for people with stroke,
both 100%KR and 67% faded KR were equally as effective. While adding to the
body of knowledge in the application of Motor Learning principles to stroke, caution
should be exercised due to the highly specific and non-functional nature of the task.
4.5.2.2
Knowledge of Performance
Knowledge of Performance (KP) relates to the movement strategy adopted to
achieve the task (Shumway Cook and Woollacott 2007; Schmidt and Lee 2005).
KP is often used by physiotherapists to provide information about movement
performance for people with motor impairments and altered “normal” movement
patterns (for example “… try to relax your shoulders when reaching forwards”).
While KP is mainly thought of as being provided verbally, it may also be provided
visually with filmed or photographed material.
While most of the research on
feedback relates to KR, it is often KP that therapists provide as feedback to people
with stroke.
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The only study found investigating KP with stroke was undertaken with 28 people
with chronic stroke (Cirstea and Levin 2007). Participants were randomly allocated
to practice pointing movements and either receive 20%KR about the movement
precision or faded 26% KP about arm movement patterns.
relatively young (KR
age 55.7yrs, KP
The cohort were
age 59.1yrs), but with a mean time since
stroke of at least 11 months. The practice schedule was clinically relevant with 10
daily practice sessions for an hour daily over two weeks. In each session, the
subjects had to practice 75 pointing movements with the impaired arm to the
unimpaired side. The KR group received feedback at the end of the task on every
fifth attempt. The faded KP feedback related to shoulder and elbow movements and
was provided concurrently on each of the first 25 trials then on every second trial for
the next 25 and finally on every fifth trial. While the KR group demonstrated some
improvement at the one month retention test, it was the KP group that made greater
and statistically significant improvements in shoulder range of movement and
improved temporal coordination of shoulder and elbow joints at the end of the
intervention and on retention tests at one month. The KP group also demonstrated
significant improvement in arm strength and precision movements following
intervention.
Additional compensatory trunk movements were also found to
decrease in both groups.
This appeared to be a well controlled and clinically
relevant study and seems to indicate that in this sample of people with chronic
stroke, KP may be beneficial for learning a general set of movements potentially
strengthening a generalised motor programme.
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4.5.2.3
Manual Guidance
Manual guidance is a further form of extrinsic feedback that is generally provided
concurrently with movement, for example a therapist guiding the forearm and hand
to move smoothly within “normal” parameters when reaching forward to a target. A
number of authors following a “neuro-developmental” approach to rehabilitation for
people with neurological impairments have often advocated manual guidance to
facilitate more appropriate sensory feedback, with the assumption that enhancement
of normal movement will result in more efficient skill reacquisition (Bobath 1990;
Davies 1985; Davies 1990). It might be fair to argue that a number of therapists
working in Stroke Rehabilitation in the 21st century would still subscribe to an
approach that strongly encourages manual guidance and a philosophy that within
stroke rehabilitation errors in movement patterns should not be allowed. Counter
arguments, based on emerging neurophysiological and neuropsychological
evidence, have pointed out that while guidance may be effective in the very early
stages of skill acquisition (Magill 2007; Hochstenbach and Mulder 1999) continued
guidance may limit the patient in engaging in the active problem solving required to
relearn movement and that retention and long-term carry over of any skills will be
inhibited (Majsak 1996; Horak 1991).
One therapy related study was found that investigated manual guidance or verbal
KR in the learning of a 70% partial weight bearing task (Sidaway et al 2008). Forty
young adults were allocated to one of four groups to receive either 100% KR, 33%
KR, 100% guidance or 33% guidance during 120 acquisition trials of this task.
Retention tests were undertaken after 10 minutes, one day and one week. The
100% guidance group obviously had no error during acquisition and the 100% KR
were found to reduce error during this phase.
At retention, the KR groups
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performed with less error than the guidance groups and the subjects receiving 33%
feedback performed with less error.
Furthermore, the accuracy of the 100%
guidance group performance deteriorated was significantly worse than all other
groups across all retention tests. While this study indicates that in healthy young
adults consistent guidance was ineffective in learning a motor skill, there still
remains a gap in empirical knowledge regarding guidance for people with a
neurological impairment.
.
4.6
Neurophysiological Evidence relating to Motor Learning
The previous sections in this chapter have looked at various characteristics that
require organisation within a practice session to allow the learner the optimal chance
at acquiring or reacquiring skill. This section will consider the evidence relating to
neurophysiological processes involved in motor learning.
Over 100 years ago, Sherrington was the first to suggest a simple form of learning
by demonstrating that with repeated stimulus of the flexion reflex, habituation was
noted to occur (Sherrington 1906 as cited in Burke 2007). Habituation may be
short-term with a transient reduction in the excitatory post-synaptic potential (EPSP).
It has subsequently been demonstrated that long-term repetitive stimulation results
in structural changes, namely a reduction in the number of synaptic connections
between the sensory neurones, inter-neurones and motor neurones (Kandel et al
2000).
The application of habituation principles in rehabilitation has been
demonstrated with the application of Cooksey Cawthorne exercises in cases of
dizziness caused by inner ear disorders, whereby repeatedly undertaking
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movements that bring about dizziness gradually results in amelioration of the
dizziness (Bamiou et al 2000).
Sensitisation is another simple form of learning that has been demonstrated and
probably involves the same sensory neurones, inter-neurones and motor neurones
that are involved in habituation. Sensitisation is a response to potentially damaging
stimuli and can be summarised as prolonging the action potential to allow more
neurotransmitter to be released at synapses resulting in an increased EPSP. While
the same neurones may be involved in habituation and sensitisation, effectiveness
of the synaptic connections is enhanced in sensitisation and depressed in
habituation (Kandel et al 2000).
4.6.1 The Cerebellum and Motor Learning
The cerebellum is critically involved in motor learning. It contains the most neurones
in any anatomical subdivision of the brain, however it has comparatively few types of
neurone and therefore neuroscientists have studied cerebellar function and
understand the cerebellar circuitry relatively well and have hypothesised how the
cerebellum is involved in motor learning (Kandel, Schwarz and Jessel 2000; Siegel
and Sapru 2006, Bear, Connors and Paradiso 2007).
Structurally the cerebellar cortex is organised into three layers (see figure 4.1 and
4.2). The outer molecular layer has relatively few somata, with inhibitory stellate
and basket cells distributed between excitatory axons of deeper granule cells which
give off long parallel fibres. Dendrites from inhibitory Purkinje cells are also situated
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in the outer molecular layer and arise from Purkinje cells in the middle layer.
Inhibitory axons from the Purkinje cells extend into the deeper white matter and
afford output from the cerebellar cortex. The inner granular layer contains some
large Golgi interneurones and numerous granule cells both of which synapse with
the main cerebellar afferent input mossy fibres.
Figure 4.1. General Structural organisation of cerebellum (from Felten and
Shetty 2009, p376)
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Figure 4.2. Synaptic organisation of cerebellar circuitry showing excitatory
and inhibitory circuits: (from Kandel Schwarz and Jessel 2000 p837)
Afferent input to the cerebellum comes from two main sources: excitatory mossy
fibres and climbing fibres. Mossy fibres convey sensory information from the brain
stem and cerebral cortex and form excitatory synapses with granule cells. The
parallel fibres that branch transversely from the granule cells intersect serially with
multiple dendrites from the Purkinje cells and it is estimated that each Purkinje cell
receives input from up to a million granule cells (Kandel, Schwarz and Jessel 2000).
Climbing fibres arise from the Inferior Olivary nucleus of the Medulla Oblongata and
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carry information relating to proprioception and vision as well as information from the
cerebral cortex. The climbing fibres act as a comparator between expected and
actual sensory inputs. These fibres go on to wind around the Purkinje cell bodies
and dendrites forming strong connections with up to ten Purkinje neurones (Kandel,
Schwarz and Jessel 2000; Seigel and Sapru 2006; Bear, Connors and Pardiso
2007).
In the 1970’s two independent researchers – David Marr in England and James
Albus in America - proposed that this complex cerebellar circuitry could be involved
in motor learning. The underlying principles were that firstly the climbing fibres
identified movement error and secondly the climbing fibre induced corrections by
reducing the effectiveness of the synapse between parallel fibre and Purkinje cell.
This modification was termed Long Term Depression (LTD).
With repeated
movements, there would be inhibition of error information from the parallel fibres and
this would, over time, result in a movement with less error. (Kandel, Schwarz and
Jessel 2000; Bear, Connors and Pardiso 2007).
It is also suggested that three
important neurotransmitter modifications must also occur concurrently for LTD to
occur.
These mechanisms are a surge of calcium (Ca2+) in the Purkinje cell
dendrites; raised sodium (Na+) levels and activation of protein kinase C, these three
events result in a decrease in post synaptic membrane AMPA receptor channels
which result in a slowing of synaptic transmission.
LTD has been established by Ito and colleagues who demonstrated a smaller post
synaptic response in Purkinje cells following paired stimulation of the climbing fibres
and parallel fibres, compared to the EPSP when only parallel fibres received
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stimulation (Bear, Connors and Paradiso 2007). It is not clear whether learning
occurs in discrete areas of the cerebellum or how explicit sensory information is
involved in learning. While LTD has been demonstrated, the actual role of LTD has
not yet been fully proven in motor learning, but it is conceivable that motor learning
may arise from modifying synaptic transmission (Seigel and Sapru 2006; Bear,
Connors and Paradiso 2007).
4.6.2 Structural changes associated with Motor Learning
The process of neuroplasticity has previously been considered in section 2.6. It has
been suggested that neuroplasticity can be considered on a scale ranging from
“short term changes in the efficiency or strength of synaptic connections to
long-term structural changes in the organisation and numbers of connections
among neurons” (Shumway Cook and Woollacott 2007).
In considering Motor Learning, one would also be expecting a continuum of
changes, with evidence of learning represented by persisting structural changes
within the CNS. Learning and the memory storage of learning can occur within all
parts of the brain (Kandel, Schwarz and Jessel 2000; Shumway Cook and
Woollacott 2007).
In situations where more complex forms of learning occur with the development of
skills and refinement of movement, rather than a response to stimulus, more
intricate neural mechanisms are involved. Pascual-Leone et al (1994) undertook a
finger movement task with a computer screen and touch pad with four buttons,
participants had to press the correct button when a number was flashed onto the
computer screen. Blocks of 10 trials were presented and one group followed a
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repetitive sequence, whereas the other group followed a random sequence.
Reactions times and cortical activity were recorded using transcranial magnetic
stimulation (TMS) and it was shown that not only did reaction time reduce but also
an increase in cortical mapping was demonstrated to the relevant finger muscles.
Interestingly, subjects began to recognise the sequence of movement within six to
nine blocks of trials, at which point the cortical maps reduced to baseline size. This
study demonstrated alterations in motor cortex output and these changes were
explained as the subjects having attained explicit learning of the task and were
therefore able to predict the next number. The ability to quantify changes in cortical
activity, associated with motor performance is an exciting development for clinicians
and researchers in this field, and will enable the identification of structural and
functional changes in the brain associated with practice.
4.7
Summary
This chapter has provided an overview of some of the key issues in the motor
learning literature. As indicated, the vast majority of studies were conducted on
small samples of young healthy adults and this makes generalisation of findings to a
population with CNS impairments problematic. Within the past 15 years or so, a
limited number of studies relating to neurological populations have started to provide
some applied evidence (e.g. Winstein et al 1999; Hanlon 1996), although research
in this area should be considered as in the very early stages.
A variety of practice tasks have been studied, however a further criticism of much of
the motor learning research to date is that the vast majority relates to simple rapid,
discrete tasks such as manipulating a lever (Winstein et al 1999), or producing a
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force (Shea and Kohl 1990).
Furthermore, the number of repetitions undertaken
within practice schedules have tended to be low, often with acquisition of a task
claimed with less than 100 trials (e.g. Bilodeau and Bilodeayu 1958; Shea and
Morgan 1979; Lee and Carnahan 1990; Winstein et al 1996; Hanlon 1996; Winstein
et al 1999 ) with no explanation for the variable number of practice trials adopted.
Some influential authors have advocated applying motor learning principles to
people with stroke (Carr and Shepherd 1998, Carr and Shepherd 2000), particularly
with recommendations for how to structure the practice of functional exercises,
however the evidence to support this view is inadequate. There is an urgent need
for more work using well designed studies with patient populations to ascertain the
appropriateness of applying motor learning principles derived from young healthy
adults to the rehabilitation of people with stroke. The need to test Motor Learning
theory in a rehabilitation context forms the basis for this study.
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5
5.1
RATIONALE FOR STUDY
Introduction
The preceding chapters have explored literature relating to Stroke and recovery
mechanisms, appraised knowledge relating to Physiotherapy for people with latestage stroke and reviewed evidence to support Motor Learning theory.
The
rationale for the current study and a brief overview is presented in this chapter.
It is well accepted that the greatest and most rapid recovery following stroke occurs
within the first three months (Wade et al 1985; Wade and Langton Hewer, 1987). It
is also acknowledged that post-stroke recovery does not stop at three months.
People with stroke have the capacity for ongoing recovery for months and years (for
example Wade et al 1992; Dam et al 1993; Green et al 2002; Ouelette et al, 2004).
Despite this knowledge, there is a tension between the desire or guidance to provide
on-going rehabilitation (SIGN 2010, RCP 2008) and increasingly limited healthcare
resources. There is therefore a need to investigate whether people with late-stage
stroke are capable of undertaking exercise at home without therapist supervision.
As identified in 4.4, the majority of studies reported in Motor Learning literature have
been undertaken with young healthy participants undertaking rapid discrete or serial
tasks (for example Shea and Morgan 1979; Wulf and Lee 1993; Hansen et al 2009).
Recommendations have been extrapolated from these findings and these
recommendations have been applied to structuring stroke rehabilitation practice
sessions despite no empirical supporting evidence (Carr and Shepherd 1998; Carr
and Shepherd 2003). It has been argued in 4.4 that while a variety of practice
paradigms exist, the need to establish appropriate structures within which to
undertake exercise practice is still required for people with stroke.
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Rationale for the Study
Of particular interest in this study was whether to encourage part practice (PP) or
whole practice (WP) of functional tasks, this stemmed in part, from clinical
experience of structuring practice sessions for people with stroke. In developing the
protocol, it was considered prudent to attempt to recruit people with late-stage
stroke who had been discharged from formal rehabilitation. There were two main
reasons for this decision. Firstly, people who sustained a stroke at least 12 months
prior to entering the trial would they be considered to be outwith the stage of natural,
or rapid recovery. Secondly, the normal “treatment” for this population would be no
treatment and therefore it would be possible to have a control group (Con) who
received no intervention – a situation that would be impossible and unethical to
justify for people in the earlier stages of recovery.
Questions to be addressed in the study included:

Does a home physiotherapy programme based on either part- or whole
practice strategies result in changes in performance of functional tasks for
people with late-stage stroke?

practice strategies result in changes in parameters of activity limitation,
participation and health status for people with late-stage stroke?

Are any changes in performance retained after cessation of the intervention
phase of the home physiotherapy programme?
A secondary question was

How much activity is undertaken by people with late-stage stroke in the
community?
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An important consideration in developing the intervention was to select functional
tasks that would be meaningful to people with late-stage stroke. As participants
would be requested to practice in their own home, without regular therapist
supervision, safety was of prime importance.
Consideration was also given to
ensuring the tasks would be relevant to the vast majority of community dwelling
people with late-stage stroke. Each task had to be capable of being practised safely
in its entirety, and also to be divided into meaningful and discrete parts to enable
physical practice.
The study reported in this thesis was developed as a phase II exploratory
randomised controlled pilot study to test the feasibility of a targeted but complex
intervention for community-dwelling people with late-stage stroke (Campbell et al
2000; Anderson 2008).
The process of developing and piloting the interventions are reported in chapter six,
the final methodology in chapter seven and the results in chapter eight.
5.2
Research Aims
The primary aim of this study was to investigate the effects of a home exercise
programme based on Motor Learning principles of part practice (PP) or whole
practice (WP) of selected functional tasks for people with late-stage stroke.
Recommendations in some physiotherapy texts have advocated one or other
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approach, but with no empirical evidence (Carr and Shepherd 1998; Carr and
Shepherd 2003; Shumway Cook and Woollacott 2007).
As part of the study, participants would be requested to document the number of
repetitions of each exercise. As participants would be undertaking practice in the
home setting, without therapist supervision, it was decided to try and gain some
confirmation of activity by the simple use of an activity monitor worn for a single day.
The additional benefit of this strategy was that an indication would be provided of
the amount of activity undertaken by community dwelling people with late-stage
stroke.
A secondary aim was, therefore, to explore activity undertaken by community
dwelling people with late-stage stroke.
5.2.1 Hypotheses
The null hypotheses under investigation are identified below
Global measures of impairment, activity and participation
HO1
There will be no significant difference in Motor Assessment Scale score between
Con, PP or WP groups from baseline to end of intervention, or short- or long-term
follow-up
HO2
There will be no significant difference in Barthel Index total score between Con, PP
or WP groups from baseline to end of intervention, or short- or long-term follow-up
HO3
There will be no significant difference in Frenchay Activity Index score between
Con, PP or WP groups from baseline to end of intervention, or long-term follow-up
HO4
There will be no significant difference in Frenchay Arm Test score between Con,
PP or WP groups from baseline to end of intervention, or short- or long-term followup
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Measures of mobility
HO5
There will be no significant difference in Timed Up and Go time between Con, PP or
WP groups from baseline to end of intervention, or short- or long-term follow-up
HO6
There will be no significant difference in gait speed between Con, PP or WP groups
from baseline to end of intervention, or short- or long-term follow-up
HO7
There will be no significant difference in Rise to Stand time between Con, PP or WP
groups from baseline to end of intervention, or short- or long-term follow-up
HO8
There will be no significant difference in Step Test ability with affected leg between
follow-up
HO9
There will be no significant difference in Step Test ability with unaffected leg between
follow-up
Measure of mood and health status
HO10
There will be no significant difference in Hospital Anxiety and Depression Scale
(HADS) total score between Con, PP or WP groups from baseline to end of
intervention, or short- or long-term follow-up
HO11
There will be no significant difference in HADS Anxiety or Depression subscale
scores between Con, PP or WP groups from baseline to end of intervention, or longterm follow-up
HO12
There will be no significant difference in Stroke Impact Scale domain scores between
Con, PP or WP groups from baseline to end of intervention, or long-term follow-up
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6 DEVELOPMENT OF THE METHODOLOGY FOR A
RANDOMISED CONTROLLED TRIAL OF PHYSIOTHERAPY
FOR LATE-STAGE STROKE.
6.1
Introduction
This chapter details the chronological journey charting the development of the
methodology for the main study.
During this development phase, cognisance
needed to be taken of the safety and feasibility issues relating to unsupervised
practice of functional
activities within the home setting as well as the limited
personnel and financial resources available to support the study.
At times,
therefore, a pragmatic approach to problem solving and to developing the
methodology was, by necessity, adopted.
The main stages of development of the methodology for the main study are reported
in this chapter and are detailed in figure 6.1.
6.2
Development of the Exercise Intervention
The aim of this exploratory study was to establish exercises that could be practised
in either a whole practice (WP) or part practice (PP) format by people living with
chronic stroke, as part of the main study.
Participants in this phase of the
methodology development were also canvassed as to some of the residual poststroke physical problems that were most important to them to improve.
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Development of Methodology
1a:
1b:
Development of
Exercise Intervention
Determining Screening Tests and
Outcome Measures to be used in main
study
2: Documentation of Exercise Practice regimes
3: Pilot of Proposed Methodology in
the Community
4: Testing the activPAL
5: Establishing psychometric
properties of a Modified
Outcome Measure
6: Finalising documentation, intervention
and study protocol
Figure 6.1.
Flow diagram of the stages of development of the Methodology
for a pilot randomised controlled trial of Physiotherapy for LateStage Stroke
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6.2.1
Sample and Recruitment Procedures for the development of the
Exercise Intervention
Four people with stroke were recruited from a database of stroke patients who had
previously attended the Physiotherapy Department at Astley Ainslie Hospital
Edinburgh, a tertiary centre specialising in post-acute care and in–patient and outpatient rehabilitation. Participants were recruited if they had sustained a stroke,
were living at home, had been discharged from formal stroke rehabilitation and were
at least four months post-stroke and had no other major co-morbid neurological
(such as Multiple Sclerosis), musculoskeletal (such as recent fracture or severe
arthritis) or cardiorespiratory (such as unstable angina) conditions that might have
precluded their ability to participate. Potential participants that were still attending
the Physiotherapy department for monitoring visits were approached by the senior
physiotherapist in stroke rehabilitation and provided with verbal and written
information about the study (appendix Ia). On return of signed informed consent
(appendix Ib), the principal investigator made contact with them and a date was
made for the participant to attend the stroke rehabilitation gym.
6.2.2
Selecting and refining the exercises
In order to meet the primary aim of the study, the exercises needed to be designed
to be performed not only in their entirety (WP) but also in component parts (PP). In
addition, the exercise parts for the PP regime needed to make sense to people with
stroke, as they would be required to practice independently. All the exercises would
need to be undertaken safely in the home environment without supervision. The
exercises that were explored in this initial pilot phase were designed be as
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functionally relevant as possible. In considering the actions required for the tasks
being piloted, it was clear that the tasks would fall into a closed skill category with
elements of body transport or body manipulation (Gentile 1987). Some exercises
appeared to lend themselves better to being broken down into component parts than
others. The exercises piloted at this stage are listed in table 6.1.
6.2.3
Pilot Exercise Procedure – in Hospital
Participants who had agreed to take part in this in-hospital, pilot exercise
development phase of the study attended the stroke rehabilitation gym on an agreed
date.
The principal investigator spent the first five or ten minutes of their visit
building a rapport and becoming familiar with the individual’s history of stroke, their
experience of rehabilitation and exploring if there were tasks that were still
problematic.
Following this, exploration of potential exercises and piloting of
potential outcome measures was undertaken. Selection and critique of outcome
measures is reported in 6.3.
Participants initially undertook one or two repetitions of the exercise in its entirety
(WP) to ensure understanding of the nature of the task. Following this, exploration
of PP structure was undertaken. The in-hospital pilot exercise phase investigated
the effects of :

The number of components contributing to PP structure of exercises

The number of repetitions

How feedback could be gained when the exercise was undertaken without
supervision

The perceived functional relevance to the participant
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Exercise
P1
Standing up from dining (no arms) chair (height 46cm)
With no support in front
With zimmer frame in front
With chair in front
P2
Sitting Down onto chair
With no support in front
With zimmer frame in front
With chair in front
P3
Stepping sideways
Affected foot crossing over in front
Affected foot crossing over behind
P4
Stepping up
Different height blocks (from 2 – 12cm)
With and without support on the unaffected side
With and without support in front
P5
Stepping down
Different height blocks (from 2 – 12cm)
With and without support on the unaffected side
With and without support in front
P6
Touching floor
P7
Pinch Grip, transport and release - Thumb and varying other fingers
3cm square block
4cm diameter ball
2cm diameter marble
P8
Forearm pronation – supination
With various objects – sticks, cones, bottle
P9
Making shapes with putty
P10 Taking objects out of pot
P11 Grasp tennis ball, transport and release
P12 Grasp plastic cup from table, transport and release
Empty or half full of water
Start position varied from close to far
Elbow on / off table
Transport to mouth / transport to new end position
P13 Bridging
Arms out to side / across chest
P14 ½ Bridging
Table 6.1.
Exercises attempted
intervention
during
development
of
exercise
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6.2.4
Analysis of pilot exercises in-hospital and impact on final pilot protocol
Analysis of the pilot exercises in-hospital led to a number of conclusions that
subsequently influenced the community pilot. It was found that:

For a number of the exercises initially, the number of component parts were too
numerous and too confusing for the participants. For example – for exercise P4
– stepping up; seven components had been considered (weight shift, knee bend,
heel raise, toe push, knee flexion, foot plant, weight transfer). Reducing the
number of components to two or three, facilitated practice of discrete
components that made sense to the participants.

Structuring variable practice of different components, out of sequence, detracted
from the comprehension of the exercise.
Blocking the practice to repetitive
practice of one component prior to moving to the next component enhanced
understanding.
Given that participants would practice without supervision,
blocked practice of PP or WP was considered to make more intuitive sense and
potentially could increase compliance.

The number of repetitions was set at 10 per exercise initially, however for some
participants, this resulted in fatigue. It was therefore decided to commence the
exercises in the community pilot at between six and 10 repetitions. During the
four weeks of intervention, it was envisaged that the number of repetitions would
be increased, on an individual basis.

Exercises P6 (touching floor), P9 (rolling putty), P10 (objects from pot), P13
(bridging) and P14 (½ bridging) were too difficult to structure as component parts
that were deemed relevant. These exercises were therefore discarded.

Two participants lost balance during exercise P6 (touching floor). Given that
safe practice of the exercise regime was paramount, the decision to discard this
exercise was vindicated.
Similar safety concerns with exercise P1 and P2
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(standing up and sitting down) using the option of a zimmer frame, resulted in
discarding the zimmer frame option.

For participants with minimal recovery of the upper limb, exercises P7, P8, P11
and P12 were problematic. It was decided to include an element of upper limb
weight-bearing with these exercises to allow participants to undertake at least
one component of the exercise, to allow smaller amplitude movement and to
undertake mental rehearsal of the remaining components.

Of the nine remaining exercises that had not been discarded, it was felt that
there was overlap between P7(pinch grip), P11 (tennis ball) and P12 (plastic
cup) and that not all exercises should be included. P12 was felt to be most
functionally relevant and this was therefore retained for the community pilot.
Exercise P3 was also discarded, because of some minor safety concerns
relating to tripping.
Following the in-hospital pilot, six exercises (P1, P2, P4, P5, P8 and P12) that could
be practiced as PP or WP were undertaken in a small community pilot.
The
exercises were feasible to structure so that practice was undertaken in a manner
that was meaningful to the pilot participants.
Documentation to support the
exercises and the practice regime in the community pilot was developed (appendix
II). The pilot community intervention and pilot of outcome measures is reported in
6.4.
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6.3
Determining Screening Tests and Outcome Measures to be used in final
protocol
This section reports the screening tests and outcome measures that had been
considered to be used for the final study. Prior to exploring the utility of the potential
outcome measures for this study, a review of related literature was undertaken.
Each outcome measure is reported with an associated summary of available
evidence relating to psychometric properties. A whole battery of outcome measures
were tested for use as the final trial was exploratory in nature and although the aim
was to encapsulate different dimensions of impairment, activity and participation
some dimensions were tested with more than one outcome measure.
6.3.1
The Mini-Mental State Examination (MMSE)
A brief screening test to establish cognitive ability was required to ensure that any
person recruited to the study would have the ability to undertake the required tasks,
particularly if they did not have a carer to assist with exercises. The MMSE was first
published in 1975 as a short test of “the cognitive aspects of mental functions” and
is scored between 0 – 30 (Folstein et al, 1975). A cut off score of 23 is generally
accepted as indicating cognitive impairment (Anthony et al, 1982; Tombaugh and
McIntyre 1992). The MMSE is brief to administer, taking around five to ten minutes
(Folstein et al, 1975), does not require any specialist equipment, has standardised
instructions, and has been tested for it’s psychometric properties, therefore making it
an appealing tool in research when a battery of outcome measures are to be used.
This therefore has made it a popular measure in many studies with stroke patients
(Pederson et al, 1996b, Anderson et al, 1995).
While some criticism has been
levelled at the MMSE for being uni-dimensional, Jones and Gallo (2000) argue that
inclusion of tasks that test memory, orientation, attention and concentration make
the test multidimensional.
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During the development of the MMSE it was tested with 206 people with various
conditions including dementia, depression, schizophrenia and in 63 people without
impairment. It was found that the MMSE discriminated between people with and
without cognitive impairment and that a mean score for normal elderly was 27.6.
Additionally the originators found that the MMSE possessed both intra-rater
reliability, inter-rater reliability over 24 hours and test-retest reliability over 28 days
(Folstein et al, 1975). Many of the studies investigating the psychometric properties
of the MMSE have been established in non-stroke populations. In the limited papers
establishing psychometric properties of the MMSE with stroke the findings have not
been conclusive. Nys et al, (2005) reported no definitive cut-off score for the MMSE
in stroke patients, while an earlier study by Blake et al, (2002) recommended a cutoff score of 24 indicating cognitive impairment with good specificity of 88%.
Varied scores on the MMSE have been reported with healthy populations.
Depending on age, scores based on lower quartile values, normal cut off scores of
29 (age 40 – 49), 28 (age 50 – 79), and 26 (age over 80) have been reported
(Bleecker et al, 1988). These data were however, established with a relatively small
sample of 194 subjects (Bleecker et al, 1988). In a much larger study of over
18,000 participants, that took age and educational attainment into account, slightly
lower values were reported. Total MMSE scores declined with age from a lower
quartile score of between 25 - 29 (associated with between eight years school
education to degree level education) for 40 – 50 year olds and lower quartile scores
of between 22 – 26 for 80 year olds with the same educational experience (Crum et
al, 1993).
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The use of the MMSE as a brief screen for cognitive impairment was appropriate for
this study as the aim was not to diagnose specificity of cognitive impairments, but to
ascertain that participants had sufficient cognitive capacity to participate, for
example to follow a three-stage command. The use of the MMSE in this way has
therefore made it a popular screening measure in many studies with stroke patients
(Anderson et al, 1995; Pedersen et al, 1996b).
6.3.2
The Functional Reach Test (FRT)
One of the major aspects of the study was to enable and encourage participants to
practise exercises without therapist supervision in their own home. Many people
with stroke complain of on-going balance problems (Wade et al, 1992; Green et al,
2002; Tyson et al, 2006) and some of the exercises would be challenging balance
and potentially could lead to falls. It was, therefore, important to attempt to screen
out potential participants with a higher risk of falls.
A simple screening test was required and while most of the literature related to nonstroke specific populations, there were still important parameters that could be
applied to this study. A variety of clinical measures have been developed to assess
balance and infer falls risk and these include the Berg Balance Scale (Berg et al,
1989) and the Tinetti Performance Oriented Mobility Assessment (Tinetti et al,
1986). While both of these measures have been demonstrated to be valid and
reliable, they take around 15 - 20 minutes to perform and therefore, when forming
part of an initial assessment battery, this would be too time-consuming.
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An alternative tool is the Functional Reach Test (FRT) (Duncan et al, 1990). The
FRT is performed by asking the subject to stand next to a wall, lift one arm straight
in front of the body to shoulder level and then stretch as far forward as possible
without moving the feet or touching the wall.
The forward reach distance is
measured from start to end position, usually with a ruler attached to the wall. The
ability to reach less than a distance of six inches (15cm) has been shown to be
predictive of falls (Duncan et al, 1992a) although this has not been replicated in
stroke. This test only takes a minute to perform and has been shown to have interobserver and test retest reliability (Duncan et al, 1990, Duncan et al, 1992a) and
concurrent validity (Bernhardt et al, 1998). While a number of criticisms have been
levelled at the FRT, including that there is a need to standardise reach strategies
(Wernick-Robinson et al, 1999), that the factors contributing to poor balance are not
assessed (Perrell et al, 2001), and that sensitivity has not yet been established
(Duncan et al, 1992a), the FRT is still a quick, cheap and easily administered
screening test for falls risk.
An FRT of less than 17.5cm has been shown to identify physical frailty, limited
mobility and limitations in ADL (Weiner et al, 1992). It has also been established
that a history of two or more falls within a prior six months period can also classify a
person as a “recurrent faller” (Duncan et al, 1992a, Shumway Cook et al, 1997). In
a study of community-dwelling elderly (over 70 years) men, it was shown that there
was significant difference between the FRT of “fallers” <15 cm and the FRT of “nonfallers” >25 cm (Duncan et al, 1992a).
As a screening measure for falls risk it was therefore decided to ensure that subjects
demonstrated acceptable results for both FRT ability (reach greater than 15cm) and
that they did not have a history of more than two or more falls in the preceding six
months.
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6.3.3
Mixed Measures of Impairment and Activity Limitation
The initial exploration of the potential functional task exercises, indicated that the
intervention was likely to consist of exercises targeting at both an impairment and
activity level, therefore it was important to have a measure in the battery of outcome
measures that reflected this.
Many mixed measures of impairment and activity
limitation exist, however some of these are intimately linked to treatment
approaches (Fugl-Meyer et al, 1975) which can bias the activities being tested,
some take a considerable amount of time (around 60 minutes) to administer, such
as the Fugl-Meyer Assessment (Fugl-Meyer et al, 1975), the Chedoke McMaster
Stroke Assessment (Gowland et al, 1993) and the Stroke Rehabilitation Assessment
of Movement or STREAM,
(Daley et al, 1997, Daley et al, 1999) or require a
considerable amount of equipment such as the Chedoke McMaster Stroke
Assessment (Gowland et al, 1993).
It was therefore decided to pilot two brief
measures of impairment and activity limitation that required little specialist
equipment and were suitable for use in a community setting: the Rivermead Motor
Assessment (RMA) and the Motor Assessment Scale (MAS).
6.3.3.1 The Rivermead Motor Assessment (RMA)
The Rivermead Motor Assessment was first developed in 1979 by a physiotherapist
and clinical psychologist and published as the Rivermead Stroke Assessment
(Lincoln and Leadbitter 1979). It was developed using a population of 51 young
(under 65) people with stroke to provide a short, valid and reliable assessment of
post-stroke physical recovery. A dichotomous yes (1 point), no (0 points) scoring
system was developed and the RMA was divided into three sub-sections Gross
Function (13 items), Leg and Trunk (10 items) and Arm (15 items). One strength of
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the RMA is that it was reported, initially, as being broadly hierarchical in nature, after
three consecutive fails in one section the assessor moves to the next section. While
it has been reported as fairly brief to administer, the time can be up to 45 minutes
(Lincoln and Leadbitter 1979).
The RMA has been reported as having scalability, inter-rater reliability and testretest reliability by the originators in a reasonable sample size of young (under 65)
stroke patients (Lincoln and Leadbitter 1979). However scalability in older people
with stroke has been challenged, with recommendations that the hierarchy of items
may not be appropriate, and attempts at higher level items should be undertaken
(Adams et al, 1997; Kurtaiş et al, 2009).
Sensitivity to change has been
demonstrated by all three sub-sections of the RMA (Kurtaiş et al, 2009). Concurrent
validity with the Barthel Index has been reported by Endres et al, (1990), and strong
correlations indicative of concurrent validity have also been found with the Trunk
Control Test and Motricity Index (Collin and Wade 1990).
6.3.3.2 The Motor Assessment Scale (MAS)
The Motor Assessment Scale (MAS) was developed to overcome some of the
shortcomings of existing measures of the time, with the aim to measure the progress
of stroke patients (Carr et al, 1985). The original MAS consisted of eight everyday
motor activities scored on a seven point ordinal scale and a ninth item to measure
general muscle tone.
Operational definitions were provided for each item to
promote consistency in application.
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In the original reporting of the MAS, substantial correlations and high levels of
percentage agreements were reported to substantiate the inter-rater and test-retest
reliability of the MAS with video data of people with stroke being tested on the MAS
items, and samples of twenty physiotherapists and one physiotherapist respectively
(Carr et al, 1985). Reliability of general muscle tone however was not assessed by
Carr et al, (1985). High correlations for all eight MAS items (r 0.92 – 1.0) but not for
tone (r = 0.29) were found in a population of 24 people with chronic stroke (mean
time post-stroke 12 months) and using two raters, (Poole and Whitney 1988).
Subsequent publications have dropped the general tonus item from the MAS, and
while the eight item test is a “modified MAS”, it is consistently described as MAS in
the stroke rehabilitation literature and any discussion related to MAS in this thesis
will refer to the eight item version.
The reliability of MAS has been established in a number of small-scale studies.
Loewen and Anderson (1988) video-taped seven people with stroke undertaking
MAS and presented these data to 14 physiotherapists, one month apart. The MAS
was found to have good to excellent intra-rater reliability and inter-rater reliability
(Loewen and Anderson 1988).
Various components of validity of the MAS have been established. Content validity
of the MAS has not been reported, although the items included in the MAS are said
to be reflective of everyday tasks and independent of any treatment philosophy
(Carr et al, 1985). The MAS could, however be argued to be linked with the Motor
Relearning Programme (MRP) (Carr and Shepherd 1988), as many of the items
included on the MAS are addressed within the MRP.
Acceptable levels of
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concurrent validity have been established against the Fugl-Meyer Assessment
(Poole and Whitney 1988; Malouin et al, 1994) and a newly developed outcome
measure - the Mobility Scale for Acute Stroke Patients (Simondsen et al, 2003). In a
retrospective audit of 70 stroke patients notes, it was reported that the MAS was
responsive to change with no patients regressing from initial admission scores and
with mean increase in scores on each item of at least one point (Dean and MacKay
1992). These findings are questioned by English et al, (2006) who found large floor
and ceiling effects of the MAS particularly for the three arm items, although the gait
item was found to be more sensitive.
There has been recent interest regarding the properties of the three upper limb
items on the MAS, with these items identified as the UL-MAS subscale (Lannin
2004).
Malouin et al, (1994) found the arm items from MAS to have good
agreement with arm items from the FMA indicating concurrent validity. The testretest reliability of the three arm items from MAS was found to be good, with scores
of Kendal’s T between 0.94 – 1.00 (Loewen and Anderson 1988). Lannin (2004)
established that the UL-MAS could be used as a single item score and argued that a
single composite UL-MAS score would be useful in research and clinical practice.
The suggestion of using the UL-MAS as a valid measure was proposed after data
collection on this study had commenced, therefore it was not considered as an
independent test of upper limb function.
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6.3.3.3 Piloting the Rivermead Motor Assessment and the Motor Assessment
Scale
From the literature available at the time of planning the study, it appeared that both
the MAS and the RMA had established psychometric properties, were fairly brief to
administer, used little equipment and could be feasible to undertake in the
community setting.
Both outcome measures were piloted with four people with
stroke in the out-patient stroke rehabilitation gym at Astley Ainslie Hospital. While
both measures were found to be feasible to use with no requirement for large pieces
of specialist equipment, the MAS was completed more rapidly (maximum time 21
minutes), while the RMA took longer, particularly in subjects with upper extremity
recovery (maximum time 32 minutes). The operational definitions for MAS were
also felt to be clearer and the seven item ordinal scale gave more potential for
greater sensitivity in identifying recovery. On a pragmatic level, it was therefore
decided to use the MAS for the definitive trial
6.3.3.4 The Frenchay Arm Test (FAT)
At the time of developing the study, a simple measure of upper limb activity was
sought as the outcome measures already identified did not have comprehensive
items relating to arm function, that could be used as independent measures. While
simple tests such as the nine hole peg test (Kellor et al, 1971; Mathiowetz et al,
1985) exist, a substantial amount of hand dexterity and UL recovery is required to
undertake the test. Having considered the available measures, the FAT (Parker et
al, 1986) was considered to be a reasonable measure to pilot as it was concise,
administered in under five minutes, and measured five fundamental aspects of arm
and hand function. Items are scored on a dichotomous scale of zero or one giving a
total possible maximum score of five (Parker et al, 1986; Wade 1989).
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Originally, the FAT included seven items (Wade et al, 1983) and was found to be
useful for detecting change in upper limb recovery post-stroke.
The original
measure was reduced to five items by Parker et al, (1986) and appears to have
been used in this way ever since. In a study of 187 people at three and six months
after stroke, the FAT was found to detect functional change whereas the nine hole
peg test (9HPT) did not (Parker et al, 1986). It has been noted however, that the
addition of a 9HPT once a person scores fully on the FAT can identify further
recovery (Heller et al, 1987). The FAT does have floor and ceiling effects, it does
not give an indication of arm strength and is not particularly sensitive (Wade 1989).
A person scoring four or five on the FAT however, is likely to have relatively good
functional recovery of their hemiplegic arm and for that reason it was decided to use
the FAT in this study.
6.3.4
Global Measures of Activity Limitation
6.3.4.1 The Barthel Index (BI)
A simple global measure of disability was required and the two main contenders for
this were the Barthel Index (BI) and the Functional Independence Measure (FIM).
Both measures aim to record actual not potential function (Keith et al, 1987; Collin et
al, 1988). Both measures use an ordinal scale, although some proponents argue
that the greater number of categories on the FIM (seven) makes it more responsive
than the Barthel (between two and four categories). The responsiveness however,
has been found to be similar between the FIM and BI in stroke populations (van der
Putten et al, 1999; Hsueh et al, 2002).
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The FIM consists of 18 items assessing six functional areas and takes around 45
minutes to administer.
Rigorous development procedures for the FIM were
undertaken with 114 healthcare professionals from 8 disciplines with a sample of
over 100 patients (Keith et al, 1987). The psychometric properties of FIM have been
well established with stroke, with FIM possessing face and content validity (Keith et
al, 1987), concurrent validity with BI (Hsueh et al, 2002; Kwon et al, 2004) and with
the Rankin Scale (Kwon 2004) and good predictive validity (Timbeck et al, 2003).
When used with neurological populations FIM demonstrates good intra-rater, interrater and test-retest reliability (Ottenbacher et al, 1996), although stability of the
social cognition domain when administered over two separate occasions by two
different raters with a population of people with chronic stroke was only fair to
adequate (Daving et al, 2001). One of the major disadvantages to using the FIM
however, when only one person would be undertaking outcome measures, was the
administration time (at least 45 minutes), the costs and the need for training and
accreditation to use the FIM.
The Barthel Index (BI) was first published in 1958 (Mahoney et al, 1958) and was
tested with 144 patients, of whom 68% (n= 99) had neurological conditions. The BI
scored from 0 – 100 and originated as a measure of independence, primarily in selfcare (Mahoney et al, 1958; Tennant et al, 1996). In the original paper it was claimed
that a person scoring 100 was independent, although this has been shown
subsequently not to be the case, with floor and ceiling effects noted (van der Putten
1989, Duncan et al, 1997; Turner-Stokes and Turner-Stokes 1997).
A major
criticism of the BI is that it primarily focuses on bed mobility and walking ability with
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Chapter 6
only crude assessment of upper limb function or more complex tasks of activities of
daily living (Kelly Hayes et al 1998).
The scoring of 0 – 100 on the original BI was amended to provide a 0 – 20 point
scale by Collin et al (1988). Both the 100 point and 20 point BI are in use today,
with no distinction made in the title of the test. The 20 point BI was tested for
reliability with 25 patients during four different modes of administration (interview of
patient, interview of nurse, actual testing by a trained nurse or by an Occupational
Therapist) and a close agreement between all four methods was found. It was
noted that the middle scores on complex, multidimensional tasks such as feeding
and toileting were the most difficult to get agreement on and following this study, the
authors expanded the guidelines for administration (Collin et al, 1988). Test-retest
reliability of the BI in a small sample (n=22) of people with late-stage stroke has
been established (Green et al, 2001).
6.3.4.2 Piloting the Barthel Index
The BI has been used extensively in stroke research and despite arguments being
made to use the FIM in preference to the BI in the UK (Turner-Stokes et al, 1997),
there is no clear standard measure of “disability” (Wade and Collin 1987). When
deciding which measure of disability to use, a pragmatic decision was taken to use
the BI as it required minimal equiment, had established validity when administered
by interview (Wyller et al, 1995) and would be brief to administer within the battery of
outcome measures.
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During pilot procedures with four people with stroke, the BI was completed within
five minutes. The principal investigator [GB] (who was already familiar with the
content) developed standardised prompts to try to ensure as accurate capture of the
patients ability level as possible (for example – “you have said you are independent
going to the toilet – are you able to manage your clothes? Zips? Do you manage
one handed or do you need a little bit of help?”).
The reasons for selecting to use the Barthel Index are presented above. In addition,
the vast majority of papers relating to research into stroke rehabilitation use either
the BI or the FIM, so in order to draw comparisons with previous work it was prudent
to use one of these measures.
However, the BI does predominantly measure
independence in activity in and around the home setting, therefore a more global
measure of activity, which incorporated social activities, was also required.
6.3.4.3 The Frenchay Activity Index (FAI)
The Frenchay Activity Index (FAI) was developed to use with Stroke Patients as a
measure that gave more information regarding lifestyle activities rather than selfcare (Holbrook and Skilbeck 1983).
The FAI measures the broad domains of
“Domestic Chores”, “Leisure and Work” and “Outdoor Activity” within the past six
months. Although it was initially developed for the period of acute care and in-patient
rehabilitation, it has been used with later stage stroke patients (Holbrook and
Skilbeck 1983; Schuling et al, 1993; Wyller et al, 1996; Green et al, 2001).
Maximum score on the FAI is 45, using a four point scoring system from zero to
three (Wade et al, 1985) which is a modification from the original one to four scale
(Holbrook and Skilbeck 1983).
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Factor Analysis has been argued as one manner of determining construct validity of
an outcome measure and all items on the FAI have been shown to have a high
degree of communality indicating the items are associated with a single concept
(Wade et al, 1985).
While the ordinal scoring is quite crude, it has been
demonstrated that the FAI is able to reflect changes in activity levels pre- and poststroke (Wade et al, 1985; Schuling et al, 2006).
A Dutch version of the FAI was
tested with 185 people at 26 weeks post-stroke and demonstrated the homogeneity
of the scale and a “substantial” relationship with the BI (Pearsons r 0.66) (Schuling
et al, 2006).
Various aspects of reliability have been established with the FAI. Bland and Altman
methods to look at agreement between the FAI completed twice with an interval of
seven days showed good levels of agreement with a mean difference of 0.6 and
with over half the total scores within two points of each other (Green et al, 2001). A
study to investigate whether people with stroke perceived their activity to be the
same as the perception of their carer showed good to very good agreement in six
items (kappa 0.61 – 1) and moderate agreement in seven items (kappa 0.41- 0.6),
with a tendency for carers to score patients lower, particularly on domestic chores,
than they score themselves (Wyller et al, 1996).
Piloting the FAI with four people with stroke showed that it was administered in
around five to ten minutes, was easily understandable with no requirement for
standardised prompt questions.
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6.3.5
Measuring aspects of mobility and balance
6.3.5.1 The Timed Up and Go (TUG)
A simple measure of mobility including balance was required and the Timed Up and
Go (TUG) seemed a suitable measure for use in the home setting as it is conducted
with the patient rising from a chair, walking three metres turning and returning back
to sit down in the chair (Podsiadlo and Richardson 1991).
It was originally
developed with 60 elderly patients (mean age 79.5 years) of whom 23 had sustained
a stroke and the time to complete the TUG was between 10 and 240 seconds. Testretest (ICC 0.95, Ng and Hui-Chan 2005) and inter-rater reliability were reported as
very good (ICC – 0.99, Podsiadlo and Richardson 1991; ICC – 0.98, Shumway
Cook et al, 2000). A good correlation with Berg Balance Scale (r= -0.81), gait speed
(r = 0.61) and Barthel Index (r =-0.78) has also been found, indicating aspects of
concurrent validity (Podsiadlo and Richardson 1991). A cut-off time of 30 seconds
has been reported to discriminate between “fast” and “slow” walkers, as well as the
ability to independently walk outside (Podsiadlo and Richardson 1991; Freter and
Fruchter 2000). Furthermore, Nikolaus et al, (1996) reported that in a sample of
elderly people a mean TUG time of 31.7 seconds was found in people living in a
nursing home, compared to a mean TUG time of 20.6 of community dwelling elderly.
Given some of the anticipated environmental restrictions of performing outcome
measures in a community setting, a development of the TUG to incorporate timing of
component parts using a multi-memory stopwatch (Wall et al, 2000) appeared to be
an expedient modification of the TUG. This modification was developed over a 10m
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walking course with the lap timer being used to measure discrete events consisting
of sit-to-stand time, walking speed, turning time and sitting down time. Recently the
reliability and aspects of validity have been established with the stopwatch method
of measuring component parts over a three metre walking course (Botolfson et al,
2008).
6.3.5.2 Familiarisation with timing the Timed Up and Go
The timing of components of the TUG was piloted with four subjects performing the
TUG while being video-recorded on three trials. Real-time recording of the six TUG
component parts was undertaken and these data were compared to video data of
the same TUG performance two weeks later. Raw data are available in appendix
IV.
The results showed very good intra-rater reliability between actual and video
data with ICC 2,1 all over 0.98.
6.3.5.3 Step Test
A dynamic test of balance, including the ability to balance on the hemiplegic leg
while moving the other leg, was included as the exercise intervention was likely to
include a task to challenge dynamic balance. The Step Test (ST) was developed
with a sample of 41 community dwelling older subjects and 41 people with stroke. It
was designed to be a simple, clinically relevant test of dynamic single leg stance
(Hill et al, 1996). The test consists of stepping one foot on and off a 7.5cm block as
many times as possible within 15 seconds (Hill et al, 1996; Bernhardt et al, 1998;
Tyson and Connell 2009).
Normative values for healthy elderly was mean steps
17.67 + 3.22 (right leg) and 17.37 + 3.03 (left leg). In the stroke population, mean
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steps with the unaffected leg was 6.95 + 4.55, mean steps with the affected leg was
6.39 + 4.53.
Overbalancing while performing the ST occurred in 10% of people
with stroke, therefore safety measures in the form of stand-by assistance should be
adopted (Hill et al, 1996). Furthermore, due to a slight practice effect being noted
on the ST, it is recommended that at least one practice session is allowed (Hill et al,
1996, Tyson 2007).
Psychometric properties of the ST have been established by the originators and
other investigators. Hill et al, (1996) established very good test-retest reliability in
healthy elderly (ICC 0.9 – 0.94) and people with stroke (ICC 0.88 – 0.97).
Good
correlations have also been demonstrated with the FRT, gait velocity and stride
length, (Hill et al, 1996, Bernhardt et al, 1998) and the balance item on MAS
(Bernhardt et al, 1998) indicating aspects of criterion related (concurrent) validity. In
terms of predictive validity of the ST in stroke, each additional step with the affected
leg corresponded to a 0.07 m/s – 0.09 m/s increase in gait speed, while an
additional step with the unaffected leg corresponded to a 0.07 m/s – 0.08 m/s
increase (Mercer et al, 2009a; Mercer et al 2009b). The ST was found to be
responsive to change in performance in the first eight weeks following stroke with a
significant improvement noted for both ST with the affected and unaffected leg
(Bernhardt et al, 1998). One drawback of the ST is the potential for a floor effect in
cases where single leg stance is not possible.
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6.3.6
Measuring Aspects of Mood
It is well recognised that undertaking exercise may have a beneficial effect on mood
(Lai et al, 2006; Bassey 2000), which may or may not be associated with functional
improvements post-stroke. It was, therefore, important to include a simple measure
of mood. While a number of measures are available such as the General Health
Questionnaire and the Beck Depression Inventory, after consideration of the
psychometric properties and pragmatic issues of administration, it was decided to
use the Hospital Anxiety and Depression Scale as it takes under five minutes to
complete and is easy to score (Snaith 2003).
6.3.6.1 The Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) was originally designed as a
tool for self-assessment of mood in non-hospitalised patients such as people
attending an out-patient department for a chronic condition but not a psychiatric
disorder (Zigmond and Snaith 1983).
Although the concepts of “anxiety” and
“depression” were not defined in the original paper, the authors stated that they
“distinguish[ed] between the concepts of anxiety and depression” and took
measures to ensure the original items in each sub-scale derived from appropriate
theoretical constructs. The HADS was originally tested with 98 out-patients aged
between 16 – 65 years. Each sub-scale consists of seven items scored from zero to
three making a total possible score of 21 for each subscale (Zigmond and Snaith
1983).
A score of over 11-15 indicates “moderate cases” and scores over 16
identifies “severe cases” (Snaith and Zigmond 1994). Within the stroke population
it has been noted that an optimal cut-off score for the total HADS is 11, and a cut-off
of 8 for the HADS-D (Aben et al, 2002).
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Chapter 6
The HADS has been recommended for use in studies of mood for the general
population (Herrmann 1997; Crawford et al, 2001) and for people with stroke (Aben
et al, 2002; Bennett et al, 2006). The psychometric properties of HADS have been
established, for example it has been found to show good internal consistency
(Zigmond and Snaith 1983; Cameron et al, 2008), has construct validity as shown
by factor structure analyses (Zigmond and Snaith 1983; Bennett et al, 2006); shows
discriminant validity (Cameron et al, 2008) and is responsive to change in symptoms
(Bjelland et al, 2002; Cameron et al, 2008).
Some weaknesses have also been identified, for example the item on the
depression subscale “I feel as if I am slowed down” is problematic for reflecting
depression as, for people with stroke, it is also central to the physical condition
(Johnston et al, 2000). Overall however, it was felt that the use of HADS to provide
an indication of mood was appropriate for this study.
6.3.7
Measuring Quality of Life
Quality of Life (QoL) is a complex entity that is represented differently to different
individuals. Despite there being no consensus for a definition of QoL, it is accepted
that it is multidimensional, encompassing social domains alongside physical and
mental domains (Buck et al, 2000). QoL is not a static phenomenon and may
change over time (de Haan et al, 1993). A deterioration in QoL has been reported in
people with stroke at three and four years after the initial event (Patel et al, 2007;
Niemi et al 1988). The most significant declines contributing to a reduced QoL have
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been reported as occurring in domains such as self-care needs, personal
relationships, coping with life events, home management and recreation (Saladin,
2000).
Quality of Life (QoL) is potentially best assessed on an individual basis using indepth interviews, (de Haan et al, 1993; Tennant 1996), however this methodology
was not felt to be appropriate for this study due to time constraints. A number of
standardised questionnaires were therefore considered for use, to capture an
overview of QoL. Many generic QoL measures have been criticised for not including
behaviours or domains more specific to stroke (de Haan et al, 1993; Williams et al,
1999a, Buck et al, 2000), therefore two stroke specific QoL measures were
considered for use: the Stroke Impact Scale (SIS) (Duncan et al, 1999) and the
Stroke Specific Quality of Life (SSQoL) (Williams et al, 1999b).
6.3.7.1 The Stroke Impact Scale
The Stroke Impact Scale (SIS) was one of the first stroke specific QoL measure to
have been published. It was developed to assess a number of areas considered
important for QoL post-stroke. The 64 items on the SIS evaluate the perceived
functional effects of motor impairments, as well as the domains of emotion,
communication, memory, thinking ability and social role function (Duncan et al,
1999a). The SIS was refined in 2003 to become the SIS v3.0 (Duncan et al, 2003).
It has been found to be valid to administer the SIS via telephone, post, or via proxy
response (Edwards and O’Connell 2003; Duncan et al, 2002a; Duncan et al, 2002b,
Kwon et al 2006).
Furthermore, recent recommendations have been made for
meaningful minimal detectable changes in each physical domain (Lin et al 2010a).
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These are changes of 4.5, 5.9, 9.2 and 17.8 points on the domains of mobility, ADL,
strength and hand function respectively (Lin et al 2010a).
Since the development of the SIS, a number of studies have established its
psychometric properties. Internal consistency showed very good acceptability with
Cronbach  from 0.83 to 0.90 (Duncan et al, 1999a). Test–retest reliability over one
week was also found to be good in all domains (ICC 0.7 – 0.92) except for emotion
which was moderate (ICC 0.57) (Duncan et al, 1999a).
Content validity was
established through involvement of people with stroke (n=32), care-givers (n=23)
and stroke experts (n=9) (Duncan et al, 2001). Concurrent validity has been
established against existing measures such as the SF36 and the SIS has been
found to cover a broader and more relevant stroke-specific domains than the SF36
(Lai et al, 2003)
While there is the potential for floor effects in some domains such as hand function
or ceiling effects in the communication domain (Duncan et al, 1999b), overall the
SIS has been found to show good levels of responsiveness to change in condition
(Lin et al, 2010b).
6.3.7.2 The Stroke Specific Quality of Life Scale (SSQoL)
The Stroke Specific Quality of Life Scale (SSQoL) was developed from interviews
with 34 people with stroke within the first six months after stroke. The interviews
allowed the most common domains affected by stroke to be identified and typical
activities within the domains to be ascertained. Following piloting and refinement
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Chapter 6
the definitve SSQoL consisted of 49 items in 12 domains, was scored on a five point
Likert scale and, similarly to the SIS, questions related to how responders felt their
stroke had affected them within the past week. In a sample of 71 relatively young
(mean age 61 years) people at least one month after stroke, the SSQoL was found
to be significantly associated with Health Related QOL and to be more sensitive to
change whereas the use of the generic Short Form 36 (SF36) showed no
association (Williams et al, 1999b). In testing proxy versus patient response to
SSQoL, proxies were found to score all domains lower than the patients, with the
largest discrepancy in domains of mood, thinking and energy (Williams et al 2006).
This trait is commonly seen when gaining proxy responses and the same responder
should be involved when undertaking testing on multiple occasions.
6.3.7.3 Comparisons between the Stroke Impact Scale and the Stroke
Specific Quality of Life Scale.
The SIS and the SSQoL have been cited as being the most comprehensive stroke
specific QoL measures, providing comprehensive evaluation of domains meaningful
to people post-stroke (Salter et al, 2008; Lin et al 2010b). Both the measures have
been investigated to determine responsiveness and aspects of criterion validity, but
only one recent study has compared the psychometric properties of the two
measures (Lin et al, 2010b). 74 people at least six months post-stroke participating
in an RCT of UL rehabilitation were assessed on a battery of outcome measures,
including the SIS and SSQoL.
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Chapter 6
While most SIS responsiveness scores were low to medium for pre- to posttreatment measures, this was better than the responsiveness of the SSQoL where
no response was found despite patient self-reports of change. The Standardised
Response Mean (SRM) of the SIS =0.5, 95%CI = 0.27 – 0.78, compared to SRM of
SSQoL 0.14, 95% CI -0.7 - -0.39. The SIS hand function domain was the only
domain on any scale to show medium responsiveness, all other domains were low
to moderate.
SIS hand function also demonstrated better concurrent validity with
good correlations between SIS and criterion measures of FMA and between SIS
and the Motor Activity Log, whereas SSQoL UL domain demonstrated fair
correlations. A similar pattern was found for concurrent validity with the FAI (Lin et
al, 2010b). While these are interesting findings, this information was not available at
the time of planning the current study and therefore exploration of the use of both
outcome measures was undertaken as part of pilot procedures.
6.3.7.4 Piloting the Stroke Impact Scale and the Stroke Specific Quality of
Life Scale
At the time of developing the study there were very few papers published supporting
either the psychometric properties of the SIS or the SSQoL, although in 2010, it is
clear that the SIS has been more rigorously tested. The investigator had felt prior to
piloting that the SSQoL probably had broader coverage of domains that would be
relevant to people with stroke, but as both the SIS and SSQoL were new measures
it seemed appropriate to determine if they were acceptable to potential participants.
The SIS and SSQoL were piloted with four people with stroke. It was found that
once the scoring system had been explained to the participants, there were no items
that appeared confusing. One participant needed further explanation that there was
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Chapter 6
no “correct” answer, but that the questionnaires sought to identify how well the
person perceived they had recovered from their stroke.
Both measures took between 20 – 30 minutes to complete. One item on the SSQoL
however required a response to a question related to sexual activity “I have had sex
less often than I would like”. This question, or the prospect of answering this type of
question caused distress to two of the four pilot subjects (one subject on direct
questioning and one subject who had been left to complete the SSQoL without
supervision omitted to answer that question and, indeed, the whole page of
questions). Due to the potential that offence at, or reluctance to answer a question
on SSQoL relating to sexual activity might result in a considerable amount of
missing data, a decision was taken to use the SIS in the final study.
6.3.8
The final selection of outcome measures
Following review of relevant literature as indicated in the preceding sections the final
outcome measures that were selected for use in the final pilot are listed in table 6.2.
It was anticipated that administration of the battery of outcome measures would take
around 90 minutes to two hours, depending on the ability of the participant.
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Chapter 6
Test
Used as
Screening Test
The Mini Mental State Examination

Functional Reach Test

Used in
Outcome battery
The Hospital Anxiety and Depression Scale

The Motor Assessment Scale

The Frenchay Arm Test

The Barthel Index

The Frenchay Activities Index

The Step Test

The Timed Up and Go

The Stroke Impact Scale.

Table 6.2.
6.4
Screening tests and outcome measures to be used in definitive
trial
Pilot of Exercise Intervention and Outcome Measures in the Community
A community pilot of a four week home exercise programme of the six exercises
identified following the hospital pilot phase was undertaken to ascertain whether any
further refinements to the exercise interventions or the battery of outcome measures
would be required. The exercises are detailed in appendix II. There were two main
aims of the community pilot phase. The first aim was to explore the feasibility of
undertaking the exercises structured as PP or WP in the community setting. The
second aim was to ensure the battery of outcome measures were suitable for
administration in the community setting and to further familiarise the outcome
assessor [GB] with carrying out the outcome measurements.
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Chapter 6
6.4.1
Methodology of Community pilot of exercise intervention
Six participants with stroke were recruited to the community pilot phase, via referral
from the Senior Physiotherapist.
This was therefore a sample of convenience,
selected to provide a range of ability and not to compromise the definitive trial. The
pilot phase was exploratory in nature, and considered the viability of the practice
regime and gained feedback on the utility of the documentation.
Subject
characteristics are presented in table 6.3.
Participant group
identifier
J
D
E
G
A
K
PP1
WP2
PP3
WP4
PP5
WP6
Age
68
62.3
61.1
58.7
57.8
64
time
since
stroke
(weeks)
56
28
37
50
34
39
side of
Dominant
hemiplegia hand
L
R
L
L
L
L
R
R
R
L
R
R
Table 6.3. Characteristics of Community Pilot participants
Community pilot participants were no longer receiving formal rehabilitation, but had
all previously undergone stroke rehabilitation at Astley Ainslie Hospital, Edinburgh, a
tertiary rehabilitation centre.
Inclusion criteria ensured that pilot participants had a
diagnosis of stroke as confirmed by CT or MRI scan; were over 18, were > six
months post-stroke, were no longer receiving formal rehabilitation and were able to
provide informed consent. Potential participants were identified by physiotherapists
in the Stroke Rehabilitation team. An initial contact by phone, during which the aim
of the pilot was explained, was followed by providing written information relating to
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Chapter 6
the community pilot phase, an informed consent form and a return envelope. Once
recruited to the community pilot phase a date was made for an initial visit.
The Community pilot phase was conducted as a pre-post treatment study.
Participants were allocated, alternately, to either a PP or WP exercise group, no
control group was included. This format was not analogous to the definitive trial
design which would include a control group and would comprise two baselines and
repeated follow-ups on cessation of intervention. However, the design adopted did
correspond to the exploratory nature of this phase in investigating feasibility of the
exercise structure, documentation and utility of outcome measures.
For this community pilot phase, the outcome assessor (GB) was not blinded to
group allocation. In the definitive trial outcome assessment would be blinded, but
there were no resources to support this for the pilot phase. On the initial preintervention visit participants were tested on the battery of screening tests and
outcome measures as identified in table 6.2.
Field notes were made to refine
administration and to ensure standardisation.
The exercise interventions were provided in visual and written format in an “Exercise
Diary” (appendix II). The specific PP or WP exercises were taught to the participant.
Care was taken to ensure that the environment in which exercises would be
practiced was safe. This analysis of the environment was taken on an individual
basis, as is standard clinical practice. For example if balance was an issue for the
stepping up and down exercises, then the practice area might be set up in the
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kitchen next to the work surface, the environment was cleared of hazards (rugs, pet
food bowls), a chair was positioned appropriately close to the practice area. In the
event that the participant lived alone, every care was taken to ensure that the
exercise area (or areas) could either be set up by the participant or could be left in
situ.
If the participant had a particular problem with an exercise, for example
symmetrical weight bearing during rise to stand, then simple, additional prompt
notes were included on the Exercise Diary. The target number of repetitions of each
exercise was documented in the Exercise Diary and participants were requested to
document the actual number undertaken. In addition, participants were requested to
document other sustained activity (for example, walk to corner shop and back – 20
minutes).
A visit was made to the participants mid way through the four week exercise
intervention, to check on progress, ensure the exercises were being practiced
correctly, to discuss any issues that had arisen for the participant and to encourage
the participant to maintain or increase the number of repetitions for each exercise.
At the end of the four week exercise intervention an outcome assessment visit was
undertaken and all outcome measures were administered again.
6.4.2
Results of Community pilot of exercise intervention
All participants completed the community pilot. Pre – post data were available for all
outcome measures for all participants. One participant mislaid his exercise diary
between the mid-way and end of intervention visit, therefore data relating to number
of repetitions undertaken for each exercise was only available for five participants.
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Data are summarised firstly by number of repetitions undertaken for each exercise
and the findings for the pre- post outcome measures. Raw data are found in
appendix VII.
6.4.2.1 Number of Repetitions for each Exercise
Selected graphs are presented in this section. The number of repetitions for the
Rise-to-Stand exercise and the Sitting Down exercise were recorded as being
identical by all subjects therefore only the rise to stand graph has been presented as
figure 6.2.
As can be seen two participants increased the number of repetitions
each week, while three participants practiced in a relatively constant manner. The
maximum number of repetitions was 250 (PP1 in week 3) and minimum 40 (WP4
week 4).
300
participants
repetitions
250
PP1
200
WP2
150
PP3
WP4
100
PP5
50
0
STS1
STS2
STS3
STS4
weeks
Figure 6.2. Line graph of weekly total of Rise to stand repetitions by pilot
participants
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Chapter 6
For the Stepping Up and Stepping Down exercises with the unaffected leg
(necessitating dynamic balance and weight bearing through the affected leg), a
similar pattern of repetitions was undertaken by each participant and therefore a
representative graph is presented in figure 6.3.
As can be seen
PP1 again
increased the number of repetitions markedly from week one, while the remaining
participants stayed relatively stable. The maximum number of repetitions was 230
(PP1 in week 2) and minimum 40 (WP4 week 4).
250
participants
200
Repetitions
PP1
WP2
150
PP3
100
WP4
PP5
50
0
Step Up1
Step Up2
Step Up3
Step Up 4
weeks
Figure 6.3. Line graph of weekly total of Stepping Up with the Unaffected Leg
repetitions by pilot participants
Figure 6.4 indicates the number of repetitions of Cuppa Time exercises with the
affected upper limb and figure 6.5 indicates TipTap. Only one participant (PP1) had
good recovery in his upper limb and this participant maintained the same number of
high repetitions (maximum 230 in week 3) with arm exercises as with lower
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Chapter 6
extremity exercises. The remaining participants demonstrated far fewer repetitions
of upper limb exercises. WP4 had minimal upper limb recovery and did not practice
the exercise, despite being able to undertake forearm weight-bearing. As PP5 had
minimal upper limb recovery, this participant (represented by the dashed line in
figure 6.4) was encouraged to position the arm as if to undertake the exercise, to
practice the weightbearing component and to undertake mental practice of the
remaining components
250
participants
200
repetitions
PP1
WP2
150
PP3
100
WP4
PP5
50
0
Cuppa1
Cuppa2
Cuppa3
Cuppa4
weeks
Figure 6.4. Line graph of weekly total of Cuppa Time exercise repetitions by
pilot participants
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Chapter 6
250
200
repetitions
PP1
WP2
150
PP3
100
WP4
PP5
50
0
Tip1
Tip2
Tip3
Tip4
weeks
Figure 6.5. Line graph of weekly total of TipTap exercise repetitions by pilot
participants
6.4.2.2 Baseline to end of intervention Outcome Measurement Data
Pre and post measures were taken on all six pilot participants for the Motor
Assessment Scale, Timed Up and Go, The Step Test, Frenchay Arm Test and the
Barthel Index. Data were plotted to allow comparisons to be made pre and post the
four week intervention phase. Data are presented in figures 6.6 – 6.10.
Figure 6.6 shows the MAS scores for pilot participants. Two PP (PP1, PP5) and
two WP (WP2, WP4) participants made small gains on the MAS, the other two
participants demonstrated no change in score. The improvements in all cases were
related to sitting balance or rise to stand components and the walking component.
Only one participant demonstrated an improvement on the UL items. . From a
practical point of view, it became apparent that it was helpful to warn participants of
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Chapter 6
the activities to be conducted during testing as one participant was not keen initially
to undertake the bed mobility tests.
Figure 6.6.
Pilot Motor Assessment Scale pre- post-intervention scores
Timed Up and Go (TUG)
The TUG total time is presented in figure 6.7. The TUG was conducted over three
metres. Two PP (PP1, PP3) and two WP (WP2, WP4) participants reduced their
total time for the TUG. The other two participants demonstrated a small increase in
total time (+0.17 sec PP3 and +0.82 sec WP6) in score. WP4 reduced total TUG
time by over 12 seconds, this was possibly related to familiarity with the test
procedure and the assessor. An issue relating to having sufficient space to conduct
the test became apparent during the pilot phase. This necessitated undertaking a
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Chapter 6
further pilot to establish the concurrent validity of a TUG over a shorter distance
(reported in section 6.6).
Figure 6.7.
Pilot Timed Up and Go pre- post-intervention scores
Rise to stand
The TUG was timed using a multi memory stopwatch with lap timer, this allowed
calculation of certain components of the TUG. Rise to stand time was of interest as
this was an exercise that the pilot participants had practised during the four weeks
intervention. Results for rise to stand times are presented in figure 6.8
Five of the six pilot participants improved their time on the rise to stand component
of the TUG. PP1 reduced their time from 3.11 to 2.20 seconds – a reduction in time
by a third. Most of the other changes were modest and PP5 demonstrated a slight
increase in rise to stand time
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Chapter 6
Figure 6.8.
Pilot Rise to stand time
Operationally, it was apparent that it was beneficial to demonstrate the TUG before
each testing session, as without doing so some participants waited for a command
to walk or turn and this adversely affected their times.
The Step Test
Data are presented in figure 6.9 for stepping up with the unaffected leg.
Undertaking this test required the participant to balance and weight bear through the
leg most affected by their stroke. Five of the six pilot participants improved the
number of step ups they were able to perform, with WP4 improving by 4 steps, WP6
improving by 3 and WP2 and PP1 improving by two steps. Only PP5 maintained
their pre-test score.
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Chapter 6
Figure 6.9
Pilot Step Test data – stepping up with the unaffected leg.
Frenchay Arm Test
Data relating to the Frenchay Arm Test are presented in figure 6.10
Figure 6.10
Pilot Frenchay Arm Test data
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Chapter 6
As can be seen from the bar chart, only two of the pilot participants were able to
gain a score on the Frenchay Arm Test, and only PP1 demonstrated a change. On
consideration of the physical status of the pilot participants, it was felt that four out of
the six participants with minimal return of UL function was not necessarily
representative of the stroke population at large and a decision made to retain the
Frenchay Arm Test for the definitive trial.
Barthel Index
Data were collected for the Barthel Index at pre- post-interventio9n points. All pilot
participants Barthel Index scores remained stable. Data are available in appendix
VII.
6.4.3
Summary of key findings from Community Pilot
The Community pilot phase raised a number of issues that needed to be addressed
in the definitive study and these are outlined in this section.
The number of repetitions undertaken by the participants was variable and indicated
that while a starting level of between six to ten daily repetitions of each exercise was
feasible, for some participants there would be a need to commence with a higher
number of repetitions. In relation to the number of reported repetitions, the accuracy
of reporting could not be verified and in the definitive trial, it was felt that a method
for capturing activity over a period of time (to include the exercise practice) might
allow a form of verification.
Consideration was therefore given to the use of an
accelerometer (see 6.5).
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Chapter 6
Scheduling visits two weeks apart did not allow time for the therapist to identify that
the exercises were being undertaken correctly at an early stage. While the two WP
participants understood how to structure the practice sessions, there were a number
of queries from the PP participants. It was felt that any issues that arose early
during the study needed to be addressed within the first few days of the intervention
phase, to ensure the practice structure was understood. This issue was highlighted
by PP1, PP3 and the researcher.
For participants who had minimal upper limb recovery, the two exercises relating to
upper limb posed some problems.
Given that poor arm function is a common
feature post-stroke, it was felt that including exercises to target upper limb activity
was relevant. It was decided that for those participants who might demonstrate
minimal or no upper limb activity, the affected upper limb would be positioned on the
table with the cup or bottle placed in the hand and physical practice would be
encouraged. In the situation where physical practice was not possible, the affected
upper limb would be placed in the start position, weight bearing encouraged and
mental practice with an external focus on movement of the object (cup or bottle)
would be followed.
The Community pilot raised two main environmental issues. The first of these was
the need to be sensitive to the home setting. While there was a need to ensure
adequate organisation to enable the exercise practice to occur, this had to be
balanced to ensure the home environment did not end up as a mini rehabilitation
gym. Creative solutions to storage of the step-up block, particularly for people who
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lived alone in a relatively small dwelling, were required.
The other issue that
became apparent was linked to being sensitive to the home setting.
One pilot
participant lived in cramped conditions with numerous ornaments, furniture and
other equipment. For this participant, it was not possible to sort out a satisfactory
space in which to undertake the Timed Up and Go (TUG), as a clear space of nearly
five metres was required to allow chair placement and turning space.
It was
therefore decided to explore whether undertaking the TUG over a shorter distance
would be a valid test in this population (see 6.6).
Feedback from pilot participants resulted in a number of changes to the exercise
documentation so that it was more user friendly.

The terms “affected” and “unaffected” referring to limbs were disliked, two
participants recommended changing the documentation to read “bad” and
“good”, as this was the terminology used colloquially by participants and
carers.

A5 size documentation was preferred to A4, as it was less unwieldy.

Collating the documentation into a loose leaf, hard covered, A5 ringbinder
was suggested to make the whole activity diary more substantial.

The use of page dividers with tab extensions was another suggestion that
enabled the participants to turn directly to the exercise instructions and
exercise record page.

The diary exercise record pages had been pre-printed to provide a record for
seven days, starting on a Monday. Not all participants commenced on a
Monday and found it confusing how to document the final week as five
exercise record pages would be required and only four were provided.
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Omitting the pre-printed days from the seven day exercise record, solved this
problem
One participant provided extensive typed feedback, concluding with the statement
“The major sense of achievement from doing exercises comes from
transferring an exercise activity into my daily life routine. This has given me a
great sense of achievement”
Modifications to the exercises and documentation that arose from the pilot were
applied to the definitive trial.
6.5
Testing the ActivPAL
During the development of the exercise practice schedule, consideration was given
to how reliable participants might be in reporting the number of exercises they had
undertaken (see 6.4.3). Associated with this consideration was a secondary aim of
the study, namely to explore activity undertaken by people with late-stage stroke in
their home environment. A simple activity monitor that was unobtrusive and easy to
operate was required.
A number of commercially available devices such as
pedometers and accelerometers are available (Rowe 1999; Macko et al, 2002;
Tudor-Locke et al, 2002) and consideration was given to using a pedometer for this
task. However, while pedometers are simple to use and can quantify cumulative
step count within a given period, a pedometer does not provide data relating to other
activity. A pragmatic decision was made therefore, to utilise the activPAL™ as step
count was only one activity of interest, and the activPAL can measure time spent in
different positions: sitting or lying, standing and walking as well as taking a record of
the number of rise to stand transitions (Grant et al, 2006; Godfrey et al, 2007).
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Chapter 6
The activPAL is a small (35mm x 53mm x 7 mm), lightweight (20 gm) uni-axial
accelerometer, worn in the midline, one third of the way up the anterior aspect of the
thigh (figure 6.11).
It has a sampling rate of 10Hz and operates by detecting
alterations in the amplitude of the acceleration signal with the shape of the signal
over time. Using proprietary algorithms it then categorises the acceleration signal
derived from positional change as time spent in a position, a change from horizontal
to vertical (rise to stand (RTS)), or cyclical change from the vertical (stepping).
Figure 6.11
Placement of activPAL
At the time of planning the study, data was available on the fore-runner to the
activPAL (Egerton et al, 2002), but no independent publications were found related
to the activPAL. Since 2004, a number of papers have been published that support
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the validity and reliability of the activPAL as a measure of free-living activity (Grant
et al, 2006; Ryan et al, 2006; Grant et al, 2008; Dahlgren et al, 2010). Many of
these studies have been undertaken with small samples of healthy subjects which
could raise queries as to the potential of the activPAL to accurately record
movements of rise to stand and walking given some of the movement anomalies
displayed by people with stroke. In studies where walking speed has been dictated
by a treadmill, speeds have ranged generally from 0.6m/s to 1.4m/s (Maddocks et
al, 2010; Grant 2008; Dahlgren 2010), which may be faster than the comfortable
walking speed for many people with stroke. Tsavourelou et al, (2009), in a small
sample of young healthy subjects, did investigate a range of treadmill speeds,
starting at 0.27m/s. and found activPAL to be reliable. Only one small study has
been found that used activPAL with stroke (Britton et al, 2008). In that study, the
activPAL was accepted as a valid and reliable measurement instrument and used to
record the number of RTS transitions which was the focus of the intervention under
investigation (Britton et al, 2008).
Initial bench testing of the activPAL was undertaken in order to gain familiarity with
the equipment. From the bench testing it became apparent that some operational
issues could arise and therefore a plain english user guide was created (appendix
VI). In summary, there were three main operational issues. Firstly some hardware
problems were identified with two of the activPAL units, manifest by “connection
error” messages. The hardware problems required the units to be returned to the
manufacturer for repair. Secondly, the clock on the activPAL and computer where
data download would occur required to be synchronised in-between each download.
An issue with failure to synchronise between the activPAL unit and the computer led
to problems with identifying when events had occurred. Finally although battery life
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was reported to enable recordings to be made for up to seven days continuously, it
was found that after five individual day recordings, a new battery was required to
ensure the unit did not fail, as this would result in a lack of data.
6.5.1
Methodology for establishing the agreement of activPAL and video
data at different walking speeds
With the definitive home-based exercise study ongoing, a further piece of work was
undertaken in order to ascertain the accuracy of activPAL at various walking speeds
(Baer and O’Loughlin 2007). The aim of this pilot was to establish the agreement
between activPAL and gold standard video data when walking on a treadmill at
speeds of 0.69m/s, 1.36m/s and 2.08m/s.
Twenty young, healthy subjects (four male), with mean age 24.8 years (+ 2.6) were
recruited from a population of university students.
Participants walked on a
treadmill at speeds of 2.5 kilometres per hour (km/h), 5 km/h and 7.5 km/h for 10
minutes at each speed. The activPAL recording was stopped between the walking
trial at each speed. Bland and Altman plots were drawn up to explore the levels of
agreement between the two methods of measurement (Bland and Altman 1986) of
activPAL and video recordings and these are displayed in figures 6.3 – 6.5. The
Bland and Altman technique allows the determination of agreement between two
clinical measures by plotting the difference between each measure against the
mean of the differences (also referred to as “bias”). Plotting the mean difference
plus or minus 1.96 standard deviations of the differences (sdiff) allows upper and
lower limits of agreement to be determined. There is no fixed value for limits of
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agreement and therefore a judgement has to be made as to whether the spread of
data are acceptable (Bland and Altman 1991).
6.5.2
Results for agreement between activPAL and video data at different
walking speeds
At speeds of 2.5 km/h (figure 6.3) and 5 km/h (figure 6.4), the activPAL showed very
good levels of agreement with the gold standard video observation, with the mean
bias when walking at speeds of 2.5km/h or 5 km/h, being very close to zero. Mean
percentage errors in step count were also very low at -0.42% and -0.15% at speeds
of 2.5 km/h and 5 km/h respectively. At the very fast speed of 7.5 km/h (figure 6.5)
however, the agreement was poor, the data are markedly dispersed and large errors
in step count resulted in mean bias overestimates by 18.2%.
On the basis of these data, and given that people with stroke tend to walk at slow to
normal speeds of age-matched healthy people (Olney et al, 1994; Olney and
Richards 1996; Lamontagne and Fung 2004), it was felt that the activPAL was an
appropriate device to gain an indication of step count during the day.
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Difference in Step Count (steps)
Upper limit of
agreement +25 steps
20
0
Mean bias -3.4 steps
-20
Lower limit of
agreement -32 steps
-40
-60
-80
450
550
650
750
850
950
Average Step Count (steps)
Figure 6.12. Bland and Altman plot of agreement between step counts
recorded by activPAL and video at 2.5 km/h
20
15
Upper limit of
agreement +25 steps
Difference step count (steps)
10
5
0
-5
Mean bias +1.6 steps
-10
-15
-20
Lower limit of
agreement -17 steps
-25
-30
-35
950
1000
1050
1100
1150
1200
1250
Average step count (steps)
Figure 6.13
recorded by activPAL and video at 5 km/h
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Chapter 6
1400
Upper limit of agreement
+1066 steps
1200
Difference step count (steps)
1000
800
600
400
Mean bias +250 steps
200
0
-200
Lower limit of
agreement -506 steps
-400
-600
1200
1300
1400
1500
1600
1700
1800
1900
2000
2100
Average step count (steps)
Figure 6.14
6.6
recorded by activPAL and video at 7.km/h
Establishing Concurrent validity of a modified Timed Up and Go test
over two metres
During the pilot of the practice exercise regime and testing the feasibility of the
battery of outcome measures (section 6.4.), it was found that the Timed Up and Go
(TUG) could not be performed easily in the home environment of one pilot
participant. In order to undertake the TUG, the participant is required to standup
from a chair, walk three metres, turn around and walk back to the chair and sit
down. With the turning space required, and the space for the chair a clear testing
area of approximately five metres is required. The home environment that was
found to be unsuitable did not have a clear testing area of five metres and the
participant was not able to be tested outwith the home environment.
The
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unsuitability of the environment related to the need to rearrange considerable
amounts of furniture and the removal of ornaments and copious personal
possessions from the testing area.
This was not felt to be satisfactory for the
participant.
It was decided to retain the TUG within the testing battery, but with modifications, as
important information relating to balance and time to stand up was derived from the
test. Furthermore, it was possible to derive a measure of gait speed from the three
metre walk component of the TUG (Wall et al, 2000). It was therefore decided that
modifying the TUG over a shorter distance, might be a viable option in order to allow
it to be included within the outcome measure test battery.
A pilot study was thus
undertaken to investigate the properties of a TUG performed over two metres.
The aims of this pilot study were to:
1. establish the concurrent validity of the TUG2m with the TUG
2. investigate the effect of a modified Timed Up and Go over 2 metres (TUG2m)
on the gait characteristics of stroke patients
6.6.1
Methodology of a pilot study investigating the Concurrent Validity of
the Timed Up and Go over two metres (TUG2m).
Non acute stroke patients were recruited from rehabilitation wards at Astley Ainslie
Hospital, Edinburgh. All participants gave informed consent to participating in the
pilot study, this included consent to having a video taken while undertaking the TUG.
Inclusion criteria ensured that participants were independently ambulant with or
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without an aid and were at least 3 months post-stroke. Participants were excluded if
they required physical assistance during walking, had comorbid neurological
conditions such as Parkinson’s Disease or were unable to understand the nature of
the study.
Once informed consent had been obtained, brief personal data were gathered from
the participant and patient notes. Participants were required to undertake the Timed
Up and Go test over both two and three metres. A two minute rest was permitted
between the tests. A standard height dining chair, without arms, (seat height 46cm)
was used for all participants.
An explanation of how to perform the TUG was
provided to the participant and this was followed by a demonstration.
Participants
were randomised, by the toss of a coin, either to undertake the TUG2m followed by
the TUG over 3 metres, or vice versa. A video of performance was undertaken and
real-time recordings of component parts of the TUG, using a hand-held stop watch
were also made (Wall et al, 2000).
6.6.2
Results of the pilot of the Timed Up and Go
Fifteen people with sub-acute stroke were recruited to the TUG pilot. Participant
characteristics are summarised in table 6.4.
TUG pilot - participant characteristics
Gender
9 male : 6 female
Mean age (years)
67.4 (+ 14.9)
time since stroke (weeks)
24 (+ 18.3)
Side of hemiplegia
4 right : 11 left
Table 6.4.
Timed Up and Go pilot study - subject characteristics
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In order to establish whether the TUG2m could be used interchangeably with
TUG3m, concurrent validity between the two tests was established by looking at the
agreement between the two on a number of key gait parameters. The TUG2m was
also examined for stability when the test was undertaken one week apart by five
subjects. The characteristics relating to gait parameters and components of the
TUG are presented in table 6.5.
Gait parameter
TUG 2m
TUG 3m
TUG total time (s)
9.32 (+ 5.35)
13.12 (+ 6.8)
0.27 (+ 0.11)
0.30 (+ 0.17)
5.79 (+ 3.0)
5.84 (+ 2.9)
6.4 (+ 1.9)
6.1 (+ 1.8)
Mean (+ standard deviation)
Gait velocity (m/s)
Turning time (s)
Number of
component
steps
during
turn
Table 6.5.
Timed Up and Go pilot study - Summary of gait parameters and
components of Timed Up and Go
On examining the data for the 15 participants, it was found that, as expected, the
TUG2m was completed in 71% of the time (9.32 seconds) taken to perform the TUG
over 3m (13.12 seconds). Data were then examined to determine whether gait
speed had been affected by the distance walked. On looking at the data, there
appeared to be similarity between the gait velocity obtained, in order to determine
whether there was agreement between the data, Bland and Altman plots with limits
of agreement were calculated (Bland and Altman 1986) and are shown in figure
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6.15. The mean bias on figure 6.15 is very close to zero and overall it can be seen
that the two values from TUG2m against TUG3m agree, with 95% of cases falling
within two standard deviations of the difference, which equates to + 0.2m/s. This
was felt to show an acceptable level of agreement between gait velocity for TUG2m
and TUG3m.
Difference in gait velocity (m/s)
0.3
0.2
mean + 2SD
0.1
0
mean bias
-0.1
-0.2
mean -2SD
-0.3
-0.4
0
Figure 6.15
0.1
0.2
0.3
0.4
0.5
mean gait velocity over TUG3m and TUG2m
0.6
Bland and Altman plot of gait velocity for Timed Up and GO
performed over 2 metres (TUG2m) or 3 metres (TUG3m)
On considering the turning times, only the turn when participants crossed the line on
the outbound walk in order to commence the return walk was analysed. The reason
for this is that various turn strategies were adopted when approaching the chair,
some only turning halfway and collapsing onto the chair, others turning a full
180degrees.
It was hypothesised that there would be no significant difference
between the turn times for TUG2m or TUG3m, as the nature of the task of turning
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had not changed. The turn time of just under 6 seconds was similar in both TUG
conditions. A paired t-test showed that there was no significant difference between
time taken for turns during the TUG2m and TUG3m, p=0.96. Once again the data
Difference turn times TUG2m & TUG3m
were plotted to ascertain limits of agreement and these are shown in figure 6.16.
4
3
m ean +2SD
2
1
m ean bias
0
-1
-2
m ean -2SD
-3
0
2
4
6
8
10
Mean turn times TUG2m & TUG3m (secs)
Figure 6.16. Bland and Altman plot of turn times (in seconds) for Timed Up
and Go performed over 2 metres (TUG2m) or 3 metres (TUG3m)
It was not anticipated that the number of steps taken during the turn component of
the TUG would vary depending on the outbound distance walked. As can be seen
from table 6.5, the mean number of steps during turning was approximately six and
figure 6.17 demonstrates the consistency of performance with all but one subject
falling within the limits of agreement.
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Chapter 6
12
Difference in steps to turn (no. of
steps)
2.5
2
mean + 2SD
1.5
1
0.5
mean bias
0
-0.5
-1
mean - 2SD
-1.5
0
2
4
6
8
10
mean steps to turn 3m and 2m TUG
Figure 6.17
Bland and Altman plot of the number of steps taken during
turning for Timed Up and Go performed over 2 metres (TUG2m)
or 3 metres (TUG3m)
These data relating to key gait parameters establish that the TUG2m demonstrates
concurrent validity with the TUG over three metres and therefore the tests can be
used interchangeably for people with stroke.
In order to determine stability of the TUG2m, test – retest reliability was calculated
using Intraclass Correlation Coefficients (ICC). Five people with stroke were tested
one week apart. Intraclass correlation coefficients ICC (2,1) were calculated for
three key parameters and these are presented in table 6.6.
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Chapter 6
Gait parameter
ICC (2,1)
reliability
Gait velocity (m/s)
0.86
Good
Number of steps
0.92
High
Turn times (s)
0.75
Fair
Table 6.6.
Test – retest reliability of TUG2m over one week
In order to determine how reliable the ICC data were, the classification according to
Youdas et al, (1991) was followed. This system assigns high reliability for an ICC of
> 0.91, good reliability for ICC of 0.81 – 0.9, fair reliability for ICC of 0.71 – 0.8 and
an ICC of < 0.7 as poor. As can be seen, the gait characteristics of the number of
steps taken and gait velocity demonstrated high to good reliability and the turn times
with an ICC of 0.75 had fair reliability. These findings support the stability of the
TUG2m over time in a small sample of people with stroke.
6.6.3
Summary of Findings from Timed Up and Go pilot
This pilot was undertaken to determine whether reducing the walking distance of the
TUG to 2m would affect psychometric properties of the measure. As the TUG over
3m has been shown to be a valid and reliable measure with stroke (Podsiadlo and
Richardson 1989; Ng and Hui-Chan 2005; Flansbjer et al, 2005), this version was
used as a gold standard to look at concurrent validity of a reduced TUG2m. There
was a good level of agreement between gait velocity and turning times over both
tests, which would support the view that the TUG2m has concurrent validity with the
TUG over three metres. The time for TUG2m over a distance 33% shorter than
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TUG was reduced by just under 30% in the TUG2m – and there was no significant
difference in turning time. These findings conform to what was anticipated, as it was
not envisaged that shortening the distance would change the properties of the TUG.
It could be argued that a shortened walking distance of two metres does not allow
initial gait acceleration to occur, however this would be the same for all participants.
In summary, the TUG2m can be used in place of the TUG over three metres for
people with sub-acute or later-stage stroke.
6.7
Summary
Extensive pilot work was undertaken in-hospital and within the community setting to
develop the methodology to be followed for the definitive trial. Four in-hospital pilot
participants and six community pilot participants took part in the development,
refinement and piloting of the exercise practice structure for PP and WP of six
functional tasks.
Documentation was created, piloted and refined in order to support participants in
undertaking the practice regime and to provide a tool for documenting practice and
indicate key activities.
The outcome measures battery that was piloted was acceptable to the participants
and, with the exception of TUG, was suitable for use in a community setting. The
community pilot demonstrated the need to modify the distance of the TUG. The
newly developed TUG2m demonstrated concurrent validity with the TUG and
therefore can be used in its place for people with stroke.
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The community pilot phase identified further that a means of verifying exercise
practice would be beneficial. Following pilot work, the use of an accelerometer that
could identify step count, body position and number of rise to stand transitions was
included in the definitive trial.
The definitive trial methodology is reported in chapter seven.
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7.0
7.1
METHODOLOGY
Introduction
This chapter presents the trial design and experimental methods employed in this
study. The development of the Methodology has been reported in chapter 6. The
main study reported in this chapter investigated the efficacy of a home-exercise
programme for people with late-stage stroke. The design of the home exercises was
based either on part-practice (PP) or whole-practice (WP) principles.
7.2
Trial Design Overview
The study was conducted on participants with late-stage stroke and investigated the
efficacy of a programme of functional home exercises based on either PP principles,
or WP principles. This was a prospective, single blind, randomised controlled pilot
study with three groups of participants: PP, WP or a control (CON) group.
Ethical approval was received from Lothian Regional Ethics Committee (LREC).
Participants meeting inclusion criteria (7.3.1.) were randomly allocated to undergo
either a four week programme of exercises following part practice (PP), a four week
programme of exercises following whole practice (WP) or to receive “normal”
intervention (which at this point post-stroke consisted of no formal rehabilitation).
An initial letter of invitation and consent form (appendix VIII) to participate in the
study was sent to individuals who had been identified as meeting inclusion criteria.
If the individual returned the consent form a short telephone screening interview was
undertaken by the principal investigator (PI). During the screening interview the PI
clearly explained the nature of the study and highlighted that if the potential
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Methodology
participant was randomised to the control group they would receive no treatment.
This strategy was adopted following statistical consultation as it was identified that
informing potential participants of the odds of being randomised to a treatment
group would help to minimise drop out. A small number of individuals did drop out
at this stage (see figure 8.2).
Once informed consent was confirmed, participants were visited by the PI to gather
the first of two baseline outcome measurements. Once one set of baseline data
were collected, details of side of stroke and Motor Assessment Scale (MAS) total
score were passed to the clinical research assistant (CRA). The CRA undertook
participant group allocation according to an allocation schedule previously drawn up
by the statistician. Randomised blocks within four strata, based on side and severity
of stroke, were used to allocate participants to groups (Altman 1991). Participants
then underwent a second set of baseline measurements at approximately two
weeks after the first baseline outcome measurements. Following the two baseline
measurement procedures, the four week intervention phase was instigated by the
CRA. Further outcome measurements were subsequently taken at four weeks (end
of intervention), approximately four weeks and three days (retention / short-term
follow-up) and approximately three months (long-term follow-up) after baseline two.
The study was designed as a randomised controlled trial (RCT) in order to ensure
participants would have an equal chance of receiving exercise or not. Side of stroke
affects the presenting impairments (see chapter 2) and therefore it was important to
ensure randomisation would allocate participants with cognitive or language
impairments approximately equally among the groups. Also it was not clear whether
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Methodology
starting level of severity could have an impact on potential for improvement and
therefore it was felt that this should be accounted for to ensure that no group had a
disproportionate number of mild or severely disabled participants. A flow diagram
providing an overview of the trial design can be found in Figure 7.2.
7.3
Subject Populations
The literature that advocates the application of PP or WP paradigms in stroke
rehabilitation does not derive from evidence acquired from people with stroke. At
the time of planning the study, available literature did not advocate whether specific
abilities were a pre-requisite for people with stroke to exercise using either a PP or
WP paradigm. While the literature claims that WP is the preferred exercise approach
in people with stroke (Shumway Cook and Woollacott 2002), this has not been
objectively demonstrated. No literature was identified that suggested neurological
impairments would contra-indicate either PP or WP of functional tasks for individuals
with stroke.
Given the lack of definitive evidence to support the application of PP or WP exercise
paradigms for people with stroke, combined with the well documented evidence of
the first three months stroke as being a natural period of the most rapid post-stroke
improvement (Langton Hewer et al; 1987), it was decided to recruit people with
stroke that could be considered as being at a plateau in terms of recovery. The
population that the sample was drawn from was, therefore, individuals with
hemiplegia from Lothian region, who had previously received uni- or multidisciplinary stroke rehabilitation but who had been discharged from formal care.
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The following inclusion and exclusion criteria were applied.
7.3.1
i.
Inclusion Criteria
Age over 18
ii. At least 12 months post-stroke (*this was later modified to 6 months post-stroke
see section 7.4.2.)
iii. Residual neurological physical deficit due to stroke
iv. Discharged from formal Physiotherapy
v. Mini Mental State Examination (MMSE) score ≥ 22 (Tombaugh and McIntyre
1992; Crum et al 1993)
vi. Functional Reach Test ≥15 c.m. (Duncan et al, 1992)
vii. Able to understand the nature of the study and give informed consent
7.3.2
i.
Exclusion Criteria
Age under 18
ii. Pre-existing gross neuropathology – e.g. Multiple Sclerosis, Parkinson’s Disease
iii. Co-existing pathology that would prohibit independent exercise – e.g. lower limb
fracture
iv. Pre-existing disabilities with grossly limited mobility (e.g. lower limb amputation)
v. History of two falls within the previous six months
7.4
Recruitment
This section reports the original recruitment strategy.
A sample size calculation
was undertaken based on gait outcomes and a significance level of 0.05.
For
between groups comparisons for parametric outcomes, a sample size of 33 in each
group would have 90% power to detect an effect size of 0.80 using a two group t-
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Methodology
test with a 0.05 two-sided significance level, and for 80% power, an effect size of
0.70. The non-parametric equivalent, Mann Whitney U tests would be able to detect
an effect size of 0.851, for 90% power, and 0.736 for 80% power. For within group
comparisons; for parametric outcomes a sample size of 33 will have 90% power to
detect an effect size of 0.58 using a paired t-test with a 0.050 two-sided significance
level, and for 80% power, an effect size of 0.50. The non-parametric equivalent,
Wilcoxon test, would be able to detect an effect size of 0.61, for 90% power, and
0.53 for 80% power
This strategy required three separate amendments due to a number of issues which
adversely affected recruitment. Consideration of the issues and the steps taken to
overcome them are outlined in this section.
Ethical approval was gained from
Lothian Research Ethics committee (ref number LREC/2001/1/17) for the original
recruitment strategy and for all subsequent amendments.
At the time that this study was undertaken, there were very few published
randomised controlled trials of rehabilitation undertaken with a population of people
with chronic stroke and conducted in the primary care setting. Extensive advice was
therefore sought in the design of the recruitment strategy, as it has been well
documented that failure to recruit to randomised controlled trials results in
underpowered studies and a lack of external validity (Altman 1991; Blanton et al,
2006; Lannin and Cusick 2006). Advice was solicited from the General Manager of
the North East Edinburgh Local Healthcare Co-operative. (LHCC), the Professor of
General Practice – University of Edinburgh, the Research Co-ordinator of the
Lothian Primary Care Research Network (LPCRN), the Medical Director of the
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Methodology
LPCRN, two non research active General Practitioners, the Superintendent
Physiotherapist
for
Domicillary
Physiotherapy
within
Lothian,
a
research
physiotherapist with experience of primary care trials and a medical statistician.
During development of the Recruitment strategy the proposed protocol was
presented to physiotherapy colleagues and to the LPCRN and minor modifications
made based on subsequent discussions. Participants were recruited to the trial
from November 2002 to November 2004.
7.4.1
Initial Recruitment Strategy (Recruitment strategy v1)
Initially the recruitment plan was to gain as representative a sample population of
stroke subjects from as diverse a social, economic and cultural background as
possible. It was recognised that not all stroke subjects would necessarily have
accessed hospital services and a minority of the stroke population may have
remained at home.
It was therefore decided that recruitment via General
Practitioner (GP) practices would be the optimal strategy for getting as
representative sample as possible.
Following advice from the LPCRN and the
Manager of the LHCC, it was decided to attempt to recruit from a single LHCC within
Edinburgh, with recruitment via neighbouring LHCC’s if the target sample was not
recruited from a single LHCC. This was also a pragmatic decision given the limited
personnel resources available to support the trial (0.6 whole time equivalent Clinical
Research Assistant and 0.2 Principal Investigator).
North-East Edinburgh LHCC (NEE LHCC) was targeted as the initial recruitment
consortium given that the geographical area of the LHCC covered a spectrum of
social class A - E. From a 2002 survey, for example, 30% of the responders of NEE
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Methodology
LHCC had the highest educational qualification as a degree or technical qualification
and 20% had standard grade or no qualification; around 22% earnt over £30,000 per
annum and around 20% earned £9,000 or less, around 1.8% were unemployed or
looking for work.
(NEE LHP 2002)
Figure 7.1:
Map of North East Edinburgh LHCC
The initial recruitment strategy was to target people with chronic stroke, chronic was
defined as at least 12 months post-stroke onset. A presentation of the study aims
and design as well as potential benefits for participants was given to representatives
from each GP practice within the NEE LHCC (n = 14). At this presentation, GP
practices were invited to take part and identify potential participants for the study.
Four practices were not recruited at this point (one because it was the principal
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Methodology
investigators home GP practice, one because of refurbishment, and two because
the practices were already involved in other trials or not interested). This left a total
of ten practices from which to recruit. Given that an average GP practice in the UK
can be estimated to have approximately 6,000 patients (RCGP 2006) and that
prevalence estimates of stroke are around 3 - 6 per 1,000 (Jørgenson et al 1995;
Warlaw et al 2001) then even at the lowest estimates it was hypothesised that each
practice might yield approximately 18 potential stroke subjects (3 [prevalence] x 6
[practice size in 1,000]. Anticipating a pessimistic 50% uptake to the trial, it was
estimated that around nine subjects per practice might be recruited.
Following the initial presentation of the study aims to GP practices within NEE
LHCC, one practice responded positively immediately and became the first GP
practice to recruit potential participants to the trial.
The agreed protocol for
recruitment was followed.

The PI explained the nature of the study to the practice manager, provided a
list of inclusion and exclusion criteria and 30 pre-stamped “recruitment
envelopes” containing a letter of invitation and explanation of the study (see
appendix VIII), a consent form (see appendix VIII), and a postage paid return
envelope.

the manager was asked to identify individuals with stroke from the practice
computer database,

following this, a list of names and addresses was generated,

the practice manager then entered the name and address onto the prestamped recruitment envelope and posted the envelopes
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Methodology

in the event of more than 30 potential participants being identified from a
single practice, the practice manager was to select every second subject on
the list until 30 envelopes were sent out.
This first practice and initial recruitment strategy revealed a number of problems that
needed to be addressed before the trial could progress. In summary, the practice
initially identified over 60 individuals with stroke, however it transpired that a
miscoding issue meant that people with stroke were not accurately identified. More
worryingly, people who did not have a stroke were identified as potential
participants.
Therefore individuals who had not sustained a stroke were
inappropriately referred to the trial.
The next two GP practices were unable to differentiate between resolved stroke
symptoms such as Transient Ischaemic Attack (TIA) and full stroke.
Therefore
letters of invitation were sent to people that had sustained a full stroke as well as
people with no residual neurological symptoms following a TIA. This issue was
common to all GP records systems using GPAS (General Practitioner Administration
System) and therefore the recruitment strategy was modified to try and address
these issues.
In the event that an individual fitting the inclusion criteria returned an informed
consent form, an initial phone-call was made to them by the PI. During this first
contact between PI and potential participant, a standard explanation of the study
was given. The potential participant was asked verbally whether they understood
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the exclusion criteria and could they confirm they were eligible.
The potential
participants were also informed that, if recruited, they would not necessarily receive
exercises. If the participant was still keen to take part in the trial, then an initial
contact visit was arranged for a mutually convenient time.
7.4.2
Recruitment strategy version 2
A refinement of the recruitment strategy was undertaken to address the issues of
miscoding and the sensitivity of the GPAS system. Following discussions with the
project team, the method remained essentially the same as detailed in 7.4.1, with
the exception that the initial meeting with the practice manager was a more
extensive meeting. A minor modification ensured that both a practice manager and
a GP representative attended a meeting with the PI at subsequent GP practice
recruitment visits.
In addition, once the list of potential participants had been
generated, this was circulated to GPs by the Practice Manager to ascertain that not
only did the potential participant definitely have a confirmed diagnosis of stroke, but
that the subject also fitted the inclusion and exclusion criteria and still had residual
physical deficits.
An amended list was then given to the practice manager to
address the recruitment envelopes and send out. While this strategy resulted in an
approximately further delay of four weeks, the identified subjects were more likely to
be suitable to participate in the study.
At this point in time, at seven months from the commencement of subject
recruitment, it was felt that due to the sluggish recruitment (11 participants recruited
in five months), decisive measures had to be implemented in an attempt to bolster
recruitment.
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7.4.3
The original recruitment strategies had been developed with extensive advice from
experts within the area with the aim to recruit as representative sample as possible
from the population within north-east Edinburgh. The revised recruitment strategy
v3 was developed to overcome some of the identified shortfalls in recruitment.
A twofold strategy was devised and received ethical approval in April 2003
i.
Length of time since stroke in order to be eligible for recruitment was
reduced from 12 to six months. The original strategy had been formulated to
ensure participants would be stable in terms of physical recovery and
unlikely to still be receiving formal physiotherapy.
The revisions to
recruitment strategy v3 to amend inclusion criteria to include people at least
six months post-stroke was envisaged to target individuals who would still be
relatively stable in terms of physical ability. Furthermore, the strategy of
taking two baseline measures was felt appropriate to identify if there were
some fluctuations in performance.
ii. In addition to recruiting from GP practices, failure of the GPAS system to
appropriately identify suitable individuals would still remain, despite the
reduction for eligibility to six months post-stroke. It was therefore decided to
extend recruitment to include not only GP practices but also to include
physiotherapists. The reason for not using physiotherapists in the original
recruitment strategy, was associated with the desire to include participants
whether or not they had received physiotherapy as part of their post-stroke
rehabilitation.
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With recruitment strategy v3, potential participants were referred from nine discrete
physiotherapy services within Lothian (McLeod Street, Royal Victoria Hospital
(RVH), Day Hospital at RVH, Western General Hospital, Astley Ainslie Hospital,
Liberton Hospital, the Edinburgh Community Rehabilitation Team, Roodlands
Hospital, Eastern General Hospital).
7.4.4
The amended recruitment strategy v3 was highly successful in improving
recruitment to the study. It was calculated however that target numbers would not
be achieved within the timeframe for which the study had received funding and
therefore a final amendment to the recruitment strategy was applied for and granted
ethical approval in May 2004.
The final recruitment strategy v4 involved the placement of a recruitment
advertisement in the local free paper which was delivered weekly to households in
Edinburgh. The advertisement was placed twice with a gap of two weeks between
each insertion. Individuals who had sustained a stroke and were interested in taking
part in a physiotherapy research project were asked to contact the PI. At the time of
initial contact the following procedure was undertaken:

A script was followed, explaining the nature of the study; identifying the
exclusion criteria; explaining that if recruited, participants would not
necessarily receive exercises and checking that the potential participants
were happy for the PI to contact the GP to ensure that the participant met
inclusion criteria.
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
If the participant was still interested in taking part, the GP was then
contacted by letter which explained the nature of study.
The GP was
requested to confirm, by a set date, that the individual was fit to participate in
the study.

Once approval had been received from the GP, an initial visit was carried
out.
This whole procedure took approximately four to six weeks from initial contact to first
recruitment visit.
7.4.5 Consent
Once potential participants had been identified through the strategies cited above, a
“recruitment envelope” was sent out.
The “recruitment envelope” comprised an
explanation about the study (appendix VIIIa, a consent form (appendix VIIIb) and a
stamped address envelope.
If no consent form was returned to the PI, no followed up was undertaken, the
assumption being that the individual had decided not to participate any further.
Participants who did return the consent form were then followed up by phone to
arrange an initial visit (as described in 7.4.1).
7.5 Outcome Measures Procedures
Data relating to physical, cognitive and perceptual impairments, and functional
abilities and a stroke specific measure of quality of life were gathered by the
principal investigator who was blinded to group allocation.
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Following extensive pilot procedures standardised, validated outcome measures
were used to document ability (see section 6.3). Five outcome measure visits were
undertaken.
Outcome measurement (OM) data were collected twice during the
baseline stage, to determine stability of performance (OM1 and OM2). The two
baseline measures were taken approximately two weeks apart. Outcomes were also
measured at the end of the four week intervention phase (OM3), and at
approximately 72 hours (OM4) and three months (OM5) after cessation of the
intervention phase. OM4 was taken to ascertain whether any changes that were
apparent at OM3, were retained due to short-term changes in performance. OM5
was taken to determine whether any changes noted at the end of intervention (OM3)
persisted which would indicate long-term retention and learning.
Not all outcomes were tested at each measurement visit. The MMSE and FRT were
solely used for screening purposes and were the first two measures undertaken on
the initial visit. Measures of physical ability were taken at all five measurement
visits. Measurement of mood, using HADS and recall of activity using FAI, was
taken at the first baseline visit, at the end of intervention and at long-term follow-up
(OM1, OM3 and OM5).
Measurement of self-perceived general status using the
SIS was taken at all measurement points with the exception of short-term follow-up.
Table 7.1 summarises the outcome measures that were taken at each visit.
The activPAL was used to record activity during a single day and to potentially allow
triangulation of the exercise session for PP and WP participants. The activPAL was
worn for one waking day during week three or week four of the intervention phase of
the trial.
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Time point
Baseline
1
Baseline
2
End
intervention
48-72 hrs
post end
intervention
(short-term
follow-up
Retention)
3 months
post end
intervention
(Long-term
follow-up)
Outcome Measure
OM1
OM2
OM3
OM4
OM5
Mini-Mental State
Exam (MMSE)

Functional Reach
Test (FRT)

Hospital Anxiety &
Depression
Scale
(HAD)



Frenchay
Index (FAI)



Activity
Barthel Index (BI)





Motor Assessment
Scale (MAS)





Timed Up and Go
2m (TUG2m)





Frenchay Arm Test
(FAT)





Step Test





Stroke Impact Scale
(SIS)



Table 7.1.

Schedule of outcome measure visits
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Recruitment
Eligibility checked / informed consent gained
Baseline visits (OM1 and OM2)
Randomisation using randomised blocks within four
strata of patients
Control
(CON)
Part Practice
(PP)
Whole Practice
(WP)
Four week “intervention” period
“Post-Intervention” Outcome Measures (OM3)
Taken at end of intervention
“Retention” Outcome Measures (OM4)
Taken at 48 - 72 hours post end of intervention
“Long-term follow-up” Outcome Measures (OM5)
Taken 3 months post end of intervention
Figure 7.2.
Flow Diagram of Trial Design
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7.6
Randomisation
Randomisation with minimisation was initially planned for use in this study.
Following further discussion with a statistician however, it was decided to use
randomised blocks within four strata of patients based on side and severity of
stroke, due to the small numbers of patients. Block randomisation with stratification
allows approximately equal numbers of participants to be allocated to each group
and for each group to consist of participants with a balance of features that could
influence outcome (Altman 1991). Severity of stroke was determined by total MAS
score with > 32 designated as “mild” and total MAS score < 31 designated
“moderate to severe”. Following participant recruitment, and the first recruitment
visit, details relating to side of stroke and severity of motor impairment as measured
by the Motor Assessment Scale were provided to the Clinical Research Assistant
(CRA).
The CRA then allocated participants to the Whole Practice (WP), Part
Practice (PP) or Control (Con) group following a pre-determined randomisation list
(see appendix IX). The PI was blind to group allocation and blind to the content of
the randomisation list until the very last outcome measure on the very last
participant in the trial had been taken.
7.7
Procedures
As described in 7.6, participants were randomised to either a Con, PP or WP group.
The Con group received no physical intervention, but were visited by the CRA.
Participants in the PP or WP group undertook a four week intervention programme
with practice of exercises for functional tasks.
Following completion of the two baseline OM visits, the CRA visited all participants
on three or four “intervention visits” during the four week intervention period. The
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Con group received the same number of visits as the participants allocated to the
intervention arms of the trial in order to counteract the potential therapist-interaction
effect. In addition, participants from all groups wore an activPAL for one waking day
during week 3, to record activity and to triangulate recorded exercise activity in the
diary with activity measured by the activPAL.
7.7.1
Baseline Outcome Measures visits
At the first baseline visit (OM1), the principal investigator explained the nature of the
study, highlighting that if the participant were suitable to take part in the trial, they
would not necessarily receive exercises. If participants were still happy to take part,
exclusion criteria were discussed and checked verbally. While assurance had been
received previously that participants did meet inclusion criteria from the GP practice
or from the referring physiotherapist a fall history may well have been missed.
Participants then completed screening tests that required minimum scores in order
to fulfil eligibility (Functional Reach Test > 15cm, no history of more than 2 falls in 6
months and a Mini Mental State Exam score of >22).
Participants who passed the screening tests were subsequently tested on a battery
of outcome measures that included self-report questionnaires (Hospital Anxiety &
Depression Scale (HAD), Frenchay Activity Index (FAI), Barthel Index (BI));
impairment and activity ordinal scales (Motor Assessment Scale (MAS), Timed Up
and Go 2m (TUG2m), Frenchay Arm Test (FAT), and Brunel Step Test) and a
quality of life scale (Stroke Impact Scale (SIS)).
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At the second baseline visit the following outcome measures were repeated Barthel
Index, Motor Assessment Scale, Timed Up and Go 2m, Frenchay Arm Test, Brunel
Step Test and the Stroke Impact Scale.
7.7.2
Intervention Visit 1
The clinical research assistant followed a standard format during the first visit. Initial
conversation reiterated the aim of the study and ascertained that the participant was
still prepared to be involved. This procedure, which permitted drop out, had been
strongly advised by the statistician, as experience with clinical trials had shown that
at the point of group allocation, a number of participants may drop out early in the
study, if unhappy with their group allocation.
Where participants had a spouse or carer that lived in the same premises, the carer
was invited to participate in initial conversations and explanations as it was common
practice that the carer assisted the stroke participant filling in the exercise and
activity diary or with the exercises. All participants were asked questions about their
daily activity and shown how to fill in a simple self-report activity diary.
All
participants were given information about stroke using a standard Chest Heart and
Stroke Scotland (CHSS) booklet “Living With Stroke”.
Participants allocated to one of the two exercise groups were taught six exercises to
practice. The exercises consisted of practising standing up from a chair, sitting
down, stepping onto a step, stepping off a step, pronation and supination holding a
bottle and reaching and grasping. All participants allocated to an exercise “arm” of
the trial practised the same functional exercises but in different ways.
The
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developments of the exercises are detailed in section 6.2 and 6.4. Participants
allocated to the control group did not receive any exercise instruction.
7.7.3
Intervention visit 2
Intervention visit 2, occurred at approximately one week after Intervention visit 1. It
was not possible to set an exact time-scale as the CRA worked 0.6 whole time
equivalent, participants were community dwelling and therefore had a number of
other commitments (e.g. voluntary groups, adult education, visits to or from
relatives). In order to preserve numbers of participants enrolled into the study, it
was necessary to work with an extremely high degree of flexibility.
The focus of visit 2 was to ensure that all participants were filling in the diary
correctly and to assist completion retrospectively if required. Furthermore, this visit
provided an opportunity to discuss and to clarify any questions that participants’ or
their carers had about stroke. In addition, participants randomised to the WP or PP
groups were checked practising exercises to ensure that they were undertaking the
exercises correctly, individualised pointers were given if deemed necessary (for
example how to position the arm during “TipTap”).
The CRA encouraged
participants to increase the number of repetitions of exercises practiced if assessed
to be appropriate. Whether exercise repetitions were increased during visit 2, the
CRA discussed with all WP and PP participants procedures for increasing exercise
repetitions. Participants were reminded at this point that they were able to phone
the CRA for advice during the study, if they were unsure of any of the exercises.
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7.7.4
Intervention visits 3 and 4
The final intervention visit occurred during week 3 or beginning of week 4. The
focus of this visit was to attach the activPAL and ensure it was working. Additionally
this visit gave the opportunity to ensure that diary completion was on-going and to
discuss any further concerns that the participant or carer may have about their
stroke condition in general. Frequency of exercise repetitions was again monitored
and increasing the number of exercises being practised was encouraged whenever
appropriate. If the participants reported having problems with undertaking any of the
exercises, there was the opportunity to contact the CRA again and an exceptional
visit could be undertaken.
7.8
Data Analysis
The study reported in this thesis was a single blind, exploratory randomised
controlled trial with repeated measures. The study investigated a home programme
of exercises based on part- or whole-practice for people with late-stage stroke. The
questions to be were addressed were:

practice strategies result in changes in performance of functional tasks for
people with late-stage stroke?

practice strategies result in changes in parameters of activity limitation,
participation and health status for people with late-stage stroke?

Are any changes in performance retained after cessation of the intervention
phase of the home physiotherapy programme? and

How much activity is undertaken by people with late-stage stroke in the
community?
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Data were a mixture of ordinal data (Hospital Anxiety and Depression Scale; the
Frenchay Activity Index; the Barthel Index; the Motor Assessment Scale; the
Frenchay Arm Test; and the Stroke Impact Scale) and ratio data (Timed Up and Go
2metre Test and the Step Test). Descriptive data and ratio data were presented for
activPAL.
Initially data were entered into Microsoft Excel 2003 for preliminary analysis of
demographic data. Data were subsequently transferred to SPSS 12.0 for Windows
(Statistical Package for Social Sciences) and, during later analysis, SPSS 17.0 for
Windows was used.
Data were plotted using histograms to explore normality of distribution and
skewness of data. Shapiro Wilks tests were carried out on all data sets to ascertain
whether data were normally distributed (Altman 1991). The majority of data were
non-normally distributed data and therefore data will be presented in the Results
chapter using median values and inter-quartile ranges (Altman 1991; Hicks 2004).
Due to the non-normal distribution, data are graphically presented by means of box
and whisker plots and statistical analysis will be undertaken using non-parametric
statistical tests (Altman 1991; Field 2009).
Where outcome measures of physical impairments and activity limitations had been
obtained twice at baseline, initial testing using the Mann Whitney U test was
undertaken to ascertain whether there was any difference between the two baseline
outcome measurement points.
In all cases, there was no significant difference
between the two baseline outcome measurement points; a decision was therefore
made to consistently make comparisons between the post-intervention tests and
baseline two.
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In order to determine if there were any statistically significant differences between
the groups at each measurement point, between-group comparisons were
undertaken by applying a Kruskal Wallis test to the data.
In the event that a
statistically significant difference was found between the groups, then post hoc
testing using a Mann Whitney U test would be undertaken to determine exactly
where the difference was found (Altman 1991; Field 2009). In order to ascertain
whether any of the groups demonstrated a statistically significant change over the
course of the trial, a within-groups comparison for each outcome measure over time
was made using a Friedman’s Anova. In the event that a significant difference was
found over time within the group, this was followed up by undertaking post hoc
testing using a Wilcoxon test (Altman 1991; Field 2009). Due to the multiple tests
that potentially could be carried out with post hoc testing, there is a danger of a type
I error occurring (i.e. the null hypothesis being rejected incorrectly). In order to
account for this, a Bonferroni correction (p / number of comparisons made) was
applied to all post hoc tests. Using the Bonferroni method results in the data having
to satisfy an exceptionally small p value, this method has therefore been criticised
as being highly restrictive (Field 2009). The positive aspect of using a Bonferroni
correction is that if statistical significance is found, then the null hypothesis can be
rejected with confidence.
The findings from the definitive RCT are presented in chapter eight.
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8.0
8.1
RESULTS
Introduction
This chapter reports the participant characteristics, the results for each outcome
measured as well as identifying at which points data were missing, the exercise
repetitions undertaken by subjects and an indication of the level of activity for a
sample of the participants over a single day. Data were plotted initially to determine
normality. This process revealed that the majority of data for all outcome measures
were positively skewed.
As a consequence, non-parametric analyses were
conducted throughout (as indicated in 7.8).
8.2
Subject Characteristics
Three hundred and fifty letters of invitation were sent to potential stroke subjects.
From this initial invitation, 64 people with chronic stroke were recruited for the study,
31 male and 33 female (see Consort diagram figure 8.1). Mean age was 72.9 (+
9.0) years, with a median of 72.3 years and ranging from 54.3 to 90.8 years. Mean
time since stroke was 30.3 months (+ 28.8) with a median time of 21 months and
ranging from six months to 13.5 years. 38 subjects had suffered a right
Cerebrovascular accident (CVA), 26 suffered a left CVA.
n
ALL
SUBJECTS
Control
(CON)
Part (PP)
64
Age - years
x (+ sd dev)
Median (min – max)
72.9 (+ 9.0)
72.3 (54.3 – 90.8)
21 73.3 (+9.2),
75.0 (62.2 - 88.1)
23 72.3 (+9.5)
72.3 (54.3 - 86.6)
Whole (WP)
20 73.2 (+8.5)
71.4 (59.8 - 90.8).
Table 8.1 Subject characteristics
Time since stroke Gender Side of
- months
M:F
stroke
x (+ sd dev)
R:L
Median (min – max)
30.3 (+ 28.8)
31 : 33 38 : 26
21 (6 – 162.5)
8 : 13
13 : 8
15 : 8
13 : 10
8 : 12
12 : 8
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Twenty one participants were randomly allocated to the control group, 23 to the Part
Practice group and 20 to the Whole Practice Group.
Participants in the Control group had a mean age of 73.3 years (+9.2), with a
median of 75.0 years and ranging from 62.2 to 88.1 years. Eight control participants
were male, 13 female. Thirteen control participants had suffered a right CVA and 8
suffered a left CVA.
Participants in the Part Practice group had a mean age of 72.3 years (+9.5), with a
median of 72.3 years and ranging from 54.3 to 86.6 years. Fifteen part practice
participants were male, eight female. Thirteen PP participants had suffered a right
CVA and 10 suffered a left CVA.
Participants in the Whole Practice group had a mean age of 73.2 years (+8.5), with
a median of 71.4 years and ranging from 59.8 to 90.8 years. Eight WP participants
were male, 12 female. Twelve WP participants had suffered a right CVA and 8
suffered a left CVA.
The sample of people with chronic stroke was, therefore, consistent with existing
published demographic data.
The sample size however was lower than that
originally anticipated, despite strategies implemented as outlined in chapter seven to
attempt to boost recruitment.
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8.3
8.3.1
Drop Outs and Missing Data.
Drop Outs
Table 8.1 indicates selected sample characteristics from the 64 people with stroke
recruited to the initial study. Baseline data were collected on all 64 participants,
however four participants dropped out, and their data have not been used to analyse
effects of intervention. The data from only 60 participants, therefore, are utilised in
subsequent data analysis: Control n=19; Part Practice n=22; Whole Practice n=19.
The reasons for drop-out are given in table 8.2 and a Consort diagram of the trial is
presented in figure 8.1
Participant ID
Group
Reason for drop-out
28
Con
Admitted to hospital following baseline visits for nonstroke related condition. Health status deteriorated
and inappropriate to make further visits.
56
WP
Drop out during first visit
physiotherapist – no reason given.
60
Con
Drop out once allocated to group
64
PP
Chest pain during initial intervention visit. Referred
back to GP
Table 8.2
by
intervention
Reasons for drop-out following recruitment to the study
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Referred to study (sent invitation letter
to participate) n= 350
Non Responders n = 190
Excluded
Inclusion criteria not met n = 84
Refused / not interested n =12
Baseline outcome
measures 1 and 2
Recruited n = 64
Randomised with stratification
Control Group n = 21
Received intervention n= 19
Drop out before intervention n=2
Drop out n = 0
Drop out n = 0
Part Practice Group
Assessed n= 21
Drop out n = 1
Died n = 0
Whole Practice group
Assessed n= 18
Drop out n = 0
Died n = 1
Outcome 5
Assessed n=18
Unable to assess n = 1
[UTA= 1 - hospital admission]
Outcome 4
Part Practice Group
Assessed n=19
Unable to assess n =3
[UTA=3- ill]
long-term
follow-up
Control Group
Assessed n= 19
Drop out n = 0
Died n = 0
Assessed n= 19
Dropped out n = 0
short-term
follow-up
Control Group
Assessed n=14
Unable to assess n =5
[UTA=2 – ill; 1= refused; 2= away]
Drop out n = 0
Part Practice Group
Assessed n=21
Unable to assess n= 1 [ill]
Dropped out n = 0
Whole Practice Group n=20
Outcome 3
end intervention
Control Group
Assessed n=19
Dropped out n = 0
Part Practice Group n = 23
Figure 8.1. CONSORT DIAGRAM
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8.3.2
Missing Data
During the study period, there were a small number of occasions when it was not
possible to undertake data collection. In order to identify valid and missing data
points, these occurrences are summarised in table 8.3. with ensuing discussion of
the underlying reason.
Valid
Missing
TIMEPOINT
group n
Percent n
Percent
BASELINE
control 19*
100.0% 0
.0%
part
22
100.0% 0
.0%
whole
19
100.0% 0
.0%
95.0%
0
.0%
1
4.5%
END
INTERVENTION
SHORT-TERM
FOLLOW-UP
LONG-TERM
FOLLOW-UP
Table 8.3:
OF control 19*
part
21
95.5%
whole
19
100.0% 0
.0%
control 14*
70.0%
5
30.0%
part
19
86.4%
3
13.6%
whole
18
94.7%
1
5.3%
control 19*
95.0%
0
.0%
part
21
95.5%
1
4.5%
whole
18
94.7%
1
5.3%
Summary of valid and missing data points for all outcome
measures at each measurement timepoint.
*=n-1 for Stroke Impact Scale data due to aphasia of participant C46
At baseline there was 100% completion of all outcome measures, with the exception
of the Stroke Impact Scale (SIS) for one participant (C46) who had dysphasia and
tired easily. The lack of SIS data for this one participant was constant at each
measurement point.
At the end of intervention measurement point, data were
missing for one participant (P17).
This participant had developed trigeminal
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neuralgia just prior to the end of the intervention phase and was extremely unwell
with severe pain. It was therefore deemed inappropriate to visit.
At the short-term follow-up (retention) measurement point data were missing for five
participants in the control group, three PP participants and one WP participant. The
reasons for the missing data for five control group participants were: illness (n=2
C45 and C58), refused visit (C9), away on short break (C2) and moving
accommodation (C63).
Missing data for the three PP participants was due to:
trigeminal neuralgia (P17) and illness (n=2 P4 and P8). The one WP participant for
whom data were missing at the short-term follow-up point had been admitted to
hospital for an acute, non-stroke related, condition (W61).
At the final, long-term follow-up measurement point, data were missing for one PP
subject (P31) who cancelled two appointments and refused a further attempt to
organise a visit. The other missing data point was, sadly, due to the death of one
WP participant (W21).
Given the nature of this community- based RCT, the amount of missing data is
relatively low and the reasons for missed outcome measurement visits were not
unexpected.
8.4
8.4.1
Global Measures of Impairment, Activity and Participation
The Barthel Index (BI) - Descriptive Data (BI)
The Barthel Index is an ordinal scale with a possible score between zero and 20
(Mahoney & Barthel, 1965). Numerical median, 25th and 75th percentile and mean
and standard deviation data are shown in table 8.4. The median, interquartile range
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and range of the BI scores for the control (CON), part practice (PP) and whole
practice (WP) participants are shown graphically in figure 8.2.
Control
Group
Baseline
Median
25th percentile
75th percentile
Mean (s.d)
End of Intervention
Median
25th percentile
75th percentile
Mean (s.d)
Short-term
retention
Median
25th percentile
75th percentile
Mean (s.d)
Long-term
retention
Median
25th percentile
75th percentile
Mean (s.d)
Significance
Testing Within
Groups
Table 8.4:
Part
Practice
Group
Whole
Group
Practice
Significance
Test
Between groups
18
15
19
17 (2.5)
18
17
19
17.7 (1.7)
17
15
19
16.8 (2.3)
NS
18
16
19
17.3 (2.3)
19
17.5
19.5
18.2 (2.0)
18
16
19
17.6 (2.1)
NS
18.5
15.75
19
17.5 (2.3)
18
18
19
18.2 (1.8)
18
15.75
19.25
17.7 (2.2)
NS
NS
18
15
19
17.2 (2.4)
18
17
19.5
18 (1.9)
18
16
19.25
17.6 (2.4)
NS
p<0.005
p<0.005
Descriptive data for Barthel Index total scores
At baseline measure, BI scores showed very little variation with only a difference of
one point in the median value for any of the groups. All groups increased their
median BI score from baseline to outcome measure taken at the end of intervention.
At short term follow-up the median score for the part-practice group had returned to
baseline value and stayed at that value at long-term follow-up. The pattern for both
the control and the whole practice groups showed the median BI score reduced
slightly at both short-term and long-term follow-up, but did not return to baseline
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values. It may be that the missing data for three subjects in the part-practice group
at short-term follow up may have affected these data, however the control group had
double the number of missing subjects at this short-term follow up time point and
data from the control group did not return to baseline median values.
Figure 8.2
Box Plot of scores on Barthel Index
8.4.1.1 Statistical Testing for Barthel Index data
Data were analysed to see if there were any differences both within-group over time,
and also whether there were any differences between-groups at each time point.
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8.4.1.2 Within group comparisons – Barthel Index
In order to compare whether there were any changes within each group over time, a
Friedman’s Anova was undertaken on the data for each group from the baseline and
at the three subsequent measurements following the intervention period.
The
Barthel Index for Con participants did not significantly change during the study
period, 2 (3) = 1.67, p=0.64. The part practice participants Barthel Index score did
show a statistically significant change during the study period, 2 (3) = 14.73,
p<0.005. The whole practice participants Barthel Index score also demonstrated a
statistically significant change during the study period, 2 (3) = 16.6, p<0.005.
Post hoc tests using the Wilcoxon signed ranks test were used to follow up this data
for the part-practice and whole-practice participants. A Bonferroni correction was
applied to the data and so all effects are reported at an adjusted 0.008 level of
significance (0.05/6). For the part practice participants it was found that while the
Barthel Index score was not significantly greater at the end of intervention compared
to baseline, z = 2.5, p= 0.01, r = 0.55; the Barthel Index score was, however,
significantly greater at the short-term follow up timepoint compared to baseline, z =
2.67, p=0.008, r = 0.61. For the whole practice participants a similar pattern was
demonstrated.
The Barthel Index score was significantly greater at the end of
intervention compared to baseline, z = 2.95, p= 0.003, r = 0.68; the Barthel Index
score was also significantly greater at the short-term follow up timepoint compared
to baseline, z = 3.18, p=0.001, r = 0.75.
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8.4.1.3 Between group comparisons – Barthel Index
To compare whether there were any differences between the groups at each time
point, a Kruskal Wallis test was applied to the data. It was found that there was no
significant difference between the control, part-practice or whole practice
participants Barthel Index scores at baseline H (2) = 1.67, p = 0.44; at the end of the
intervention period H (2) = 1.37, p = 0.51; at the short-term follow up period H (2) =
0.61, p = 0.74; nor at the long-term follow-up H (2) = 0.84, p = 0.66.
8.4.2
Frenchay Activity Index (FAI)
8.4.2.1 Descriptive Data for Frenchay Activities Index
The Frenchay Activity Index is a four point ordinal scale, with sub-components for
activities undertaken over the past three or six months and a summed total score.
Possible scores range between zero and 30 for the three month sub-component,
zero and 15 for the six month component and a total possible score ranging
between zero and 45 (Holbrook and Skilbeck 1983). Numerical median, 25th and
75th percentile, mean and standard deviation data are shown in table 8.5. Median,
interquartile range and range of the FAI scores for the control (CON), part practice
(PP) and whole practice (WP) participants are shown graphically in figure 8.3.
At baseline measure, FAI scores showed slight variation between the groups, but
only with a three point difference for the median values between the groups (Con 7,
PP 10.5 and WP10). All groups increased their median FAI score from baseline to
the end of intervention and this change was maintained at the long-term follow-up.
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FAI past 6 months
Significance
Test Between
groups
FAI total
FAI past 3 months
con
part
whole con
part
whole con
part
whole
BASELINE
Median
7
10.5
10
3
3
4
11
14.5
14
th
6
6.75
5
2
1.75
4
8
9.25
9
th
18
17
4
5
5
21
20
25 percentile
75 percentile
Means
(sd)
11
11
(6.25) (5.43)
15
10.7
(6.1)
3.3
3.4
(1.6) (1.9)
4
(0.9)
14.3 14.3
(7.1) (6.3)
NS
20
14.7
(6.5)
END
INTERVENTION
Median
th
11
13
12
2
3
4
13
17
19
25 percentile
5
9
5
2
2
4
9
11.5
10
75th percentile
22
17.5
18
4
5
6
25
25.5
23
Means
(s.d)
13.2 13
(8.4) (5.8)
11.8
(6.5)
3.5
4.3
(1.6) (2.6)
4.7
(1.4)
16.7 17.2
(9.2) (7.5)
NS
16.5
(7.1)
LONG-TERM
FOLLOW-UP
Median
9
12
13.5
4
3
5
14
16
18.5
25th percentile
4
7.5
8.5
3
2
4
8
11.5
10.5
75th percentile
23
16.5
19.25
5
5.5
6
27
23
24
Means
(s.d)
12.9 12.4
(8.6) (6.3)
13.4
(5.7)
Significance
test within
groups
NS p<0. P<0.0 NS p<0. P<0.0 NS p<0. P<0.0
01
5
01
5
01
5
Table 8.5:
4.1
3.9
(1.6) (2.3)
4.7
(1.2)
17 16.3
(9.6) (7.6)
NS
17.3
(7.2)
Descriptive Data for Frenchay Activity Index scores
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Figure 8.3
Boxplot of Frenchay Activity Index total scores
8.4.2.2 Within group comparisons Frenchay Activity Index
A within-group comparison was undertaken using a Friedman’s ANOVA on the data
for each group from the baseline and at the end of intervention and long-term followup. For both part practice (PP) and whole practice (WP) participants, the Frenchay
Activity Index score did show a statistically significant change during the study
period, PP: 2 (2) = 8.96, p=0.01; WP: 2 (2) = 6.84, p=0.03. The control participants
Frenchay Activity Index total score did not significantly change during the study
period, 2 (2) = 3.61, p=0.16.
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for the part-practice and whole-practice participants. A Bonferroni correction was
applied to the data and so all effects are reported at a 0.017 level of significance
(0.05/3). For the part practice participants it was found that the total FAI score was
significantly greater at the end of intervention compared to baseline, z = -3.47, p<
0.005, r = 0.74. For the part practice group, there were no statistically significant
differences at any of the other time points. For the whole practice participants the
same pattern was demonstrated. The Frenchay Activity Index total score was only
significantly greater at the end of intervention compared to baseline, z =-2.4, p<0.05,
r = 0.55, but no other statistically significant differences were found at any of the
other timepoints.
8.4.2.3 Between group comparisons Frenchay Activity Index
participants Frenchay Activity Index scores at baseline H (2) = 0.04, p = 0.98; at the
end of the intervention period H (2) = 0.14, p = 0.93; nor at the long-term follow-up H
(2) = 0.11, p = 0.95.
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8.4.3
Motor Assessment Scale (MAS)
8.4.3.1 Descriptive Data Motor Assessment Scale
The Motor Assessment Scale (MAS) is an ordinal rating scale consisting of eight
items. Each item can be assigned a score of between one and six, giving a total
possible score of between eight and 48 (Carr and Shepherd 1985).
Numerical
median, 25th and 75th percentile, mean and standard deviation data are shown in
table 8.6. The median, interquartile range and range of the MAS scores for the
control (CON), part practice (PP) and whole practice (WP) participants are shown
graphically in figure 8.4.
Baseline
Median
25th percentile
75th percentile
Mean (sd)
End of Intervention
Median
25th percentile
75th percentile
Mean (sd)
Short-term retention
Median
25th percentile
75th percentile
Mean (sd)
Long-term retention
Median
25th percentile
75th percentile
Mean (sd)
Significance test
within groups
Control
Group
Part
Practice
Group
Whole
Practice
Group
Significance
test
between
groups
26
19
35
26.5 (8.9)
27
20.75
34.25
28.1 (7.9)
28
19
35
26.5 (8.5)
NS
29
21
39
29.4 (9.0)
32
23.5
40
31.7 (8.4)
35
19
37
29.1 (10.0)
NS
27
18.5
34.5
27 (9.4)
32
24
39
31.5 (8.0)
35
19
38.25
29.7 (10.2)
NS
31
20
38
29.5 (8.9)
34
22
39
31.9 (8.5)
32.5
19.75
40.25
29.7 (10.3)
NS
p<0.005
p<0.005
p<0.005
Table 8.6: Descriptive data for the Motor Assessment Scale total scores
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Motor Assessment Scale total scores at baseline showed very little variation
between the groups with only a difference of two points in the median value for any
of the groups (Control 26, PP 27, WP 28). All groups increased their median MAS
total score from baseline to outcome measure taken at the end of intervention and
short-term follow-up, although this change was less for the control group (increase
of three points) than the PP or WP group (increase by five and seven points
respectively).. At long-term follow-up the median score for the WP had reduced
slightly, although not to baseline value, while the control and the PP groups
demonstrated a continued small increase in median score. The fact that the control
group increased their MAS score was unexpected and will be discussed further in
the Discussion chapter (see 9.4.4).
Figure 8.4
Boxplot of Motor Assessment Scale total scores
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8.4.3.2 Statistical Testing for Motor Assessment Scale data
Data were analysed to see if there were any differences both within-group over time,
and also whether there were any differences between-groups at each time point for
MAS scores
8.4.3.3 Within group comparisons Motor Assessment Scale total scores
In order to compare whether there were any changes in MAS scores within each
group over time, a Friedman’s Anova was undertaken on the data for each group
from the baseline and at the three subsequent measurements following the
intervention period.
Both the intervention (PP and WP) as well as the control
participants showed an improvement in MAS total score over time.
Control
participants MAS score showed a statistically significant change during the study
period, 2 (3) = 17.05, p<0.005; PP participants also demonstrated a statistically
significant change during the study period, 2 (3) = 31.3, p<0.005 and WP
participants also demonstrated a statistically significant change on the MAS total
score during the study period, 2 (3) = 15.08, p<0.005.
for all groups. A Bonferroni correction was applied to the data and so all effects are
reported at a 0.008 level of significance (0.05/6).
For the control group participants, statistically significant differences were found
between baseline and the other three outcome measurement points.
These
significant differences were between baseline and end of intervention z = -3.19, p <
0.005, r = 0.73; baseline and short-term follow-up z =- 2.81, p< 0.005, r = 0.65; and
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between baseline and long-term follow-up z = -3.29, p< 0.005, r = 0.75.
No
statistically significant differences were found for MAS total scores for the control
group at any other time point comparisons.
The same pattern was found for the PP group. Statistically significant differences
were found between baseline and end of intervention z = -3.73, p <0.005, r = 0.8;
baseline and short-term follow-up z =- 3.63, p<0.005, r = 0.78; and between
baseline and long-term follow-up z = -3.45, p< 0.005, r = 0.74. No statistically
significant differences were found for MAS total scores for the PP group at any other
time point comparisons.
A similar pattern was found again for the WP group on MAS total scores. For the
WP group however, only one time point demonstrated a statistically significant
difference. This was found between baseline and the short-term follow-up point z =
-2.77, p < 0.005, r = 0.64. While no statistically significant differences were found
for MAS total scores for the WP group at any other time point comparisons, a trend
towards significance was demonstrated
between the
baseline and end of
intervention z =- 2.63, p= 0.009; and between baseline and long-term follow-up z = 2.63, p= 0.009.
8.4.3.4 Between group comparisons Motor Assessment Scale total score
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participants Motor Assessment Scale total scores at baseline H (2) = 0.62, p = 0.74;
at the end of the intervention period H (2) = 1.30, p = 0.52; at the short-term follow
up period H (2) = 1.93, p = 0.38; nor at the long-term follow-up H (2) = 0.93, p =
0.63.
8.5
Measures of Mobility
8.5.1
The Timed Up and Go over 2 metres (TUG2m) – descriptive data
The Timed Up and Go is a validated timed test of walking, balance and transfer
ability that was first developed by Podsiadlo and Richardson (1991). As described
in chapter 7, the original distance was modified from three to two metres (Timed Up
and Go over 2m – TUG2m) and the validity established with people with stroke
(Baer et al, 2003). Data relating to total time, gait speed and time to stand up will be
presented. Numerical median, percentile and interquartile range data are shown in
table 8.7. Boxplots showing the distribution of data for the TUG2m for the control
(CON), part practice (PP) and whole practice (WP) participants are shown
graphically in figures 8.5 a, 8.5.b. and 8.5.c.
The TUG2m total time demonstrated very little variation between the groups with
no more than five seconds between median values at any of the timepoints. All
groups showed a very slight decrease in TUG2m total time as the study progressed,
however the stability of the time to perform the items in this measure is a striking
feature. A minority of participants in the control group demonstrated extreme values
when undertaking the TUG2m (up to four minutes) and the reasons for this will be
discussed in chapter 9 (section 9.4.2).
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TUG2m total time (s) Gait speed m/s
Time to stand up (s)
control part whole control part whole control part whole
BASELINE
Median
25th percentile
75th percentile
Interquartile
range
32.85
20.68
48.41
27.73
30.83
15.9
55.11
40.79
35.36
22.33
59.41
37.08
0.21
0.11
0.36
0.25
0.21
0.12
0.44
0.32
0.21
0.13
0.26
0.13
2.93
2.11
4.65
2.54
2.6
1.94
4.07
2.13
3.22
1.87
4.67
2.8
29.98
23.52
47.4
23.88
26.23
14.4
51.79
37.39
30.26
22.59
62.29
39.7
0.26
0.12
0.32
0.2
0.24
0.12
0.53
0.41
0.24
0.1
0.39
0.29
2.84
1.96
4.19
2.23
2.65
1.44
4.43
2.99
3.6
1.93
4.76
2.83
31.48
22.78
48.36
25.58
28.63
11.58
49.72
38.14
28.98
21.74
57.68
35.94
0.25
0.15
0.36
0.21
0.32
0.13
0.55
0.42
0.2
0.12
0.35
0.23
2.9
2.08
4.16
2.08
2.42
1.25
3.96
2.71
2.67
1.56
5.4
3.84
27.42
19.86
55.7
35.84
27.94
15.28
46.16
30.88
31.24
20.04
51.68
31.64
0.25
0.1
0.42
0.32
0.23
0.16
0.43
0.27
0.2
0.12
0.38
0.26
3.51
1.86
4.1
2.24
2.23
1.65
4.39
2.74
3.23
1.81
5.76
3.95
END
INTERVENTION
Median
25th percentile
75th percentile
Interquartile
range
SHORT-TERM
FOLLOW-UP
Median
25th percentile
75th percentile
Interquartile
range
LONG-TERM
FOLLOW-UP
Median
25th percentile
75th percentile
Interquartile
range
Table 8.7:
Descriptive Data for Timed Up and Go 2m components
The TUG2m gait speed was relatively stable over time, with median gait speed
consistently recorded at 0.2 – 0.25 m/s. All groups, including the control group,
exhibited a slight increase in gait speed demonstrated at the end of intervention,
however the improvement was transient and returned to approximate baseline levels
by long-term follow-up.
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The time to rise to stand (RTS) (the first component of the TUG2m), demonstrated
very little variation between the groups median values at any of the timepoints,
however there was quite some disparity in the time taken to RTS.
All groups
contained a minority of participants who exhibited marked difficulty in rising from a
chair, as revealed by times in excess of 10 seconds, discussion relating to this
characteristic is presented in chapter 9 (section 9.4.2).
Figure 8.5.a. Boxplot of Timed Up and Go 2m total time
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Chapter 8
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Figure 8.5.b. Boxplot of Timed Up and Go 2m – gait speed
Figure 8.5.c. Boxplot of Rise to Stand (RTS) time during TUG2m
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8.5.1.1 Statistical Testing for Timed Up and Go 2m (TUG2m) data
Data were analysed to determine if there were any differences both within-group
over time, and also whether there were any differences between-groups at each
time point for TUG2m total time; TUG2m gait speed and TUG2m time to stand.
8.5.1.2 Within group comparisons TUG2m total time
A Friedman’s ANOVA was undertaken on the TUG2m total time data for each group
from baseline and at the three subsequent measurement points following the
intervention period. Total time stayed relatively stable over time for all groups.
There was no statistically significant difference for any of the groups during the
study period: Control participants: 2 (3) = 3.77, p=0.29; PP participants: 2 (3) =
6.67, p = 0.08; WP participants: 2 (3) = 5.47, p=0.14. As there were no statistically
significant differences, no post hoc tests were undertaken.
8.5.1.3 Between group comparisons TUG2m total time
point for TUG2m total time, a Kruskal Wallis test was applied to the data.
No
statistically significant difference was found between the control, PP or WP groups
TUG2m total time at baseline H (2) = 0.73, p = 0.69; at the end of the intervention
period H (2) = 0.73, p = 0.69; at the short-term follow up period H (2) = 0.75, p =
0.70; nor at the long-term follow-up H (2) = 0.75, p = 0.69.
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8.5.1.4 Within group comparisons TUG2m gait speed
A Friedman’s ANOVA was undertaken on the TUG2m gait speed data for each
group from baseline and at the three subsequent measurement points following the
intervention period. There was no statistically significant difference for any of the
groups during the study period: Control participants - 2 (3) = 2.96, p=0.40; PP
participants - 2 (3) = 2.44, p = 0.49; WP participants - 2 (3) = 1.59, p=0.66. As
there were no statistically significant differences, no post hoc tests were necessary.
8.5.1.5
Between group comparisons TUG2m gait speed
point for gait speed on the TUG2m, a Kruskal Wallis test was applied to the data. It
was found that there was no significant difference between the control, PP or WP
groups TUG2m gait speed at baseline H (2) = 0.30, p = 0.86; at the end of the
8.5.1.6 Within group comparisons rising to stand
A Friedman’s ANOVA was undertaken on the TUG2m gait speed data for each
group from baseline and at the three subsequent measurement points following the
intervention period. There was no statistically significant difference for any of the
groups during the study period: control participants - 2 (3) = 0.24, p=0.50; PP
participants - 2 (3) = 3.91, p = 0.27; WP participants - 2 (3) = 2.86, p=0.41. As
there were no statistically significant differences, no post hoc tests were necessary.
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8.5.1.7
Between group comparisons rising to stand (RTS)
To identify whether there were any differences between the groups in time taken to
rise to stand during the TUG2m, a Kruskal Wallis test was applied to the data. It
was found that there was no statistically significant difference in the RTS time for
control, PP or WP groups TUG2m at baseline H (2) = 0.51, p = 0.78; at the end of
the intervention period H (2) = 0.99, p = 0.61; at the short-term follow up period H (2)
= 1.77, p = 0.41; nor at the long-term follow-up H (2) = 1.15, p = 0.56.
8.5.2
The Step Test - Descriptive Data
The Step Test is a simple measure of dynamic balance and produces ratio level
data of the number of steps onto a block are achieved within a set time period (Hill
1996). Data were collected both for the Step Test with both the impaired and nonimpaired limb. Median, percentile and interquartile range data are presented in
table 8.8 and graphical representation of median, interquartile range and range of
the Step Test scores for the control (CON), part practice (PP) and whole practice
(WP) participants are shown graphically in figures 8.6.a. and 8.6.b.
The Step Test scores at baseline showed a slight difference between median
scores. For stepping up with the unaffected foot, the WP group median score was
zero compared to median of two for the control and PP groups. During the course
of the study, when stepping with the unaffected foot, both the PP and WP groups
increased their median Step Test scores from baseline and this persisted to the end
of the long-term follow-up. Interestingly, the control group demonstrated a similar
pattern, although the changes were smaller.
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Baseline
Median
25th percentile
75th percentile
Interquartile range
End of Intervention
Median
25th percentile
75th percentile
Interquartile range
Short-term
retention
Median
25th percentile
75th percentile
Interquartile range
Long-term
retention
Median
25th percentile
75th percentile
Interquartile range
UNAFFECTED LEG
AFFECTED LEG
stepping up
stepping up
control
Part
Whole
Control Part
Whole
2
0
4
4
2
0
3.5
3.5
0
0
3
3
0
0
2
2
1.5
0
3.25
3.25
0
0
3
3
1
0
5
5
4
0.5
6
5.5
3
0
4
4
2
0
3
3
2
0
5
5
2
0
3
3
2
0
7
7
4
0
7
7
1.5
0
5
5
3
0
4.25
4.25
3
0
5
5
2
0
3
3
2
0
6
6
4
0
8
8
2
0
5
5
2
0
5
5
3
0
4.5
4.5
1
0
3
3
Table 8.8: Descriptive data for number of steps on the Step Test
Examining the data for stepping up with the affected leg, a similar pattern of change
was found, although the magnitude of improvement was smaller for the PP and WP
groups than the control group. The observation that the control group demonstrated
positive changes on the Step Test was unexpected and will be discussed further in
the Discussion chapter (see section 9.4.3).
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Figure 8.6.a. Boxplot of Step Test - number of steps onto block with
unaffected leg
8.5.2.1 Statistical Testing - Step Test data
Data were analysed for the Step Test to see if there were any differences both
within-group over time, and also whether there were any differences betweengroups at each time point for Step Test scores. The number of steps on the Step
Test with affected foot and with the unaffected foot were analysed separately.
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Chapter 8
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Figure 8.6.b. Boxplot of Step Test - number of steps onto block with affected leg
8.5.2.2 Within group comparisons Step Test scores
A comparison of changes in Step Test scores within each group over time was
undertaken using, Friedman’s ANOVA.
Data for each group were analysed to
determine if there were any changes from the baseline to the three subsequent
measurements following the intervention period.
Step Test performance with the unaffected leg for PP participants demonstrated
a statistically significant change during the study period, Friedman’s ANOVA test 2
(3) = 15.52, p<0.005, and while there was a strong trend towards improvement for
the WP group, this did not reach statistical significance WP participants 2 (3) =
7.59, p=0.055.
The control participants demonstrated no statistically significant
changes in ability to step up with the unaffected leg during the study period, 2 (3) =
6.118, p=0.106.
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for the PP group. A Bonferroni correction was applied to the data and so all effects
are reported at an adjusted 0.008 level of significance (0.05/6). For the PP group,
Wilcoxon signed ranks tests demonstrated that the statistically significant
improvements in Step Test performance with the unaffected leg occurred between
baseline and the end of intervention, z = -2.84, p<0.005, r= 0.61; between baseline
and short-term follow-up z = -2.69, p<0.00, r= 0.57; and between baseline and longterm follow-up z = -2.99, p<0.00, r= 0.64..
Step Test performance with the affected leg. Friedmans ANOVA showed no
statistically significant changes for the PP group 2 (3) = 5.64, p=0.13 when
performing the step test with the affected leg. The WP group demonstrated a trend
towards improvement, however, this did not reach statistical significance 2 (3) =
6.60, p=0.08,.
Surprisingly, the control group did demonstrate a statistically
significant improvement in performance of the step test with the affected leg over
time, 2 (3) = 8.97, p=0.03.
Post hoc tests using the Wilcoxon signed ranks test with a Bonferroni correction
with significance level at 0.008 level were used to determine where the differences
occurred.
It was found that statistically significant improvements in Step Test
performance with the affected leg for the control group occurred only between
baseline and the end of intervention, z = -2.74, p=0.006, r= 0.62. The reasons for
this finding will be considered in the Discussion (section 9.4.3).
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8.5.2.3 Between group comparisons – Step Test
To compare whether there were any differences in step up ability between the
groups at each time point, a Kruskal Wallis test was applied to the Step Test data.
For stepping up with the unaffected leg, necessitating balance and weightbearing ability on the affected leg, no statistically significant differences were found
between the control, part-practice or whole practice participants Step Test scores at
baseline H (2) = 1.08, p = 0.58; at the end of the intervention period H (2) = 2.19, p =
0.33; at the short-term follow up period H (2) = 1.59, p = 0.45; nor at the long-term
follow-up H (2) = 2.58, p = 0.28.
Stepping up with the affected leg, demonstrated a similar pattern, with no
statistically significant differences found between the control, part-practice or whole
practice participants Step Test scores at baseline H (2) = 1.20, p = 0.55; at the end
of the intervention period H (2) = 0.40, p = 0.82; at the short-term follow up period H
(2) = 1.67, p = 0.43; nor at the long-term follow-up H (2) = 1.05, p = 0.60.
8.6
8.6.1
Measures of arm and hand function
The Frenchay Arm Test (FAT) – descriptive data
The Frenchay Arm Test (FAT) is a five item, dichotomous scale of unilateral and
bilateral upper limb tasks (Heller et al 1987). Items are either able to be performed
(score 1) or not performed (score 0), giving a total possible score between 0 – 5.
Numerical median, 25th and 75th percentile, mean and standard deviation data are
shown in table 8.9. The median, interquartile range and range of the FAT scores for
the Con, PP and WP participants are shown graphically in figure 8.7.
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Baseline
Median
25th percentile
75th percentile
Mean (sd)
End of Intervention
Median
25th percentile
75th percentile
Mean (sd)
Short-term retention
Median
25th percentile
75th percentile
Mean (sd)
Long-term retention
Median
25th percentile
75th percentile
Mean (sd)
Significance test
within groups
Control
Group
Part
Practice
Group
Whole
Practice
Group
Significance
test
between
groups
2
0
4
2.1 (2.0)
2
0
4
1.9 (1.7)
0.5
0
4
1.8 (2.1)
NS
3
0
4
2.3 (2.0)
3
0
4.5
2.5 (2.1)
2
0
4
1.9 (2.1)
NS
1
0
4
1.9 (2.0)
3
0
4
2.3 (2.1)
2
0
4
2.0 (2.1)
NS
2
1
4
2.5 (2.0)
3.5
0.25
4
2.6 (1.8)
2
0
4
2.2 (2.1)
NS
p<0.005
p<0.005
NS
Table 8.9: Descriptive data for the Frenchay Arm Test
The Frenchay Arm Test scores at baseline showed a slight difference between
median scores with the WP group being slightly lower than the mean for the control
or PP groups.
During the course of the study, both the PP and WP groups
increased their median FAT scores from baseline and this persisted to the end of
the long-term follow-up.
The control group showed more variation with an
unexpected increase in the median score of one point at the end of “intervention” but
this dropped at short-term follow up. The fact that the control group demonstrated
positive changes on the FAT score was unexpected and will be discussed further in
chapter 9 (section 9.4.3).
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Figure 8.7
Boxplot of Frenchay Arm Test scores
8.6.1.1 Statistical Testing for Frenchay Arm Test (FAT) data
Data were analysed for the FAT to see if there were any differences both withingroup over time, and also whether there were any differences between-groups at
each time point for FAT scores
8.6.1.2 Within group comparisons Frenchay Arm Test scores
In order to compare whether there were any changes in FAT scores within each
group over time, a Friedman’s Anova was undertaken on the data for each group
from the baseline and at the three subsequent measurements following the
intervention period.
FAT scores for PP participants demonstrated a statistically
significant change during the study period, 2 (3) = 13.29, p<0.005. There were,
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however, no statistically significant changes for WP participants 2 (3) = 4.71,
p=0.19. Interestingly, the control participants also showed a statistically significant
change during the study period, 2 (3) = 12.35, p<0.005.
for the PP and the control groups. A Bonferroni correction was applied to the data
and all effects are reported at a 0.008 level of significance (0.05/6). This analysis
demonstrated that the statistically significant improvement on FAT scores for PP
participants occured between the baseline and end of intervention measures z = 2.72, p=0.006, r=0.58. For the FAT scores of the control group participants, once
the Bonferroni correction was applied, there were no statistically significant
differences between any of the time point comparisons at the 0.008 level. This may
be due to the conservative nature of the Bonferroni method (Altman 1991). There
was a trend towards significance between baseline and short-term follow up for the
FAT scores of control subjects z=2.0, p = 0.05. Post hoc analysis with Wilcoxon
tests were not applied to the WP FAT scores as the initial Friedman’s ANOVA did
not demonstrate any statistically significant differences in this group over time.
8.6.1.3 Between group comparisons Frenchay Arm Test score
point, a Kruskal Wallis test was applied to the FAT data. No statistically significant
differences were found between the control, part-practice or whole practice
participants FAT scores at baseline H (2) = 0.37, p = 0.83; at the end of the
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8.7
8.7.1
Measures of Mood
The Hospital Anxiety and Depression Scale (HADS) descriptive data
The Hospital Anxiety and Depression Scale (HADS) is a simple, 14 item screening
tool to identify depression and anxiety (Zigmond and Snaith 1983). HADS uses a
four point ordinal scale, to score seven items to screen for depression and seven
items to screen for anxiety. Each sub-scale has a total possible score range from
zero to 21. Numerical median, percentile and interquartile range data are shown in
table 8.10.
The median, interquartile range and range of the HADS scores for the
control (CON), part practice (PP) and whole practice (WP) participants are shown
graphically in figures 8.8.a. and 8.8.b.
For the HADS-A subscale, all groups demonstrated the same pattern of change.
Scores reduced from baseline to the end of intervention and this was followed by a
slight increase at long-term follow-up.
This pattern of change was also
demonstrated by the WP and control groups on the HADS-D subscale, however the
PP group showed a very slight increase in HADS-D score over time – this change
was less than two points in the median value.
8.7.1.1 Statistical Testing for the Hospital Anxiety and Depression Scale data
Data for both subscales, were analysed to determine if there were any differences
both within-group over time, and also whether there were any differences betweengroups at each time point.
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HADS-A
control part
HADS-D
whole control part
whole
BASELINE
Median
6
6
8
6
4
6
th
4
4
4.25
3
3
3.75
th
75 percentile
7
11.5
10
7
7.75
8.25
Interquartile range
3
7.5
5.75
4
4.75
4.5
25 percentile
END
INTERVENTION
Median
4
5
4
5
5
5
th
2
4
3
3
2.25
3
th
75 percentile
6
9.75
7
7
7.75
6
Interquartile range
4
5.75
4
4
5.5
3
25 percentile
LONG-TERM
FOLLOW-UP
Median
5
6
5.5
5
5.5
6
th
2
5
1.75
3
3.25
3.75
th
75 percentile
6
8.75
7
7
8
7.5
Interquartile range
4
3.75
5.25
4
4.75
3.75
25 percentile
Table 8.10:
Descriptive data for the Hospital Anxiety and Depression Scale
Figure 8.8.a Boxplot of Hospital Anxiety and Depression Scale – Anxiety subscale
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Figure 8.8.b.
Boxplot of Hospital Anxiety & Depression Scale – Depression subscale
8.7.1.2 Hospital Anxiety and Depression Scale (HADS) Within group
comparisons
HADS-A
Friedman’s ANOVA was undertaken on the data for each group from the baseline
and at the end of intervention and long-term follow-up. Participants in the WP group
demonstrated a statistically significant reduction in their anxiety level, during the
duration of the study, 2 (2) = 8.09, p=0.02. This statistically significant finding was
also demonstrated by the control participants, whose HADS-A subscale score
demonstrated a statistically significant change during the study period, 2 (2) = 7.86,
p=0.02. There was no statistically significant difference for the PP participants, 2 (2)
= 2.64, p=0.27.
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Post hoc tests using the Wilcoxon signed ranks test were undertaken to follow up
these findings for HADS-A for the WP and control participants.
A Bonferroni
correction was applied to the data and so all effects are reported at an adjusted
0.017 level of significance (0.05/3). For the Control group the HADS-A subscale
score was statistically significantly reduced between baseline and the end of
intervention, z = -2.58, p = 0.010, r = 0.59.
No other statistically significant
differences were demonstrated at any of the other time point comparisons for the
Control group. Although the Friedman’s ANOVA had demonstrated a statistically
significant difference on HADS-A for both the WP and control groups over time, on
post hoc Wilcoxon tests applying the Bonferroni correction, the significant difference
for the WP group could not be confirmed by statistical testing. A trend towards
significance was noted for WP comparisons between the HADS-A baseline and end
of intervention measures z = -2.27, p=0.02, r = 0.52 and between baseline and longterm follow-up z = -2.26, p=0.02, r = 0.52.
HADS-D
A Friedman’s ANOVA was undertaken on the subscale data for each group on the
HADS-D from the baseline and at the end of intervention and long-term follow-up to
compare whether there were any changes within each group over time. There was
no statistically significant difference on the HADS-D subscale over time for any of
the groups, PP participants, 2 (2) = 2.32, p=0.31, WP 2 (2) = 2.8, p=0.25, Control
participants, 2 (2) = 2.91, p=0.23.
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8.7.1.3 Hospital Anxiety and Depression Scale (HADS)- Between group
comparisons
The HADS data were analysed for differences between the groups at each timepoint
for the subscales of Anxiety and Depression.
HADS-A Between Group analysis
A Kruskal Wallis test was applied to the HADS Anxiety subscale data. It was found
that there was no significant difference between the control, PP or WP participants
HADS-A subscale score at baseline H (2) = 1.61, p = 0.49; at the end of the
intervention period H (2) = 1.45, p = 0.49; nor at the long-term follow-up H (2) =
3.39, p = 0.18
HADS-D Between Group analysis
A Kruskal Wallis test was applied to the HADS Depression subscale data. It was
found that there was no significant difference between the control, PP or WP
participants HADS-A subscale score at baseline H (2) = 1.09, p = 0.58; at the end of
the intervention period H (2) = 0.66, p = 0.72; nor at the long-term follow-up H (2) =
0.29, p = 0.86.
8.8
8.8.1
Measure of Health Status
The Stroke Impact Scale (SIS) descriptive data
The Stroke Impact Scale (SIS) is a self-report, stroke specific questionnaire that
provides a multidimensional measure of the effects of stroke. It consists of 59 items
that measure outcomes, from the patient perspective, in eight domains (Duncan et
al 2002). The domains covered are: Strength, Hand function, Activities of Daily
Living (ADL), Mobility, Communication, Memory and thinking, Emotion and
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Chapter 8
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Participation. Domain scores are transformed to give a scale of 0 -100. In addition
to the eight domains, there is a vertical visual analogue scale (0 – 100) for
respondents to rate self-perceived recovery.
Each domain will be reported
separately.
8.8.2
Stroke Impact Scale – Strength (SIS-str) Descriptive Data
Numerical median, percentile and interquartile range data for the domain of SIS-str
are shown in table 8.11.
The median, interquartile range and range of the SIS-str
domain scores for the control (CON), part practice (PP) and whole practice (WP)
participants are shown in figure 8.9.
Baseline
Median
25th percentile
75th percentile
Interquartile range
End of Intervention
Median
25th percentile
75th percentile
Interquartile range
Long-term retention
Median
25th percentile
75th percentile
Interquartile range
Table 8.11
Control
Group
Part
Group
Practice Whole
Practice
Group
46.88
35.94
56.25
20.31
37.5
29.7
50
20.3
25
25
50
25
43.75
37.5
62.5
25
43.75
37.5
62.5
25
37.5
18.75
56.25
37.5
46.88
31.25
60.94
29.69
43.75
37.5
65.6
28.1
43.75
18.75
59.38
40.63
Median and Interquartile range data for Stroke Impact Scale –
strength domain
Clear perceived improvements in strength were reported by WP participants, with an
increase in median score of 18 points over the course of the study, while more
modest improvements (an increase in median score of five points) were reported by
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Chapter 8
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PP participants. The control participants perceived their strength as being relatively
stable over the course of the study.
Figure 8.9
Boxplot for Stroke Impact Scale – strength domain
8.8.2.1 Stroke Impact Scale – Strength (SIS-str) Within group Statistical
Analysis
and at the end of intervention and long-term follow-up.
The PP group demonstrated a statistically significant improvement for SIS-str
domain over time 2 (2) = 9.32, p<0.005. Post hoc analysis using the Wilcoxon
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Chapter 8
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signed ranks test with Bonferroni correction at 0.017 was undertaken on the SIS-str
domain for the PP group. A statistically significant difference was found between
baseline and end of intervention on SIS-str for the PP group z = -3.05, p < 0.005, r =
0.65 and a trend towards significance was found between baseline and long-term
follow-up z = -2.35, p = 0.019.
The WP group and the control group demonstrated no statistically significant
differences in SIS-str domain scores over time as tested by Friedmans ANOVA: WP
group 2 (2) = 1.75, p=0.42; control group 2 (2) = 1.82, p=0.4.
8.8.2.2 Stroke Impact Scale – Strength (SIS-str) Between group Statistical
Analysis
A Kruskal Wallis test was applied to the SIS-str domain data to determine if there
were any differences between groups at each timepoint. No significant difference
was found between the control, PP or WP participants on SIS-str domain score at
8.8.3
Stroke Impact Scale – Memory (SIS-mem)
Numerical median, percentile and interquartile range data for the domain of SISmem are shown in table 8.12.
As can be seen, the data for all groups are relatively
stable with median scores consistently over 80, which indicates that memory was
not perceived as a major issue for this cohort. The median, interquartile range and
range of the SIS-mem domain scores for the control (CON), part practice (PP) and
whole practice (WP) participants are shown in figure 8.10.
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Baseline
Median
25th percentile
75th percentile
Interquartile range
End of Intervention
Median
25th percentile
75th percentile
Interquartile range
Long-term retention
Median
25th percentile
75th percentile
Interquartile range
Control
Group
Part
Group
Practice Whole
Practice
Group
85.71
56.25
100
43.75
82.14
67.86
93.75
25.89
82.14
64.29
96.43
32.14
82.14
68.75
100
31.25
89.29
70.54
97.32
26.78
92.86
71.43
96.43
25
85.71
72.32
100
27.68
89.29
64.29
100
35.71
78.57
66.07
92.86
25.79
Table 8.12
Median and IQR data for Stroke Impact Scale – memory domain
Figure 8.10
Boxplot for Stroke Impact Scale – memory domain
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Chapter 8
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8.8.3.1 Stroke Impact Scale – Memory (SIS-mem) Within group Statistical
Analysis
and at the end of intervention and long-term follow-up. There were no statistically
significant changes on the SIS-mem domain over time for any of the groups: Control
2 (2) = 2.13, p=0.35; PP group 2 (2) = 2.68, p=0.26; WP group 2 (2) = 4.11,
p=0.13.
8.8.3.2 Stroke Impact Scale – Memory (SIS-mem) Between group Statistical
Analysis
A Kruskal Wallis test was applied to the SIS-mem domain data to determine if there
was found between the control, PP or WP participants on SIS-mem domain score at
8.8.4
Stroke Impact Scale – Mood (SIS-mood)
Numerical median, percentile and interquartile range data for the domain of SISmood are shown in table 8.13.
As can be seen, the SIS-mood data for the control
group reduce slightly over the course of the study, the PP group show a slight
increase after intervention and the WP group stay relatively stable during the study.
A boxplot of median, interquartile range and range of the SIS-mood domain scores
for the control (CON), part practice (PP) and whole practice (WP) participants are
shown in figure 8.11.
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Chapter 8
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Baseline
Median
25th percentile
75th percentile
Interquartile range
End of Intervention
Median
25th percentile
75th percentile
Interquartile range
Long-term retention
Median
25th percentile
75th percentile
Interquartile range
Control
Group
Part
Group
Practice Whole
Practice
Group
69.44
63.89
79.17
15.28
61.11
54.17
78.47
24.3
69.44
58.33
80.56
21.23
66.67
58.33
86.81
28.48
73.61
64.58
81.25
16.67
69.44
61.11
77.78
16.67
62.5
58.3
73.61
15.28
70.83
54.17
80.56
25.39
66.67
55.56
83.33
27.77
Table 8.13
Mood domain
Figure 8.11
Boxplot for Stroke Impact Scale – mood domain
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Chapter 8
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8.8.4.1 Stroke Impact Scale – Mood (SIS-mood) Within group Statistical
Analysis
Friedman’s ANOVA was undertaken on the data for each group from the baseline to
the end of intervention and long-term follow-up.
The PP group demonstrated a statistically significant improvement for SIS-mood
domain over time 2 (2) = 11.09, p<0.005. Post hoc analysis using the Wilcoxon
signed ranks test with Bonferroni correction at 0.017 was undertaken on the SISmood domain for the PP group.
This further analysis revealed a statistically
significant difference between baseline and end of intervention on SIS-mood: PP
group z = -3.3, p < 0.005, r = 0.7. No significant differences were found at any other
timepoint comparisons.
The WP group and the control group showed no statistically significant differences in
SIS-mood domain scores over time as tested by Friedmans ANOVA: WP group 2
(2) = 1.66, p=0.44; control group 2 (2) = 3.19, p=0.2.
8.8.4.2 Stroke Impact Scale – Mood (SIS-mood) Between group Statistical
Analysis
A Kruskal Wallis test was applied to the SIS-mood domain data to determine if there
were any differences between groups at each timepoint. No significant differences
were found between the control, PP or WP participants on SIS-mood domain score
at baseline H (2) = 1.97, p = 0.37; at the end of the intervention period H (2) = 0.48,
p = 0.79; nor at the long-term follow-up H (2) = 0.64, p = 0.73.
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8.8.5
Stroke Impact Scale – Communication (SIS-comm)
Numerical median, percentile and interquartile range data for the domain of SIScomm are shown in table 8.14.
With a few exceptions, the SIS-comm data are
clustered towards the high score end of the domain. As might be expected in a
cohort of people with late-stage stroke, there was minimal variability in
communication ability for any group over time. A boxplot of median, interquartile
range and range of the SIS-comm domain scores for the control (CON), part
practice (PP) and whole practice (WP) participants are shown in figure 8.12.
Baseline
Median
25th percentile
75th percentile
Interquartile range
End of Intervention
Median
25th percentile
75th percentile
Interquartile range
Long-term retention
Median
25th percentile
75th percentile
Interquartile range
Table 8.14
Control
Group
Part
Group
Practice Whole
Practice
Group
92.86
69.94
100
30.06
91.07
85.71
100
14.29
92.86
85.71
100
14.29
87.5
68.75
100
31.25
94.64
83.93
100
16.07
96.43
92.86
100
7.14
96.43
73.21
100
26.79
92.86
87.5
100
12.5
96.43
85.71
100
14.29
communication domain
8.8.5.1 Stroke Impact Scale – Communication (SIS-comm) Within group
Statistical Analysis
A Friedman’s ANOVA was undertaken on the data for each group from the baseline
and at the end of intervention and long-term follow-up to determine whether there
were any changes within each group over time. No statistically significant changes
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on the SIS-comm domain over time for any of the groups were found: Control 2 (2)
= 2.8, p=0.25; PP group 2 (2) = 4.43, p=0.11; WP group 2 (2) = 5.05, p=0.08.
Figure 8.12
Boxplot for Stroke Impact Scale – communication domain
8.8.5.2 Stroke Impact Scale – Communication (SIS-comm) Between group
A Kruskal Wallis test was applied to the SIS-comm domain data to determine if there
was found between the control, PP or WP participants on SIS-comm domain score
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8.8.6
Stroke Impact Scale – Activities of Daily Living (SIS-ADL) domain
Numerical median, percentile and interquartile range data for the domain of SISADL are shown in table 8.15.
While slight variability in SIS-ADL domain scores
was demonstrated by all the groups, essentially scores remained stable over time.
A boxplot of median, interquartile range and range of the SIS-ADL domain scores
for the control (CON), part practice (PP) and whole practice (WP) participants is
shown in figure 8.13.
Baseline
Median
25th percentile
75th percentile
Interquartile range
End of Intervention
Median
25th percentile
75th percentile
Interquartile range
Long-term retention
Median
25th percentile
75th percentile
Interquartile range
Table 8.15
Control
Group
Part
Group
Practice Whole
Practice
Group
51.25
39.38
68.13
28.75
62.5
47.5
68.13
20.63
55
45
62.5
17.5
50
40.63
62.5
21.87
62.5
57.5
70.63
23.13
62.5
35
65
30
53.75
31.88
77.5
45.62
67.5
58.75
72.5
13.75
52.5
41.25
65
23.75
ADL domain
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Chapter 8
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Figure 8.13
Boxplot for Stroke Impact Scale – ADL domain
8.8.6.1 Stroke Impact Scale – Activities of Daily Living (SIS-ADL) Within
group Statistical Analysis
A
Friedman’s ANOVA was undertaken on the data for each group from the
baseline, the end of intervention and long-term follow-up to determine whether there
were any changes within each group over time. No statistically significant changes
on the SIS-ADL domain over time for any of the groups were found: Control 2 (2) =
1.25, p=0.53; PP group 2 (2) = 0.56, p=0.76; WP group 2 (2) = 3.46, p=0.18.
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8.8.6.2 Stroke Impact Scale – Activities of Daily Living (SIS-ADL) Between
group Statistical Analysis
A Kruskal Wallis test was applied to the SIS-ADL domain data to determine if there
was found between the control, PP or WP participants on SIS-ADL domain score at
8.8.7
Stroke Impact Scale – Mobility (SIS-mob) domain
Numerical median, percentile and interquartile range data for the domain of SISmob are shown in table 8.16.
The control group demonstrated stability on scores
between baseline and end of intervention period, followed by a slight rise in SISmob domain score. The PP group demonstrated an increase in SIS-mob domain
score over the three measurement periods, while the WP group demonstrated an
initial slight reduction in SIS-mob score, followed by a rise to just above baseline
level at the final follow-up measurement point. A boxplot of median, interquartile
range and range of the SIS-mob domain scores for the control, PP and
WP
participants is shown in figure 8.14.
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Baseline
Median
25th percentile
75th percentile
Interquartile range
End of Intervention
Median
25th percentile
75th percentile
Interquartile range
Long-term retention
Median
25th percentile
75th percentile
Interquartile range
Control
Group
Part
Group
Practice Whole
Practice
Group
54.17
38.89
75
36.11
59.72
43.75
72.22
28.47
55.56
36.11
66.67
30.56
54.17
40.97
81.25
40.28
62.5
46.53
81.25
34.72
50
47.22
75
27.78
61.11
47.22
79.86
32.64
66.67
43.06
83.33
40.27
55.56
50
65.28
15.28
Table 8.16
mobility domain
Figure 8.14
Boxplot for Stroke Impact Scale –mobility domain
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8.8.7.1 Stroke Impact Scale – Mobility
Analysis
(SIS-mob) Within group Statistical
The PP group demonstrated a statistically significant improvement for SIS-mob
domain over time 2 (2) = 7.29, p=0.03. Post hoc analysis using the Wilcoxon
signed ranks test with Bonferroni correction at 0.017 was undertaken on the SISmob domain for the PP group.
A statistically significant difference was found
between baseline and end of intervention on SIS-mob for the PP group z = -2.59, p
= 0.01, r = 0.55, no other timepoint comparisons showed a statistically significant
difference for PP SIS-mob.
The WP group and the control group showed no statistically significant differences in
SIS-mob domain scores over time as tested by Friedman’s ANOVA: WP group 2
(2) = 0.43, p=0.80; control group 2 (2) = 4.67, p=0.09.
8.8.7.2 Stroke Impact Scale – Mobility (SIS-mob) Between group Statistical
Analysis
A Kruskal Wallis test was applied to the SIS-mob domain data to determine if there
was found between the control, PP or WP participants on SIS-mob domain score at
252
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8.8.8
Stroke Impact Scale – Hand (SIS-hnd) domain
Numerical median, percentile and interquartile range data for the domain of SIShnd are shown in table 8.17. The baseline medians are comparable between the
control and PP group, however the WP group had a lower median baseline
inidicating extreme difficulty with hand function. While there was a slight increase in
median SIS-hnd score for the control and WP group after the intervention period,
this was not sustained at long-term follow-up. Conversely, the PP group SIS-hnd
score remained stable at the end of intervention but increased at long-term followup. A boxplot of median, interquartile range and range of the SIS-hnd domain scores
for the control, PP and WP participants is shown in figure 8.15
Baseline
Median
25th percentile
75th percentile
Interquartile range
End of Intervention
Median
25th percentile
75th percentile
Interquartile range
Long-term retention
Median
25th percentile
75th percentile
Interquartile range
Table 8.17
Control
Group
Part
Group
Practice Whole
Practice
Group
15
0
45
45
12.5
0
40
40
0
0
35
35
30
0
51.25
51.25
12.5
0
56.25
56.25
15
0
40
40
17.5
0
67.5
67.5
20
7.5
60
52.5
10
0
50
50
hand domain
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Chapter 8
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Figure 8.15
Boxplot for Stroke Impact Scale –hand domain
8.8.8.1 Stroke Impact Scale – Hand (SIS-hnd) Between group Statistical
Analysis
A Kruskal Wallis test was applied to the SIS-hnd domain data to determine if there
was found between the control, PP or WP participants on SIS-hnd domain score at
8.8.9
Stroke Impact Scale – Participation (SIS-partic) domain
Numerical median, percentile and interquartile range data for the domain of SISmob are shown in table 8.18.
All groups demonstrated an increase in SIS-partic
254
Chapter 8
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domain scores over time. The potential reasons for this finding will be considered in
chapter 9.
A boxplot of median, interquartile range and range of the SIS-mob
domain scores for the control, PP and WP participants is shown in figure 8.16.
Baseline
Median
25th percentile
75th percentile
Interquartile range
End of Intervention
Median
25th percentile
75th percentile
Interquartile range
Long-term retention
Median
25th percentile
75th percentile
Interquartile range
Table 8.18
Control
Group
Part
Group
Practice Whole
Practice
Group
35.93
17.97
53.13
35.16
39.06
19.53
69.53
50
37.5
28.13
50
21.87
46.88
25
64.06
39.06
46.88
29.69
60.16
30.47
40.63
28.13
71.88
43.75
51.56
26.56
80.47
53.91
68.75
37.5
75
37.5
50
37.5
76.99
39.49
Participation domain
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Chapter 8
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Figure 8.16
Boxplot for Stroke Impact Scale –Participation domain
8.8.9.1 Stroke Impact Scale
–Participation
(SIS-partic)
Within
group
Both the PP and WP groups demonstrated a statistically significant improvement for
SIS-partic domain over time. PP SIS-partic 2 (2) = 17.26, p<0.00; WP SIS-partic 2
(2) = 13.78, p<0.005. Post hoc analysis using the Wilcoxon signed ranks test with
Bonferroni correction at 0.017 was undertaken to determine where the differences
lay. It was shown that for the PP group, a statistically significant difference was
found between baseline and the long-term follow-up point , z = -2.63, p < 0.005, r =
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0.56, and between the end of intervention and the long-term follow-up z = -2.88, p
<0.005, r = 0.61.
For the WP group, the statistically significant difference was
shown between baseline and long-term follow-up z = -2.69, p<0.005, r = 0.62.
The control group data showed no statistically significant differences in SIS-partic
domain scores over time Friedman’s ANOVA 2 (2) = 3.48, p=0.18.
8.8.9.2 Stroke Impact Scale – Participation (SIS-partic) Between group
A Kruskal Wallis test was applied to the SIS-partic domain data to determine if there
was found between the control, PP or WP participants on SIS-partic domain score
8.8.10
Stroke Impact Scale – Recovery visual analogue scale (SIS-VAS)
Numerical median, percentile and interquartile range data for self – perceived
recovery from stroke as measured by vertical visual analogue scale (VAS) on the
SIS are shown in table 8.19.
All groups demonstrated an increase in perceived
recovery VAS over time, with similar spread of data for all groups. A boxplot of
median, interquartile range and range of the SIS-mob domain scores for the control,
PP and WP participants is shown in figure 8.17.
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Chapter 8
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Baseline
Median
25th percentile
75th percentile
Interquartile range
End of Intervention
Median
25th percentile
75th percentile
Interquartile range
Long-term retention
Median
25th percentile
75th percentile
Interquartile range
Table 8.19
Control
Group
Part
Group
Practice Whole
Practice
Group
50
40
63.5
23.5
50
41.75
61.25
19.5
50
40
65
25
56.5
41
71.5
30.5
50.5
43.75
70
26.25
51
40
70
30
56
50
71.75
21.75
60
45
69.5
24.5
61
50.5
74
24.5
Median and Interquartile range data for Stroke Impact Scale – VAS
8.8.10.1 Stroke Impact Scale –Recovery Visual Analogue Scale (SIS-VAS)
Within group Statistical Analysis
and at the end of intervention and long-term follow-up. No statistically significant
differences were demonstrated for any of the groups over time. Control 2 (2) =
3.40, p = 0.18; PP 2 (2) = 3.32, p = 0.19; WP 2 (2) = 5.61, p = 0.06.
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Figure 8.17
Boxplot for Stroke Impact Scale –Recovery VAS
8.8.10.2 Stroke Impact Scale – Recovery Visual Analogue Scale (SIS-VAS)
Between group Statistical Analysis
A Kruskal Wallis test was applied to the perceived recovery VAS data to determine if
there were any differences between groups at each timepoint.
No significant
difference was found between the control, PP or WP participants at baseline H (2) =
0.01, p = 0.99; at the end of the intervention period H (2) = 0.23, p = 0.89; or at the
long-term follow-up H (2) = 0.86, p = 0.65.
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8.9
Exercise Repetitions
The exercise diary records were analysed to determine how many repetitions of
each exercise were undertaken by PP and WP participants.
Participants were
requested to practice exercises daily, but reassured that if they were unable to
practice on a particular day or days, that would be understandable and a request
was made that they state the reason. Reassurance was given that they could miss
days and continue to participate in the trial, this was undertaken to limit drop out if a
participant had missed a number of consecutive days. On scrutinising the data,
there were multiple and random days with no exercises for a variety of reasons such
as hospital appointments, family visits, leisure activities, and lack of motivation. In
order to allow scrutiny of the data, data have been summed over the four weeks of
intervention and total number of repetitions and weekly averages are presented in
table 8.20.
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PART PRACTICE Group
Exercise
TOTAL
Weekly
repetitions
average
Sit to Stand (component parts
Exercise
436.19 (+ 117.25)
406
(372 – 500)
Mean (s.d.)
Median
(IQR)
Mean (s.d.)
Median
(IQR)
Sit to stand
109.05 (+29.31)
101.5
(93 – 125)
Sitting Down (component parts)
Mean (s.d.)
Median
(IQR)
436.19 (+ 117.25)
406
(372 – 500)
434.77 (+ 134.78)
404
(362 – 492)
109.05 (+29.31)
101.5
(93 – 125)
434.77 (+ 134.78)
404
(362 – 492)
472.71(+ 117.22)
460
(406 = 490)
Table 8.20.
463.09 (+ 138.69)
464
(400 - 500)
111.67 (+45.06)
106
(84 – 122.75)
411.74 (+ 139.04)
392
(336 – 475.5)
102.93 (+34.76)
98
(84 – 118.88)
Step Up-Down BAD leg lead
108.62 (+33.7)
101
(90.5 – 123)
411.74 (+ 139.04)
392
(336 – 475.5)
102.93 (+34.76)
98
(84 – 118.88)
459.5 (+ 194.9)
442
(387 - 538)
114.88 (+48.72)
110.5
(96.75 – 134.5)
472.67 (+ 191.39)
467
(406 - 543)
118.17 (+47.84)
116.75
(101.5 –135.75)
Cuppa Time
118.18 (+29.31)
115
(101.5 – 122.5)
TIP TAP
(component parts)
Mean (s.d.)
Median
(IQR)
446.68 (+ 180.25)
424
(336 - 491)
108.62 (+33.7)
101
(90.5 – 123)
Cuppa Time
(component parts)
Mean (s.d.)
Median
(IQR)
111.67 (+45.06)
106
(84 – 122.75)
Step Up-Down GOOD leg lead
Step Up-Down BAD leg lead
(component parts)
Mean (s.d.)
Median
(IQR)
446.68 (+ 180.25)
424
(336 - 491)
Sitting Down
Step Up-Down GOOD leg lead
(component parts)
Mean (s.d.)
Median
(IQR)
WHOLE PRACTICE
Group
TOTAL
Weekly
repetitions
average
TIP TAP
115.77 (+34.67)
116
(100 – 125)
Summary of Exercise repetitions undertaken by participants
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8.10 Monitoring Activity
During the four weeks of the intervention phase of the study, participants were
requested to wear an ActivPAL™ 1activity monitor – for a single day. Collecting
data on amount of activity was a subsidiary element of the study and was
undertaken to gain an indicative picture of how community dwelling people with latestage stroke spend their time. Only 45 activPAL records were available for analysis.
Summary results are presented in table 8.21 and figures 8.18 – 8.20.
PERCENTILES
25th
50th
Percentage time in sitting or lying
Percentage time in standing
Percentage time in walking
Number of steps
Sit to stand transitions
Table 8.21.
75th
control
part
whole
control
part
71.75
71.00
71.00
3.25
7.50
84.00
79.00
74.50
10.50
12.00
94.50
88.00
89.25
14.50
17.00
whole
6.00
18.50
21.00
control
part
1.00
4.50
5.50
8.00
12.50
11.50
whole
4.00
6.50
9.50
control
part
181.00
1219.50
1296.00
2465.00
3550.00
4398.50
whole
851.50
1335.50
2123.00
control
part
18.00
29.50
29.50
42.00
40.75
60.00
whole
27.50
47.50
79.00
Summary descriptive data of activity undertaken during a single
day
As can be seen from table 8.21 and figures 8.18 to 8.20, the vast majority of time for
all participants, irrespective of group allocation, was spent inactive - either lying
down or sitting. While selected data are presented here, the raw data available in
appendix 8, revealed that, nine of the 45 participants (20%) spent less than two
percent of their waking day in walking. Furthermore, just one of the cohort took
1
PALtechnologies http://www.paltech.plus.com/
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more than 10,000 steps during the day and only a further four participants took more
than 5,000 steps. These findings relating to indicative pattern of activity will be
discussed further in chapter 9 (section 9.9).
Figure 8.18
Percentage of time spent in a specific position or activity
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Figure 8.19.
Number of sit to stand transitions undertaken during a single day
Figure 8.20. Number of steps taken during a single day
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8.11 Summary of Findings
This pilot study demonstrated that an RCT of physiotherapy based on different
practice paradigms for community-dwelling people with late-stage stroke was
feasible. Although recruitment was protracted, a reasonably sized cohort (n=64)
were enrolled onto the study and data from 60 participants were available for
analysis. A sample of this size in a community-based rehabilitation study in stroke is
of a reasonable size, however given the relatively insensitive nature of the outcome
measures used, combined with the number of participants in each arm of the trial,
any interpretation of key findings presented in the Discussion chapter can not be
generalised to the stroke population in general and therefore must be viewed with
caution.
Key findings are summarised below
There were no between group differences at any of the time points, therefore none
of the null hypotheses (stated in chapter 5) can be rejected. There were however
some within group differences over time, demonstrating capacity for improvement.
Impairment was measured by the MAS, the Step Test and the FAT. For MAS which
can be considered a mix of impairment and activity items, all three groups
demonstrated statistically significant improvements.
For both Con and PP
participants these improvements were found within each group over time, between
baseline and end of intervention and at both follow-up points. For WP participants
the within group change was only found between baseline and long-term follow-up.
There were however, no differences between the groups at any of the time points,
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indicating that neither PP or WP or no intervention was more beneficial in gaining
improvements as measured by MAS.
It was surprising to find the sustained
improvements on MAS demonstrated by Con participants and is potentially one of
the confounding methodological issues of undertaking a study with multiple
measurement points using simple physical outcome measures.
Impairment level as measured by the Step Test demonstrated a statistically
significant improvement only within the PP group over time when stepping up with
the unaffected leg. This test required participants to maintain stability in weightbearing and balance through the affected limb, while moving the unaffected limb on
and off a block. When undertaking the Step Test moving the affected limb onto a
block only the control participants improved over time.
Once again this was a
surprising finding and may be partly explained by the multiple measurement issues
as well as the motivation to improve demonstrated by the people recruited to this
study.
Arm impairment levels were measured by the FAT.
A statistically significant
improvement in FAT was only demonstrated within the PP group, and this
improvement was found between the baseline and the end of intervention. This
improvement was not sustained however and therefore can only be considered as
an indication of improvement in upper limb performance as oppose to improvements
in learning. Self perception of hand function as measured by SIS-hnd did not show
any significant changes, either between or within any of the groups
Activity was measured by self-reported outcomes on the FAI and SIS-partic
(participation in usual activities). For both PP and WP participants, there was a
statistically significant positive improvement within each group, between baseline
measures and the long-term follow-up point for SIS-partic. For FAI there was a
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statistically significant positive improvement within each group, between baseline
measures and the end of intervention. It appears that taking part in this study
resulted in participants randomised to one of the intervention arms becoming more
active over time, even though this was not a primary aim of the study.
In terms of mood, this aspect was measured by HADS-A, HADS-D and SIS-mood.
Once again while there were no statistically significant changes between the groups
at any of the measurement points, there were some significant changes within
groups over time.
The Control group significantly reduced their HADS-A score
between baseline and the end of intervention period, which can be considered as a
transient beneficial effect of participating in this study. Although the median HADSA score increased at the long-term follow-up, it had not increased back to baseline
level. No other changes in HADS-A or HADS-D scores were found for any of the
other groups at any other time points.
For SIS-mood, there was only a statistically significant improvement in mood within
the PP participants, between baseline and end of intervention. Once again this
needs to be considered a transient change, with no sustained benefits.
Finally, there was a perceived improvement on SIS-mob, which is a self-rated
domain and combines perception of impairment (e.g. balance) with perceptions of
ability (to walk fast or walk several blocks). Once again, it was the PP group that
demonstrated a transient improvement in SIS-mob scores between baseline and the
end of intervention, but this was not sustained at long-term follow-up.
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In the Discussion chapter, the findings from the current study will be placed into
context with existing knowledge. While, on first glance, it could be argued that there
appears to be some indications for adopting PP of functional tasks, most of the
changes in outcome appear to indicate transient changes in performance - with the
exception of the MAS and the Step Test (leading with the unaffected leg).
Confounders such as motivation, the effect of multiple testing and the power of the
study will all be considered in relation to the findings presented here.
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9.
DISCUSSION
9.1.
Introduction
The theoretical issues being addressed in this thesis derive from Motor Learning
theory and relate to how to structure exercise practice when undertaking practice of
functional tasks. The primary aim of the exploratory randomised controlled trial
(RCT) reported in this thesis was to investigate the effects of undertaking a homebased exercise programme of functional tasks based either on part-practice (PP) or
whole practice (WP) in a sample of community dwelling people with late stage
stroke. The methodology adopted in the RCT used randomisation with stratification,
by side and severity of stroke, to allocate participants to a Control, PP or WP group.
All participants received three or four visits from the research assistant during the
four week intervention phase. Participants in the PP or WP groups undertook a four
week programme of standardised exercises during the intervention phase, while the
Con participants received “treatment as normal” which was no intervention.
Assessment was undertaken using standardised outcome measures of impairment,
activity and participation as well as measures of mood and general health status.
Following baseline measures, outcomes were measured at the end of four weeks
intervention, at a short term retention follow-up (within 72 hours of end of
intervention) and at a long-term follow-up (approximately 3 months following the end
of intervention).
Data obtained in this study need to be treated cautiously for the following reasons.
Firstly the vast majority of data were non-normally distributed, secondly a number of
the outcome measures utilise summed ordinal level data and there are inherent
limitations associated with this process, in that an increase score in one item and a
269
decrease in another can result in the same total score, thirdly, there were a number
of missing data points with 16% (n = 10) missing at the short-term follow up point.
In addition, a Bonferroni correction was used when making multiple comparisons on
the data in the event that a within-group statistically significant difference was found.
Using this type of correction is recognised to be conservative and may result in a
Type II error, resulting in false negative decisions regarding the null hypotheses.
Furthermore, using a post hoc test with Bonferroni correction can result in a situation
where the original comparison identifies a statistically significant difference, which is
not identifiable on the post-hoc testing and therefore only trends can be reported
(Altman 1991). Conversely, if a statistically significant difference was identified on
post hoc testing using a conservative Bonferroni correction, then one can be
confident that a true difference does exist.
This chapter will discuss the results in relation to relevant literature and current
theoretical positions.
Study limitations and potential sources of error will be
considered and their potential influence on the results will be examined. Finally,
implications for clinical practice will be explored and recommendations for future
research will be presented.
A note of caution however, when considering
comparisons of the current study to existing work. It is difficult to compare studies in
this area, as although the published literature included in this chapter broadly looked
at home or community exercise programmes, with people with chronic or sub-acute
stroke and some studies were based on Motor Learning theory, there are many
discrepancies in the overall aims of the included studies, the trial designs, sample
sizes, and length and composition of the interventions.
270
9.2.
Sample Characteristics
From the 350 letters of initial invitation to participate in the study, 64 people with
stroke were recruited into the study which is a recruitment rate of 18.3%. This
recruitment rate was much lower than had originally been anticipated, but is in line
with other community based rehabilitation research (Lloyd et al 2010). Overall, the
sample of 64 participants that were recruited to the study comprised a much larger
sample than many other reported studies investigating physiotherapy for late-stage
stroke (such as Texeira-Salmela et al 1999; Dean et al 2000; Monger et al 2002;
McLellan and Ada 2004, Michaelsen et al 2006; Combs et al 2009).
The
characteristics of the cohort were representative of the stroke population at large
with median age of 72.3 years (range 54.3 – 90.8), median time since stroke of 21
months (range six months to 13.5 years) and there were almost equal numbers of
male (31) and female (33) participants.
People who had sustained a right
cerebrovascular accident (CVA) were recruited at a ratio of 1.5:1 compared to
people with a left CVA (38:26). Despite the characteristic features of the sample,
the trial design resulted in a maximum of 22 people in any arm of the trial and
therefore interpretation of results still require to be made with caution due to the
heterogeneous nature of the stroke population.
All attempts were made to ensure that as large a sample as possible would be
eligible for inclusion. The key safety exclusion criteria was a history of more than
two falls within the past six months, plus a requirement to meet the inclusion criteria
of functional reach of > 15 cm, this was to ensure that participants would not be at
high risk of falling when undertaking exercise. However as was reported in 8.9, four
of the participants did fall during the study period and this will be discussed further in
271
9.4. Potential participants also had to score at least 22 on the Mini Mental State
Examination, to ensure there should be adequate cognition and memory to follow
the exercise programme if allocated to the PP or WP arm of the trial.
The
exclusion criteria resulted in rejection of people with co-existing neuropathologies,
as this could have influenced the ability to undertake the independent exercises that
had been designed for this study, and it may also have affected the learning
process.
Co-existing disability (such as lower limb amputation) or co-existing
concurrent pathology (such as fracture of lower limbs) would also lead to exclusion
as the participants would not be able to undertake the exercise programme.
Participants with normal, age related pathologies that did allow exercise (such as
Osteoarthritis of the hip or knee) were included in the sample. No screening was
made for pain, fatigue or depression which are factors commonly associated with
stroke (for example Johnson et al 1995; Staub and Bogousslavsky 2001; Glader et
al 2002; Hackett et al 2005). It may be that potential participants who had been
contacted by letter chose not to respond, finding the prospect of an exercise
programme unappealing or worried that it may be too exhausting.
Four of the original 64 (6%) participants recruited dropped out, or their data were not
considered as part of the analysis (see 8.3.1.). The reasons for drop out were not
unexpected. Only one participant dropped out on allocation to the Con group. This
single incident supported the strategy of clearly identifying to potential participants,
on the initial phone contact and at the first baseline visit, the odds of not receiving
exercise (see 7.2). Two participants were withdrawn from the study for medical
reasons and one further subject withdrew and requested no further contact. While
four drop outs is disappointing, a 6% drop out rate can be considered highly
272
acceptable in a community-based RCT with people with a chronic condition
(Freemantle et al 1992).
The missing data at key time points (See 8.3.2), particularly at short-term follow-up,
may have affected the findings. Given the nature of the research environment and
the population under investigation, combined with the limited resources of one parttime clinical research assistant and one part-time blinded outcome assessor, to only
have few missing outcome records from a possible 240 was highly satisfactory and
provided a reasonably comprehensive dataset for analysis.
Data will now be
considered in relation to the findings presented in the Results chapter.
9.3.
Discussion of
Participation
Global
Measures
of
Impairment,
Activity
and
9.3.1. Barthel Index
Barthel Index (BI) data was scored 0 – 20 (Collin et al 1988). The median scores
showed slight improvement in all groups from baseline, with slight fluctuations in
median scores from 17 – 19 points, and changes in median scores of one point in
both PP and WP. A median BI score of 18 would indicate that the participants are
functioning at a relatively high level (McDowell and Newell 1996) and therefore there
may not be much capacity for change in score. The BI was included in the battery
of outcome measures however, to allow comparisons to be made with other work in
this area, with a recognition of the limitations of the index.
273
Considering the statistical testing, there was no statistically significant difference
between the groups at any of the measurement points indicating that the
intervention or lack of intervention resulted in no difference in performance on the
BI.
When examining the change over time within each group, both PP and WP
showed a statistically significant improvement. This was found to be present when
comparing short-term follow-up to baseline measures and was a somewhat
surprising finding.
However, on considering the data, it may be that the seven
missing PP and WP data points at the short-term follow-up strongly influenced this
finding.
The Barthel Index is recognised as a standardised and validated measure of
disability (Wade 1992, Langhammer et al 2007) and has been used in many studies
relating to stroke rehabilitation (such as Wade et al 1992; Dam et al 1993; Green et
al 2002; Stuart et al 2009; Langhammer et al 2007). It has however been criticised
for being insensitive to change (Wade and Collin 1988; Tennant et al 1996; TurnerStokes and Turner-Stokes 1997) and for demonstrating floor and ceiling effects
(Wade 1992; Turner-Stokes and Turner Stokes 1997). Despite these limitations, a
change of two points has been proposed as demonstrating a “probably genuine
change” (Collin and Wade 1988).
The PP and WP groups therefore, while
demonstrating a within group statistically significant change over time could not be
considered as demonstrating genuine improvement and the significant finding is
potentially just an anomaly related to the amount of missing data at the short-term
follow-up measurement point.
Stability of BI scores have been reported at six
months post-stroke, with a tendency to reduce slightly at one year (Langhammer et
al, 2007) although these findings were found on a cohort who had received four
274
weeks of intervention at three, six, nine and 12 months post-stroke, so not directly
comparable to the present study.
The findings from this RCT revealed that this cohort had a higher median score on
the BI at all measurement time points (between 17 – 19) and therefore were able to
undertake ADL at a more independent level, than the cohort studied by Dam et al
(1993) or Duncan et al (1998). Dam et al (1993) recruited participants from three
months post-stroke and provided intervention with up to seven periods of treatment
for up to two years (Dam et al 1993), while the participants in the study by Duncan
et al (1998) were within three months of stroke. The findings from this study show a
similar pattern of improvement in people with chronic stroke to that reported by
Duncan et al (1998), with her cohort of sub-acute stroke (recruited within eight
weeks of stroke onset) showing a two and a half point increase from mean scores of
16.5 rising to 192 over 12 weeks of a home based exercise programme.
Slightly
greater mean BI score improvements were reported by Dam et al (1993), with
changes from 12 to 15 and 15.51 at six, 12 and 24 months after stroke (Dam et al
1993). Although the mean scores reported by Dam et al did not improve to the
same point as this study, the amount of improvement ( x 3.5) was greater than the
two point increase in median score found in the current cohort. As the participants
in the current study had a relatively high median BI score, there would be less room
for improvement however.
Wade et al (1992), Green et al (2002) and Stuart et al (2009) recruited only people
with chronic stroke with a mean time from stroke of over four years, more than one
2
Data transformed from 0-100 BI scoring
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year and over three years respectively. Interestingly, while the intervention groups
in all three studies demonstrated improved primary outcomes related to gait, only
statistically significant changes were found in relation to BI scores by Stuart et al
(2009).
Wade et al (1992) reported a minimal, non significant change in BI
( x change < -0.3), and Green et al (2002) reported both intervention and control
participants maintained their median BI score at 18 throughout the study period.
Stuart et al (2009) reported a mean change in BI score of 3.9 from the baseline of
79.5 which was statistically significant in their intervention group, but no significant
change in the BI score for the control group. These findings, may add support to the
notion that the BI may not be the most sensitive measure of ADL to identify
meaningful change in rehabilitation outcomes.
9.3.2
The Motor Assessment Scale (MAS)
Motor Assessment Scale total scores showed no significant difference at baseline
between the groups, with only a two point difference between Con (26), PP (27) and
WP (28) groups. At the end of the four weeks intervention, all groups had increased
their median scores – Con group by three points, PP by five points and WP by
seven points (WP).
At the short-term retention follow-up, these changes were
maintained by the PP and WP groups, but the Con group returned to one point of
baseline. The Motor Learning literature would indicate that this maintenance of
improvement demonstrated that the change was due to learning rather than a
transient change in performance (Schmidt and Lee 2005, Schmidt and Wrisberg
2008, Shumway Cook and Woollacott 2007, Magill 2005).
This opinion would
appear to be backed up by the long-term retention data which indicated that the PP
group had improved their median score by a further two points to a total score of
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34, the WP group had dropped slightly to a total score of 32.5, but this was still
nearly five points above the median baseline of 28. A surprising finding at long-term
follow-up was that the Con group had also improved their total score to 31.
Statistical analysis demonstrated no statistically significant differences between the
groups at any of the outcome measurement points. In contrast, the data for within
each group over time confirmed that all three groups showed a statistically
significant improvement in MAS total score. This within group improvement was
found between baseline and end of intervention and between baseline and longterm follow-up for all three groups, there was also a significant improvement in MAS
total score between baseline and short-term follow-up for the Con and PP group.
The finding that all three groups significantly improved their MAS total score over the
time of the RCT was an interesting finding. Within the exercise programme during
the intervention period, one exercise (sit to stand) was practised by PP and WP
participants and this activity is directly tested in the MAS (item 4). On looking at the
raw data for the MAS changes, it appears that improvements were apparent in a
number of other items as well, for example there were changes in walking ability
(item 4). It is therefore unlikely that it was just change on one item that resulted in
the significant improvement.
It may be that the functional nature of the tasks
practised in the exercise programme resulted in improvements in body structures or
functions that were not formally assessed (for example muscle strength or balance)
and that these factors contributed to improved performance on items on the MAS.
The reason that the Con group improved their performance on MAS was
unexpected.
When considering why this improvement might have occurred,
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examination of follow-up notes for at least five of Con group acknowledge that on
allocation to the group their initial feeling was of disappointment, but these five
participants also admitted that they found the outcome measure procedure
interesting and when they were asked to undertake a test that they couldn’t do (for
example item 5, level 5: “Walks 10m with no aid, turns round and picks up a small
sandbag from the floor and walks back in 25 seconds”) they then practised that item.
While the participants would have been naïve to the time and distance parameters
of the test, they remembered walking between landmarks in their house and
bending down to pick up an item while being timed. This feature, of practising tasks
that were difficult or impossible to achieve, indicates the motivation of the cohort.
Additionally it highlights one of the weaknesses of having multiple testing sessions
at relatively close intervals.
In relation to other studies of late stage stroke that have utilised the MAS as part of
a battery of outcome measures, the participants in this study formed a larger cohort
and were assessed on the validated eight item MAS, in comparison to the smaller
studies that used the MAS, often scoring a single selected item on MAS.
In a small pre- post-test design undertaken with six people at least one year poststroke, Monger et al (2002) reported statistically significant improvements on the Sitto-stand (STS) item of the MAS, following a three week programme of 30 repetitions
of STS and 30 repetitions of step ups daily. As no retention tests were undertaken
this could simply be a transient change in performance rather than a permanent
change.
McLellan and Ada (2004) did include retention tests, but found no
significant differences in the walking item of the MAS following a six week mobility
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home exercise programme. Similarly, no statistically significant differences were
found on the MAS UL subscale in a small study of 12 people at least five months
post-stroke, while more sensitive kinematic data did show statistically significant
improvements in arm trajectories (Thielman et al 2004). All these studies were
smaller and had more focused interventions than the current study, and it could be
argued that the nature of the task specific training employed related directly to the
specific item of the MAS used for measurement, and these factors restrict any
inferences that can be drawn.
9.3.3. The Frenchay Activity Index
All groups displayed low baseline scores on the Frenchay Activity Index (FAI) with
median baselines of 10, 14.5 and 14 for Con, PP and WP participants respectively.
No significant differences between the groups at any of the timepoints were found
when the FAI data were examined. There were however, statistically significant
improvements within both PP and WP groups over time demonstrated.
This
improvement was restricted to between baseline and end of intervention with an
increase in median scores of five points for the WP group and two and a half points
for the PP group. These improvements were not maintained at the long-term followup, although median scores did not return to baseline levels. It may have been that
active participation in an exercise programme had encouraged participants to
undertake more activity in and around the house such as light housework, local
shopping or walking outside, indeed some participants had noted these activities in
their exercise diaries.
It is not known what level of improvement on the FAI
indicates a clinically relevant improvement (Wyller et al 1996), so an improvement of
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five points potentially may represent a small and transient increase in activity (e.g.
from “never” to “less than once a week”).
Studies that included the FAI as part of their battery of outcome measures reported
similarly low FAI scores at baseline with median scores between 10 - 13
and
reported no significant differences between the groups in FAI score at baseline or at
three, six or nine month follow-up (Green et al 2002). Similarly, Wade et al (1992)
reported mean baseline FAI scores of 11.3 – 13.5 with no significant differences
found at any follow-up time points.
9.4 Discussion of Mobility Outcomes
Discussion of data pertaining to gait speed, the Timed Up and Go over 2metres
(TUG2m), ability to step up onto a block, and ability to rise to stand are presented in
this section.
9.4.1
The Timed Up and Go over 2metres
In administering the TUG2m, a total time during performance of the test was
recorded, using a hand held stop watch with lap-timer function to enable scrutiny of
component parts of the test – such as rise-to-stand (see 6.6). There was very little
variation between the groups on the total time taken to undertake TUG2m, although
all groups improved the total time in comparison to the baseline measure (see 8.5).
This stability of performance was noted at all measurement points, with median
TUG2m total times of around 30 seconds at the end of intervention measurement
point. Some participants recorded extreme times for completion of this test (e.g.
C31 > 210 seconds) and in part this was due to difficulty in standing up (see 9.4.4)
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as well as slow gait speed.
No significant differences were noted in TUG2m total
time either between the groups at any of the measurement points, or within the
groups over time.
The findings of no significant change in TUG2m total time contrasts to other studies
of people with chronic stroke utilising the original Timed Up and Go over three
metres (TUG). Marigold et al (2005) found a significant change (p<0.001) in TUG
time, maintained at a retention test, in their study of people with chronic stroke
undertaking exercise three times a week over ten weeks aimed at improving
balance and mobility.
Mead et al (2007) reported a significant improvement
(p<0.05) in TUG time for the intervention group ( x 10.5s) compared to the control
group ( x 11.5s) following a 12 week intervention, a change that was not maintained
at follow-up. A reduction in TUG time ( x 16.9s at baseline, x 16.6s end intervention
and x 15.8s at five month retention) was also demonstrated by the nine subjects
who undertook an intensive two week home exercise programme reported by
Combs et al (2009), with a small effect size (0.04) calculated for the change scores.
The three studies considered above, all reported much quicker TUG times (over 3m)
than the median times found in this study and possibly indicates that this cohort had
more severe impairments, certainly this appears to be reflected in terms of gait
speed.
9.4.2. Gait Speed
Gait speed was calculated from the outward two metres of the TUG2m. Median
time for all groups at baseline was 0.21m/s and this improved slightly at the end of
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intervention (Con 0.26m/s; PP 0.24m/s; PP 0.24m/s).
At follow-up a slight
deterioration in median gait speed for Con (0.25m/s) and WP (0.2m/s) at both
follow-up points was found, whereas PP demonstrated an improvement (0.32m/s) at
short-term, not sustained at long-term follow-up (0.23m/s). It is likely that the six
missing data points at short-term follow-up in the PP group inflated the median gait
speed. No statistically significant differences in gait speed were found between the
groups or within the groups over time.
The cohort in this study demonstrated a considerably slower gait speed than most of
the published studies in this area (for example Duncan et al 1998; Texeira-Salmela
et al 1999; Kim et al 2001; Green et al 2002; Monger et al 2002; Olney et al 2006;
Mead et al 2007 and Stuart et al 2009). Only the cohort recruited by Wade et al
(1992) demonstrated similar gait speed (0.21m/s – 0.25m/s) over the course of the
study. The gait speeds found in the current study are particularly low, in comparison
with comfortable healthy elderly gait speeds - reported consistently at above 1m/s
(Oberg et al 1993; Bohannon 1997; Steffen et al 2002) and with some reports of
comfortable hemiplegic gait speed measured during observation as oppose to part
of an intervention study (Kollen et al 2006; Olney et al 1994).
Gait speed calculated over two metres can be criticised as being too short a
distance to enable sufficient physical space for acceleration of body mass to result
in the attainment of comfortable walking speed to be attained. Given some of the
environmental restrictions encountered during pilot testing however, it was decided
to calculate gait speed in this standardised way.
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It is recognised that both the
activities of rising to stand at the start of the TUG2m and the turning component
following the two metre walk may also have negatively impacted on performance.
9.4.3
Stepping Up
A step test was undertaken with both the unaffected and affected leg leading the
step up. This protocol tested both the ability to have sufficient control to maintain
balance on one leg while the other leg moved, and also the ability to flex the hip,
knee and ankle of the “step up” leg to clear an obstacle. Once again, there were no
significant differences, for stepping up with either leg, between groups at any of the
timepoints. There were however statistically significant improvements within the PP
group at all 3 measurement points compared to baseline when stepping up with the
unaffected leg, which lends some support to using a PP strategy for this activity
where there is a requirement for maintaining stability, balance and weight-bearing
through the affected leg while undertaking a challenging dynamic task with the
unaffected leg. Surprisingly the Con group demonstrated a statistically significant
improvement between baseline and the end of intervention, when stepping up with
the affected leg. Five of the Con participants acknowledged, following the final
follow-up measurements, that they had practised this particular exercise as it had
caused them difficulty at baseline testing. It may be that only the “safer” option of
balancing on the unaffected leg was undertaken by these participants. While the
step they utilised to practice had different dimensions to the testing step, it is
possible that repeated practice will have strengthened the requisite motor
programme for the action of stepping up and contributed to the improved
performance.
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No other studies investigating the impact of a home exercise programme on people
with chronic stroke used the Step Test, so direct comparisons can not be made.
Texeira-Salmela et al (1999) and Kim et al (2001) however did include a stair climb
speed test as part of their outcome measure battery. While Texeira-Salmela et al
found a statistically significant improvement in stair climb with an improvement from
baseline to post–intervention of 0.85 stairs/s to 1.13 stairs/s, Kim et al (2001) found
no statistically significant differences from mean baseline speeds of 0.65 stairs/s
(experimental) and 0.61 stairs/s (control). The biomechanical demands of stair
climbing however are different to the Step test, which solely requires foot placement
on the step and no weight transference (Hill et al 1996)
9.4.4
Rising to stand
Rising to Stand (RTS) was measured as the first component of the TUG2m test and
was of interest as this activity had been practised by the PP and WP groups.
Median time to stand up at baseline was 2.93s (Con), 2.6s (PP) and 3.22 (WP) and
while there were minor changes at end of intervention - 2.84s (Con), 2.65s (PP) and
3.6 (WP); and long term follow up – 3.51s (Con), 2.23s (PP) and 3.23 (WP) no
statistically significant differences were found between groups at any of the
timepoints, or within groups over time.
Only Mead et al (2007) reported RTS times and these were considerably faster than
those found in the current study, with mean RTS times ranging between 0.94 – 1.09
seconds. While the times in the current study may have been adversely affected by
being recorded as a component of the TUG2m test, median times were considerably
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slower than mean RTS times for people with stroke that have been reported at
around 1.6 to 2s (Baer and Ashburn 1995; Tung et al 2010). Conversely, RTS
times reported by Mead et al (2007) were considerably faster than those previously
reported.
Monger et al (2002) reported item 4 (standing up) of the MAS in isolation from the
overall validated MAS. Following a three week home exercise programme five out
of a small sample of six participants demonstrated improvement. Two participants
were reported to improve by two points to get the top score of six, while a three point
improvement to a score of five was demonstrated by three participants.
This
indicates there is room for improvement in RTS ability in people with chronic stroke,
which was a finding in the current study.
9.5.
Measure of Arm Function
9.5.1
The Frenchay Arm Test
The Frenchay Arm Test (FAT) is scored between zero and five. While the WP
group appeared to be less able at baseline (median 0.5 compared to median score
2 for Con and PP), there were no statistically significant differences between the
groups at any of the time points. Only PP participants demonstrated a statistically
significant improvement over time with a change in score from two to three points
between baseline and end of intervention, while the change in median score
persisted, it was not found to be statistically significant at any other measurement
point. Interestingly there was a trend towards improvement in the WP group (gain to
two points at end of intervention and follow-ups) that did not reach significance.
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While the Con group improved by one point from baseline, once again due to
practice of difficult items on the test by a diligent sub-group, the median score
fluctuated for this group at follow-up.
No other studies of people with chronic stroke reported FAT data.
Studies of
physiotherapy interventions with people with late-stage stroke reporting grip strength
(Pang et al 2006; Langhammer et al 2007) and arm impairment as measured by
Fugl Meyer arm (FMA-UL) function (Pang et al 2006; Michaelsen et al 2006) do
allow some comparisons.
While hemiparetic grip strength has been shown to
improve with exercise intervention for people with late-stage stroke, no statistically
significant changes were found between intervention and control groups (Pang et al
2006; Langhammer et al 2007). Pang et al (2006) however did demonstrate a
statistically significant improvement in arm impairment over time as measured by the
FMA-UL, irrespective of the severity of stroke impairment.
Similar significant
improvements on the FMA-UL were demonstrated by Michaelsen et al (2006).
These findings support the finding that people with late-stage stroke have the
capacity to improve impairments in arm function, as demonstrated by the PP group.
9.6 Discussion of Measurement of Mood
9.6.1
The Hospital Anxiety and Depression Scale
Measures of anxiety and depression were presented as sub-scale scores (HADS-A
and HADS-D) in section 8.7.
All groups demonstrated a reduction in HADS-A
median scores between baseline and end of intervention followed by a slight
increase at long-term follow up (Con: 6, 4, 5; PP: 6, 5, 8; WP: 8, 4, 5.5). On
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examining HADS-D data, while PP median scores showed a very slight increase
between baseline, end of intervention and long-term follow up (PP: 4, 5, 5.5) this
pattern was not shown by the two other groups (Con: 6, 5, 5; WP: 6, 5, 6).
Over time it was found that there was a statistically significant reduction in HADS-A
only for the control group between the baseline and end of intervention measure.
The reduction on HADS-A by two points in the Con group meant that all Con
participants either had no signs of anxiety although a small minority who scored
between 8 -10, could be considered mild cases of anxiety (Snaith and Zigmond
1994). Examining the data it appeared that while most participants demonstrated no
or mild signs of anxiety and depression, a small minority of respondents scored 1115 on HADS-A or HADS-D, demonstrating moderate cases of anxiety or depression
(Snaith and Zigmond 1994).
It may be that the Con group gained benefit and
reassurance from the contact with the clinical research assistant, and consequently
reported a slight reduction in HADS-A scores.
The HADS-A data are comparable to findings in similar populations by Green et al
(2002) who reported median HADS-A scores at baseline of 7, reducing to 5 for the
treatment group and remaining stable for the control group and stabilising at 6 points
for both groups at two follow-up assessments points. Wade et al (1992) also report
similar HADS-A mean data. Mead et al (2007) report slightly lower mean HADS-A
data at end of intervention (Intervention: 3.65; Control 3.99) and at long term followup (Intervention 3.95; Control 4.2). The HADS-D data again are comparable to the
work by Green et al (2002) who reported median HADS-D scores of 7 at baseline,
reducing to 6 at end of intervention and 7 and 8 at follow-up, with similar scores on
mean HADS-D reported by Wade et al (1992). Again Mead et al (2007) reported
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slightly lower mean HADS-D at end of intervention (Intervention: 4.05; Control 3.51)
and at long term follow-up (Intervention 4.21; Control 4.03). None of the studies
discussed found a significant difference between the groups for HADS-A or HADS-D
(Wade et al 1992; Green et al 2002; and Mead et al 2007).
9.7 Discussion of Health Status
9.7.1
The Stroke Impact Scale domains
Each of the Stroke Impact Scale domains are scored out of 100 and are derived
from the patient perspective regarding the amount of recovery that has occurred
within the specific domain.
In this study there were statistically significant improvements within the PP
participants in the domains of strength (SIS-str), mood (SIS-mood) and mobility
(SIS-mob) from baseline to the end of intervention.
Additional significant
improvements in participation (SIS-partic) were found for PP and WP participants
from baseline to long-term follow-up, and between end of intervention and long-term
follow-up PP participants only.
9.7.1.1 Stroke Impact Scale – strength domain
A statistically significant 6.25 point perceived improvement in SIS-str from median
37.5 to 43.75 was found for the PP group between baseline and end of intervention.
These data are slightly greater than the mean SIS-str of 31.48 in people undergoing
community stroke rehabilitation (Hartman-Maeir et al (2007), but this was a one off
measurement and no change score was reported.
An intensive two week
community rehabilitation programme, that included strengthening, reported greater
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improvements of 10 points from a baseline mean of 59 (Combs et al 2010). As the
current study did not specifically target strength training, this might partly explain
why a lower SIS-str score was found and other domains improved more. However,
it was still an interesting finding that PP participants perceived their strength had
improved over the intervention phase of this study.
9.7.1.2 Stroke Impact Scale - mood
A statistically significant 12.5 point perceived improvement in SIS-mood from
median 61.1 to 73.6 was found for the PP group between baseline and end of
intervention, and the score only reduced by 3 points at long term follow-up. This
pattern was markedly different to the WP group whose score only varied by three
points (69 – 66) and the Con group whose score reduced from 69 to 62.5. It is not
clear why this effect was found, although it is well established that exercise has a
positive effect on mood (Fox 1999; Eng et al 2003).
This positive change on SIS-
mood score has not been reported in other studies that have used the SIS to assess
outcomes in people with chronic stroke undertaking home or community based
exercise programmes (Hartman-Maeir et al 2007; Stuart et al 2009; Combs et al
2010). While direct comparisons can not be made with studies that have used
alternative measures for assessing mood, no significant improvements have been
found in people with chronic stroke undertaking home or community based exercise
programmes with the Short Form 36 (SF36) Mental Health domain (Kim et al 2001;
Mead et al 2007), or the stroke-adapted Sickness Impact Profile (SA-SIP30)
(McLellan and Ada 2004).
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9.7.1.3
Stroke Impact Scale – mobility
A statistically significant 3 point perceived improvement in SIS-mob from median
59.7 to 62.5 was found for the PP group between baseline and end of intervention,
and a further increase to 66.7 at the long-term follow-up. This improving pattern
was markedly different to the WP group who reduced their SIS-mob score from 55.5
to 50 at end of intervention, returning to baseline 55.5 at long-term follow-up and the
Con group who stayed stable with median scores of 54.15 between baseline and
end intervention and an increase to 61 at long-term follow-up.
The mobility domain
covers topics that include community ambulation, stair negotiation and balance and
a possible explanation for the improvement in this study is that the PP group may
have felt some carryover from the rise-to-stand or step up exercises to broader
mobility performance.
The findings in this study compare positively with other
studies that have reported SIS-mob.
Stuart et al (2009) found no statistically
significant improvement in SIS-mob for their intervention group, while the community
intervention group studied by Hartman-Maier et al (2007) reported lower mean SISmob scores of 53.
9.7.1.4
Stroke Impact Scale – participation
An interesting finding was the long-term statistically significant improvement for SISpartic for both PP and WP between baseline and the final measurement point, as
well as between end intervention and long-term follow-up for PP. Almost a 30 point
increase in median score was found for PP from baseline to long-term follow-up
(39.1 to 68.75), with a 12.5 point increase in median score found in the WP group.
These findings are similar to the 13 point improvement in SIS-partic (60 to 73) found
by Combs et al (2010) in an intensive two week home exercise programme and the
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mean 11 point improvement found by Stuart et al (2009) in a 13 week community
exercise programme.
9.7.1.5
Other Stroke Impact Scale domains
In this study, no further statistically significant findings on other domains in the SIS
were reported. Other investigators that have used the SIS to measure outcome of a
community or home-based exercise programme for people with chronic stroke have
reported similar findings to those found in this study (see 9.7.1.1; 9.7.1.3 and
9.1.7.4.). However, additional significant findings have also been found by other
investigators, which did not emerge in this study.
In a 13 week programme of
community group and home exercises, a significant improvement of 7 points on the
SIS-comm domain was found (Stuart et al 2009). It is not clear whether the social
component of the community group positively influenced the communication
domain. As anticipated, no increase in score on the SIS-comm was found in the
current study.
Combs et al (2010) reported a mean 11 point improvement in
perceived recovery from stroke, as measured on the visual analogue scale,
following their two week intensive exercise programme. While the participants in
this study reported similar median improvements (10 points PP; 11 points WP), this
was not found to be statistically significant.
9.8.
The practice regime
While the Clinical Research Assistant worked with the participants on the contact
visits, to individualise the exercises to some extent (for example to ensure weight
bearing on a flat foot), there was no way to check exactly how the exercises were
being practised over the four weeks and potentially multiple movement and
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compensation strategies could have been adopted.
It was found that the WP
participants understood the exercises to be practised, however there were some
queries regarding the comprehension of some PP participants about why there were
practising just lifting their bottom off a chair and not the whole act of standing up.
Despite ensuring that each exercise had a clear descriptor and a verbal and visual
explanation, it may be that the exercises were not practiced in the intended manner.
Using video and leaving this with the participant (much like a fitness DVD) could be
considered in future studies. An alternative would be having a check list of key
features of each exercise and cross-checking these at the end of the intervention
phase, however this strategy was not compatible with the resources available for
this study.
A further consideration, is that it is not known whether there was any transfer of
ability from one exercise to another or whether there was interference between the
exercises.
With the blocked nature of the practice schedule, it is unlikely that
interference occurred, however if this did occur, the evidence relating to interference
would indicate that over the longer term this would enhance learning (Schmidt and
Lee 2005; Schmidt and Wrisberg 2007; Wulf and Lee 1993). Measuring outcome by
the use of generalised measures of physical ability and well-being as followed in this
study, is considerably different to the majority of Motor Learning studies that have
tested discrete task practice by measuring performance on the discrete task itself.
The amount of practice that was undertaken by the participants is reported in 8.9. In
summary, participants were required to undertake six main exercises and record the
number of repetitions in an exercise diary. Weekly averages were calculated from
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these data. While there were some slight differences in the median number of
repetitions undertaken by each group for each exercise, there was no statistically
significant difference between the number of repetitions undertaken by the PP and
WP groups. For each of the six exercises, participants undertook a median number
of repetitions per week of around 100, this resulted in approximately 600 exercise
repetitions each week and approximately 2,400 exercise repetitions per PP or WP
participant (400 repetitions per exercise) over the four weeks of intervention.
Many of the studies of community or home-based exercises for people with latestage stroke have either reported the amount of time spent practising specific
exercises, or reported protocols for incremental increases or have not reported the
number of repetitions of exercises (Dam et al 1993; Duncan et al 1998; TexeiraSalmela et al 1999; Marigold et al 2005; Pang et al 2006; Olney et al 2006; McLellan
and Ada 2004), this makes direct comparisons difficult. Partial details were included
in some studies, for example Mead et al (2007) reported increasing the number of
repetitions of “pole lifting” from 4 to 15 and the number of sit-to-stand (RTS)
repetitions from 4 to 10, however details are not available for other exercises and
some elements of their programme were timed.
Similar partial information related
to strengthening exercises (10 repetitions x 3 sets for five exercises) but not for
endurance or balance exercises were reported by Langhammer et al (2007). Two
community based studies provided clear details of the repetitions undertaken in their
investigations of task specific training. In a five week RCT of upper limb reaching,
participants undertook 15 one hour sessions of a therapist-supervised home
exercise programme (Michaelsen et al 2006). In each session, 10 minute blocks of
exercises (with 2 minutes rest between blocks) were practised, each block was a
different exercise with a mean number of repetitions of 51.2 (range 20 – 130).
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Assuming five blocks were practised each session and three session per week, this
means 153 repetitions of five exercises were practised each week with a total of 765
repetitions per week and 3825 repetitions in total (Michaelsen et al 2006). In a three
week study of RTS training, the mean number of RTS repetitions was 450 (150 per
week), mean number of step-up repetitions 371.8 (124 per week), and mean
number of lateral steps 334 (111 per week) (Monger et al 2002).
The literature to support practice in Motor Learning would advocate many repetitions
and intensive practice of an activity in order for learning to occur (Bach y Rita and
Baillet 1987; Carr and Shepherd 1998; Winstein et al 1999). As was identified in
section 4.7 however, the number of repetitions has often been low (under 100 in
total) in studies investigating the effectiveness of different practice regimes.
In the current study, PP and WP participants undertook approximately 400
repetitions of each of six exercises over the four week intervention period.
This is
similar to the intensity of practice reported by Monger et al (2002) but a lower
intensity of practice in comparison to the study reported by Michaelsen et al (2006).
All three studies however, have found some elements of statistically significant
improvements in physical task performance following the practice protocols. Having
considered the findings and undertaken comparisons to published literature, it is not
yet possible to state optimal levels of practice intensity for people with chronic
stroke. In future work it would be appropriate to prescribe different intensities of
practice with identical exercises conducted over varying time periods to more clearly
determine how many repetitions would be required for learning to occur.
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9.9.
Sample Measurement of Activity
A secondary aim of the study was to explore activity undertaken by community
dwelling people with late-stage stroke. Data were available from 45 participants
who wore an activPAL™ activity monitor for one waking day. Data were collected
for an average time of 11 hours and 48 minutes.
On scrutinising the data, it was possible to identify a burst of RTS activity in the
activPAL traces from some participants in the PP or WP groups that corresponded
with the approximate time of undertaking exercises.
Fewer than 20 of the
participants had noted their exercise time in the exercise diary however, so it was
not possible to confirm the number of RTS transitions for all participants.
The median number of RTS transitions differed between the groups. The PP and
WP groups undertook more RTS transitions (PP median 42 repetitions, WP median
47repetitions) compared to the Con group (29.5). These data are higher than RTS
transitions reported by Jansenn et al (2010) who report mean 16.6 RTS transitions
over eight hours at 48 weeks post-stroke, however the activity monitoring system
used to collect these data was not described and it is not clear if the system
provided valid and reliable data. Britten et al (2008) used an activPAL™ to monitor
mean 65.9 RTS transitions in a group of nine sub-acute stroke in-patients
undergoing intensive RTS training, compared to mean 18.9 RTS transitions in a
control group. The study by Britten took place in a hospital environment, and it is
therefore difficult to compare activity recorded in the home and in hospital as the
demands on the individual to move will be different, with probably less demands in
the hospital setting.
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The median amount of steps taken during the day was very low for the Con
participants - 1,219 steps and PP participants - 2,465 steps, while median step
counts for WP participants was 4,389 steps. This is reflected in the differential
amounts of time spent in walking and standing, with Con group registering 16% of
the day in these positions, PP 20% and WP25%. This means that the rest of the
day was spent sitting or lying down.
Anecdotal reports of low activity in people
post-stroke have been made, however there are very few empirical studies. In a
sample of 79 community dwelling people at least six months post-stroke, mean
1,389 steps per day were reported and this was noted to be less than the 3 – 5,000
steps that would be expected in age-matched (mean age 65) sedentary adults
(Michael and Macko 2007).
The activPAL data, may represent usual activity or, it may possibly provide an overestimation, due to the fact that wearing a monitoring device may have positively
impacted on activity levels. There were some technical issues using activPAL, with
failure to record, or interrupted recording sessions resulting in the data being
discarded.
9.10.
Possible explanations for changes in outcomes
The results from this study of a home-exercise programme based on either PP or
WP principles for people with late-stage stroke have been discussed in the
preceding sections. No statistically significant differences were found between the
groups at baseline, at the end of intervention or on short-term or long-term followups. Therefore, the intervention received did not appear to have a major influence
on outcome at any of measurement points. For some outcomes however, there
were significant changes within the groups over time, for the most part these were
improvements in relation to baseline.
Where these changes occurred, it would
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indicate that there was change in performance, or in instances when the changes
persisted, learning had occurred. This section will consider why the changes might
have occurred.
One possible reason for the changes is that a process of natural recovery was
taking place, the literature relating to motor recovery post-stroke would dispute this
(Wade et al 1985; Wade and Langton Hewer 1987). Attempts were made to ensure
stability of participant performance, by including two baseline measures of physical
outcome measures. Furthermore, including a control group within the study design
allowed comparisons to be made with a group receiving no intervention. On the
three outcome measures of physical status, where the Control group did show
improvements (MAS, Step Test and FAT), this can be partly explained by a subgroup that acknowledged they had practiced tasks that they found difficult in
outcome testing. The reduction in Con group HADS-A may possibly be explained
by inherent reassurance associated with being involved in a research study and
contact with a research physiotherapist.
Another explanation pertains to the content of the exercise programmes, the
intensity of practice and neuroplastic changes.
The content of the exercise
programmes aimed to target the functional tasks of RTS, sitting down, stepping onto
and off a block, manipulating a cup and pro- and supination of the forearm. The
number of repetitions of each exercise being around median values of 400 - 450
repetitions was, according to Motor Learning literature, insufficient for learning to
have occurred (Bach y Rita and Baillet 1987; Carr and Shepherd 1998; Winstein et
al 1999).
A definitive method to demonstrate alterations in brain activity (for
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example using functional Magnetic Resonance Imaging) was beyond the scope of
this study, therefore it is only possible to provide speculative explanations. The
practice regimes followed in this study, while directive in the exercise to be
performed, allowed errors to occur (for example, if the foot did not cover the X on
the step-up block), this then enabled the participant to problem solve how to
ameliorate the end movement. This may have activated a number of areas in the
brain including the pre-motor cortex and supplementary motor area, which have
been shown to be involved in retrieval of movements for skilled performance (van
Mier et al 1998; Rothwell 2004). By undertaking practice that required repetition and
refinement, it is possible that a number of neuroplastic changes occurred such as
unmasking of latent synapse or cortical reorganisation. These changes have been
suggested both in animal studies and in humans (Ziemann et al 2001; Kleim et al
2004; Bear et al 2007; Rosencratz et al 2007).
Within the current study, on some
measures, long-term changes were demonstrated. This would indicate that for the
activities undertaken in these measures, transient performance enhancements had
been superceded by relatively permanent changes in behaviour, or motor learning.
However the explanations as to why the changes observed in the current study
occurred must remain tentative.
It could be that the amount of practice was
sufficient to strengthen the motor programme. It would be recommended that future
studies investigating parameters of practice in people with chronic stroke need to
incorporate neuroimaging techniques to further investigate this area.
9.11.
Limitations and Sources of Error
A number of limitations and sources of error may have restricted the ability to
generalise findings and these are discussed within this section.
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9.11.1. Study Design
This study was an exploratory, single-blind, randomised controlled trial to investigate
whether part practice or whole practice of functional tasks would be beneficial in
improving functional outcome for community-dwelling people with late-stage stroke.
While every attempt was made to design as rigorous a methodology as possible to
reduce the number of confounding variables, a number of factors could not be
controlled and therefore will have impacted on the methodological quality.
A Randomised Controlled Trial of a complex intervention has been cited as being
the “gold standard” in research, however an RCT can be problematic to design and
execute (Altman 1991; Wade 1999). Undertaking an RCT in the community setting
can introduce a further multitude of variables that are difficult to control for (e.g.
individual interactions with unique environments). Nevertheless, in an attempt to
reduce bias and variability and deliver a standardised intervention which might then
start to provide evidence supporting either PP or WP, the strengths of a randomised
design were felt to be compelling.
The randomisation strategy encompassed
stratification, which has been recommended for studies with small samples (Altman
1991; Field 2009). The randomisation list resulted in four strata to ensure that the
three groups in the trial were similar for side of stroke and severity of stroke, which
are characteristics known to affect outcomes (Kwakkel et al, 1996). It could be that
different factors may have been more influential in terms of outcome, for example
stroke classification, however it was not possible to gain complete data for all
participants and therefore side and severity were deemed to be the most influential
factors.
An alternative randomisation strategy that had been considered was
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randomisation with minimisation (Altman 1991). This was discounted however, as a
robust system would have been required to update group allocation, taking into
account factors of interest, each time a new participant was recruited to the trial.
The resources available did not permit this to happen.
The number of measurement points used in the study can be both criticised and
commended. Two baselines were taken to examine stability of performance on the
outcome measures, with baseline testing on two occasions approximately two
weeks apart.
Undertaking repeated measures so close together may have
positively influenced the Con group to remember and practice the tasks that they
had identified as being difficult.
The strategy of taking repeated assessments
however is a robust method of establishing stability (Altman, 1991). Ideally, the two
baseline measures should have been undertaken with a four week interval to
establish stability over the same time-period as the length of intervention. Given the
median time since stroke of 21 months, it is likely that the participants should have
been stable (Wade and Langton Hewer 1987).
The three measurement points
undertaken following the four week intervention were included to evaluate the
effects of the four week programme (end of intervention), to determine if short-term
learning or change in status had occurred as measured by performance or response
retained in the short-term (short-term follow-up – within 72 hours), and to determine
if there was indication of persistent learning or change in status over the longer-term
(long-term follow-up at three months). While the end of intervention and long-term
follow-up outcome visits were relatively easy to organise, there were not only limited
resources within which to undertake repeated tests, but the participants or outcome
assessor were often not able to co-ordinate a mutually convenient time.
This
resulted in 12 missing outcome measurement points at short-term follow-up, and
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therefore any significant changes found at this time-point should be viewed with
caution. In any future work, care needs to be taken to ensure that the design is
feasible in terms of resources to support outcome measurement and the value of
five repeated measures within a sixteen week period should be reconsidered.
9.11.2 Recruitment Strategy
The original recruitment strategy was revised on three occasions in order to gain a
reasonable sample size. The original intention was based on power calculations
from walking recovery data and identified a target sample of 99.
Ultimately 64
subjects were recruited and 60 records were available for analysis.
This is a
reasonable sample size for a trial of community-based stroke rehabilitation. Given
the nature of the study, the insensitivity of the majority of the outcome measures and
the sample size, it is highly likely that the study was underpowered.
There were a number of difficulties associated with recruitment to the study and
these have been discussed in section 6.4. The original geographic limitations for
Recruitment Strategy v1 were set with cognisance taken of the limited personnel
resources to support the study.
Limiting the geographical area should have
facilitated multiple visits within a short timescale. Widening the geographical area to
cover all of Edinburgh assisted with recruitment, but resulted in problems with
scheduling, longer inter-participant journey times and therefore reduced the
efficiency of the research team and the number of visits that could be made daily.
Initial difficulties with identifying people with stroke from GP records systems
resulted in extremely slow initial recruitment, by widening the referral pool to include
physiotherapists will have resulted in a recruitment bias, in that all the referrals
received from a physiotherapist
would have undergone relatively recent
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rehabilitation and possibly were deemed “suitable” for further rehabilitation. The
final amendment to the recruitment strategy involved placing an advertisement in the
local Edinburgh free paper and this may have resulted in self-selected, more
motivated respondents once again adding bias to the sample.
9.11.3. The Sample
The sample size of 64 was reasonable and could be argued to be representative of
community-dwelling people with late-stage stroke.
It is likely however, that the
people that responded to letters of invitation were motivated to exercise and
therefore possibly more compliant with the programme. Certainly, participants that
were recruited through the newspaper advertising were self-selecting and less likely
to have depression, fatigue or low levels of motivation.
The inclusion and exclusion criteria were designed to ensure as representative a
sample from the stroke population as possible. Only one participant with dysphasia
was recruited however. Given that dysphasia is estimated to affect around 20 -35%
of the stroke population, with around 10% of people with stroke having long-term
problems with dysphasia (Engelter et al 2006; Law et al 2009, RCLST 2009), this
sub-population were under-represented. On reflection, that one participant was able
to be included as their carer was supportive, acted as interpreter when required and
was highly organised in completing diary details. In future studies, liaison with a
speech and language therapist to ensure relevant presentation of materials and
advice regarding more specific inclusion and exclusion criteria would be judicious.
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9.11.4. The Intervention
At the time of planning this exploratory RCT, recent reviews had recommended that
interventions in stroke rehabilitation required to be explicitly defined, in order to more
clearly plan and conduct evaluation (Pollock et al 2007; Pomeroy and Tallis 2002).
Six exercises that were considered to represent fundamental functional tasks and
could be structured for practice as a whole movement or as component part
movements were developed and piloted for feasibility and acceptability.
Clear
operational definitions were developed, with written and pictorial instructions for
carrying out the exercises included in an individual exercise diary provided for the
patient. The clinical research assistant (CRA) explained to the participant and carer,
if available, how to practice the exercises. If focus was required on a specific area
e.g. equal weight bearing during sitting down, this was noted in the diary as a written
reminder. All participants were required to undertake the same exercises and this
can be criticised as a “one size fits all approach”, however this was adopted to
standardise the intervention received.
On reflection, it may have been more
relevant to the participants to have developed a catalogue of approximately 15 – 20
exercises targeting different impairment and activity limitations.
Each exercise
would have required instructions for whole- or part-practice and every exercise
would have required piloting in the initial hospital gym and the home environment.
Participants would then have been allocated the six most appropriate exercises from
an initial assessment and discussion. Not only was there insufficient resources to
develop such a catalogue, at the end of the RCT a situation could have arisen
whereby all PP group had practiced exercises on the first half of the catalogue and
the WP group practiced the second half, which would have been a major
confounding variable.
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In the early pilot work, participants had been asked about tasks they found difficult
and so the selection of tasks for the RCT was a combination of consumer
involvement and pragmatic decisions about the feasibility of structuring the task into
logical parts.
The four tasks targeting lower limb and balance were deemed
pertinent by all the participants, however the inclusion of the upper limb tasks raised
two issues relating to severity of arm impairment. Two participants had very good
arm recovery and therefore the upper limb exercises were too easy or perceived
irrelevant. This issue had not been fully considered in piloting and it might have
been prudent to develop at least two more complex and dextrous tasks (akin to
some of the light box or switch tasks reviewed in 4.3 e.g. Pohl et al, 2006). The
opposite scenario also occurred whereby participants had no upper limb recovery.
In these cases, participants were requested to place the affected arm into position
on the table, place the cup or the bottle into the hand and try to undertake mental
practice of ten repetitions of the exercise.
Written instructions for PP or WP
practice, focused on giving an external focus for the exercise (e.g. think about
movement of the cup or bottle). This was different to the physical practice which was
the focus of the study and introduced another confounding variable. In future work
in this area, it would be judicious to ensure a specific minimal amount of upper limb
movement as part of inclusion criteria.
The exercises undertaken in this RCT were clearly defined as part- or whole
practice, however other parameters will have impacted on the practice regime.
During the development of the exercises, consideration was given to the evidence
supporting all types of practice structure from the Motor Learning literature.
From
the available evidence, the optimal structure of the practice sessions would have
been to draw up a practice list that organised the six exercises into a random pattern
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with variations given for each exercise – for example altering the chair height or cup
to be used. This would have resulted in a random, variable PP or WP regime, and
to conform to Motor Learning principles, this regime should have been distributed
in nature, so that it was practised at various times throughout the day. A pragmatic
approach however was required, especially as such a list would have been quite
detailed and, potentially, confusing for the participants.
Furthermore, the
organisation of equipment to undertake exercise sessions could be challenging for
the participants and two pilot participants who had little storage space organised
their day around a set exercise time so they could then store the equipment until the
next day. The exercise practice regime undertaken in this trial was therefore likely
to have been massed, blocked, constant, PP or WP.
The four weeks of the intervention was relatively short compared to other, nonintensive, community-based exercise programmes for people with chronic stroke
where interventions were often 12 weeks or more (e.g. Dam et al 1993; TexeiraSalmeira et al 1999; Olney et al 2006; Mead et al 2007). It may be that four weeks
is insufficient time to show all the potential effects of the intervention, however given
the resource limitations it was decided to take a pragmatic approach to this
exploratory trial and an intervention that could be delivered and evaluated was used.
Home-based exercise programmes that do not require regular therapist supervision
are an attractive management strategy in an era of health service restrictions. This
strategy may be pertinent for clinical practice, if effective interventions can be
developed. As has previously been identified, the amount of practice required for an
effective intervention is not yet established.
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The accuracy of reported exercise
repetitions could not be verified and the data reported in section 8.10 may be
questioned. In order for neuroplastic changes to occur over the long-term it would
be reasonable to argue that thousands of repetitions of an activity need to have
taken place. Data from the activity diaries however, indicate that no more than
hundreds of repetitions occurred and for some outcomes, notably the MAS and the
Step Test there was evidence of learning being retained at both the short- and longterm follow-up. One question that could arise from this finding is whether people
with late-stage stroke need to practice activities less for learning to occur.
Alternatively, might some of the inherent motor programmes prior to the stroke may
take less time to re-establish.
9.11.5. Outcome Measurement
The blinded outcome assessor became aware of the group allocation for three
participants during outcome measurement sessions. Participants were reminded
not to mention whether they had been undertaking exercise or not at the start of
each outcome measure visit. One PP participant was revealed to the outcome
assessor as being in one of the intervention arms of the trial, by a colleague
remarking that she had met the carer and she had mentioned in relation to her
husband that “he was delighted with his exercise progress”. Another PP participant
left the exercise equipment clearly in view when the outcome assessor visited. The
other participant revealed she was in one of the exercise arms of the trial when she
stated that she found imagining the exercises “a waste of time”! While strategies
had been instigated to prevent this unblinding, improvements could have been made
by ensuring the clinical research assistant had removed exercise equipment prior to
the outcome assessors visit, or by taking outcome measures at a different site,
however these strategies would not have been practical in the context of this trial.
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A trial with multiple outcome measure sessions was designed in order to ensure
stability of baseline performance, to answer the question whether undertaking a
home-based exercise programme of functional tasks based either on part-practice
(PP) or whole practice (WP) in a sample of community dwelling people with latestage stroke would be beneficial, outcomes were measured at the end of the
intervention phase.
To determine whether any changes could be attributed to
learning rather than performance both a short-term retention and a long-term followup test was undertaken.
Potentially however, this resulted in a situation of
assessment overload and participants may have learnt to improve performance on
the items in the outcome measures, which did appear to be the case for some
Control participants. The number of assessments could have been reduced by
undertaking a single baseline measure given the chronicity of the sample. The longterm follow-up might have been more usefully placed at six or 12 months from the
end of intervention, however this would not have been feasible given the timescale
of the study.
Including a short-term retention outcome measure point allowed
evaluation of short-term learning effects of the intervention and conforms to
recommended procedures within Motor Learning research (Schmidt and Lee 2005;
Magill 2008; Shumway Cook and Woollacott 2007).
Despite the missing data
points, this still allowed exploration of whether learning had taken place and it would
be appropriate to include a test of short-term retention in subsequent studies.
Perhaps one of the major limitations of this exploratory RCT could be regarding the
battery of outcome measures that were used.
The final battery were chosen
following pilot work and were representative of the domains of impairment, activity
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limitation and participation as outlined in the International Classification of
Functioning (WHO 2010) All of the selected outcome measures had been validated
for the stroke population (for example Holbrook and Skilbeck 1983; Carr et al 1985;
Parker et al 1986; Heller et al 1987; Poole and Whitney 1988; Hill et al 1996; Wyller
et al 1996; Aben et al 2002; Duncan et al 2002; Lai et al 2002; Duncan et al Ng and
Hui-Chan 2005; Bennett et al 2006) and had been employed in a standardised
manner.
However, while the interventions were targeted at specific functional
tasks, the outcome measures could be criticised as being too insensitive to
demonstrate change – for example, the FAT is a dichotomous scale, so to gain a
score of 1 on item 1 the participant must “stabilise a ruler while drawing a line with a
pencil held in the other hand.
To pass the ruler must be held firmly”.
Many
components of the task might improve over time, but unless all components are
passed then a score of 0 is given. Many of the ordinal scales that were used, such
as the BI, have also been criticised as potentially being too insensitive to
demonstrate change (Tennant et al 1996; Turner-Stokes and Turner-Stokes 1997).
Statistically significant changes were demonstrated however, both on the BI and the
MAS. Given the amount of improvement in performance required to increase the
score on the MAS, it could be argued that meaningful change to the participant had
taken place.
The time taken to administer the outcome measures was an important consideration
in drawing up the final battery. The preliminary visit could last between two to two
and a half hours, this was considered to be a maximum time that would be
acceptable to the participants. Subsequent outcome measure visits generally took
between 45 to 90 minutes (or more on a few occasions).
The time per visit
depended on the number of tests to be administered, the ability of the participant,
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limiting factors such as fatigue or pain and the testing environment. It is the nature
of exploratory trials to explore the use of potential outcome measure in order to
refine the outcome measure battery in definitive trials. This study therefore sought
to determine which outcome measures might be most suitable in a definitive trial. At
this point however, further pilot work would be required before a definitive
recommendation could be made.
9.12.
Clinical Implications
Consideration of how to structure practice, has been recommended in various texts
on stroke rehabilitation (Carr and Shepherd 1998; Carr and Shepherd 2003),
however these recommendation do not derive from evidence from people with
stroke. It is not inappropriate that recommendations should be made, however the
application of Motor Learning theory for people with stroke needs to be made with
caution and limitations of recommendations acknowledged.
The current study lends further support to the potential for post-stroke recovery a
number of years after the initial event (Dam et al 1993; Bach y Rita 2001; Page et al
2004). Following on from this, it can be recommended that services should be
provided to people with late-stage stroke to encourage self-practice of functional
tasks or specific exercises in their own home setting. This service would not need to
be therapist intensive, in fact a rehabilitation assistant under supervision of an
appropriately experienced neurological physiotherapist could be the main contact.
This suggestion may be counterintuitive to many clinical physiotherapists. Recent
guidelines have recognised the need for ongoing rehabilitation in the community
with a recommendation that people with stroke should have access to specialist
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rehabilitation services (SIGN 2010). Encouraging people with stroke to be more
responsible for their rehabilitation may, in part, overcome the tension between the
guidance to provide a service and the resources required to provide traditional
“hands-on” exercises.
On developing the study, there was some uncertainty regarding the willingness or
ability of people with late-stage stroke to undertake sufficient exercise repetitions in
their home environment. The findings from this study indicated that participants did
engage with the process, practicing around 100 exercise repetitions a week for each
exercise, although maximum repetitions was 250. Given that thousands of
repetitions may be required in order for learning to occur (Carr and Shepherd 2003),
this schedule may have been inadequate to drive learning. However, therapists
should not be cautious about encouraging more repetitions of exercises. Using
computer games to set targets and motivate the individual may be one method of
encouraging more practice.
The findings from this study point towards encouraging PP of functional tasks for
people with late stage stroke. However this statement is made cautiously as only
six tasks were practiced and this finding may not be replicable with practice of
different functional tasks.
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9.13.
Future Research
The results from this study demonstrate that it is feasible for people with chronic
stroke to undertake structured self-practice of functional tasks within the home
environment. While caution must be taken when making any recommendations for
clinical practice, the results from this study do allow recommendations for future
research to be made.
It was identified in chapter four that the majority of writing relating to Motor Learning,
skill acquisition and structuring practice relates to young healthy adults, with a focus
on learning or refining a sporting skill or practising a rapid, dextrous task.
Recommendations relating to how to structure exercise practice sessions for people
with stroke have been made, based on these normative data, by a number of
eminent authors (Carr and Shepherd 1998; Carr and Shepherd 2003; ShumwayCook and Woollacott 2007).
While a number of arguments have been proffered
that therapists working in stroke rehabilitation require to understand what
components of therapy are actually effective (Ballinger et al, 1999; Pomeroy and
Tallis 2002), there is also a related need for therapists to understand the optimal
parameters for structuring practice of those effective components. With this in mind,
the following two recommendations are made:
Recommendation a.
Undertake further research into the efficacy of different practice structures for people
at all stages of recovery following stroke.
Recommendation b.
Conduct a study to investigate the effect of varying intensity of repetitions of task
practice on task learning for people with stroke. A similar but related study could
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investigate the effects of undertaking the practice intervention over varying lengths
of time.
Exploring recommendations a. and b. would allow identification of the optimal
intensity for practice schedules, which may vary during different stages of the stroke
rehabilitation process. It would also allow investigation of whether self-practice or
therapist-assisted practice required to be structured differently.
Furthermore, it
would allow therapists to determine whether recommendations of practice schedules
derived from healthy young adults are applicable to people with stroke.
Currently, as identified in section 4.4.1, the majority of work to have investigated
structure of exercise practice for people with stroke is in the area of massed practice
undertaken in Constraint Induced Therapy (Taub et al 2000; Vearrier et al 2004;
Marklund and Klässbo 2006; Massie et al 2009). Limited investigations of random
and blocked practice in people with stroke (Hanlon, 1996; Pohl et al, 2006) have
also been undertaken. While more work related to the structure of exercise practice
in a less intense massed manner and in random practice of functional tasks is still
required, there is an urgent need to explore further whether people with stroke
should practice complex functional tasks as a whole or in their entirety. In extending
the work reported in this thesis the following further research should be undertaken:
Recommendation c.
Conduct a study of PP and WP of functional tasks for people with stroke, using a
catalogue of set exercise instructions for each task. One could potentially look to
match pairs with similar levels and patterns of impairment.
The difficulties encountered in developing practice strategies in the exploratory
phase of the work reported in this thesis could be addressed by developing set
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exercises. Developing a set catalogue with a greater and more diverse sample of
people with stroke may allow for more successful generalisation of the exercises.
There was some uncertainty regarding the ability of participants to practice
exercises correctly, therefore a further recommendation (d) is presented:
Recommendation d.
Examine alternative means of providing instruction such as video or audio
instruction in a study of home-based functional exercises.
Providing video instruction, that is available when a therapist is absent, would allow
refinement of appropriate directions. Using video of the participant undertaking the
exercise, may assist with comprehension of the exercises and may improve
compliance.
Recommendations for further research a. – d. are essential to allow physiotherapists
to advance evidence-based practice in stroke rehabilitation. In light of diminishing
resources in the NHS, knowing optimal methods for practising functional tasks
combined with knowing the optimal intensity for self-practice will allow skilled
therapists to use their time most efficiently.
In the current study, a snapshot of activity was gathered during one waking day.
Activity is linked to a healthier lifestyle, may reduce some of the risks associated
with recurrent stroke and should therefore be encouraged (Greenlund et al 2002;
Lee et al, 2003; Chiuve et al, 2008). In order to explore and understand the activity
levels for community-dwelling people with stroke the following recommendation (e)
is made. Given the limited mobility of many people with stroke, these data would
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allow relevant stroke-specific recommendations for activity and it would allow for
triangulation of self-reported data with reliable instrumentation
Recommendation e.
Undertake a larger study comparing self-report and activPAL monitoring of daily
activity for community dwelling people with late-stage stroke.
Having made recommendations a – e, it is also to gain the “consumer” view on selfpractice and any facilitators or barriers to exercise and activity.
Traditionally
physiotherapists working in stroke rehabilitation as well as the person with stroke,
have considered therapy to be “hands on”.
This traditional approach is not
necessarily viable for people with chronic stroke, however information requires to be
sought in order to determine whether self practice is an acceptable alternative
approach to rehabilitation.
Understanding what self-practice means from the
perspective of the person with stroke will aid therapists when introducing this
concept to people with stroke and agreeing and structuring goals to work towards.
Furthermore, appropriate written and graphical aids to facilitate practice can best be
developed with input from the target population.
Recommendation f.
Use mixed methods quantitative and qualitative approach to gain a fuller
understanding of how acceptable self-practice is to people with stroke and to
determine how well they understood the exercise instructions.
In chapter 7, numerous problems with recruitment were identified. Although the
RCT reported in this thesis can be commended as being of a reasonably sized study
into an aspect of stroke rehabilitation, it was under-powered.
Additionally, the
selected functional outcome measures can be criticised as being too insensitive to
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identify some changes.
The lack of sensitivity of the ordinal scales used, coupled
with recruitment difficulties and lack of power lead to the next recommendation.
Recommendation g.
Refine the battery of outcome measures utilised and include more responsive
kinematic or kinetic measures in addition to the rather insensitive measures included
in this study.
A more expensive recommendation, and one that should only be undertaken if
further work does identify optimal ways to structure practice is identified as
recommendation h. If specific practice schedules are shown to be beneficial in
terms of functional gains, it is important to determine whether the benefits are due to
compensatory strategies or whether there is a central alteration in neurological
function.
Recommendation h.
Include neuroimaging as a key outcome to examine both short- and long-term
neurological change following the practice intervention.
A final recommendation, and of particular relevance in the current economic climate
where resources are limited is provided in recommendation i. While questions
relating to how to structure practice and the acceptability or promotion of selfpractice may be of interest to some physiotherapists and some people with stroke, it
is only a very small part of the overall experience of stroke rehabilitation. Research
needs to link in to and inform practice development and this can only be achieved by
involving all relevant stakeholders in drawing up programmes of research (Tallon et
al 2000; Boote et al 2002).
315
Recommendation i.
Undertake
qualitative
work
to
investigate
the
views
of
policy
makers,
physiotherapists and service users regarding the requirements for rehabilitation for
people with late-stage stroke.
9.14.
Conclusions
The primary aim of this study was to investigate a home exercise programme, with
practice based on PP or WP of functional tasks, for people with late-stage stroke.
Sixty four people with late-stage stroke were recruited to the study, drop out was low
(n=4), and data were available for analysis of 60 participants. The sample was
representative of the general stroke population.
Undertaking a randomised
controlled trial in the community setting in Edinburgh was challenging, but feasible.
Identifying people with stroke from GP record systems proved problematic and the
recruitment strategy required four modifications.
Recruitment took 12 months
longer than anticipated and the cohort recruited was two thirds of the required
sample size.
The results showed that in terms of a standardised global measure of activity
limitation (the Barthel Index), there was no difference between groups at any of the
measurement points. Looking longitudinally within each group, both PP and WP
demonstrated a one point median improvement between baseline and short term
follow-up. This improvement was shown to statistically significant.
When considering self reported activity as measured by the Frenchay Activity Index,
there was no difference between groups at any of the measurement points. Looking
longitudinally within each group, both PP and WP demonstrated increased activity
316
from baseline to end of intervention. This improvement of 2.5 point by PP and 5
points by WP was shown to statistically significant.
Results for the Motor Assessment Scale demonstrated no difference between
groups at any of the measurement points. Looking longitudinally within each group,
an unexpected finding was that all three groups demonstrated improvements over
time.
Both the Control and PP groups demonstrated statistically significant
improvements from baseline to all subsequent measurement points, while the WP
group demonstrated a statistically significant improvement between baseline and
short term follow-up.
The results relating to gait were derived from the Timed up and Go over two metres.
No statistically significant difference was found between groups at any of the
measurement points for the components of total time, gait speed or rise to stand
time. Looking longitudinally within each group, again there were no differences
within the groups.
Testing step up ability with the affected leg stepping up on the Step Test, once again
there was no significant difference between the groups.
Looking longitudinally
within the groups, only the Control group demonstrated a statistically significant
improvement, a change from a median score of zero to two. The data for stepping
up with the unaffected leg demonstrated that the PP group made a statistically
significant improvement from a median score of two at baseline to four at end of
intervention.
Testing arm function with the Frenchay Arm Test, once again there was no
significant difference between the groups at any time point. Looking longitudinally
within the groups, only the PP group demonstrated a statistically significant
improvement from baseline to end of intervention.
317
Mood was measured using the Hospital Anxiety and Depression Measure. For the
Anxiety sub-scale there was no significant difference between the groups at any
time point. Looking longitudinally within the groups, once again the unexpected
finding was that the Control group demonstrated a statistically significant reduction
in anxiety from baseline to end of intervention. For the Depression sub-scale there
was no significant difference between the groups at any time point or within the
groups over time.
The Stroke Impact Scale was used as a general indicator of health status. There
was no significant difference between the groups at any time point for any of the
domains. Looking longitudinally within the groups, the PP group showed statistically
significant improvements on the domains of strength, mood, and mobility from
baseline to end of intervention. On the domain of participation, both PP and WP
showed a statistically significant improvement between baseline and long-term
follow-up, and the PP group demonstrated this improvement between end of
intervention and follow up too.
In terms of monitoring activity over one day, data were available for 45 participants.
Between 75% and 85% of the day was spent in sitting or lying. Only one participant
took more than 10,000 steps and only a further four participants took more than
5000 steps.
Participants were able to follow the exercise programme, undertake the six
exercises and record the number of exercises undertaken. Weekly averages of the
exercises were calculated and ranged from 102 for the WP step ups to 118 for PP
and WP groups undertaking UL exercises. The amount of repetitions was less than
the thousands recommended in Motor Learning literature to effect learning, however
318
as can be seen from this section, there were some positive improvements, some
changes were retained at long-term follow-up and this would indicate Motor
Learning had occurred.
While some positive findings arose from this study, the work should be viewed as
embryonic in providing one small fragment of clinically based evidence relating to
how to the structure of functional task practice for people with late stage stroke.
319
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APPENDICES
355
Appendices
Appendix I
Pilot subject Information
INFORMATION SHEET FOR PATIENTS
HOME-BASED PHYSIOTHERAPY FOR LATE-STAGE STROKE: A PILOT STUDY
Thank you for considering to take part in the above study which will involve helping to develop an
exercise programme that Stroke patients can practice at home.
The study is being undertaken jointly between Queen Margaret University College, Edinburgh,
Edinburgh University and Lothian Primary Care NHS Trust
How did I get your name?
I asked your treating physiotherapist to enquire whether you might be interested in taking part. If you
said you might want to know more about the study she has given you this information sheet. If you
might be interested, please read on.
Why has your help been requested help?



After your stroke you have received treatment from physiotherapists who aimed to help you
regain as much movement as possible.
I am planning to look at whether a short programme of physiotherapy at least a year after stroke
may be of further benefit to patients.
Before I can undertake a large study I need to finalise exactly what patients want to practice, the
best way to help patients practice exercises at home and the best way to write down exercise
instructions. In order to do this I need to ask several stroke patients to try out the exercises and
give me some feedback on how easy or hard they are.
Where does the study take place?

This study will take place in the physiotherapy gym at Astley Ainslie Hospital, and may also
involve a visit to your own home if you are agreeable.
If I agree to take part – what happens?



I will talk to you about what activities you think are important to practice after your stroke.
I will then show you some exercises to practice and some written instructions. I would like you to
practice for a couple of days and then I will arrange to meet and discuss what you felt about the
exercise programme.
I will ask you to fill in a couple of questionnaires about your health and well-being, and will also
ask you to demonstrate how you do a few daily activities such as getting in and out of a chair,
picking up an object, as I want to see how long this takes. I estimate that this should take no
more than an hour.
How much time will this take?

I would want to see you between 2 and 4 times over a 4-week period. Each session will last no
more than 2 hours.
More information overleaf 
356
Appendices
Appendix I
Pilot subject Information
How do I agree to take part?

Please sign the attached consent form (or ask your carer to sign it for you) and either return it to
your physiotherapist in the attached envelope and your physiotherapist will forward the form to me
or else send it back to me directly.
Can I refuse to take part?


You have every right to refuse – don’t sign the form.
If you start the programme and then want to stop, that is fine and this would not affect your normal
physiotherapy treatment or any other treatment in any way.
What information do I need to give and will it be confidential?




I will need to know when you had your stroke.
I may ask to video you. You don’t have to agree to this. If you do agree, only myself and another
researcher will view the video and the tape will be destroyed at the end of the pilot study (in about
6 months time).
All information you provide will be treated as strictly confidential, your name will not be revealed in
any published papers related to this study.
The researcher who will discuss the study with you and will show you exercises is a qualified
physiotherapist working within Edinburgh. Physiotherapy rules of conduct oblige us to treat all
patient information with professional confidence.
If you have any other questions
Please phone Gill Baer - the research physiotherapist, on 0131 317 3356.
Alternatively you can contact your treating physiotherapist …………………………………. ..
or
Katie Wilkie (a senior physiotherapist with Lothian Primary Care NHS Trust) on 0131 537 9163 who
is the external and independent advisor to this project.
You are not expected to make an immediate decision about taking part. Think about it for a few days.
If you do decide to take part in this physiotherapy programme please sign the attached consent form,
and return it in attached envelope to your physiotherapist.
Thank You so much for your consideration
Gillian Baer
M.Sc. M.C.S.P.
(Study co-ordinator: Home-Based Physiotherapy late after stroke)
357
Appendices
Appendix I
Pilot consent
A PILOT STUDY OF HOME-BASED PHYSIOTHERAPY FOR LATE-STAGE STROKE
PATIENT CONSENT TO PARTICIPATE and for VIDEOTAPE RECORDING
NAME:
D.o.B.
ADDRESS:
PHONE NO
CONSULTANT NAME
QMUC STAFF
RESPONSIBLE: Gillian Baer
I hereby give my consent to participating in the above study. I also give/ do not give*
consent to a video being recorded for use in the study.
(delete as appropriate)
my
The purpose of the study has been explained to me and I understand that I can withdraw my consent at
any stage.
I understand that I will be asked to practice a number of functional tasks and to fill in a couple of
questionnaires. I understand that this is to allow the development of a study into exercise for late stage
stroke.
I am also aware that I will be asked how long it took to practice exercises, fill in questionnaires and
whether I felt the exercises were relevant.
I am aware that any information I give will be treated in the strictest confidence and I will not be identifiable
in any published results.
I understand that no personal details (e.g. name, address) will be available in the video and that the video
is being produced to allow the researchers to develop appropriate exercise practice for Stroke patients. I
am aware that any information viewed will be treated in the strictest confidence, that the video will only be
used for research purposes and that the tape will be destroyed on completion of the study (approximately
6 months time).
SIGNATURE PATIENT / ADVOCATE
DATE
(print name and relationship to patient if advocate)
358
Appendices
Appendix II
Pilot exercises (PP)
359
Appendices
Appendix II
360
Appendices
Appendix II
361
Appendices
Appendix II
362
Appendices
Appendix II
363
Appendices
Appendix II
364
Appendices
Appendix II
365
Appendices
Appendix II
Pilot exercises (WP)
366
Appendices
Appendix II
367
Appendices
Appendix II
368
Appendices
Appendix II
369
Appendices
Appendix II
370
Appendices
Appendix II
371
Appendices
Appendix II
372
Appendices
Appendix II
373
Appendices
Appendix IV
TUG raw data
age
2m1st
side
3metre
Patcode
3m
Stand
3m-out
3m
Turn1
3mback
3m
Turn2
3m Sit
total
2m
Stand
2m-out
2m
turn 1
2mback
2m
Turn2
2m Sit
total
velocity
3m ->
3m <->
2m ->
2m <->
3metre
Pat-code
3m Stand
3m-out
3m
Turn1
3mback
3m
Turn2
3m Sit
2m Stand
2m-out
2m
turn 1
2mback
2m
Turn2
2m1st
right
2m1st
right
2m1st
right
Time
B2
3m1st
2m1st
3m1st
3m1st
2m1st
right
right
right
right
right
right
stick
D1
D2
E
F1
F2
G
H1
H2
I
2.93
1.14
1.25
2.15
2.15
1.64
2m1st
3m1st
3m1st
right
right
right
left
stick
K
Knostic
L
M
k
2.26
3.03
2.64
1.76
5.54
3.02
12.65
6.21
11.92
4.64
7.68
3.87
16.52
4.12
13.96
4.243
11.25
3.03
11.96
6.36
11.7
4.3
7.58
3.44
21.55
9.86
27.69
11.21
11.06
4.04
14.04
4.54
9.02
4.11
22.98
8.73
19.01
5.04
6.8
5.77
10.44
8.63
6.64
14.82
12.79
10.16
9.69
7.77
7.5
19.4
31.38
7.35
12.01
6.06
30.13
13.96
3.11
2.8
2.38
5.81
1.99
2.88
4.11
3.33
2.72
5.16
3.23
2.99
5.82
6.4
5.35
7.73
2.16
4.83
4.48
1.06
17.25
1.29
2.21
28.63
1.86
1.4
22.46
1.25
1.06
19.53
1.47
2.63
40.67
2.17
1.07
29.39
1.73
1.02
23.34
1.25
1.72
43.44
2.15
1.29
37.763
2.11
1.55
30.35
1.38
3.82
39.25
2.29
2.72
32.75
2.08
1.78
25.93
2.02
2.12
60.51
2.78
2.55
81.92
2.01
3.35
34.52
2.98
2.78
43.88
1.63
1.87
30.95
1.54
2.87
73.23
4.05
3.24
50.3
3.74
5.06
3.03
3.78
2.08
4.21
3.03
4.68
3.44
4.15
2.17
6.87
5.34
6.83
4.35
6.07
3.09
10.25
4.2
10.19
4.61
6.82
2.83
9.35
5.98
7.63
4.3
5.44
2.64
15.8
11.82
21.25
8.44
5.3
11.44
9.07
6.12
5.33
3.78
19.45
8.16
10.87
5.39
4.87
4.11
3.27
7.48
4.02
4.41
7.69
5.25
4.45
9.31
8.4
6.34
6.24
5.2
6.28
15.01
19.52
2.98
7.54
4.03
14.87
10.25
3.54
2.71
2.59
1.86
2.6
3.25
1.91
4.2
4.63
1.94
3.1
3.34
1.82
3.68
4.92
2.88
6.4
6.44
5.91
5.57
1.82
6.86
7.97
2.05
24.97
1.64
25.15
1.54
19.3
1.3
17.47
1.5
13.78
1.54
20.72
2.64
19.28
1.25
15.36
1.93
28.2
1.37
24.16
1.6
18.4
1.91
30.92
1.92
30.57
1.39
20.58
2.11
29.65
4.98
29.11
1.58
20.84
4.91
56.72
3.35
61.01
4.02
32.63
4.47
34.4
2.07
18.57
1.74
55.13
3.96
42.18
0.29
0.31
0.27
0.30
0.36
0.34
0.29
0.29
0.50
0.45
0.42
0.42
0.53
0.52
0.40
0.44
0.59
0.59
0.53
0.57
0.42
0.33
0.48
0.34
0.43
0.44
0.43
0.46
0.54
0.53
0.48
0.47
0.24
0.26
0.29
0.27
0.25
0.29
0.29
0.33
0.39
0.42
0.33
0.38
0.18
0.19
0.20
0.20
0.21
0.22
0.20
0.22
0.27
0.28
0.29
0.30
0.25
0.28
0.21
0.26
0.26
0.31
0.26
0.31
0.40
0.40
0.37
0.34
0.14
0.15
0.13
0.13
0.11
0.10
0.09
0.10
0.27
0.33
0.38
0.48
0.21
0.23
0.22
0.24
0.33
0.40
0.38
0.43
0.13
0.11
0.10
0.12
0.16
0.18
0.18
0.19
A
B
2.54
3.99
1.25
1.68
1.39
2.49
1.48
1.76
10.49
2.55
8.35
3.55
6.06
2.74
5.71
2.74
5.11
2.3
7.07
2.55
6.92
3.06
9.11
9.11
7.35
5.83
4.98
11.2
5.88
4.03
1.96
2.06
2.41
2.09
32.66
2.26
2.73
31.76
2.11
0.77
20.13
1.29
1.49
19.51
1.38
7.3
3.96
6.95
4.2
4.72
4.17
5.82
6.71
3.58
2m1st
right
stick
2m1st
right
2m1st
right
2m1st
right
stick
J1
2m1st
right
J2
2m1st
right
3m1st
right
rolator
N
3m1st
right
3m1st
left
3m1st
right
delta
Q
2m1st
left
3m1st
right
O
P
R
S
2.69
3.37
2.78
2.16
3.69
4.57
Steps
JC1
10
4
8
5
8
5
8
4
8
4
10
6
9
6
7
5
11
6
10
5
9
4
17
6
15
5
12
4
12
8
13
7
8
4
16
9
14
6
15
8
16
10
8
4
14
7
16
7
10
7
8
8
7
9
9
6
10
9
8
16
15
12
11
12
8
16
14
13
16
8
14
15
3
5
4
3
2
5
5
5
5
5
4
6
4
4
7
7
4
7
6
8
10
4
7
7
6
4
7
5
6
5
5
4
5
4
7
5
6
6
5
5
7
5
7
6
6
4
12
6
11
5
8
4
8
7
9
7
6
4
11
10
9
6
11
8
10
8
6
4
8
7
12
6
7
6
6
5
5
7
6
5
7
6
5
11
10
7
7
8
6
11
10
10
10
6
7
11
3
4
4
4
3
5
5
4
5
6
4
5
5
4
6
6
4
8
6
7
9
4
6
6
374
Appendices - TUG pilot raw data
Appendix V
PILOT OUTCOME MEASURES raw data
PILOT OUTCOME MEASURE DATA
TUG time
PP1
PP3
PP5
WP2
WP4
WP6
pretime posttime
31.64
28.58
32.38
31.46
36.72
36.89
34.55
31.76
43.44
30.35
21.13
21.96
post1 post2 post3 post4 post5 post6
2.2
8.23
3.1 8.71 4.12 2.22
2.87 10.31 2.98 9.54 3.89 1.87
3.13
12.1 4.65 9.89
3.4 3.72
3.99
8.35 3.55 9.11 4.03 2.73
1.64 11.25 3.03 10.16 2.72 1.55
1.76
5.54 3.43 6.77 3.38 1.08
PP1
PP3
PP5
WP2
WP4
WP6
PP1
PP3
PP5
WP2
WP4
WP6
pre1
pre2
pre3 pre4 pre5 pre6
3.11
8.95
3.2 9.71 4.54 2.13
3.13 10.21 3.57 9.77
3.2
2.5
2.87
12.9
4.2 11.25
3.2
2.3
4.33 10.12 3.45 9.98 4.23 2.44
2.15 16.52 4.12 14.82 4.11 1.72
1.89
5.55 3.12 5.41 2.91 2.25
preRTS postRTS
3.11
2.2
3.13
2.87
2.87
3.13
4.33
3.99
2.15
1.64
1.89
1.76
375
Appendices – pilot outcome measures raw data
Appendix V
MOTOR ASSESSMENT SCALE
PP1
PP3
PP5
WP2
WP4
WP6
PreMA post
pre
pre
pre
pre
pre
pre
pre
pre
S
MAS
MAS MAS MAS MAS MAS MAS MAS MAS
total
total
1
2
3
4
5
6
7
8
32
35
6
6
4
2
4
4
4
2
25
25
6
6
4
5
4
0
0
0
25
27
6
6
4
5
4
0
0
0
33
36
6
6
4
2
4
5
4
2
21
23
6
6
4
2
3
0
0
0
22
22
6
6
4
2
4
0
0
0
post
PreMAS MAS
total
total
post
post
post
post
post
post
post
post
MAS1 MAS2 MAS3 MAS4 MAS5 MAS6 MAS7 MAS8
PP1
32
35
PP3
25
25
PP5
25
27
WP2
33
36
WP4
21
23
WP6
22
22
6
6
5
5
4
4
3
2
6
6
4
5
4
0
0
0
6
6
5
6
4
0
0
0
6
6
5
4
4
5
4
2
6
6
3
5
3
0
0
0
6
6
4
2
4
0
0
0
376
Appendix V
STEP TEST
preSTEP
good
PP1
PP3
PP5
WP2
WP4
WP6
2
2
2
3
2
6
postSTEPgood preSTEPbad postSTEPbad
4
3
3
3
2
2
2
2
2
5
3
4
6
3
7
9
6
7
377
Appendix V
BARTHEL INDEX
PP1
PP3
PP5
WP2
WP4
WP6
preBarthel postBarthel
19
19
19
19
18
18
19
19
19
19
19
19
FRENCHAY ARM TEST
PP1
PP3
PP5
WP2
WP4
WP6
preFAT postFAT
3
4
0
0
0
0
3
3
0
0
0
0
378
Appendix VI
ActivPAL guide
ACTIVEPAL QUICK START TIPS:
(to be read in conjunction with ActivPAL Idiots guide)
1. Start softwear.
2. Select “communicate with ActivePal from menu.
3. Connect to PC
4. Press on/off button (constant red light)
5. Select “connect” from menu.
6. Press “update”.
7. (Press “reprogram and clear memory”).
8. Disconnect from menu PC.
9. Press on/off button (flashing red light).
10.Tape ActivePal to mid-line of thigh.
11.Press on/off button to switch off.
12.Max 8 sessions recorded.
379
Appendices – ActivPAL
Appendix VI
ActivPAL guide
ACTIV PAL
INTRODUCTION
The ActivePal is a small device worn on the leg to measure physical activity. When
the leg moves, it generates totals for the periods spent sitting, standing or stepping.
It also records the number of transitions from sitting to standing and vice versa. It
can record up to 8 sessions and for multiple days (continuous recording in excess of
7 days/110 hours). It should be accurate to within 5%. The stored activity profile is
retrieved and processed using a PC.
The main uses for the ActivePal are in monitoring patient compliance and response
to clinical interventions.
THE DEVICE (sensing component)
The ActivePal is small, lightweight (20g, including battery) and only 7mm thick. It is
worn discreetly on the mid-thigh, either attached to the skin with medical adhesive
tape, or to clothing. It can be worn either on the front or the side of the thigh, but
tends to be most comfortable for the user when worn on the side of the thigh,
midway between hip and knee. The correct orientation of the Pal is indicated by a
figure on the front panel – the figure should be upright when the user is upright. The
ActivePal can be switched on/off at any time using the ball point of a pen, and the
data can be downloaded whenever convenient. A flashing red light will indicate that
the device is recording. It requires a battery to operate. It is not waterproof.
Adhesive Tape – recommend 3M Medipore tape
PC running Microsoft Windows (95, 98, Millennium, 2000, NT, XP), which must have
a serial port to allow the ActivePal to communicate with the computer via the
interface cable.
USING THE ACTIVE PAL
SOFTWARE
The software package analyses the recorded activity profile and identifies duration
and intensity of the activities. The primary outcome measures are duration of
stepping, standing and sitting events and cadence. These totals are calculated on a
second by second basis allowing the frequency and duration of activities to be
analysed. It uses intelligent activity classification algorithms. It offers both
quantitative and graphical display options for the activity record.
380
Appendix VI
ActivPAL guide
BATTERY
Recommended: Varta CR2430.
The battery should be inserted with the positive terminal surface uppermost, as
shown in the polarity diagram on the back of the device. A fresh battery should
provide in excess of one week of continuous recording, but performance will vary
according to the number and length of recordings, and subject activity. Use the
battery removal tool (small blue pin) to remove the battery, by inserting the pin
through the aperture on the side of the device. Clearing data and reprogramming
the device will greatly reduce the battery lifespan.
PROGRAMMING
1.
2.
3.
4.
5.
Start the ActivePal professional software (START, PROGRAMS, ACTIVEPAL).
Select “Communicate with ActivePal” from the file menu or icon.
Make sure there is a battery in the ActivePal.
Connect the ActivePal to the PC using the interface cable.
Press the ON/OFF button on the ActivePal, using a ball point pen. The red light
will come on constantly.
6. Select “connect” from the ActivePal menu or icon.
7. When connected, press the “update” button to synchronise the ActivePal with
the PC’s clock.
8. If there is unwanted data on the ActivePal, press the “Reprogram and Clear
Memory” button (NB, frequent use of this function will reduce the life of the
battery).
9. The ActivePal should disconnect automatically after reprogramming– if not,
select “disconnect” from the ActivePal menu.
10. Unplug the ActivePal from the interface cable. The red light should go off.
RECORDING SESSIONS
Before wearing the ActivePal, it must be activated by connecting to the PC in the
first instance, and then once it is removed from the PC cabe, by pressing the
ON/OFF switch on the front panel, using a ball point pen. A flashing red light
indicates that the ActivePal is active. To end the session, press the ON/OFF switch
again, so the red light is off.
Position the ActivePal on the mid-thigh for optimal comfort and performance of the
device – midway between hip and knee. It is best secured to the skin with Medipore
tape.
381
Appendix VI
ActivPAL guide
The ActivePal must be taken off for bathing/showering as it is not waterproof. For
these periods remove it and place it on a flat surface, then re-apply it as before. If
the ActivePal is removed for longer periods (eg, overnight), it should be switched off
at the ON/OFF switch.
Note, the ActivePal can hold a maximum of 8 sessions. After 8 sessions have been
recorded, a red light will appear constantly and the ActivePal will be unable to record
further until the sessions have been deleted. It is not possible to delete one session
at a time, only to clear the entire memory, so ensure any data required for further
processing has been saved.
PROCESSING RECORDINGS
1. Start the software and connect the ActivePal to the PC using the interface cable
as before.
2. Press the ON/OFF switch on the ActivePal. The red light will stay on constantly.
3. Select “communicate with ActivePal” and then “connect” from the menu.
4. When connected, all recorded sessions will be displayed in a list. To view the
data, click on a session from the list and press the SAVE button. Graphs will be
generated for that session, which can be saved to CD-ROM or hard drive
(usually too big for disk). Each session will have to be downloaded individually
in this way.
5. To view downloaded data, start professional software, and open relevant file.
DATA
Recordings downloaded from the ActivePal are automatically processed.
There is no maximum length for a recording (depends on battery life), but the
minimum recording time to be able to process data is 60 seconds.
If the recording covers multiple days, only one day can be displayed at a time.
Recordings are displayed in two formats:
-
as a summary hour by hour of the recording period;
as totals for the recording period.
Each recording can be saved for further analysis or printed.
“Print” option prints the selected window.
382
Appendix VI
ActivPAL guide
“Save” saves the data from the selected window to a .csv file, which can be opened
in Microsoft Excel for further analysis.
When viewing data that has already been saved to a file, go into ActivePal softwear
and open file from there.
Summary by Hour Presentation – the recording is presented with an interval
resolution of 15 secs. Different colours represent sitting/lying, standing and
stepping, and at the end of each hour there is a summary of the number of minutes
spent in each activity, number of steps and number of transitions from sitting to
standing. Energy expenditure is also given in METs.
Totals for Recording Period summary – lists the overall time spent in each activity,
alongside number of steps taken and sit/stand transitions.
PROTOCOL FOR USE – Getting Started
1. Install ActivePal professional software to your PC.
2. Insert new battery into device. It is advisable to tape the battery into place, and
mark with date of insertion/programming (to avoid accidental removal of battery
and to give an indication of how long battery has left if in frequent use).
3. Start software (Start, Programs, ActivePal professional).
4.








Program the device:
Select “communicate with ActivePal” from the file menu;
Connect to PC using interface cable;
Press on/off switch on device – to get constant red light;
Select “connect” from menu;
Note the serial port being used to establish the connection;
Select “update” to synchronise clocks;
Press “reprogram and clear memory”;
Unplug ActivePal from interface cable (red light should now go off).
5. Use as required, following details given above.
383
Appendix VI
ActivPAL guide
TROUBLE SHOOTING
1. Unable to Establish a Connection:
- check you have selected the correct serial port, and that the port is not in use by
any other device. (into Software, ‘communicate with ActivePal’, go to
‘SETTINGS’ and click on the serial port to which you have connected your
interface cable).
- Check battery is correctly inserted.
- Ensure interface cable properly connected to PC and device.
2. Constant red light when ActivePal not connected to interface cable:
- either a system error has occurred, so the ActivePal must be reset by removing
and re-inserting the battery and then reprogrammed as before (note, this
process uses up the battery life more quickly). This will not affect data stored;
- or, the memory is full or the maximum number of recording sessions has been
reached. Memory requires to be cleared by erasing recorded data.
3.
-
No flashing red light when depress on/off switch
memory may be full, in which case clear recorded data;
system error, in which case remove battery and reprogram;
battery expired, in which case replace battery.
384
Appendix VII
Pilot Exercise Repetitions
PILOT REPETITIONS
Subject characteristics
intials
J
D
E
G
A
K
group
PP1
WP2
PP3
WP4
PP5
WP6
age
68
62.3
61.1
58.7
57.8
64
time
since
stroke
(WEEKS)
56
28
37
50
34
39
side
hemiplegia
L
R
L
L
L
L
dom
hand
R
R
R
L
R
R
Rise to stand exercise
subject
J
D
E
G
A
gp
PP1
WP2
PP3
WP4
PP5
K
WP6
sts1 sts2
sts3
sts4
tot_STS_Down wk_STS_Down
68
185
250
210
713
178.25
150
180
210
210
750
187.5
72
72
72
72
288
72
60
48
42
40
190
47.5
48
48
48
48
192
48
PATIENT LOST DIARY - BUT INCLUDE PRE POST
MEASURES
Step ups
subje
ct
gp
J
PP1
D
WP2
E
PP3
G
WP4
A
K
PP5
WP6
stepupdo
wn1
stepupdo
wn2
stepupdo
wn3
stepupdo
wn4
tot_stepup
down
wk_stepupd
own
79
230
230
210
749
187.25
58
60
70
70
258
64.5
72
72
72
72
288
72
52
44
40
40
176
44
48
48
48
48
192
48
PATIENT LOST DIARY - BUT INCLUDE PRE POST MEASURES
385
Appendices – Pilot Exercise repetitions
Appendix VII
Pilot Exercise Repetitions
Arm exercises
cuppa
1
subject
gp
J
PP1
D
WP2
E
PP3
G
WP4
A
K
PP5
WP6
subject
gp
J
PP1
D
WP2
E
PP3
G
WP4
A
K
PP5
WP6
cuppa
2
cuppa
3
cuppa
4
tot_cuppa
wk_cuppa
66
210
230
210
716
96
52
50
70
70
242
60.5
6
12
12
8
38
9.5
0
0
0
0
0
0
10
25
22
25
82
20.5
tiptap1
tiptap2
tiptap3
tiptap4
92
210
210
230
742
185.5
80
100
140
120
440
110
12
12
12
6
42
10.5
0
0
0
0
0
0
10
18
20
22
70
17.5
tot_tiptap
wk_tiptap
386
Appendices – Pilot Exercise repetitions
Appendix VIII
Final Information sheet and consent
INFORMATION SHEET FOR PATIENTS
HOME-BASED PHYSIOTHERAPY FOR LATE-STAGE STROKE
Thank you for considering to take part in the above study which will investigate different management
strategies for late-stage stroke.
This study is being undertaken jointly between Queen Margaret
University College, Edinburgh, Edinburgh University and Lothian Primary Care NHS Trust
Your GP practice was asked to send out a letter to all patients on their register who they know to have
had a stroke over 12 months ago.
Only your GP or the GP practice staff had access to your personal information.
If you don’t want to take part in this study simply don’t send the form back. If you might be interested,
please read on.
Why have we requested your help?


After your stroke you may have received treatment from physiotherapists who aimed to help you
regain as much movement as possible.
This study aims to look at whether a short programme of physiotherapy at least a year after your
stroke may be of further benefit to you.
We have developed a number of simple procedures and exercises that we think may help improve
tasks such as walking or using your arm. What we want to do now is to study the effect of these
exercises with a number of patients who had their stroke at least a year ago. Some patients will be
asked to do the exercises, others will not. We do however want to look at all participants movement
over a 12 month period.
Where does the study take place?

The study takes place in your own home. We will travel to you.
If I agree to take part – what happens?





You will receive a number of visits from both a researcher and a physiotherapist over the next12
months.
Before starting the study, the researcher will visit and ask you to fill in a couple of questionnaires
about your health and well-being. They will also ask how you manage daily activities such as
getting in and out of a chair, walking ability and will ask you to demonstrate how you do a few of
these tasks. This information will be gathered on 2 visits over about 2 weeks before the exercises
start. Each visit will take about an hour.
After these visits, a physiotherapist will come and teach you the exercises and check you can do
them safely. The physiotherapist will leave an instruction booklet on how to perform the exercises
and will visit you regularly to check your progress.
The physiotherapist will also leave a diary for you to record daily how many times you practised
the exercises.
The researcher will visit and re-test you on the tasks at the end of the exercise programme, with
3 further visits just after you finish the programme and at 3 and 12 months later. (This is to see if
you improve and also whether any improvement is long-lasting.
More information overleaf 
387
Appendices
Appendix VIII
How long does the programme last?

The exercise programme lasts 4 weeks, but as indicated above, the researcher will continue to
visit you on 3 occasions over the next 12 months.
How do I agree to take part?

Please sign or put your mark on the attached consent form and return it to the researcher – Gill
Baer – in the attached envelope.
Do I have to take part?


You have every right to refuse – don’t send this form back.
If you start the programme and then want to stop, that is fine and this would not affect your normal
physiotherapy treatment or any other treatment in any way.
What information do I need to give and will it be confidential?



We will need to know when you had your stroke. This information will be obtained from your
medical records. No other medical information is required.
All information will be treated as strictly confidential, your name will not be revealed in any
published papers related to this study.
The researcher and the physiotherapist who will treat you are qualified physiotherapists working
within Edinburgh. Physiotherapy rules of conduct oblige us to treat all patient information with
professional confidence.
If you have any other questions
Please phone Gill Baer (0131 317 3356).
Alternatively you can contact Katie Wilkie (a senior physiotherapist with Lothian Primary Care NHS
Trust) on 0131 537 9163 who is the external and independent advisor to this project.
We do not expect you to make an immediate decision about taking part. Think about it for a few days.
If you do decide to take part in this physiotherapy programme please sign the attached consent form,
and return it in attached the pre-paid envelope to:
Gill Baer
(Study co-ordinator: Home-Based Physiotherapy late after stroke)
Department of Physiotherapy
Queen Margaret University College
Duke St
Edinburgh EH6 8HF
Thank You so much for your consideration
388
Appendices
Appendix VIII
A STUDY OF HOME-BASED PHYSIOTHERAPY FOR LATE-STAGE STROKE
PATIENT CONSENT TO PARTICIPATE
NAME:
D.o.B.
ADDRESS:
PHONE NO
GP NAME
ADDRESS
QMUC STAFF
RESPONSIBLE: Gillian Baer
I hereby give my consent to participating in the above study.
I understand the purpose of the study and I understand that I can withdraw my consent at
any stage.
I understand that I will be tested on a number of functional tasks and asked to fill in a couple
of questionnaires. I understand that the study may involve a 4 week exercise programme. I
am aware that any information given to Health Professionals will be treated in the strictest
confidence and I will not be identifiable in any published results.
SIGNATURE / MARK of PATIENT
DATE
389
Appendices
Appendix IX
Randomisation list
390
Appendices
Appendix IX
Randomisation list
391
Appendices
Appendix X
Data
ActivPAL
subject
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
gp
W
C
P
P
W
P
C
P
C
W
C
W
C
W
C
P
P
P
W
C
W
C
P
C
P
P
C
W
P
W
C
C
P
P
W
W
W
W
P
P
C
W
C
C
P
C
%sit_ly
%stand
%walk
no_steps
no_STS
hrs
mins
no data
no data
no data
no data
no data
90
80
79
8
13
14
2
7
7
211
1326
1704
28
43
45
11
9
10
40
14
19
83
43
71
16
42
19
1
16
10
83
3307
2340
31
65
45
9
8
8
13
5
1
75
46
6
21
41
21
4
13
6
844
3631
1186
87
34
103
13
9
13
13
27
5
88
84
83
7
12
10
5
4
7
3077
874
2638
52
50
30
18
9
10
13
51
26
98
1
1
116
24
13
10
68
88
69
69
96
81
13
4
22
15
3
13
19
8
9
17
1
5
7093
2465
1814
5303
141
2416
32
32
40
63
10
68
7
12
8
9
14
15
54
35
21
49
22
37
81
96
50
79
74
91
71
52
90
77
97
15
3
34
9
18
4
21
28
6
18
2
4
1
16
12
7
5
8
19
4
4
1
1266
76
3629
4824
1350
1335
1472
7275
1105
1253
56
57
17
50
42
126
27
51
102
24
28
16
13
8
13
9
11
12
10
12
11
10
8
36
36
55
9
56
10
17
0
52
14
11
93
88
94
95
6
11
5
3
1
1
1
2
376
79
140
415
21
12
23
8
12
13
14
11
34
32
25
11
no data
no data
no data
no data
no data
no data
no data
392
Appendices
Appendix X
Data
49
50
51
52
53
54
55
57
58
59
61
62
63
65
subject
W
P
W
C
W
P
P
P
C
W
W
P
C
P
gp
74
19
7
1336
29
11
26
85
91
70
80
82
83
4
3
13
12
9
11
11
6
17
8
9
6
4328
950
10324
3973
5350
1505
22
26
291
31
47
33
14
12
15
14
12
13
44
0
57
30
7
4
61
72
90
77
%sit_ly
25
16
5
12
%stand
14
12
5
11
%walk
4399
3646
1266
5036
no_steps
55
38
29
154
no_STS
13
10
12
12
hrs
43
27
46
44
mins
no data
no data
no data
393
Appendices
Appendix XI
Final part practice diary
FINAL ACTIVITY DIARY (part)
394
Appendices
Appendix XI
395
Appendices
Appendix XI
396
Appendices
Appendix XI
397
Appendices
Appendix XI
398
Appendices
Appendix XI
399
Appendices
Appendix XI
400
Appendices
Appendix XI
401
Appendices
Appendix XI
402
Appendices
Appendix XI
403
Appendices
Appendix XI
404
Appendices
Appendix XI
405
Appendices
Appendix XI
406
Appendices
Appendix XI
407
Appendices
Appendix XI
408
Appendices
409

- QMU eTheses Repository

Transcription

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