Trial Description

DRKS-ID: DRKS00007762
Date of Registration in DRKS: 2015/04/21
Date of Registration in Partner Registry or other Primary Registry: [---]*
PLEASE NOTE: This trial has been registered retrospectively.
Trial Description
Title
Assesment of the mobility and activity of patients with vertigo and dizziness
Trial Acronym
[---]*
URL of the trial
[---]*
Brief Summary in Lay Language
Up to now, the effect of vertigo and balance disorders on the day-to-day mobility
with or without falls and fall-associated restrictions has not been assessed. Aim of
the study:
1) Assessment of mobility parameters and measures of physical activity in
patients with different vestibular or non-vestibular vertigo and balance disorders
2) Assessment of the association of mobility parameters and measures of physical
activity with occurrence of falls and related morbidity
Patients to be recruited:
Patients with vertigo and balance disorders of different etiology.
Course of the study:
During a single study visit at the study site we will measure gait and stance. Falls
will be assessed as well as different questionnaires and scores (subjective
evaluation of activity and mobility, general health questionnaire, test for
dementia). We will attach a sensor (accelerometer) at the patient’s leg that shall
measure daily activity for 14 days. Furthermore, we will instruct the patients to
document falls for the following 12 months including monthly telephone
interviews.
Brief Summary in Scientific Language
Up to now, the effect of vertigo and balance disorders on the day-to-day mobility
with or without falls, fall-associated morbidity and mortality has not been
assessed. Especially for the benign course of disease of vertigo and balance
disorders the assessment of disease-specific restrictions of activity and mobility in
the daily life and the following reduction of disease-related quality of life is of
central importance.
Aim of the study:
A) Assessment of mobility parameters and measures of physical activity in
patients with different vestibular or non-vestibular vertigo and balance disorders
a. Do patients with vertigo and balance disorders show deviations in the day-today physical activity?
b. If yes: is there an association between (a) the entity of the disorder and (b)
Page 1 of 7
DRKS-ID: DRKS00007762
Date of Registration in DRKS: 2015/04/21
Date of Registration in Partner Registry or other Primary Registry: [---]*
course of the disease (chronic vs. episodic vs. paroxysmal)?
c. Is there an association between mobility and physical activity in the patients?
B) Assessment of the association of mobility parameters and measures of physical
activity with occurrence of falls and related morbidity
a. Is an increased risk of falls associated with manifest restrictions of the mobility
or physical activity?
b. If yes: Can certain mobility parameters or measures of physical activity be used
to predict the individual risk of falls?
Patients to be recruited:
1) Unilateral vestibular disorder (unilateral vestibulopathy, benign paroxysmal
positional vertigo, Menière's disease, vestibular paroxysmia, perilymph fistula)
2) Bilateral vestibular disorder (bilateral vestibulopathy)
3) Somatoform vertigo (incl. phobic postural vertigo)
4) Central vestibular disorders (downbeat-nystagmus syndrome, cerebellar
oculomotor disorders, Wallenberg syndrome, post infarction or craniocerebral
injury)
5) Sensory vertigo (polyneuropathy, reduction of visus)
6) Normal subjects as controls
Patients will be recruited in the out-patient clinic of the German Center of Vertigo
and Balance disorders (out of the clinical routine or out of its database).
Course of the study:
Investigations at the study site:
Gait and stance analysis (pait analysis (GaitRite), Timed up and go-Test,
Functional Gait Assessment (FGA), posturography); systemic history of falls and
near-falls; cognitive impairment (MoCA); clinical-neurological work-up, specific
instrument-based diagnostics; history of other diseases and medication;
questionnaires (health-related quality of life, concerns of falling)
Every participant will receive a mini sensor (accelerometer and goniometer) that
will be attached at the patient’s thigh with a plaster. The sensor will be active 14
hours a day for 14 days. Data is stored within an internal SD-chip.
One-year follow-up of falls and near-falls using a diary (frequency of falling,
severity of falls and trigger factors), additionally monthly interviews via
telephone.
Organizational Data
DRKS-ID: DRKS00007762
Date of Registration in DRKS: 2015/04/21
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee Nr.: 421-13 , Ethik-Kommission der Medizinischen Fakultät
der Ludwig-Maximilians-Universität München
Secondary IDs
Page 2 of 7
DRKS-ID: DRKS00007762
Date of Registration in DRKS: 2015/04/21
Date of Registration in Partner Registry or other Primary Registry: [---]*
Health condition or Problem studied
Free text: Meniere's disease, benign paroxysmal postuarl vertigo, perilymph
fistula, bilateral vestibulopathy, unilateral vestubulopathy, cerebellar
oculomotor disorder, Downbeatnystagmus syndrome, Wallenberg's syndrome,
polyneuropathy, visus reduction, somatoform vertigo, phobic postural vertigo
ICD10: H81.0 - Ménière disease
ICD10: H81.1 - Benign paroxysmal vertigo
ICD10: H55 - Nystagmus and other irregular eye movements
ICD10: H81.2 - Vestibular neuronitis
ICD10: G62.9 - Polyneuropathy, unspecified
ICD10: H54.9 - Unspecified visual impairment (binocular)
ICD10: F45.8 - Other somatoform disorders
Interventions/Observational Groups
Arm 1: Investigations at the study site:
Gait and stance analysis (pait analysis (GaitRite), Timed up and go-Test,
Functional Gait Assessment (FGA), posturography); systemic history of falls
and near-falls; cognitive impairment (MoCA); clinical-neurological work-up,
specific instrument-based diagnostics; history of other diseases and
medication; questionnaires (health-related quality of life, concerns of falling)
Every participant will receive a mini sensor (accelerometer and goniometer)
that will be attached at the patient’s thigh with a plaster. The sensor will be
active 14 hours a day for 14 days. Data is stored within an internal SD-chip.
One-year follow-up of falls and near-falls using a diary (frequency of falling,
severity of falls and trigger factors), additionally monthly interviews via
telephone.
Arm 2: Normal subjects as controls. Interventions and folow up will be eqal to
arm 1.
Characteristics
Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Non-randomized controlled trial
Blinding: [---]*
Who is blinded: [---]*
Control: Other
Page 3 of 7
DRKS-ID: DRKS00007762
Date of Registration in DRKS: 2015/04/21
Date of Registration in Partner Registry or other Primary Registry: [---]*
Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Non-randomized controlled trial
Blinding: [---]*
Who is blinded: [---]*
Control: Other
Purpose: Basic research/physiological study
Assignment: Parallel
Phase: N/A
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A
Primary Outcome
Assessment of mobility parameters and measures of physical activity in patients
with different vestibular or non-vestibular vertigo and balance disorders with the
accelerometer data
Secondary Outcome
Assessment of the association of mobility parameters and measures of physical
activity with occurrence of falls and related morbidity with one-year-follow-up
(falls diary and monthly telephone interview)
Countries of recruitment
DE Germany
Locations of Recruitment
University Medical Center Deutsches Schwindel- und Gleichgewichtszentrum,
München
Recruitment
Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2014/01/29
Target Sample Size: 250
Monocenter/Multicenter trial: Monocenter trial
National/International: National
Page 4 of 7
DRKS-ID: DRKS00007762
Date of Registration in DRKS: 2015/04/21
Date of Registration in Partner Registry or other Primary Registry: [---]*
Inclusion Criteria
Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 90 Years
Additional Inclusion Criteria
Arm 1: Distinct primary diagnosis, Age between 18 and 90 years, Written informed
consent, Patient is able cooperate
Arm 2: no vertigo, dizziness or balance disorder, no sensory or motor deficit at the
lower extremities, age between 18 and 90 years, written informed consent,
patient is able to cooperate.
Exclusion criteria
Arm 1: Other diseases that cause a gait disorder (paresis of the lower extremity
after stroke, multiple sclerosis, stenosis of the spinal canal etc.; insertion of a
endoprosthesis within the preceding 6 months), deficits preventing informed
consent
Arm 2: vertigo, dizziness or balance disorder; sensory deficits and weakness or
other motor defitis of the lower extremity.
Addresses
Primary Sponsor
Ludwigs-Maximimillian-Universität München, Neurologische Klinik und
Poliklinik
Mr. Dr. Roman Schniepp
Marchioninistr. 15
81337 München
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Contact for Scientific Queries
Deutsches Schwindel- und Gleichgewichtszentrum und Neurologische Poliklinik
und Klinik der Universität München
Mr. Dr. Roman Schniepp
Machioninistr. 15
81377 München
Germany
Page 5 of 7
DRKS-ID: DRKS00007762
Date of Registration in DRKS: 2015/04/21
Date of Registration in Partner Registry or other Primary Registry: [---]*
Contact for Scientific Queries
Deutsches Schwindel- und Gleichgewichtszentrum und Neurologische Poliklinik
und Klinik der Universität München
Mr. Dr. Roman Schniepp
Machioninistr. 15
81377 München
Germany
Telephone: 089/4400 76950
Fax: 089 4400-78794
E-mail: roman.schniepp at med.uni-muenchen.de
URL: http://www.schwindelambulanz-muenchen.de/
Contact for Public Queries
Deutsches Schwindel- und Gleichgewichtszentrum, Klinikum der Universität
München
Ms. Kristin Heßelbarth
Marchioninistr. 15
81377 München
Germany
Telephone: 089/4400 76950
Fax: 089 4400-78794
E-mail: kristin.heßelbarth at med.uni-muenchen.de
URL: http://www.schwindelambulanz-muenchen.de/
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
Deutsches Schwindel- und Gleichgewichtszentrum und Neurologische Poliklinik
und Klinik der Universität München; Finanzierung: Ludwigs-MaximiliansUniversität München, FöFoLe
Mr. Dr. Roman Schniepp
Machioninistr. 15
81377 München
Germany
Telephone: 089/4400 76950
Fax: 089 4400-78794
E-mail: roman.schniepp at med.uni-muenchen.de
URL: http://www.schwindelambulanz-muenchen.de/
Status
Recruitment Status: Recruiting ongoing
Page 6 of 7
DRKS-ID: DRKS00007762
Date of Registration in DRKS: 2015/04/21
Date of Registration in Partner Registry or other Primary Registry: [---]*
Study Closing (LPLV): [---]*
Trial Publications, Results and other documents
Please note:
There are additional attributes available concerning this trial. To open an extended view please
click here.