Complete August 2012 Issue
Transcription
Complete August 2012 Issue
August 2012 Volume 92 Number 8 Research Reports 992 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes 1006 Therapist-Based Versus Robotic Bilateral Arm Training 1017 Rasch Validation of the Short Form of the Wolf Motor Function Test 1027 Repeated Measurements of Arm Joint Passive Range of Motion After Stroke 1036 Italian Version of the Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire 1046 Development and Psychometric Properties of the Activity-based Balance Level Evaluation Case Reports 1055 Cervical Disk Pathology in Multiple Sclerosis 1065 Integrated Motor Imagery at Home to Improve Walking After Stroke LEAP: Linking Evidence And Practice 987 Neuromuscular Training for Chronic Ankle Instability Want to give your patients up to 16 hours of drug-free back pain relief? Only ThermaCare® has patented heat cell technology Use as directed. Visit Pfizerpro.com/thermacare to register for samples. 1 ThermaCare® provides 8 hours of relief while your patients are wearing the HeatWrap, plus an additional 8 hours of relief after they take it off.1-3 89% of patients reported strong overall satisfaction with the product.*4 Visit Pfizerpro.com/thermacare today! *Results from a national online data collection including people who had treated their pain and/or used an external pain treatment within the past 6 months from January 2010 to June 2010 (N=2940). Strong satisfaction is defined as “completely satisfied” or “mostly satisfied” on a 5-point scale.4 References: 1. Nadler SF, Steiner DJ, Erasala GN, et al. Continuous low-level heat wrap therapy provides more efficacy than ibuprofen and acetaminophen for acute low back pain. Spine. 2002;27(10):1012-1017. 2. Nadler SF, Steiner DJ, Erasala GN, Hengehold DA, Abeln SB, Weingand KW. Continuous low-level heatwrap therapy for treating acute nonspecific low back pain. Arch Phys Med Rehabil. 2003;84(3):329-334. 3. Nadler SF, Steiner DJ, Petty SR, Erasala GN, Hengehold DA, Weingand KW. Overnight use of continuous low-level heatwrap therapy for relief of low back pain. Arch Phys Med Rehabil. 2003;84(3):335-342. 4. Data on file. Pfizer Consumer Healthcare. ©2012 Pfizer Inc. THC051216 Ads_8.12.indd 2 05/12 ThermaCare.com 7/13/12 4:12 PM Physical Therapy Journal of the American Physical Therapy Association ■ Volume 92 ■ Number 8 ■ August 2012 <LEAP> Linking Evidence And Practice 987 Neuromuscular Training for Chronic Ankle Instability / Chung-Wei Christine Lin, Eamonn Delahunt, Enda King Research Reports 992 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes for People With Musculoskeletal Conditions of the Shoulder / Bhagwant S. Sindhu, Leigh A. Lehman, Sergey Tarima, Mark D. Bishop, Dennis L. Hart, Matthew R. Klein, Mikesh Shivakoti, Ying-Chih Wang Winslow Homer (American, 1836–1910). A Basket of Clams, 1873. Copyright © The Metropolitan Museum of Art, New York, NY. Photo Credit: Art Resource, NY Homer spent the summer of 1873 in Gloucester, Massachusetts, where he painted a number of works that observed children in their daily activities. Here, 2 boys carry a heavy bucket of clams; the smaller boy looks awkwardly—and perhaps warily—at the contents, rotating his neck with lateral flexion to the right. The older boy appears to be looking at the beached ship, or perhaps looking away from a dead fish in the foreground. Art historians note that, in the period immediately following the Civil War, many American artists seemed to focus on children as symbols of both a simpler past and a brighter future. 1006 Effect of Therapist-Based Versus Robot-Assisted Bilateral Arm Training on Motor Control, Functional Performance, and Quality of Life After Chronic Stroke: A Clinical Trial / Ching-yi Wu, Chieh-ling Yang, Li-ling Chuang, Keh-chung Lin, Hsieh-ching Chen, Ming-de Chen, Wan-chien Huang 1017 Rasch Validation of the Streamlined Wolf Motor Function Test in People With Chronic Stroke and Subacute Stroke / Hui-fang Chen, Ching-yi Wu, Keh-chung Lin, Hsieh-ching Chen, Carl P-C. Chen, Chih-kuang Chen 1027 Repeated Measurements of Arm Joint Passive Range of Motion After Stroke: Interobserver Reliability and Sources of Variation / Lex D. de Jong, Pieter U. Dijkstra, Roy E. Stewart, Klaas Postema 1036 Cross-Cultural Adaptation and Measurement Properties of the Italian Version of the Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire / Angelo Cacchio, Stefano Necozione, Joy C. MacDermid, Jan Dirk Rompe, Nicola Maffulli, Ferdinando di Orio, Valter Santilli, Marco Paoloni Craikcast Listen to PTJ’s new monthly podcast series! Editor in Chief Rebecca Craik gives her unique insights on the August issue. Available at ptjournal.apta.org/ content/92/8/suppl/DC1 and through iTunes. 982 ■ Physical Therapy Volume 92 Number 8 August 2012 1046 The ABLE Scale: The Development and Psychometric Properties of an Outcome Measure for the Spinal Cord Injury Population / Elizabeth M. Ardolino, Karen J. Hutchinson, Departments 986 The Bottom Line 1081 Scholarships, Fellowships, and Grants Genevieve Pinto Zipp, MaryAnn Clark, Susan J. Harkema News from the Foundation for Physical Therapy Case Reports 1055 Cervical Disk Pathology in Patients With Multiple Sclerosis: Two Case Reports / Ann E. Mullen, 1083 Product Highlights 1084 Ad Index Mary Ann Wilmarth, Sue Lowe 1065 Patient-Centered Integrated Motor Imagery Delivered in the Home With Telerehabilitation to Improve Walking After Stroke / Judith E. Deutsch, Inbal Maidan, Ruth Dickstein Health Policy in Perspective 1078 Rothstein Roundtable Podcast “Medical Homes, PACA, IFDS—Where Do Physical Therapists Fit in a Reforming Health Care Environment?” Corrections 1079 Kersten RF, Stevens M, van Raay JJAM, et al. Habitual physical activity after total knee replacement: analysis in 830 patients and comparison with a sex- and age-matched normative population. Phys Ther. doi: 10.2522/ptj.20110273. 1079 Niemeijer AS, Reinders-Messelink HA, Disseldorp LM, et al. Feasibility, reliability, and agreement of the WeeFIM instrument in Dutch children with burns. Phys Ther. 2012;92:958–966. Visit ptjournal.apta.org Listen to audio podcasts. View videoclips. Listen to discussion podcasts. August 2012 TOC_8.12.indd 983 Volume 92 Number 8 Physical Therapy ■ 983 7/19/12 3:42 PM Physical Therapy Journal of the American Physical Therapy Association Editor in Chief Deputy Editor in Chief Daniel L. Riddle, PT, PhD, FAPTA Richmond, VA Rebecca L. Craik, PT, PhD, FAPTA Philadelphia, PA [email protected] Editor in Chief Emeritus Jules M. Rothstein, PT, PhD, FAPTA (1947–2005) Editorial Board Rachelle Buchbinder, MBBS(Hons), MSc, PhD, FRACP, Malvern, Victoria, Australia; W. Todd Cade, PT, PhD, St Louis, MO; James R. Carey, PT, PhD, Minneapolis, MN; John Childs, PT, PhD, Schertz, TX; Joshua Cleland, PT, DPT, PhD, OCS, FAAOMPT, Concord, NH; Janice J. Eng, PT/OT, PhD, Vancouver, BC, Canada; Steven Z. George, PT, PhD, Gainesville, FL; Kathleen Gill-Body, PT, DPT, NCS, Boston, MA; Jan Willem Gorter, PhD, MD, FRCPC, Hamilton, Ont, Canada; Rana Shane Hinman, PT, PhD, Melbourne, Victoria, Australia; Diane U. Jette, PT, DSc, FAPTA, Burlington, VT; Sarah H. Kagan, PhD, FAAN, RN, Philadelphia, PA; Michel D. Landry, BScPT, PhD, Durham, NC; Teresa Liu-Ambrose, PT, PhD, Vancouver, BC, Canada; Christopher Maher, PT, PhD, Sydney, NSW, Australia; Chris J. Main, PhD, FBPsS, Keele, United Kingdom; Kathleen Kline Mangione, PT, PhD, GCS, Philadelphia, PA; Sarah Westcott McCoy, PT, PhD, Seattle, WA; Patricia J. Ohtake, PT, PhD, Buffalo, NY; Carolynn Patten, PT, PhD, Gainesville, FL; Linda Resnik, PT, PhD, OCS, Providence, RI; Kathleen Sluka, PT, PhD, Iowa City, IA; Nicholas Stergiou, PhD, Omaha, NE; Chair, Rothstein Roundtable: Anthony Delitto, PT, PhD, FAPTA, Pittsburgh, PA Statistical Consultants Steven E. Hanna, PhD, Hamilton, Ont, Canada; John E. Hewett, PhD, Columbia, MO; Melissa Krauss, MPH, St Louis, MO; Hang Lee, PhD, Boston, MA; Xiangrong Kong, PhD, Baltimore, MD; Michael E. Robinson, PhD, Gainesville, FL; Paul Stratford, PT, MSc, Hamilton, Ont, Canada; David Thompson, PT, PhD, Oklahoma City, OK; Samuel Wu, PhD, Gainesville, FL Committee on Health Policy and Ethics Linda Resnik, PT, PhD, OCS (Chair), Providence, RI; Janet Freburger, PT, PhD, Chapel Hill, NC; Alan M. Jette, PT, PhD, FAPTA, Boston, MA; Michael Johnson, PT, PhD, OCS, Philadelphia, PA; Justin Moore, PT, DPT, Alexandria, VA; Ruth B. Purtilo, PT, PhD, FAPTA, Boston, MA <LEAP> Linking Evidence And Practice Advisory Group Rachelle Buchbinder, MBBS(Hons), MSc, PhD, FRACP, Malvern, Victoria, Australia (Co-Chair); Diane U. Jette, PT, DSc, FAPTA, Burlington, VT (Co-Chair); W. Todd Cade, PT, PhD, St Louis, MO; Christopher Maher, PT, PhD, Sydney, NSW, Australia; Kathleen Kline Mangione, PT, PhD, GCS, Philadelphia, PA; David Scalzitti, PT, PhD, OCS, Alexandria, VA Senior Reviewers J. Haxby Abbott, PT, PhD, FNZCP; Karen Abraham-Justice, PT, PhD; Louis Amundsen, PT; Paul Beattie, PT, PhD, OCS, FAPTA; Anjana Bhat, PT, PhD; Joel Bialosky, PT, PhD; Jill Boissonnault, PT, PhD; Jennifer Brach, PT, PhD; Timothy Brindle, PT, PhD, ATC; Daniel Cipriani, PT, PhD; Chad Cook, PT, PhD, MBA, OCS, FAAOMPT; Janet Copeland, Dip PT, BA, MHealSc; Leonardo Costa, PT, PhD; Vanina Dal Bello-Haas, PT, PhD; Diane Damiano, PT, PhD; Todd Davenport, PT, DPT, OCS; Richard Debigare, PT, PhD; Joost Dekker, PhD; Nandini Deshpande, PhD; Susan Deusinger, PT, PhD, FAPTA; Nancy Devine, PT, DPT; Elizabeth Domholdt, PT, EdD, FAPTA; Sheryl Finucane, PT, PhD; Janet Freburger, PT, PhD; Julie Fritz, PT, PhD, ATC; Marc Goldstein, EdD; Bruce Greenfield, PT, PhD, OCS; Christina Gummesson, PT, PhD; Janet Gwyer, PT, PhD, FAPTA; Mijna Hadders-Algra, MD, PhD; Timothy Hanke, PT, PhD; Lisa (Elizabeth) Hannold, PhD; Regina Harbourne, PT, PhD, PCS; Lisa Harvey, PT, PhD; Chris Hass, PhD; Karen Hayes, PT, PhD, FAPTA; Thomas Hornby, PT, PhD; Gail Jensen, PT, PhD, FAPTA; Dianne Jewell, PT, DPT, PhD, CCS; Suzanne Kuys; Pamela Levangie, PT, DSc, DPT, FAPTA; Sandra Levi, PT, PhD; Patricia Manns, PT, PhD; Ray Marks, EdD; Sunita Mathur, PT; Karen McCulloch, PT, PhD, NCS; Christine McDonough, PT, PhD; Irene McEwen, PT, PhD, FAPTA; Chris McGibbon, PhD; Jan Mehrholz, PT, DrPH, MPH; Susanne Morton, PT, PhD; Michael Mueller, PT, PhD, FAPTA; Gina Musolino, PT, MSEd, EdD; Kerstin Palombaro, PT, PhD; Claire Peel, PT, PhD, FAPTA; Andrew Ray, PT, PhD; Kathryn Roach, PT, PhD; Kathleen Rockefeller, PT, ScD, MPH; Dorian Rose, PT, PhD; Michael Ross, PT, DHS, OCS; Robert Sandstrom, PT, PhD; Ruth Sapsford, AUA, DipPhty; Sheila Schindler-Ivens, PT, PhD; Timothy Sell, PT, PhD; Patricia Sinnott, PT, PhD, MPH; Jill Stewart, PT, PhD, NCS; Laura Swisher, PT, PhD, MDiv; Julie Tilson, PT, DPT, NCS; Carole Tucker, PT, PhD, PCS; Kirsti Uusi-Rasi, PhD; Ying-Chih Wang, PhD; Gilbert Willett, PT, PhD, OCS, CSCS; Rick Wilson, PT, PhD Editorial Office Managing Editor / Director of Evidence-Based Resources: Jan P. Reynolds, [email protected]; PTJ Online Editor / Assistant Managing Editor: Steven Glaros; Associate Editor: Stephen Brooks, ELS; Production Manager: Liz Haberkorn; Manuscripts Coordinator: Karen Darley; Permissions / Reprint Coordinator: Michele Tillson; Advertising Manager: Julie Hilgenberg; Art Director: Barbara Cross; Publisher: Lois Douthitt APTA Executive Staff Vice President for Communications: Felicity Feather Clancy; Chief Financial Officer: Rob Batarla; Chief Executive Officer: John D. Barnes Advertising Sales Ad Marketing Group, Inc, 2200 Wilson Blvd, Suite 102-333, Arlington, VA 22201; 703/243-9046, ext 102; President / Advertising Account Manager: Jane Dees Richardson Board of Directors President: Paul A. Rockar Jr, PT, DPT, MS; Vice President: Sharon L. Dunn, PT, PhD, OCS; Secretary: Laurita M. Hack, PT, DPT, MBA, PhD, FAPTA; Treasurer: Elmer Platz, PT; Speaker of the House: Shawne E. Soper, PT, DPT, MBA; Vice Speaker of the House: William F. McGehee, PT, MHS; Directors: Jennifer E. Green-Wilson, PT, MBA, EdD; Jeanine M. Gunn, PT, DPT; Roger A. Herr, PT, MPA, COS-C; Dianne V. Jewell, PT, DPT, PhD, CCS, FAACVPR; Stephen M. Levine, PT, DPT, MSHA; Kathleen K. Mairella, PT, DPT, MA; Dave Pariser, PT, PhD; Mary C. Sinnott, PT, DPT, MEd; Nicole L. Stout, PT, MPT, CLT-LANA 984 ■ Physical Therapy Volume 92 Number 8 Masthead_8.12.indd 984 August 2012 7/13/12 4:13 PM Subscriptions Physical Therapy (PTJ) (ISSN 00319023) is published monthly by the American Physical Therapy Association (APTA), 1111 North Fairfax Street, Alexandria, VA 22314-1488, at an annual subscription rate of $17 for members, included in dues. Nonmember rates are as follows: Individual (inside USA)—$104; individual (outside USA)—$124 surface mail, $184 air mail. Institutional (inside USA)—$144; institutional (outside USA)—$164 surface mail, $224 air mail. Periodical postage is paid at Alexandria, VA, and at additional mailing offices. Postmaster: Send address changes to Physical Therapy, 1111 North Fairfax Street, Alexandria, VA 22314-1488. Single copies: $15 USA, $15 outside USA. All orders payable in US currency. No replacements for nonreceipt after a 3-month period has elapsed. Canada Post International Publications Mail Product Sales Agreement No. 0055832. Members and Subscribers Send changes of address to: APTA, Attn: Member Services Dept, 1111 North Fairfax St, Alexandria, VA 22314-1488. Subscription inquiries: 703/684-2782, ext 3124. PTJ is available in a special format for readers who are visually impaired. For information, contact APTA’s Member Services Department at 703/684-2782, ext 3124. Mission Statement Physical Therapy (PTJ) engages and inspires an international readership on topics related to physical therapy. As the leading international journal for research in physical therapy and related fields, PTJ publishes innovative and highly relevant content for both clinicians and scientists and uses a variety of interactive approaches to communicate that content, with the expressed purpose of improving patient care. Readers are invited to submit manuscripts to PTJ. PTJ’s content—including editorials, commentaries, and letters—represents the opinions of the authors and should not be attributed to PTJ or its Editorial Board. Content does not reflect the official policy of APTA or the institution with which the author is affiliated, unless expressly stated. Masthead_8.12.indd 985 Full-text articles are available for free at ptjournal.apta.org 12 months after the publication date. Full text also is provided through DataStar, Dialog, EBSCOHost Academic Search, Factiva, InfoTrac, ProFound, and ProQuest. Reprints PTJ Online at ptjournal.apta.org PTJ Online is available via RSS feeds. PTJ posts articles ahead of print and rapid reader responses to articles. Articles, letters to the editor, and editorials are available in full text starting with Volume 79 (1999) and in searchable PDF format starting with Volume 60 (1980). Entire issues are available online beginning with Volume 86 (2006) and include additional data, video clips, and podcasts. Indexing and Document Delivery PTJ is indexed and/or abstracted by Abridged Index Medicus, Abstracts of Health Care Management Studies, AgeLine, Allied and Complementary Medicine Database (AMED), Bibliography of Developmental Medicine and Child Neurology, Current Contents, Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE/Exerpta Medica, Exceptional Child Education Resources, Focus on: Sports Science and Medicine, General Science Index (GSI), Health Index, Hospital and Health Administration Index, Index Medicus, Inpharma Weekly, International Nursing Index, ISR, Medical & Surgical Dermatology, MEDLINE, Neuroscience Citation Index, Personal Alert: Automatic Subject Citation Alert (ASCA), Pharmacoeconomics and Outcomes News, Physical Education Index, Reactions Weekly, RECAL Bibliographic Database, Science Citation Index (SCI), Social Sciences Citation Index (SSCI), and SportsS. Article abstracts are available online at ptjournal.apta.org (1980 through present) and via DataStar, Dialog, FirstSearch, Information Access, and August 2012 Ovid Technologies. Ingenta provides online document delivery for articles published since September 1988. Readers should direct requests for reprints to the corresponding author of the article. Students and other academic customers may receive permission to reprint copyrighted material from this publication by contacting the Copyright Clearance Center Inc, 222 Rosewood Dr, Danvers, MA 01923. Authors who want reprints should contact June Billman, Cadmus Communications, at 800/4875625, or [email protected]. Nonacademic institutions needing reprint permission information should go to ptjournal.apta.org/site/misc/terms. xhtml. Advertising Advertisements are accepted by PTJ when they conform to the ethical standards of the American Physical Therapy Association. PTJ does not verify the accuracy of claims made in advertisements, and acceptance does not imply endorsement by PTJ or the Association. Acceptance of advertisements for professional development courses addressing advanced-level competencies in clinical specialty areas does not imply review or endorsement by the American Board of Physical Therapy Specialties. Statement of Nondiscrimination APTA prohibits preferential or adverse discrimination on the basis of race, creed, color, gender, age, national or ethnic origin, sexual orientation, disability, or health status in all areas including, but not limited to, its qualifications for membership, rights of members, policies, programs, activities, and employment practices. APTA is committed to promoting cultural diversity throughout the profession. Volume 92 Number 8 Physical Therapy ■ 985 7/13/12 4:13 PM The Bottom Line The Bottom Line summarizes the key points of articles that report research with a direct impact on patient care. Influence of Fear-Avoidance Beliefs on Functional Status Outcomes Fear-avoidance beliefs related to pain are prevalent among people with musculoskeletal conditions, and these beliefs have been associated with greater disability and functional limitations. However, it is not known how pain-related fear-avoidance beliefs affect the outcome of rehabilitation in people with shoulder impairments. Elevated fear-avoidance beliefs were associated with poorer improvement in functional status from in- take to discharge among people in the following 2 shoulder disease categories: (1) muscle, tendon, and soft-tissue disorders, and (2) osteopathies, chondropathies, and acquired musculoskeletal deformities. Message for patients: The data from this study suggest that if you have a condition in 1 of the 2 disease categories above, your physical therapist may be able to improve your treatment outcomes by assessing for the presence of fear-avoidance beliefs and helping you manage those beliefs. See page 992. Guidelines for Clinicians Domestic Violence Guidelines These guidelines give you needed background on the issues and the roles that you have in identifying, treating, and advocating for people who are abused. Take and pass the exam at the end of each booklet and earn .2 CEU. Regular price: $22.00 each APTA Member price: $12.95 each OR G iddelines for Gu Recco Re ognizing es for Guidelin izing aanndd n Recog and e ar ing C Provid tims of for Vic stic Dome ce n Viole Prov Pr ovid iding Care for Vic for fo ctims off Ellde E der Abuse BUY ALL 3 Domestic Violence Guidelines and SAVE! Guidelines for Order No. KIT-ABUSE Regular price: $55.00 APTA Member price: $32.95 Guidelines for Recognizing and Providing Care for Victims of Elder Abuse (ISBN 978-1-931369-39-8, 50 pgs, 2007) Order No. P-160-07 Recognizing Recog Rec ogn gniizi izin zing ng andd Providing Provi Provi ovid din din ng Care C e for Victim Victims V ictims off Child Ab Abuse Guidelines for Recognizing and Providing Care for Victims of Domestic Violence (ISBN 978-1-887759-31-1, 40 pgs, 2005) Order No. P-138 Guidelines for Recognizing and Providing Care for Victims of Child Abuse (ISBN 978-1-887759-80-9, 36 pgs, 2005) Order No. P-159 Order now at www.apta.org/store. 986 ■ Physical Therapy Volume 92 Number 8 August 2012 ⬍LEAP⬎ LINKING EVIDENCE AND PRACTICE Neuromuscular Training for Chronic Ankle Instability Chung-Wei Christine Lin, Eamonn Delahunt, Enda King <LEAP> highlights the findings and application of Cochrane reviews and other evidence pertinent to the practice of physical therapy. The Cochrane Library is a respected source of reliable evidence related to health care. Cochrane systematic reviews explore the evidence for and against the effectiveness and appropriateness of interventions—medications, surgery, education, nutrition, exercise—and the evidence for and against the use of diagnostic tests for specific conditions. Cochrane reviews are designed to facilitate the decisions of clinicians, patients, and others in health care by providing a careful review and interpretation of research studies published in the scientific literature.1 Each article in this PTJ series summarizes a Cochrane review or other scientific evidence on a single topic and presents clinical scenarios based on real patients or programs to illustrate how the results of the review can be used to directly inform clinical decisions. This article focuses on a patient with chronic ankle instability who has re-sprained his ankle and is now unable to participate in sports. Could a neuromuscular training program improve his functional outcomes? Find the <LEAP> case archive at http://ptjournal.apta.org/cgi/ collection/leap. August 2012 Ankle sprain, in particular injury to the lateral ligament complex of the ankle joint, is one of the most frequently encountered lower-limb injuries in sporting populations.2 In the acute phase, ankle sprains are associated with pain, swelling, ecchymosis, and loss of function, with up to one quarter of all injured people being unable to attend work for more than 7 days postsprain.3 In addition to restricted joint range of motion and increased joint laxity, common clinical and research findings are disruption in neuromuscular control as manifested by decreased postural stability, altered muscle activation patterns, and aberrant joint physiological and accessory movement. In the weeks following an ankle sprain, activities of daily living can be compromised, and, even though acute symptoms resolve, persistent symptoms are reported to occur in 30% to 40% of people,4 with higher incidences being reported in athletes involved in high-velocity, dynamic sports.5 These symptoms, which include a feeling of joint instability and repeated episodes of the ankle joint giving way, are part of the clinically described entity chronic ankle instability.6 “Chronic ankle instability” is an encompassing term used to describe the presence of mechanical instability and functional instability following ankle sprain.6 The symptoms still persist in up to 25% of people at 3 years after the initial sprain.7 There are few evidence-based clinical guidelines for ankle sprain management in primary care. Clinical practice varies widely and often can be limited to basic advice followed by immediate discharge in the absence of ankle joint fracture.8 Recently, Hertel9 developed a widely accepted paradigm of chronic ankle instability, whereby various functional insufficiencies and mechanical insufficiencies are described. Clinicians can use strategies to treat the various functional insufficiencies described in the paradigm of Hertel.9 The generic term “neuromuscular training” is used to describe a combination of functionally based exercises, including postural stability, proprioceptive, and strength training, as part of a rehabilitation regimen. A recent Cochrane review investigated the effectiveness of any conservative or surgical treatments for chronic ankle instability in adults.10 Of the 10 included studies, 4 evaluated neuromuscular training. The remaining studies examined surgical interventions (4 studies) or mobilization versus immobilization after surgery (2 studies). Only the results concerning neuromuscular training are presented here (Appendix). Studies compared 4 weeks of supervised neuromuscular training (including wobble board and other balance exercises) with no training (3 studies) and bidirectional to unidirectional pedaling on a recumbent stationary bicycle (1 study). The study sample sizes were small, and most studies had methodological flaws (eg, no concealed allocation). The studies did not provide follow-up data other than data collected at the end of the treatment period. The pooled results from 2 studies showed statistically significant but small functional gains when neuromuscular training was compared with no training. A third study comparing neuromuscular training with no training also showed similar Volume 92 Number 8 Physical Therapy f 987 <LEAP> Case #9 Neuromuscular Training for Chronic Ankle Instability results. There was no difference between bidirectional or unidirectional pedaling. The Cochrane review did not report adverse events as an outcome, but reviewing the included studies showed that 1 of the 4 studies reported on adverse events. Hale et al11 compared a 4-week neuromuscular training program with no training and reported that no participant withdrew from the study due to adverse events. Take-Home Message Because of the low number of studies, the small sample sizes, and the risk of bias, there is only limited evidence regarding the efficacy of neuromuscular training for ankle instability. However, the results showed a small, short-term treatment benefit supporting supervised neuromuscular training conducted over 20 to 30 minutes a few times a week for 4 weeks. <LEAP> Case #9 Neuromuscular Training for Chronic Ankle Instability Can neuromuscular training help this patient? Mr. R is a 28-year-old amateur soccer player who works as an accountant. He had an acute right ankle sprain, sustained while running during training, on a background of chronic ankle instability. He played with a club in his local competitive league and had 2 pitch training sessions and 1 game every week during the season, which lasted approximately 32 weeks. He has had recurrent episodes of ankle instability over the past 4 years, with 2 to 3 re-sprains per year. All of the episodes have occurred while participating in or training for his sport. Mr. R reported his current symptoms over the lateral aspect of his right ankle, with 5/10 pain on the visual analog scale. His ankle was stiffer getting out of bed in the morning, and it took a few minutes before he 988 f Physical Therapy Volume 92 could walk freely. His pain was aggravated by running or any sudden twisting or turning, and he was currently unable to participate in training or competition. There was moderate effusion of the ankle joint and bruising along the lateral aspect of the dorsum of the foot, with marked laxity on the anterior drawer test and pain and moderate laxity on the talar tilt test. There was tenderness along the lateral ankle, particularly over the anterior talofibular ligament (ATFL) and calcaneofibular ligament (CFL). He had mild weakness through his peroneal and gastrocnemius muscles, reduced passive dorsiflexion of the talocrural joint, and hypomobililty on an anteroposterior glide of the talus. His knee to the wall score was 11 cm on the left side and 6 cm on the right side, with reported stiffness and lateral ankle pain.12 His timed single-leg stance postural stability test with eyes closed was reduced on the right side (4 seconds; left side, 16 seconds). He scored 58 on the Foot and Ankle Score Scale component of the Foot and Ankle Outcomes Questionnaire. The Foot and Ankle Score Scale is a 20-item questionnaire on stiffness, swelling, pain, activity limitation, balance, and giving way, where 0 represents a poor outcome and 100 represents the best possible outcome.13 The scale has good content and construct validity and reliability for a variety of ankle and foot conditions.14 Mr. R’s score placed him well below the 25th percentile of the normative data, suggesting marked disability.15 Magnetic resonance imaging of Mr. R’s right ankle showed complete rupture of his ATFL and a grade 2 tear of his CFL. There was no evidence of any fracture, but there was mild periosteal bruising of the talus. Number 8 How did the physical therapist apply the results of the Cochrane Systematic Review to the patient? Mr. R reported having an acute ankle sprain with a background of chronic ankle instability affecting his sporting and daily activities. The clinical question, using the PICO (Patient, Intervention, Comparison, Outcome) format, is: Would Mr. R benefit from a neuromuscular training program to improve his functional outcomes? The Cochrane review supports the use of neuromuscular training to improve function in chronic ankle instability. The review reported on studies that recruited participants who had characteristics similar to those of Mr. R; thus, the results could be generalized to him. Mr. R was otherwise healthy and did not have comorbidities that would prohibit his participation in a supervised exercise program. Based on Mr. R’s presentation and the evidence from the systematic review, the physical therapist recommended a neuromuscular training program to the patient. Mr. R had reported carrying out some neuromuscular training after his previous ankle sprains. His adherence to prescribed programs was poor, but he was willing to start a new neuromuscular training program. Mr. R received treatment once a week for the first 4 weeks and then had his final review appointment on week 6. His treatment consisted initially of reduction of pain and swelling through ice, compression, and nonsteroidal anti-inflammatory drugs, as well as passive accessory and passive physiological joint mobilizations to restore full talocrural mobility. He was given a home neuromuscular training program to improve his balance, ankle mobility, and ankle strength (Tab.). He was expected to carry out this program 5 days a week. As there was ongoing structural laxity, Mr. R had his ankle taped August 2012 <LEAP> Case #9 Neuromuscular Training for Chronic Ankle Instability Table. Mr. R’s Neuromuscular Training Program as Prescribed by His Physical Therapista Time Week 1 a b Exercise Progressed by: Frequency Postural stability: ● Single-leg standing ● Uneven surfaces ● Closed eyes ● Perturbations 5 min, twice per day Peroneal muscle strengthening: ● Thera-Band (Hygenic Corporation, Akron, Ohio) exercises ● Calf raises ● Strength of Thera-Band ● Double leg to single leg as soon as symptoms allowed (day 5). Then weight added (via a dumbbell) starting at 5 kg and increased by 2.5 kg per week until full return to play. 3 sets of 10 repetitions, once per day Week 3b Landing off a step in multiple directions Target hopping in multiple directions 3 sets of 1 min Week 4 Straight-line running Alternate days for 30 min Weeks 5 and 6 Running with increased speed and multiple direction changes Alternate days for 30 min The exercises that were included in the programs investigated by studies from the Cochrane review are shown in italics. After regaining full pain-free range of movement. during all training sessions and matches as he returned to soccer to provide additional structural support while continuing to improve his postural stability and strength. How well do the outcomes of the intervention provided to the patient match those suggested by the systematic review? After 6 weeks, Mr. R had returned to full training. He had full talocrural mobility and full strength in his peroneal and calf muscles. There was ongoing but pain-free laxity on anterior drawer and talar tilt testing. His single-leg stance postural stability test with eyes closed improved to 10 seconds on his affected side. He scored 97 on the Foot and Ankle Score Scale, indicating he had almost returned to full function (normative mean⫽93.15, SD⫽12.33).15 Mr. R understood the importance on continuing to improve his static postural stability and the need to achieve symmetry and maintain these improvements during the season to avoid further re-sprain. Can you apply the results of the systematic review to your patients? The findings of the Cochrane review provide some evidence that neuroAugust 2012 muscular training can lead to small, short-term improvements in function compared with no training. For Mr. R, the training effect allowed him to improve function and return to sporting activities. Although the studies in the Cochrane review recruited patients with an average age in the 20s, as in Mr. R’s case, there is no reason why the same benefits would not be expected in the general adult or adolescent population seen by physical therapists for chronic ankle instability. Studies in the Cochrane review do not provide evidence on the long-term benefits of neuromuscular training, and, to our knowledge, no relevant randomized controlled trials have been published since the last search date of this Cochrane review (February 2010). However, evidence from exercise trials in other musculoskeletal conditions suggests that benefits of a training program decline over time and booster sessions are useful to maintain long-term benefits.16 There are measures related to the functional and mechanical insufficiencies that are thought to contribute to chronic ankle instability, such as deficits in strength, proprioception, and neuromuscular or postural control9 (for a clinical case using some of these measures, see the case report by O’Driscoll et al17). These measures were not included as outcomes in the Cochrane review; however, other evidence is available to supplement the review’s findings. A recent systematic review with best evidence synthesis concurs with the findings of the Cochrane review and concludes that neuromuscular training can improve discrete functional insufficiencies (eg, static and dynamic postural stability) associated with chronic ankle instability.18 The results indicate that in the future significant emphasis should be placed on the mode specificity of neuromuscular training. This would seem a pertinent point given the multifactorial nature of chronic ankle instability. Another recent systematic review shows that neuromuscular training can reduce lowerlimb injuries in an athletic population.19 Furthermore, a neuromuscular training program could be implemented in people after acute ankle sprain without the diagnosis of chronic ankle instability. Hupperets and colleagues20,21 showed that after an ankle sprain, a home proprioceptive exercise program is effective and cost-effective at preventing re-sprain at 1 year. Volume 92 Number 8 Physical Therapy f 989 <LEAP> Case #9 Neuromuscular Training for Chronic Ankle Instability What can be advised based on the results of this systematic review? The results of the Cochrane review provide stronger evidence than individual studies that neuromuscular training can improve short-term functional outcomes in people with chronic ankle instability. The programs used in the reviewed studies are 20 to 30 minutes in duration a few times a week for 4 to 6 weeks and mostly consist of progressive postural stability, proprioceptive, and strengthening exercises. The long-term benefits of neuromuscular training in chronic ankle instability are not known, but studies have shown that neuromuscular training can reduce the risk of other lowerlimb injuries, including ankle re-sprain.19,21 The Cochrane review also provides insights for future research in neuromuscular training for ankle instability. What is required is large, adequately powered trials with a broad age group and information on costeffectiveness. There also is a need to establish treatment effects beyond the immediate treatment period and identify the specific training components that constitute the most effective form of neuromuscular training. C-W.C. Lin, PT, PhD, Musculoskeletal Division, The George Institute for Global Health and Sydney Medical School, The University of Sydney, PO Box M201, Missenden Road, New South Wales 2050, Australia. Address all correspondence to Dr Lin at: clin@ george.org.au. E. Delahunt, PT, PhD, School of Public Health, Physiotherapy and Population Science and Institute for Sport and Health, University College Dublin, Dublin, Ireland. E. King, PT, MScManipTher, Physiotherapy Department, Sports Surgery Clinic, Dublin, Ireland. Dr Lin is funded by the National Health and Medical Research Council, Australia. 990 f Physical Therapy Volume 92 [Lin C-WC, Delahunt E, King E. Neuromuscular training for chronic ankle instability. Phys Ther. 2012;92:987–991.] © 2012 American Physical Therapy Association Published Ahead of Print: May 24, 2012 Accepted: April 11, 2012 Submitted: October 13, 2011 DOI: 10.2522/ptj.20110345 References 1 The Cochrane Library. Available at: http:// www.thecochranelibrary.com/view/0/ index.html. Accessed March 14, 2012. 2 Fong DT, Hong Y, Chan LK, et al. A systematic review on ankle injury and ankle sprain in sports. Sports Med. 2007;37:73– 94. 3 de Bie RA, de Vet HC, van den Wildenberg FA, et al. The prognosis of ankle sprains. Int J Sports Med. 1994;18:285–289. 4 Gerber JP, Williams GN, Scoville CR, et al. Persistent disability associated with ankle sprains: a prospective examination of an athletic population. Foot Ankle Int. 1998; 19:653– 660. 5 Yeung MS, Chan KM, So CH, Yuan WY. An epidemiological survey on ankle sprain. Br J Sports Med. 1994;28:112–116. 6 Delahunt E, Coughlan GF, Caulfield B, et al. Inclusion criteria when investigating insufficiencies in chronic ankle instability. Med Sci Sports Exerc. 2010;42:2106 – 2121. 7 van Rijn RM, van Os AG, Bernsen RM, et al. What is the clinical course of acute ankle sprains? A systematic literature review. Am J Med. 2008;121:324 –331. 8 Fong DT, Man CY, Yung PS, et al. Sportrelated ankle injuries attending an accident and emergency department. Injury. 2008;39:1222–1227. 9 Hertel J. Functional anatomy, pathomechanics, and pathophysiology of lateral ankle instability. J Athl Train. 2002;37: 364 –375. 10 de Vries JS, Krips R, Sierevelt IN, et al. Interventions for treating chronic ankle instability. Cochrane Database Syst Rev. 2011;(8):CD004124. 11 Hale SA, Hertel J, Olmsted-Kramer LC. The effect of a 4-week comprehensive rehabilitation program on postural control and lower extremity function in individuals with chronic ankle instability. J Orthop Sports Phys Ther. 2007;37:303–311. 12 Bennell K, Talbot R, Wajswelner H, et al. Intra-rater and inter-rater reliability of a weight-bearing lunge measure of ankle dorsiflexion. Aust J Physiother. 1998;44: 175–180. 13 Foot and Ankle Outcomes Questionnaire. Available at: http://www.aaos.org/research/ outcomes/Foot_Ankle.pdf. Accessed December 21, 2011. Number 8 14 Johanson NA, Liang MH, Daltroy L, et al. American Academy of Orthopaedic Surgeons lower limb outcomes assessment instruments: reliability, validity, and sensitivity to change. J Bone Joint Surg Am. 2004;86:902–909. 15 American Academy of Orthopaedic Surgeons website. Available at: http://www. aaos.org/research/outcomes/outcomes meanstable.pdf. Accessed December 21, 2011. 16 Pisters MF, Veenhof C, van Meeteren NL, et al. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review. Arthritis Rheum. 2007;57:1245–1253. 17 O’Driscoll J, Kerin F, Delahunt E. Effect of a 6-week dynamic neuromuscular training programme on ankle joint function: a case report. Sports Med Arthrosc Rehabil Ther Technol. 2011;3:13. 18 O’Driscoll J, Delahunt E. Neuromuscular training to enhance sensorimotor and functional deficits in subjects with chronic ankle instability: a systematic review and best evidence synthesis. Sports Med Arthrosc Rehabil Ther Technol. 2011;3: 19. 19 Hübscher M, Zech A, Pfeifer K, et al. Neuromuscular training for sports injury prevention: a systematic review. Med Sci Sports Exerc. 2010;42:413– 421. 20 Hupperets MD, Verhagen EA, Heymans MW, et al. Potential savings of a program to prevent ankle sprain recurrence: economic evaluation of a randomized controlled trial. Am J Sports Med. 2010;38: 2194 –2200. 21 Hupperets MD, Verhagen EA, van Mechelen W. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial. BMJ. 2009;339:b2684. 22 Martin RL, Burdett RG, Irrgang JJ. Development of the Foot and Ankle Disability Index (FADI) [abstract]. J Orthop Sports Phys Ther. 1999;29:A32–A33. 23 Martin RL, Irrgang JJ. A survey of selfreported outcome instruments for the foot and ankle. J Orthop Sports Phys Ther. 2007;37:72– 84. 24 Rozzi SL, Lephart SM, Sterner R, Kuligowski L. Balance training for persons with functionally unstable ankles. J Orthop Sports Phys Ther. 1999;29:478 – 486. 25 Karlsson J, Peterson L. Evaluation of the ankle joint function: the use of a scoring scale. Foot. 1991;1:15–19. 26 Higgins JPT, Altman DG, Sterne JAC; on behalf of the Cochrane Statistical Methods Group and the Cochrane Bias Methods Group. Assessing risk of bias in included studies. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0. 2011. Available at: http://www.cochranehandbook.org. Accessed October 12, 2011. August 2012 <LEAP> Case #9 Neuromuscular Training for Chronic Ankle Instability Appendix. Neuromuscular Training for Chronic Ankle Instability: Cochrane Review Results10 Characteristics of included trials: Literature search was conducted in February 2010. Four randomized controlled trials investigating neuromuscular training were included. The study populations were small (n⫽19–31) and young (mean age⫽20.9–29.7 years), providing data on 98 male and female participants. Participant inclusion criteria varied slightly across studies, but all participants were required to have a history of ankle sprain with a self-report of ankle instability, ankle weakness, or recurrent sprains. Details of the interventions: Three of the 4 included studies compared neuromuscular training with no training. Neuromuscular training included wobble board, hopping, and single-leg standing exercises and consisted of 8 to 12 supervised sessions of 20 to 30 minutes lasting 4 weeks. One study also included range of motion, strengthening, and functional exercises, as well as a home exercise component. One of the 4 included studies compared bidirectional with unidirectional pedaling on a recumbent stationary bicycle. The bidirectional pedal was able to tilt 20° in the frontal plane and thus was used to challenge ankle joint stability, ankle joint movement, proprioception, and evertor torque. The sessions were 3 times a week, 45 minutes a day, and lasted for 6 weeks. Outcome assessment: All studies evaluated outcomes at the end of the treatment period without a longer-term follow-up. The primary outcomes of the review were functional outcome and patient-reported stability. Results on function were reported by the included studies using the following self-report questionnaires: ● Foot and Ankle Disability Index (FADI)22—consisting of 22 items measuring the activity limitation of daily activities (eg, walking) and 4 items on pain. ● Foot and Ankle Disability Index Sport Scale (FADI-Sport)22—consisting of 8 items measuring the activity limitation of daily activities (eg, running). ● Both the FADI and FADI-Sport are scored from 0 (lowest score) to 100 (highest score). Although some measurement properties have been investigated,23 the minimal clinically important difference is not known. ● Ankle Joint Functional Assessment Tool24—consisting of 12 items on impairments (eg, pain) and activity limitation (eg, ability to walk), with unknown measurement properties. ● Modified Karlsson Functional Score25—consisting of 7 items on impairments (eg, pain) and activity limitation (eg, work, activities), with limited information on its measurement properties.23 The included studies also reported physiological outcomes (eg, surface electromyography on sudden ankle inversion), but these outcomes were not outcomes of the review and thus were not presented. Risk of bias: The risk of bias tool of the Cochrane Collaboration was used.26 ● Selection bias (random sequence generation and allocation concealment): only 1 study had a low risk of bias in random sequence generation. None of the studies provided enough information on allocation concealment. Overall, the studies had an unclear risk of selection bias. ● Blinding: blinding is difficult in exercise trials using patient-reported outcomes. None of the studies used blinding. ● Attrition bias (incomplete outcome data): All studies had an unclear risk, as there was either no reporting of loss to follow-up or the methods used to account for loss to follow-up. ● Reporting bias: Three studies reported all of the outcomes specified in the “Method” section and scored a low risk of bias. One study was unclear, as the reporting was incomplete for most outcomes. Results: Overall, there was a small benefit toward neuromuscular training compared with no training. Neuromuscular training versus no training (3 studies) ● There was a statistically significant between-group difference showing a treatment effect in favor of neuromuscular training. The pooled results from 2 studies showed a mean between-group difference of 8.83/100 (95% confidence interval⫽4.46–13.20) on the FADI and 11.59/100 (95% confidence interval⫽6.48–16.69) on the FADI-Sport. No information is available on the minimal clinically important difference for either scale. However, the between-group differences are around 10 points on a 100-point scale and, therefore, could be considered small in magnitude. ● A third study also showed a small and statistically significant treatment effect favoring neuromuscular training (mean between-group difference of 3 on the 48-point Ankle Joint Functional Assessment Tool, 95% confidence interval⫽0.3–5.70). Bidirectional versus unidirectional pedaling (1 study) ● No statistically significant difference was found. As measured on the Modified Karlsson Functional Score, where the highest score is 85, the scores at the end of the program were 76.9 in the bidirectional group and 66.3 in the unidirectional group. No measure of dispersion was given. August 2012 Volume 92 Number 8 Physical Therapy f 991 Research Report B.S. Sindhu, PhD, OTR, Department of Occupational Science and Technology, University of Wisconsin–Milwaukee, 2400 E Hartford Ave, Milwaukee, WI 53211 (USA). Address all correspondence to Dr Sindhu at: [email protected]. L.A. Lehman, PhD, OT, Department of Psychology, University of South Carolina Upstate, Spartanburg, South Carolina. S. Tarima, PhD, Division of Biostatistics, Medical College of Wisconsin, Milwaukee, Wisconsin. Influence of Fear-Avoidance Beliefs on Functional Status Outcomes for People With Musculoskeletal Conditions of the Shoulder Bhagwant S. Sindhu, Leigh A. Lehman, Sergey Tarima, Mark D. Bishop, Dennis L. Hart,† Matthew R. Klein, Mikesh Shivakoti, Ying-Chih Wang Background. The influence of elevated fear-avoidance beliefs on change in functional status is unclear. Objective. The purpose of this study was to determine the influence of fear- M.D. Bishop, PT, PhD, Department of Physical Therapy, University of Florida, Gainesville, Florida. avoidance on recovery of functional status during rehabilitation for people with shoulder impairments. D.L. Hart, PT, PhD, Focus On Therapeutic Outcomes, Inc, Knoxville, Tennessee. Design. A retrospective longitudinal cohort study was conducted. M.R. Klein, BS, Department of Occupational Science and Technology, University of Wisconsin– Milwaukee. tions of the shoulder receiving rehabilitation. At intake and discharge, upperextremity function was measured using the shoulder Computerized Adaptive Test. Pain intensity was measured using an 11-point numerical rating scale. Completion rate at discharge was 57% for function and 47% for pain intensity. A single-item screen was used to classify patients into groups with low versus elevated fear-avoidance beliefs at intake. A general linear model (GLM) was used to describe how change in function is affected by fear avoidance in 8 disease categories. This study also accounted for within-clinic correlation and controlled for other important predictors of functional change in functional status, including various demographic and healthrelated variables. The parameters of the GLM and their standard errors were estimated with the weighted generalized estimating equations method. M. Shivakoti, MS, Division of Biostatistics, Medical College of Wisconsin. Y-C. Wang, PhD, OTR/L, Department of Occupational Science and Technology, University of Wisconsin–Milwaukee, and Focus On Therapeutic Outcomes, Inc, Knoxville, Tennessee. † Dr Hart died April 11, 2012. [Sindhu BS, Lehman LA, Tarima S, et al. Influence of fear-avoidance beliefs on functional status outcomes for people with musculoskeletal conditions of the shoulder. Phys Ther. 2012;92: 992–1005.] Methods. Data were collected from 3,362 people with musculoskeletal condi- Results. Functional change was predicted by the interaction between fear and disease categories. On further examination of 8 disease categories using GLM adjusted for other confounders, improvement in function was greater for the low fear group than for the elevated fear group among people with muscle, tendon, and soft tissue disorders (⌬⫽1.37, P⬍.01) and those with osteopathies, chondropathies, and acquired musculoskeletal deformities (⌬⫽5.52, P⬍.02). These differences were below the minimal detectable change. © 2012 American Physical Therapy Association Limitations. Information was not available on whether therapists used information on level of fear to implement treatment plans. Published Ahead of Print: May 24, 2012 Accepted: May 21, 2012 Submitted: September 17, 2011 Conclusions. The influence of fear-avoidance beliefs on change in functional status varies among specific shoulder impairments. Post a Rapid Response to this article at: ptjournal.apta.org 992 f Physical Therapy Volume 92 Number 8 August 2012 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes E very year, 4 million people receive medical care for musculoskeletal conditions of the shoulder,1,2 resulting in direct health care costs of an estimated 7 billion dollars.3 Pain is the most common symptom associated with these conditions.1,2 Many times, shoulder pain is associated with repetitive motions at work or during participation in athletics.4 –7 Among people with musculoskeletal conditions, fearavoidance beliefs related to pain are prevalent and have been associated with greater disability and functional limitations.8,9 Among individuals with fewer fear-avoidance beliefs, fear usually dissipates as the condition resolves. However, elevated fearavoidance beliefs can be maladaptive, leading to chronic pain, disability, and reduced function.10 –15 Chronic pain and disability result from elevated fear, as described by the fear-avoidance model (FAM).10,14,16,17 According to this model, some individuals consider a painful stimulus as negative, and avoid or postpone the presentation of an event that is considered painful.18 Also, these individuals are hypervigilant toward painful stimuli, paying less attention to other tasks. Over a long period of time, hypervigilance and avoidance of physical activity lead to deconditioning of the musculoskeletal and cardiovascular systems, which, in turn, results in the development of chronic pain and disability.10 Conflicting evidence exists regarding the influence of fear-avoidance beliefs on treatment outcomes. Study findings range from poor to improved treatment outcomes among people with elevated fear. In support of the FAM, an increasing number of studies are reporting that elevated fear-avoidance beliefs adversely affect outcomes of treatment. For example, studies indicate that outcomes of lumbar surgery are poorer when patients report ele- The Bottom Line What do we already know about this topic? Fear-avoidance beliefs related to pain are prevalent among people with musculoskeletal conditions, and these beliefs have been associated with greater disability and functional limitations. However, it is not known how pain-related fear-avoidance beliefs affect the outcome of rehabilitation in people with shoulder impairments. What new information does this study offer? Elevated fear-avoidance beliefs were associated with poorer improvement in functional status from intake to discharge among people in the following 2 shoulder disease categories: (1) muscle, tendon, and soft-tissue disorders, and (2) osteopathies, chondropathies, and acquired musculoskeletal deformities. vated levels of fear before surgery,19 as well as after surgery.20 Rehabilitation outcomes also are worse when fear is elevated at intake in people with low back pain.21,22 In contrast to these findings and clinical intuition, some studies have shown no effect of elevated fear on treatment outcomes. For example, Pincus et al24 conducted a systematic review examining the effect of fearavoidance beliefs on treatment outcomes among people with low back pain. Based on findings from 9 studies, these researchers concluded that little evidence exists to link fearavoidance beliefs with poor treatment outcomes.23 Furthermore, other studies have shown greater improvement among people with elevated fear. For instance, elevated fear due to shoulder pain at intake was associated with a larger reduction in pain at 3-month and 12-month follow-ups, as well as a greater reduction in functional disability at a 3-month follow-up, in a general practice setting.24 Likewise, elevated fear was associated with better physical therapy outcomes among people with upper-extremity musculoskeletal conditions25 and people with low back pain.26 In these studies, the associations between fear and treatment outcomes were mediated by the relationship among pain, disability, and fear. In other words, people with elevated fear reported more pain and disability despite having a greater change in function. Additional research into the phenomenon of elevated fear associated with reduced pain and greater funcAvailable With This Article at ptjournal.apta.org If you’re a patient, what might these findings mean for you? The data from this study suggests that if you have a condition in 1 of the 2 disease categories above, your physical therapist may be able to improve your treatment outcomes by assessing for the presence of fearavoidance beliefs and helping you manage those beliefs. August 2012 • Discussion Podcast with Julie Fritz and authors Bhagwant Sindhu and Mark Bishop. Moderated by Chris Main. Volume 92 Number 8 Physical Therapy f 993 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes tional gains requires a more detailed analysis of the association between fear and function. Conflicting findings regarding effects of fearavoidance beliefs on treatment outcomes might be because studies have accounted for different confounding variables in their analysis. For instance, den Boer et al19 found that preoperative levels of fear resulted in poorer outcomes of surgery after controlling for preoperative disability and pain intensity, age, sex, educational level, duration of complaints, neurological deficits, and intake of analgesics. In contrast, George and Stryker25 found a greater improvement in function among people with elevated fear after accounting for differences in anatomical region and controlling for effect of differences in clinics. Consequently, there is a need to systematically examine how the effect of fear changes from before to after accounting for various confounding variables. The purposes of the current study were: (1) to determine the effect of fear-related cognitions on functional recovery with and without accounting for various confounding variables and (2) to determine the influence of fear-related cognitions on recovery of functional status during rehabilitation across different diagnostic categories of shoulder impairments. This study builds on previous work in that it accounts for differences between 8 disease categories—(1) arthropathies; (2) muscle, tendon, and soft tissue disorders; (3) osteopathies, chondropathies, and acquired musculoskeletal deformities; (4) fractures; (5) sprains and strains, (6) postsurgical, (7) “other,” and (8) condition not reported—and other factors associated with change in function. We hypothesized that patients’ fear-avoidance beliefs at intake would be predictive of the changes in function after accounting for other factors associated with functional status outcomes. In addition, there is a need to determine the association between fear and function in specific disease categories. Previous studies have not only grouped different shoulder conditions together, but also have grouped shoulder conditions with neck and upper arm conditions.25,28 Moreover, it is uncertain how fear influences different regions of the body. For example, George and Stryker25 reported that fear-avoidance beliefs similarly affect 4 different anatomical regions of the body: cervical spine, lumbar spine, upper extremity, and lower extremity. In contrast, Feleus et al27 reported that fear of movement occurred more with shoulder impairment than neck or arm injury. This study’s findings, coupled with the large incidence of painful musculoskeletal disorders of the shoulder, indicate that varying responses to pain and levels of fear of pain in different shoulder conditions might be an important focus for future research. Method 994 f Physical Therapy Volume 92 Setting and Participants We conducted a secondary analysis of data prospectively collected from people with musculoskeletal conditions of the shoulder who attended outpatient rehabilitation clinics throughout the United States. The data were collected using the Patient Inquiry system, a patient evaluation tool provided to clinics by Focus On Therapeutic Outcomes (FOTO), Inc (Knoxville, Tennessee).28 –30 FOTO is a medical rehabilitation database management company that partners with clinics to provide outcome measures and data management services. The FOTO outcomes database includes standardized assessments of function, along with instruments that collect information on demographic characteristics, patient history, physical functioning, pain, psychosocial constructs such as fear avoidance, and characteristics of health care providers and organizations.31–33 For the present study, the Number 8 FOTO database was reduced to include 3,362 patients who received outpatient rehabilitation for shoulder conditions between 2008 and 2010 in 35 different clinics. We selected the time frame of 2008 to 2010, as we sought to determine the association between fear avoidance and recovery of shoulder functional status in the context of currently used rehabilitation strategies. Patient data were not included from clinics contributing fewer than 20 patients to the FOTO database. We assumed that smaller clinics might not have an established protocol for patients with specific conditions of the shoulder. Therefore, we excluded smaller clinics to reduce the heterogeneity attributed by their data (Appendix). People seeking rehabilitation for shoulder impairments provided demographic information (eg, age, sex, exercise history) before their initial clinical evaluation. During clinical evaluation at admission (intake) and at the end of rehabilitation (discharge), patients’ upper-extremity functional status and pain intensity were assessed. Additionally, fear-avoidance beliefs were evaluated at intake. Clinical staff entered necessary medical information at intake, such as diagnosis codes based on the International Classification of Diseases, Ninth Revision (ICD-9).34 The ICD-9 codes have been found to have variable interrater reliability (55%–98% agreement) and poor to moderate validity, with 40% to 74% agreement between coders and the gold standard.35–37 Moreover, ICD-9 codes lack sufficient specificity values (0.30 – 0.81), even though they have high sensitivity values (0.81).36 Assessments The shoulder Computerized Adaptive Test (CAT) was used to measure upper-extremity function at 2 time points: intake and discharge. The shoulder CAT estimates reliable, valid, sensitive, and responsive measures of functional status for individAugust 2012 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes uals with shoulder impairments.28,38 – 40 Specifically, the shoulder CAT is a self-report assessment of a person’s ability to perform daily tasks using the affected arm.41 It consists of a 37-item bank administered using a computer algorithm.28,39 The computer algorithm selects items at the functional level of a person; thus, patients complete only those items that provide the greatest amount of information about their functional status.42 Each item is rated on a 5-point scale ranging from 1 (“I can’t do this”) to 5 (“no difficulty”). The final functional status score represents a point estimate of functional status of a person on a linear 0 to 100 scale, with higher scores indicating higher functioning. Clinically meaningful change for shoulder CAT is 23 or more points for an intake score of 0 to 43, 10 or more points for an intake score of 44 to 52, 5 or more points for and intake score of 53 to 60, and 2 or more points for an intake score of 61 to 100.40 A numerical rating scale (NRS) was used for reporting shoulder pain intensity at intake and discharge. The NRS is a commonly used measure of pain intensity.43 The NRS has well-established psychometric properties; it is valid43– 46 and sensitive to changes in pain intensity.47– 49 The NRS used by FOTO consists of an 11-point scale, with its anchors being 0 (no pain) and 10 (worst possible pain). A reduction of 1 point on the NRS is considered as a minimal clinically important improvement (MCII) in pain intensity.50 Clinic staff asked patients to rate their current pain intensity by indicating a number from a list of integers displayed horizontally in ascending order. A single-item screening method was used to classify patients into groups with low versus elevated fearavoidance beliefs at intake. This screening item was selected from August 2012 the Fear-Avoidance Beliefs Questionnaire physical activities scale (FABQPA), which consists of 16 items describing the association between pain and physical activities.51 A single item—“I should not do physical activities that (might) make my pain worse”—was identified using item response theory (IRT) methods and receiver operating characteristic analyses. This item was found to be effective in distinguishing between elevated fear and low fear. That is, this item has a sensitivity value of 0.82, a specificity value of 0.98, and an area under the receiver operating characteristic curve of 0.94.51 The item was scored on a 5-point scale ranging from 0 to 4, where 0 means “completely disagree,” 2 means “unsure,” and 4 means “completely agree.” Responses of 2 to 4 were classified as elevated fear, and responses of 0 and 1 were classified as low fear.51 Data Analysis We divided our sample into 2 groups based on level of fear-avoidance beliefs at intake (ie, low versus elevated fear) using the IRT-based single item. In addition, the patients were divided into 3 groups based on duration of condition (acute⫽less than 22 days, subacute⫽22–90 days, and chronic⫽greater than 90 days),52 into 3 groups based on age (18 – 44 years, 45– 64 years, and 65 years and older),53 and into 8 disease categories based on their ICD-9 codes (Tab. 1). Change in functional status was calculated by subtracting the shoulder CAT score at intake from the shoulder CAT score at discharge (shoulder CAT at discharge ⫺ shoulder CAT at intake). Thus, a positive functional status change score indicated an improvement in function from intake to discharge. Differences in mean functional status change scores between the 2 fear-avoidance belief groups were calculated by subtracting the change score for the elevated fear group from the change score for the low fear group. A neg- ative difference in means indicated greater functional improvement in the elevated fear group, and a positive difference in means indicated greater functional improvement in the low fear group. Likewise, change scores for pain intensity were calculated by subtracting pain intensity at intake from pain intensity at discharge, with a positive change score indicating an increase in pain (pain intensity at discharge ⫺ pain intensity at intake). All individuals included in our sample (N⫽3,362) reported their functional status and pain scores at intake. At discharge, however, only 1,946 people reported functional status, 1,538 reported pain intensity, and 1,519 reported both functional status and pain intensity. A logistic regression analysis was used to determine whether a relationship existed between the incompletion rate (ie, not having a functional status or pain intensity score at discharge) and demographic characteristics measured at intake. This logistic regression allowed us to estimate dropout probabilities and calculate weights54,55 to account for any imbalances in demographic characteristics between those who had only intake data and those who had both intake and discharge data. This procedure was designed to reduce the effect of missing data by providing weighted demographics of the population at discharge that had similar demographic characteristics as the unweighted intake data. Using inverse probability weights generated from the logistic regression model, we estimated the parameters of a general linear model (GLM) and their standard errors with the weighted generalized estimating equations.56 This model determined how change in function is affected by fear-avoidance beliefs, as well as by interactions of fear with other demographic variables (age groups, Volume 92 Number 8 Physical Therapy f 995 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes Table 1. Demographic and Health-Related Characteristics of Patients With Shoulder Impairments Who Had Low Versus Elevated FearAvoidance Beliefsa Elevated FearAvoidance Beliefs (nⴝ766) Characteristicsb Age (y) Low FearAvoidance Beliefs (nⴝ2,596) X or n SD or % X or n SD or % 54.2 16.4 54 15.6 All (Nⴝ3,362) X or n 54.1 SD or % 15.8 Sex Male 342 44.6 1,192 45.9 1,534 45.6 Female 424 55.4 1,404 54.1 1,828 54.4 Middle Atlantic 192 25.1 501 19.3 693 20.6 Mountain 126 16.4 507 19.5 633 18.8 North Central Region of clinic 355 46.3 1,282 49.4 1,637 48.7 Pacific 10 1.3 26 1.0 36 1.1 South Atlantic 22 2.9 77 3.0 99 2.9 South Central 61 8.0 203 7.8 264 7.9 Acute (0–21 days) 180 23.5 467 18.0 647 19.2 Subacute (22–90 days) 239 31.2 836 32.2 1,075 32.0 Chronic (ⱖ91 days) 347 45.3 1,293 49.8 1,640 48.8 63 8.2 273 10.5 336 10.0 412 53.8 1,485 57.2 1,897 56.4 3 0.4 30 1.2 33 1.0 12 1.6 37 1.4 49 1.5 Duration of condition Disease categories Arthropathies (ICD-9 codes 714.41–719.81) Muscle, tendon, and soft tissue disorders (ICD-9 codes 726–729.5) Osteopathies, chondropathies and acquired musculoskeletal deformities (ICD-9 code 731.1) Fractures (ICD-9 codes 810.03–812.2) Sprains and strains (ICD-9 codes 840.0–840.972) 66 8.6 175 6.7 241 7.2 117 15.3 268 10.3 385 11.5 Other musculoskeletal conditions (ICD-9 codes 353, 714.41–719.81, 831–831.11, 923, 953.4)c 79 10.3 263 10.1 342 10.2 Not reported 14 1.8 65 2.5 79 2.3 Postsurgical (CPT codes 23000–23929) Functional status score on shoulder Computerized Adaptive Test Intake (0–100) 46.4 15.3 51.7 13.9 50.5 14.4 Discharge (0–100) 66.9 15.5 69.1 14.5 68.6 14.8 Change (discharge ⫺ intake) 20.9 19.0 17.6 16.8 18.3 17.4 Intake (0–10) 5.8 2.4 5.3 2.4 5.4 2.4 Discharge (0–10) 3.2 2.5 2.8 2.2 2.9 2.3 ⫺2.4 2.9 ⫺2.5 2.7 ⫺2.5 2.7 Pain intensity score on numerical rating scale Change (discharge ⫺ intake) a ICD-9⫽International Classification of Diseases, Ninth Edition; CPT⫽Current Procedural Terminology. Significance for differences between low versus elevated fear groups for various characteristics has not been calculated, as such significance will not be adjusted for random effects (clinics) and missing data and any reference to it will be misleading. c The category of “Other musculoskeletal conditions” was created by combining dislocations (n⫽22, ICD-9 code 831), contusions (n⫽7, ICD-9 code 923), peripheral nerve disorders (n⫽6, ICD-9 codes 353 and 953.4), and not otherwise classified musculoskeletal conditions (n⫽41) due to their very small sample size. b 996 f Physical Therapy Volume 92 Number 8 August 2012 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes sex) and health-related variables (disease category, duration of condition, function at intake, pain intensity at intake, change in pain intensity). Possible within-clinic correlation was accounted for by including in the model an exchangeable working correlation matrix. All interactions were tested for significance. Fear significantly interacted only with disease categories. A separate GLM was used to calculate estimates unadjusted for other confounders (but adjusted for within-clinic correlation) to determine the effect of fear on change in function as expressed in each disease category by including only fear and disease category as independent variables. These unadjusted estimates represented mean differences in functional status change score between low and elevated fear groups (low fear group ⫺ elevated fear group) after controlling for subject effects and missing data at discharge. Furthermore, contrast statements were used to test the significance and to assess the effect of fear on change in function separately for each disease category. Finally, we fitted a GLM adjusted for other significant predictors of change in function. In this GLM, the effect of fear on change in function for each disease category was included in the set of predictors as the variable of primary research interest. The adjusted estimates represented mean differences in functional status change score between low and elevated fear groups (low fear group ⫺ elevated fear group), while accounting for within-clinic correlation and for the effect of possible confounders. The confounders (ie, other significant predictors of change in function) that we controlled for included both pain intensity at intake and change in pain intensity from intake to discharge. These 2 pain intensity scores were included because both provide different information about change in August 2012 Figure 1. Bar graph representing functional status change score (shoulder Computerized Adaptive Test [CAT] functional status score at discharge – shoulder CAT functional status score at intake) for people with low versus elevated fear-avoidance beliefs, without accounting for differences in subject effects, missing data, disease categories, clinics, and other confounding variables (asterisk indicates significance at alpha level of ⱕ.05). functional status. Change in function was likely to be predicted by pain intensity at intake (eg, higher pain at intake resulting in smaller change in function). However, pain at intake does not indicate how pain intensity changes with treatment. A greater change in pain intensity was likely to be associated with a greater change in function. In addition to the confounders, we controlled for subject effects and missing data at discharge. We identified significant predictors with the forward stepwise variable selection procedure. The level of fear, disease categories, and their interactions were always kept in the model. All main effects and 2-way interactions were tested for significance. The significance of continuous variables was explored through their linear and quadratic effects. For categorical variables, categories with small cell counts (less than 10) were combined with adjacent categories or by creat- ing other meaningful groupings. Ordinal variables (duration of condition and age group) were treated as continuous, and their linear effect was analyzed. The data analysis for this article was generated using the SAS software, version 9.2 of the SAS System for Unix (SAS Institute Inc, Cary, North Carolina). We declared findings significant when their P values were less than .05. Role of the Funding Source This work was supported, in part, by the Office of Undergraduate Research, University of Wisconsin– Milwaukee, and the Clinical and Translational Science Institute of Southeast Wisconsin, Medical College of Wisconsin. Results For our sample of 3,362 participants, the mean age was 54.1 years (SD⫽15.8, range⫽18 –92). Women made up more than half of the sample (n⫽1,828, 54%). Almost half of Volume 92 Number 8 Physical Therapy f 997 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes Table 2. Results of Wald Statistics for Type 3 General Linear Model (GLM) Model With Functional Status Change Score as the Dependent Variablea Sourceb df 2,c P Intake shoulder CAT score 1 190.92 ⬍.001 Square of intake shoulder CAT score 1 41.87 ⬍.001 Intake pain intensity score 1 94.91 ⬍.001 Pain observed 1 59.67 ⬍.001 Pain change observed 1 263.77 ⬍.001 Age group 2 13.74 .001 Duration of condition 2 14.31 ⬍.001 15 152.85 ⬍.001 1 10.72 .001 Disease category ⫻ fear Intake shoulder CAT score ⫻ pain observed Pain observed ⫻ age group 2 18.02 ⬍.001 Pain change observed ⫻ age group 2 15.81 ⬍.001 a Only significant terms are reported. CAT⫽Computerized Adaptive Test, pain observed⫽pain intensity change score was missing (ie, 0) vs pain intensity change score was reported (ie, 1), pain change observed⫽(pain intensity change score) ⫻ (pain observed), age group⫽18 – 44 years vs 45– 64 years vs 65 years and older, duration of condition⫽acute (0 –21 days) vs subacute (22–90 days) vs chronic (ⱖ91 days), fear⫽low vs elevated fear-avoidance beliefs. c Inference of GLM regression parameters was performed using the Wald test statistic where the estimated parameter was compared with a chi-square distribution. The null hypothesis was no significant effect on change in function for a continuous variable and no significant difference in change in function between groups for a categorical variable. b the participants were classified as having chronic symptoms (⬎90 days from date of onset) (n⫽1,640, 49%), a third were classified as having subacute symptoms (22–90 days from date of onset) (n⫽1,075, 32%), and one fifth were classified as having acute symptoms (⬍22 days from date of onset) (n⫽647, 19%). Of the participants with medical or surgical codes (n⫽3,283, 98%), the most common diagnoses were associated with soft tissue disorders (ICD-9 codes 725–729, 56%). More than a tenth (12%) of the participants had postsurgical conditions such as repair of rotator cuff (Current Procedural Terminology [CPT] codes 23000 –23929) (Tab. 1). Overall, almost three fourths (72%) of the participants reported no past surgical history, with 22% reporting 1 past surgery and 5% reporting 2 or more surgeries. A third (36%) of the participants reported exercising at least 3 times a week, followed by 39% who reported seldom or never exercising, and 26% reported exercising 1 to 2 times a week. Almost a third (31%) of the participants had 2 or 3 comorbidities, a quarter (25%) reported having none, another quarter (25%) reported having 1 comorbidity, and a fifth (19%) reported having 4 or more functional comorbidities. Elevated fear-avoidance beliefs at intake were observed among more than a fifth of participants (n⫽766, 23%). The age and sex distributions were similar for the low fear group and the elevated fear group (Tab. 1). Both groups had 27% in the age range of 18 to 44 years, 45% in the age range of 45 of 64 years, and 28% in the age range of 65 years and older. However, differences existed between the low and elevated fear groups in terms of some healthrelated characteristics and not for Table 3. Results of General Linear Model Unadjusted for and Adjusted for Other Confounders to Determine Differences in Functional Status Change Scores Between Low Fear Group and Elevated Fear Group for 8 Disease Categories Unadjusted Difference in Functional Status Change Score Disease Category Estimate (⌬) Standard Error P Arthropathies ⫺2.48 2.37 .29 Muscle, tendon, and soft tissue disorders ⫺0.15 1.04 .88 4.42 2.84 .12 ⫺18.33 4.95 ⬍.01a ⫺5.29 4.26 .21 Osteopathies, chondropathies, and acquired musculoskeletal deformities Fractures Sprains and strains Postsurgical Other musculoskeletal conditions Not reported a Adjusted Difference in Functional Status Change Score Estimate (⌬) Standard Error P 0.37 2.41 .87 1.37 0.57 .01a 5.52 2.51 .02a 1.93 3.04 .52 ⫺3.73 2.81 .18 ⫺2.15 1.82 .23 0.80 1.52 .59 ⫺14.70 4.57 ⬍.01a ⫺6.66 5.29 .21 ⫺2.69 2.04 .18 ⫺1.48 1.60 .36 Significant at alpha level of .05. 998 f Physical Therapy Volume 92 Number 8 August 2012 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes others. Both groups had similar distributions of diseases. For example, muscle, tendon, and soft tissue disorders formed the most common category of disorders in both groups, with 54% in the elevated fear group and 57% in the low fear group. Other musculoskeletal conditions formed the second largest category of diseases in both fear groups (10%). Pain intensity at intake was higher by 0.5 point for the elevated fear group (5.8) compared with the low fear group (5.3). In addition, pain intensity at discharge was half a point higher for the elevated fear group (3.2) compared with the low fear group (2.8). For both fear groups, the average reduction in pain intensity was greater than the 1 point MCII for the NRS (Tab. 1). Functional status at intake was 6 points higher for the low fear group (52 points) compared with the elevated fear group (46 points). Likewise, functional status at discharge was 2 points higher for the low fear group (69 points) compared with the elevated fear group (67 points; Tab. 1). In contrast, the improvement in function from intake to discharge was greater by 4 points for the elevated fear group (21 points) compared with the low fear group (17.6 points; Tab. 1, Fig. 1). In the logistic regression analysis that we used to estimate dropout probabilities and calculate weights, 5 variables were significant: age group (P⬍.0001), pain intensity at intake (P⬍.0001), function at intake (P⫽.0473), disease category (P⫽.0053), and region where the clinic was located (P ⬍.0001). Thus, these 5 variables were directly used for calculation of the GLM weights. The GLM identified that the effect of fear-avoidance beliefs on improvement in function varied among disease categories (2⫽153, P⬍.001; Tab. 2). On further examination of unadjusted estimates (ie, mean differences between the low fear August 2012 group and the elevated fear group) while accounting for patient differences and missing data but unadjusted for possible confounders, the GLM revealed that improvement in function was greater for the elevated fear group than for the low fear group among people with fractures (⌬⫽⫺18.3, Pⱕ.0002) and people with other musculoskeletal conditions (⌬⫽⫺14.7, Pⱕ.0013). However, improvement in function was not different between the elevated and low fear groups among people with arthropathies; muscle, tendon, and soft tissue disorders; osteopathies, chondropathies, and acquired musculoskeletal deformities; sprains and strains; and postsurgical conditions, as well as among people whose condition was not reported (Tab. 3, Fig. 2). In addition to the interaction between fear-avoidance beliefs and disease category, change in function was predicted by functional status at intake (linear and quadratic effects), pain intensity at intake, change in pain intensity, pain intensity reported versus not reported, age group, and duration of condition, as well as the clinic itself (Tab. 2). The effect of these significant predictors on change in function was controlled by calculating adjusted estimates for mean differences between low and elevated fear groups for the 8 disease categories (Tab. 3, Fig. 3). After adjustment (ie, extended examination of the 8 disease categories using adjusted GLM analysis), we found that improvement in function was greater for the low fear group than for elevated fear group among people with muscle, tendon, and soft tissue disorders (⌬⫽1.37, Pⱕ.01) and among people with osteopathies, chondropathies, and acquired musculoskeletal deformities (⌬⫽5.52, Pⱕ.02) (Tab. 3, Fig. 3). In contrast, improvement in function was not different between the elevated and low fear groups among people with arthropathies (⌬⫽0.37, P⫽.87), fractures (⌬⫽1.93, P⫽.52), sprains and strains (⌬⫽⫺3.73, P⫽.18), postsurgical conditions (⌬⫽0.80, P⫽.59), other musculoskeletal conditions (⌬⫽⫺6.66, P⫽.20), and condition not reported (⌬⫽⫺1.48, P⫽.35) (Tab. 3, Fig. 3). The data presented in Table 3 were used to make simple post hoc power calculations and to determine minimal detectable change (MDC) at 80% power. Using asymptomatic normality of regression coefficients and observed standard errors, we estimated values of regression coefficients we can detect at 80% power. For muscle, tendon, and soft tissue disorders, the observed difference was 1.37, whereas the minimal detectable difference at 80% power (ie, MDC) is 1.56. If the difference is actually 1.37, the hypothesis of no difference is rejected in 67% of cases (ie, an asymptotic power or 67%). For osteopathies, chondropathies, and acquired musculoskeletal deformities, the observed difference was 5.52, whereas the detectible difference at 80% power (ie, MDC) is 7.03. The power is 59% if the difference is 5.52. Discussion The findings of the present study revealed a small but significant effect of elevated fear-avoidance beliefs. This effect was associated with poorer recovery in upper-extremity function with rehabilitation in only 2 out of 8 disease categories—(1) muscle, tendon, and soft tissue disorders and (2) osteopathies, chondropathies, and acquired musculoskeletal deformities—and the asymptotic post hoc power associated with these changes was 67% and 59%, respectively. For the 2 disease categories, the functional change difference between elevated and low fear groups was less than the MDC at 80% power. This effect of fear-avoidance beliefs existed after accounting for several variables that influence change in function, including patient Volume 92 Number 8 Physical Therapy f 999 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes Figure 2. Average values with 95% confidence intervals for unadjusted estimates of mean differences between low versus elevated fear groups (low fear – elevated fear) on functional status change score (shoulder Computerized Adaptive Test [CAT] functional status score at discharge – shoulder CAT functional status score at intake) among 8 shoulder disease categories (asterisk indicates significance at alpha level of ⱕ.05). The category “Other musculoskeletal conditions” was created by combining dislocations (n⫽22), contusions (n⫽7), peripheral nerve disorders (n⫽6), and not otherwise classified musculoskeletal conditions (n⫽41) due to their very small sample size. Dashed line at zero indicates no difference between low and elevated fear groups on change in function. Average and 95% confidence interval of unadjusted estimates lying below zero indicate that change in function was greater for the elevated fear group than for the low fear group. Similarly, average and 95% confidence interval of unadjusted estimates lying above zero indicate change in function was greater for the low fear group than for the elevated fear group. differences, missing data, clinic location, upper-extremity function at intake, change in pain intensity from intake to discharge, duration of condition, age of the patient, and disease category of the patient. Findings of the present study are similar to conclusions drawn from previous studies investigating individuals’ responses to chronic low back pain.25,26 George and colleagues25,26 found diminished rehabilitation outcomes for low back pain among individuals with elevated fear. Among people with acute low back pain, greater fear-avoidance beliefs about work at baseline were significantly associated with greater levels of disability at the 6-month follow-up.21 These differences in improvement in function provide evidence for the FAM.10,14,16,17 According to the FAM, 1000 f Physical Therapy Volume 92 elevated fear results in escape and avoidance of tasks that are anticipated to be painful. Avoidance combined with being hypervigilant toward painful stimuli results in deconditioning of muscles over time. This deconditioning leads to greater disability10 and poorer treatment outcomes.19 –22 We found differences in the influence of fear-avoidance beliefs on change in function between GLM regression analyses unadjusted for confounders and those adjusted or confounders. With the unadjusted analysis, we found that change in function was greater in the elevated fear group than in the low fear group (Fig. 1). This difference can be explained on the basis of higher functional status scores for the low fear group (X⫽51, SD⫽13) com- Number 8 pared with the elevated fear group (X⫽46, SD⫽15) at intake (t⫽8.61, P⬍.001; Tab. 1). Higher functional status scores at intake suggest that the low fear group is likely to change less with rehabilitation. However, in terms of being able to generalize to real-world situations where functional improvement is affected by multiple factors, our findings suggest the unadjusted analysis is inadequate. This inadequacy results from the fact that it does not account for factors besides fear that influence change in functional status. In addition, the unadjusted analysis revealed an interaction between fear and disease categories for predicting change in function. On further examination of this interaction, without adjusting for other important August 2012 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes Figure 3. Average values with 95% confidence intervals for adjusted estimates of mean differences between low and elevated fear groups (low fear – elevated fear) on functional status change score (shoulder Computerized Adaptive Test [CAT] functional status score at discharge – shoulder CAT functional status score at intake) among 8 shoulder disease categories (asterisk indicates significance at alpha level of ⱕ.05). The category “Other musculoskeletal conditions” was created by combining dislocations (n⫽22), contusions (n⫽7), peripheral nerve disorders (n⫽6), and not otherwise classified musculoskeletal conditions (n⫽41) due to their very small sample size. Dashed line at zero indicates no difference between low and elevated fear groups on change in function. Average and 95% confidence interval of adjusted estimates lying below zero indicate that change in function was greater for the elevated fear group than for the low fear group. Similarly, average and 95% confidence interval of adjusted estimates lying above zero indicate change in function was greater for the low fear group than for the elevated fear group. covariates, fear was found to be a predictor for change in function among individuals with fractures and those with other diseases (Fig. 2). People with fractures and other diseases were found to show greater improvement in function when they had elevated fear at baseline. This finding is similar to that of George and Stryker,25 whose repeatedmeasures analysis of variance test revealed that people receiving physical therapy for musculoskeletal conditions in 4 different regions showed greater improvement in function when experiencing elevated fear at intake. However, the influence of fear on function for people with fractures and people in other disease categories changed to not significant after adjusting for other covariates. This change in influence of fear may August 2012 be due to the effect of pain intensity on function. For example, we might imagine that a bone fracture commonly results in high levels of pain intensity. As the fracture heals, pain usually reduces and function improves, irrespective of whether fear is low or elevated. Indeed, our multivariate analysis revealed that for people with fractures, change in function was predicted by change in pain intensity but not by fearavoidance beliefs (Tab. 2, Fig. 3). Our findings also suggest that there is a need to reexamine findings of some of the earlier studies. For example, greater improvement in function among people with elevated fear, as reported by George and Stryker,25 could be different if they would have accounted for other demographic and health-related characteristics in their analysis. After adjusting for significant covariates, we found that out of 8 different disease categories, the influence of elevated fear on functional recovery existed only in 2 categories: (1) muscle, tendon, and soft tissue disorders and (2) osteopathies, chondropathies, and acquired musculoskeletal deformities. Additionally, we found that elevated fear-avoidance beliefs did not result in lower functional status outcomes among individuals in 6 of the 8 disease categories. These categories were: (1) arthropathies, (2) fractures, (3) sprains and strains, (4) postsurgical conditions, (5) other shoulder conditions, and (6) conditions not reported. To our knowledge, this is the first study to report Volume 92 Number 8 Physical Therapy f 1001 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes diagnosis-related differences in fearavoidance beliefs among people with musculoskeletal conditions of the shoulder. George et al15 found similar diagnosis-related differences between individuals with cervical spine pain and those with lumbar spine pain. Although we found statistically significant differences, it is not clear whether the difference in functional recovery was clinically meaningful between the low fear group and the elevated fear group for muscle tendon and soft tissue disorders, as well as for osteopathies, chondropathies, and acquired musculoskeletal deformities. For the 2 groups with significant differences, the asymptotic post hoc power of these changes in regression parameters was 67% and 59%, respectively. Also, the observed difference between low and elevated fear groups was less than the post hoc calculation of MDC at 80% power. However, these post hoc power calculations only describe power properties of our analyses; they do not change the statistical inference, which is based solely on P values less than .05. In addition, some regression coefficients had higher standard errors than others, which could prevent us from showing significance due to lower power. Future clinical trials need to be conducted to determine the clinical significance of this difference between low and elevated fear groups. One possible explanation for a weaker relationship between fear and change in function in the 6 disease categories is that patients may perceive the potential for pain with physical activity to be greater when pain results from muscle, tendon, and soft tissue disorders, as well as from osteopathies, chondropathies, and acquired musculoskeletal deformities. Some conditions included in these categories are rotator cuff tears, muscle impingement, chondral defects, and other bone problems. Health care professionals may 1002 f Physical Therapy Volume 92 convey a different message to patients in these 2 categories compared with patients with diagnoses in other categories where fear is not a predictor of change in function. For example, among people with sprains and strains, a rehabilitation professional may be confident of recovery in a short duration of time and may convey a reassuring message to the patient. Subsequently, patients may view their condition as temporary, which may lessen the amount of fear they feel. This reduced fear of pain related to activity may result in a more confrontational response to the pain, and thus the potential for greater functional recovery.15 In contrast, with a rotator cuff tear, a therapist may convey that rehabilitation may not be successful, and the patient may eventually need surgery if the symptoms do not improve. Such a message of more delayed recovery may support the maintenance of fear-avoidance beliefs, which, in turn, may hinder functional recovery. We could have been more certain of this explanation if we would have measured attitudes of health care professionals toward different medical conditions. An alternative explanation for differences in disease categories may be that interventions implemented by therapists may be more concentrated on reducing the effects of fear among the 6 disease categories that did not show differences between low and elevated fear groups. However, this differential effect is less likely because clinicians generally are not aware of patient fearavoidance beliefs.57,58 Furthermore, we cannot be certain about the effect of intervention because we do not know what intervention was implemented. Therefore, we have no information on the effectiveness of any interventions on reducing fear-avoidance beliefs. Number 8 Our findings are similar to those found among other musculoskeletal conditions where the association between fear-avoidance and functional status is significant, yet small.15,59,60 Overall, fear-avoidance is not one of the most important predictors of functional outcomes. However, fear-avoidance was found to be an important predictor for some people but not for others, as indicated by differences among diagnostic groups of shoulder conditions. Consequently, use of diagnostic categories may allow us to identify subgroups of individuals who benefit the most from targeted treatment for fear avoidance. The present study has 2 important clinical implications. First, it is important to assess fear-avoidance beliefs related to pain among people with shoulder conditions. Second, people with shoulder conditions may benefit from targeted treatment for fear avoidance, especially when diagnosed with a muscle, tendon, or a soft tissue disorder, or osteopathy, chondropathy, or an acquired musculoskeletal deformity. Limitations This study had several limitations. First, this study was a retrospective review of cohort data sets where the potential for patient selection bias was strong. In this case, we created disease categories based on data from patients whose health care providers had voluntarily elected to enter ICD-9 diagnostic codes into the system. Moreover, we were unable to confirm the diagnosis recorded by the clinician or the methods by which a clinician selected an individual diagnostic label. Previous studies have shown ICD-9 codes to have variable interrater reliability, poor to moderate validity,35–37 and insufficient specificity values.36 Consequently, the findings of our study could be biased because of the accuracy of the assigned ICD-9 codes. August 2012 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes Second, we do not know the rehabilitation protocol followed in treatment of the patients with shoulder conditions making up our sample. Specifically, we do not know whether therapists used patient information on elevated fear to implement interventions to reduce fear. Our study findings could be greatly influenced if some therapists implemented interventions to reduce fear and others did not implement such interventions. Finally, our findings may be influenced by other factors that were not controlled for in this analysis. Accounting for these variables in the statistical analysis could potentially change the findings of our multivariate analysis. For example, it might be important to include characteristics of treating health care professionals, including their training (specialist versus generalist) and their attitudes toward prognosis of the condition that they treated. Future studies collecting information from therapists on treatment provided to patients would be beneficial. Additionally, information on other possible predictor variables might be collected and included in the model. Finally, information on how patients were classified and details of their disease course could help clarify the extent of variability within groups and perhaps eliminate some of this variability. sionals should assess for and manage fear-avoidance beliefs to improve treatment outcomes. There is a need to investigate effectiveness of rehabilitative treatments when individuals with shoulder impairments experience elevated fear-avoidance beliefs. Dr Sindhu, Dr Lehman, and Dr Tarima provided concept/idea/research design. Dr Sindhu, Dr Lehman, Dr Bishop, and Mr Klein provided writing. Dr Hart provided data collection and participants. Dr Sindhu, Dr Lehman, Dr Tarima, Dr Bishop, Mr Klein, Mr Shivakoti, and Dr Wang provided data analysis. Dr Tarima, Dr Hart, and Mr Shivakoti provided consultation (including review of manuscript before submission). The authors thank Focus On Therapeutic Outcomes, Inc (Knoxville, Tennessee) for providing data for this research project. At the time of this study, Dr Wang and Dr Hart were employees of Focus On Therapeutic Outcomes, Inc (Knoxville, Tennessee). This study was reviewed and approved by the institutional review boards for the protection of human subjects at the University of Wisconsin–Milwaukee and FOTO, Inc. Part of the manuscript was presented orally at the American Occupational Therapy Association Annual Conference; April 26 –29, 2012; Indianapolis, Indiana. This work was supported, in part, by the Office of Undergraduate Research, University of Wisconsin–Milwaukee, and the Clinical and Translational Science Institute of Southeast Wisconsin, Medical College of Wisconsin. DOI: 10.2522/ptj.20110309 Conclusions Elevated fear-avoidance beliefs were found to be associated with poorer functional status in only 2 out of 8 disease categories: (1) muscle, tendon, and soft tissue disorders and (2) osteopathies, chondropathies, and acquired musculoskeletal deformities. This effect of fear-avoidance beliefs on improvement in function is dependent on covariates included in the analysis. We accounted for differences in clinics, age groups, sex, function and pain intensity at intake, duration of condition, and missing data. Among the 2 disease categories, our data suggest rehabilitation profesAugust 2012 References 1 Chatterjee A, Middya A, Barman A, et al. Various pathologies causing shoulder pain: their relations with demographic parameters and co-morbidities. Indian Journal of Physical Medicine and Rehabilitation. 2008;19:32–36. 2 Garzedin D, Matos M, Daltro C, et al. Pain severity in patients with painful shoulder syndrome. Acta Ortopédica Brasileira. 2008;16:165–167. 3 Johnson MP, Crossley KL, O’Neil ME, Al-Zakwani IS. Estimates of direct health care expenditures among individuals with shoulder dysfunction in the United States. Paper presented at: American Society of Shoulder and Elbow Therapists meeting; November 9 –12, 2005; West Palm Beach, Florida. 4 Armstrong TJ, Buckle P, Fine LJ, et al. A conceptual model for work-related neck and upper-limb musculoskeletal disorders. Scand J Work Environ Health. 1993;19: 73– 84. 5 Pope DP, Silman AJ, Cherry NM, et al. Association of occupational physical demands and psychosocial working environment with disabling shoulder pain. Ann Rheum Dis. 2001;60:852– 858. 6 Nordander C, Ohlsson K, Akesson I, et al. Risk of musculoskeletal disorders among females and males in repetitive/constrained work. Ergonomics. 2009;52: 1226 –1239. 7 Hill JA. Epidemiologic perspective on shoulder injuries. Clin Sports Med. 1983; 2:241–246. 8 Huis ’t Veld RM, Vollenbroek-Hutten MM, Groothuis-Oudshoorn KC, Hermens HJ. The role of the fear-avoidance model in female workers with neck-shoulder pain related to computer work. Clin J Pain. 2007;23:28 –34. 9 Lentz TA, Barabas JA, Day T, et al. The relationship of pain intensity, physical impairment, and pain-related fear to function in patients with shoulder pathology. J Orthop Sports Phys Ther. 2009;39:270 – 277. 10 Vlaeyen JW, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000;85: 317–332. 11 Chmielewski TL, Jones D, Day T, et al. The association of pain and fear of movement/ reinjury with function during anterior cruciate ligament reconstruction rehabilitation. J Orthop Sports Phys Ther. 2008;38: 746 –753. 12 Kvist J, Ek A, Sporrstedt K, Good L. Fear of re-injury: a hindrance for returning to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2005;13:393–397. 13 Bjordal JM, Arnly F, Hannestad B, Strand T. Epidemiology of anterior cruciate ligament injuries in soccer. Am J Sports Med. 1997;25:341–345. 14 Waddell G, Newton M, Henderson I, et al. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993;52:157–168. 15 George SZ, Fritz JM, Erhard RE. A comparison of fear-avoidance beliefs in patients with lumbar spine pain and cervical spine pain. Spine (Phila Pa 1976). 2001;26: 2139 –2145. 16 Lethem J, Slade P, Troup J, Bentley G. Outline of a Fear-Avoidance Model of exaggerated pain perception: I. Behav Res Ther. 1983;21:401– 408. 17 Philips HC. Avoidance behaviour and its role in sustaining chronic pain. Behav Res Ther. 1987;25:273–279. 18 Vlaeyen JW, Kole-Snijders AM, Boeren RG, van Eek H. Fear of movement/(re)injury in chronic low back pain and its relation to behavioral performance. Pain. 1995;62: 363–372. Volume 92 Number 8 Physical Therapy f 1003 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes 19 den Boer JJ, Oostendorp RA, Beems T, et al. Continued disability and pain after lumbar disc surgery: the role of cognitivebehavioral factors. Pain. 2006;123:45–52. 20 Archer KR, Wegener ST, Seebach C, et al. The effect of fear-avoidance beliefs on pain and disability after surgery for lumbar and cervical degenerative conditions. Spine (Phila Pa 1976). 2011;36:1554 – 1562. 21 George SZ, Bialosky JE, Donald DA. The centralization phenomenon and fearavoidance beliefs as prognostic factors for acute low back pain: a preliminary investigation involving patients classified for specific exercise. J Orthop Sports Phys Ther. 2005;35:580 –588. 22 Werneke MW, Hart DL, George SZ, et al. Clinical outcomes for patients classified by fear-avoidance beliefs and centralization phenomenon. Arch Phys Med Rehabil. 2009;90:768 –777. 23 Pincus T, Vogel S, Burton AK, et al. Fear avoidance and prognosis in back pain: a systematic review and synthesis of current evidence. Arthritis Rheum. 2006;54: 3999 – 4010. 24 Bot SD, van der Waal JM, Terwee CB, et al. Predictors of outcome in neck and shoulder symptoms: a cohort study in general practice. Spine (Phila Pa 1976). 2005;30: E459 –E470. 25 George SZ, Stryker SE. Fear-avoidance beliefs and clinical outcomes for patients seeking outpatient physical therapy for musculoskeletal pain conditions. J Orthop Sports Phys Ther. 2011;41:249 –259. 26 George SZ, Fritz JM, Bialosky JE, Donald DA. The effect of a fear-avoidance-based physical therapy intervention for patients with acute low back pain: results of a randomized clinical trial. Spine (Phila Pa 1976). 2003;28:2551–2560. 27 Feleus A, van Dalen T, Bierma-Zeinstra SM, et al. Kinesiophobia in patients with nontraumatic arm, neck and shoulder complaints: a prospective cohort study in general practice. BMC Musculoskelet Disord. 2007;8:117. 28 Hart DL, Cook KF, Mioduski JE, et al. Simulated computerized adaptive test for patients with shoulder impairments was efficient and produced valid measures of function. J Clin Epidemiol. 2006;59:290 – 298. 29 Hart DL, Mioduski JE, Stratford PW. Simulated computerized adaptive tests for measuring functional status were efficient with good discriminant validity in patients with hip, knee, or foot/ankle impairments. J Clin Epidemiol. 2005;58:629 – 638. 30 Hart DL, Mioduski JE, Werneke MW, Stratford PW. Simulated computerized adaptive test for patients with lumbar spine impairments was efficient and produced valid measures of function. J Clin Epidemiol. 2006;59:947–956. 31 Dobrzykowski E, Nance T. The Focus On Therapeutic Outcomes (FOTO) outpatient orthopedic rehabilitation database: results of 1994 –1996. Journal of Rehabilitation Outcomes Measurement. 1997;1:5660. 1004 f Physical Therapy Volume 92 32 Swinkels IC, van den Ende CH, de Bakker D, et al. Clinical databases in physical therapy. Physiother Theory Pract. 2007;23: 153–167. 33 Resnik L, Liu D, Mor V, Hart DL. Predictors of physical therapy clinic performance in the treatment of patients with low back pain syndromes. Phys Ther. 2008;88:989 – 1004. 34 International Classification of Diseases, Ninth Revision. Centers for Disease Control and Prevention. Available at: http:// www.cdc.gov/nchs/icd/icd9.htm. 35 Dixon J, Sanderson C, Elliott P, et al. Assessment of the reproducibility of clinical coding in routinely collected hospital activity data: a study in two hospitals. J Public Health Med. 1998;20:63– 69. 36 Goldman LE, Chu PW, Prothro C, et al. Accuracy of condition present on admission, do not resuscitate, and e-codes in California patient discharge data. California Office of Statewide Health Planning and Development, Healthcare Outcomes Center. Spring 2011. Available at: http:// www.oshpd.ca.gov/HID/Products/ PatDischargeData/ResearchReports/ PDDValidation/PDD_Validation_Study.pdf. Accessed February 15, 2012. 37 Buchbinder R, Goel V, Bombardier C. Lack of concordance between the ICD-9 classification of soft tissue disorders of the neck and upper limb and chart review diagnosis: one steel mill’s experience. Am J Ind Med. 1996;29:171–182. 38 Crane PK, Hart DL, Gibbons LE, Cook KF. A 37-item shoulder functional status item pool had negligible differential item functioning. J Clin Epidemiol. 2006;59:478 – 484. 39 Hart DL, Wang YC, Cook KF, Mioduski JE. A computerized adaptive test for patients with shoulder impairments produced responsive measures of function. Phys Ther. 2010;90:928 –938. 40 Wang YC, Hart DL, Cook KF, Mioduski JE. Translating shoulder computerized adaptive testing generated outcome measures into clinical practice. J Hand Ther. 2010; 23:372–383. 41 International Classification of Functioning, Disability and Health: ICF. Geneva, Switzerland: World Health Organization; 2001. 42 Lord F. Applications of Item Response Theory to Practical Testing Problems. Hillsdale, NJ: Erlbaum Associates; 1980. 43 Jensen MP, Karoly P. Self-report scales and procedures for assessing pain in adults. In: Turk DC, Melzack R, eds. Handbook of Pain Assessment. 2nd ed. New York, NY: Guilford Press; 2001:15–34. 44 Seymour RA. The use of pain scales in assessing the efficacy of analgesics in postoperative dental pain. Eur J Clin Pharmacol. 1982;23:441– 444. 45 Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27: 117–126. Number 8 46 Kremer E, Atkinson JH, Ignelzi RJ. Measurement of pain: patient preference does not confound pain measurement. Pain. 1981;10:241–248. 47 Breivik EK, Bjornsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Clin J Pain. 2000;16:22–28. 48 Bolton JE, Wilkinson RC. Responsiveness of pain scales: a comparison of three pain intensity measures in chiropractic patients. J Manipulative Physiol Ther. 1998;21:1–7. 49 Lundeberg T, Lund I, Dahlin L, et al. Reliability and responsiveness of three different pain assessments. J Rehabil Med. 2001;33:279 –283. 50 Salaffi F, Stancati A, Silvestri CA, et al. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004;8:283–291. 51 Hart DL, Werneke MW, George SZ, et al. Screening for elevated levels of fearavoidance beliefs regarding work or physical activities in people receiving outpatient therapy. Phys Ther. 2009;89:770 – 785. 52 Wiles MR, Williams J, Ahmad K. Essentials of Dermatology for Chiropractors. Maynard, MA: Jones and Bartlett Publishers; 2011. 53 Levinson DJ. A conception of adult development. Am Psychol. 1986;41:3. 54 Curtis LH, Hammill BG, Eisenstein EL, et al. Using inverse probability-weighted estimators in comparative effectiveness analyses with observational databases. Med Care. 2007;45:S103. 55 Cassel CM, Sarndal CE, Wretman JH. Some uses of statistical models in connection with the nonresponse problems. In: Madow WG, Olkin I, eds. Incomplete Data in Sample Surveys. Vol. 3. New York, NY: Academic Press; 1983:143–160. 56 Robins JM, Rotnitzky A, Zhao LP. Analysis of semiparametric regression-models for repeated outcomes in the presence of missing data. Journal of the American Statistical Association. 1995;90:106 –121. 57 Calley DQ, Jackson S, Collins H, George SZ. Identifying patient fear-avoidance beliefs by physical therapists managing patients with low back pain. J Orthop Sports Phys Ther. 2010;40:774 –783. 58 George SZ. Fear: a factor to consider in musculoskeletal rehabilitation. J Orthop Sports Phys Ther. 2006;36:264 –266. 59 Kamper SJ, Maher CG, Menezes Costa LC, et al. Does fear of movement mediate the relationship between pain intensity and disability in patients following whiplash injury? A prospective longitudinal study. Pain. 2012;153:113–119. 60 Scopaz KA, Piva SR, Wisniewski S, Fitzgerald GK. Relationships of fear, anxiety, and depression with physical function in patients with knee osteoarthritis. Arch Phys Med Rehabil. 2009;90:1866 –1873. August 2012 Influence of Fear-Avoidance Beliefs on Functional Status Outcomes Appendix. Flow Diagram Used for Selecting Study Participants August 2012 Volume 92 Number 8 Physical Therapy f 1005 Research Report C. Wu, ScD, OTR, Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, Chang Gung University, Taoyuan, Taiwan. C. Yang, MS, Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, Chang Gung University. L. Chuang, PT, PhD, School of Occupational Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan. K. Lin, ScD, OTR, School of Occupational Therapy, College of Medicine, National Taiwan University, and Division of Occupational Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, 17, F4, Xu Zhou Road, Taipei, Taiwan. Address all correspondence to Dr Lin at: kehchunglin@ ntu.edu.tw. H. Chen, PhD, Department and Graduate Institute of Industrial Engineering and Management, National Taipei University of Technology, Taipei, Taiwan. M. Chen, PhD, OT, Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, Chang Gung University. W. Huang, MS, Division of Occupational Therapy, Department of Physical Medicine and Rehabilitation, En Chu Kong Hospital, New Taipei City, Taiwan. Ms Yang and Dr Chuang contributed equally to the manuscript. [Wu C, Yang C, Chuang L, et al. Effect of therapist-based versus robot-assisted bilateral arm training on motor control, functional performance, and quality of life after chronic stroke: a clinical trial. Phys Ther. 2012;92:1006 –1016.] © 2012 American Physical Therapy Association Published Ahead of Print: April 19, 2012 Accepted: April 11, 2012 Submitted: September 2, 2011 Effect of Therapist-Based Versus Robot-Assisted Bilateral Arm Training on Motor Control, Functional Performance, and Quality of Life After Chronic Stroke: A Clinical Trial Ching-yi Wu, Chieh-ling Yang, Li-ling Chuang, Keh-chung Lin, Hsieh-ching Chen, Ming-de Chen, Wan-chien Huang Background. Although bilateral arm training (BAT) has been widely studied, the comparative effects of therapist-based BAT (TBAT) versus robot-assisted BAT (RBAT) remains unknown. Objective. This study compared the efficacy of TBAT, RBAT, and a control treatment (CT) on motor control, functional performance, and quality of life after chronic stroke. Design. A randomized, pretest-posttest, control group design was used. Methods. Forty-two patients (mean age⫽54.49 years, SD⫽9.69; mean length of time since stroke onset⫽17.62 months, SD⫽10.50) were randomly assigned to TBAT, RBAT, and CT groups. Each group received treatment for 90 to 105 minutes per session, 5 sessions on weekdays, for 4 weeks. Outcome measures included kinematic analyses, the Fugl-Meyer Assessment (FMA), the Motor Activity Log, and the Stroke Impact Scale (SIS). Results. Large and significant effects were found in the kinematic variables, distal part of upper-limb motor impairment, and certain aspects of quality of life in favor of TBAT or RBAT. Specifically, the TBAT group demonstrated significantly better temporal efficiency and smoothness, straighter trunk motion, and less trunk compensation compared with the CT and RBAT groups. The RBAT group had increased shoulder flexion compared with the CT and TBAT groups. On the FMA, the TBAT group showed higher distal part scores than the CT group. On the SIS, the RBAT group had better strength subscale, physical function domain, and total scores than the CT group. Limitations. This study recruited patients with mild spasticity and without cognitive impairment. Conclusions. Compared with CT, TBAT and RBAT exhibited differential effects on outcome measures. Therapist-based BAT may improve temporal efficiency, smoothness, trunk control, and motor impairment of the distal upper limb. Robotassisted BAT may improve shoulder flexion and quality of life. Post a Rapid Response to this article at: ptjournal.apta.org 1006 f Physical Therapy Volume 92 Number 8 August 2012 Therapist-Based Versus Robotic Bilateral Arm Training P atients with stroke often have adaptive compensation by using alternative movement patterns during task accomplishment,1 such as forward trunk inclination for reaching when elbow extension or shoulder flexion is limited.2 Trunk compensation for motor impairment engenders a pattern of disuse that might restrict motor improvement of the upper limb (UL).1,3 Bilateral arm training (BAT) is a promising treatment approach that improves UL function after stroke.4,5 This treatment approach usually involves the repetitive practice of bilateral, symmetrical movement of whole-arm functional training, which usually is supervised and mediated by a therapist (TBAT)4 or a robot (RBAT).6 Previous TBAT studies showed positive outcomes for reducing UL impairment,7,8 enhancing motor function,8 and increasing movement smoothness and force generation during reaching.8,9 However, TBAT requires extensive therapist guidance for treatment delivery; RBAT has emerged as an alternative approach to save manpower and costs by decreasing the time demands on the therapist. Robot-assisted BAT involves simultaneous, active movements of both limbs with a robot providing assistance or resistance.6 This treatment approach has demonstrated beneficial effects on motor impairment6,10,11 and muscle strength,6,10,11 but not on functional independence or on capacities for basic daily activities.10 –12 Proper wrist and hand use is particularly relevant for functional use of the paretic arm in daily life,13 and functional gains depend more on wrist and hand movement.14 Training of the distal UL leads to twice as much carryover effect to the proximal segments than in the reverse order of training.15 Therefore, training of bilateral forearms August 2012 and wrists was adopted in this study for RBAT. Taken together, BAT mediated by therapists or by robots has demonstrated benefits for motor or functional improvement. Therapist-based BAT involves multijoint, againstgravity, and function-oriented tasks, whereas RBAT involves single-joint, gravity-eliminated, and motor skill– oriented tasks. The different nature of training content in the 2 approaches may result in differential effects. The purpose of this study was to compare the efficacy of TBAT, RBAT, and a control treatment (CT) on kinematic analysis, functional outcome, and quality of life. Kinematic analysis provides information not only on movement quality of the UL (eg, movement directedness, smoothness, efficiency) but also on the extent of trunk compensation to reaching tasks.15 Method Participants We recruited 42 participants who met the following inclusion criteria: (1) onset of a unilateral stroke at least 6 months previously; (2) mildto-moderate motor impairment (total score of 26 – 66 on the Fugl-Meyer Assessment [FMA] for the UL)11,16; (3) no severe spasticity in the paretic arm (Modified Ashworth Scale score of ⱕ2 in any joint)17; (4) no serious cognitive deficits (Mini-Mental State Examination score of ⱖ22)18; (5) no other neurologic, neuromuscular, or orthopedic disease; and (6) no participation within the previous 3 months in any experimental rehabilitation or drug studies. All participants provided informed consent before data collection. Design A randomized, pretest-posttest, control group design was used in this study. Eligible participants were individually randomized to TBAT, RBAT, and CT groups (Fig. 1). A prestratifi- cation strategy was applied according to side of the lesion and severity of the motor impairment (total score on the FMA for UL: 26 – 40 versus 40 – 66)11 to ensure an equal distribution of the participants in each group. The allocation to group was concealed from the investigators, and the participants were blinded to the study hypotheses. Training was administered during outpatient occupational therapy sessions, in which each participant received TBAT or RBAT, depending on group allocation, along with 15 to 20 minutes of UL functional training to achieve individual treatment goals. All other routine interdisciplinary stroke rehabilitation that did not focus on UL training was continued as usual. Clinical outcome measures were administered at baseline and immediately after a 4-week intervention by certified, trained occupational therapists blinded to the participant group. Interventions All participants received a 90- to 105minute therapy session, 5 times per week, for 4 weeks. The intervention was provided at the participating hospitals under the supervision of certified occupational therapists trained to deliver standardized treatment and monitor the safety of patients undergoing the intervention. TBAT group. The TBAT group was asked to practice identical tasks with each arm simultaneously. Participants moved the unaffected arm voluntarily while also attempting to move the affected arm voluntarily. For those who had difficulty moving the affected arm simultaneously with the unaffected arm, therapists provided physical assistance to the affected arm. Participants practiced a variety of bilateral functional tasks under one-on-one supervision of the therapists. Among the tasks were lift 2 cups, stack 2 checkers, reach for- Volume 92 Number 8 Physical Therapy f 1007 Therapist-Based Versus Robotic Bilateral Arm Training ward or upward to move blocks, grasp and release 2 towels, and manipulate 2 coins simultaneously by each hand. The TBAT group also practiced 15 to 20 minutes of functional training and 5 minutes of tone normalization at the end of therapy, if necessary. Participants received verbal feedback, including knowledge of results (KR), referring to task success of failure, and knowledge of performance (KP), referring to the nature of movement pattern.19 Examples of KR include “the movement was correct” and “you missed your target,” and examples of KP include “move your trunk less” and “pick up the block faster.” RBAT group. The Bi-Manu-Track (Reha-Stim Co, Berlin, Germany; Fig. 2) robot-assisted arm trainer was used.6,20 Participants sat at a heightadjustable table with elbows at 90 degrees. They grasped the 3-cmdiameter handles with each hand or both hands, and their forearms were placed in the midposition into the arm troughs. A computer game (eg, picking up and placing apples) that tracked participants’ movements facilitated participation. The Bi-Manu-Track offers 2 movement patterns: forearm pronationsupination and wrist flexionextension. There are 3 operational modes: passive-passive mode (mode 1), with both arms being passively moved by the machine; activepassive mode (mode 2), with the nonparetic arm driving the paretic arm to move symmetrically; and active-active mode (mode 3), with both arms performing actively by overcoming resistance. Participants spent about 30 minutes in modes 1 and 2 and about 10 minutes in mode 3 for each type of movement. They received 75 to 80 minutes of RBAT, followed by 15 to 20 minutes of unilateral and bilateral functional training and 5 minutes of tone normalization at the end of therapy, if 1008 f Physical Therapy Volume 92 Assessed for eligibility (N=250) Enrollment Excluded (n=208) Did not meet inclusion criteria (n=172) Refused to participate (n=36) Randomized (n=42) TBAT Group (n=14) RBAT Group (n=14) Analyzed (n=14) Analyzed (n=14) CT Group (n=14) Analyzed (n=14) Figure 1. Flow diagram showing the randomization procedure. RBAT⫽robot-assisted bilateral arm training, TBAT⫽therapist-based bilateral arm training, CT⫽control treatment. Figure 2. The Bi-Manu-Track. (A) Pronation and supination movement of the forearm. (B) Flexion and extension movement of the wrist. necessary. The safety features of Bi-Manu-Track include mechanical braking of the movement when the torque exceeds 4 N䡠m, preventing injuries caused by excessive passive movement on the affected arm, and an emergency brake within reach of the user that enables the user to stop the arm trainer whenever he or she feels uncomfortable.21 CT group. The therapeutic activities in the CT group involved weight bearing, stretching, strengthening of the paretic arms, coordination, unilateral and bilateral fine motor tasks, balance, and compensatory practice on functional tasks. Number 8 Outcome Measures Kinematic analysis. Experimental tasks included 1 unilateral task of pressing a desk bell and 1 bimanual task of pulling open a drawer to retrieve an eyeglass case. Participants sat on a height-adjustable, straight-back chair with the seat height set to 100% of the lower leg length. In the initial position, the tested arm was pronated and the hand rested on the edge of the table in a neutral position with 90 degrees of flexion at the elbow joint. The target object (desk bell or drawer) was placed in the midline of the body. The reaching distance was standardized to the participant’s August 2012 Therapist-Based Versus Robotic Bilateral Arm Training functional arm length, defined as the distance from the medial border of the axilla to the distal wrist crease.22 If the maximum distance the participant could reach was less than the functional arm length, the reaching distance to the target was adjusted to the maximum reachable distance. No or minimal trunk movement occurs when an individual who is healthy reaches for a target within arm’s length.2 For the unilateral task, the tester’s instruction to the participants was: “When I say ‘go,’ please use the index finger of the affected hand to reach and press the task bell as fast as possible.” For the bimanual task, the instruction given to participants was: “When I say ‘go,’ please pull a drawer with the affected hand and retrieve an eyeglass case inside the drawer with the unaffected hand at a comfortable self-speed.” Only the pulling phase was analyzed. After a practice trial, 3 data-producing trials were performed. A 7-camera motion analysis system (VICON MX, Oxford Metrics Inc, Oxford, United Kingdom), recording at 120 Hz, was used with a personal computer to capture the movement of 17 markers that were placed on the participants’ sternum, spinal process (C7 and T4), bilateral thumbnails, index fingernails, ulnar styloid processes, radial styloid processes, lateral epicondyles, middle part of the humeri, acromial processes, and clavicular heads. The system was calibrated to have averaged residual errors not exceeding 0.5 mm for each camera before data acquisition. For the unilateral task, 1 channel of analog signals was collected to signal the end of the movement when the bell was pressed. Movement onset was defined as a rise of tangential wrist velocity above 5% of its peak value for both testing tasks. Movement offset for the unilateral task was defined as the time when the participant pressed the bell. During the bimanual task, end of movement August 2012 was defined as a fall of tangential wrist velocity below 5% of its peak value. Movements were digitally lowpass filtered at 5 Hz using a secondorder Butterworth filter with forward and backward pass. Data reduction for kinematic variables. An analysis program coded by LabVIEW (National Instruments Inc, Austin, Texas) language was used to process the kinematic data. Kinematic variables were chosen to describe the arm-trunk movement quality and trunk compensation. Movement quality involved reaching performance characterized by normalized movement time (NMT) and normalized movement units (NMUs), and trunk movement was characterized by normalized trunk displacement (NTD). Movement time (MT) is the interval between movement onset and offset, which refers to the time for execution of the reaching movement and represents temporal efficiency.22,23 One movement unit (MU) consists of 1 acceleration phase and 1 deceleration phase, which characterizes movement smoothness. Fewer MUs indicate smoother movement.23 The MT and MU were divided by the reaching distance to normalize for variations in reaching distance across participants and denoted as NMT and NMU, respectively. Furthermore, NTD was expressed as trunk total displacement of the sternum marker divided by trunk distance,24,25 which is illustrated in Figure 3. Trunk compensation changes were denoted by the trunk contribution slope, which is defined as the ratio of the sagittal translation of the index minus that of the sternum marker to the sagittal translation of the sternum marker, indicating the amount of trunk displacement on reaching. The lower the slope value, the more compensation (or displacement) the trunk exerted.2 Trunk movement in adults who are healthy usually Figure 3. Normalized trunk displacement denoted by trunk total displacement/trunk distance is illustrated: the solid line means trunk total displacement; the dashed line means trunk-moving distance. occurs at earlier phases of reaching. Accordingly, we divided the reaching movement equally into 3 phases, calculated the slope separately for each phase, and used the slope values at the start and middle phases as the dependent variables.2 The angular changes of the shoulder and elbow joint refer to the differences in shoulder and elbow angle from movement onset and movement offset and were divided by the reaching distance to normalize for variations in reaching distance across participants.24,26 Clinical assessment. The UL subscale of the FMA, which assesses motor impairment, consists of 33 items measuring the movement and reflexes of the shoulder/elbow/forearm, wrist, and hand and coordination/speed on a 3-point ordinal scale (0⫽cannot perform, 1⫽can perform partially, 2⫽can perform fully).27 The proximal and distal scores of the FMA were calculated to examine the treatment effects on separate UL elements of movement. A higher FMA score indicates less motor impairment. The Motor Activity Log (MAL) evaluates daily functions by using a semistructured patient interview that assesses the amount of use (AOU) and quality of movement (QOM) of Volume 92 Number 8 Physical Therapy f 1009 Therapist-Based Versus Robotic Bilateral Arm Training Table 1. Characteristics of Study Participants (n⫽42)a RBAT Group (nⴝ14) Variable TBAT Group (nⴝ14) CT Group (nⴝ14) Sex, n Male Female Age, y, X (SD) 10 12 10 4 2 4 55.13 (12.72) 57.04 (8.78) 51.30 (6.23) Side of brain lesion, n Right 7 5 4 Left 7 9 10 Statisticb P 1.05 .59 1.29 .29 1.41 .49 Results Months after stroke onset, X (SD) 18.00 (8.65) 17.29 (13.29) 17.57 (9.80) 0.02 .99 MMSE score, X (SD) 27.71 (2.33) 28.57 (1.70) 28.08 (1.50) 0.73 .49 a RBAT⫽robot-assisted bilateral arm training, TBAT⫽therapist-based bilateral arm training, CT⫽control treatment, MMSE⫽Mini-Mental State Examination. b Statistic associated with the chi-square test or the Fisher exact test for categoric variables and with the analysis of variance for continuous variables. the affected UL in 30 daily activities.28 The MAL uses a 6-point ordinal scale, with higher scores indicating better performance. The Stroke Impact Scale (SIS), version 3, is a 59-item self-report scale designed to assess quality of life. It is grouped into 8 functional subscales: strength, memory, emotion, communication, activities of daily living (ADLs)/instrumental ADLs (IADLs), mobility, hand function, and participation. The strength, hand function, ADLs/IADLs, and mobility subscales can be combined into a composite physical function domain.29 Items are rated on a 5-point Likert scale, with lower scores indicating greater difficulty in task completion during the previous week. Aggregate scores, ranging from 0 to 100, are generated for each subscale. Data Analysis Baseline differences between groups were evaluated with the chi-square test or the Fisher exact test for categoric data and analysis of variance (ANOVA) for continuous data. Given that our research aimed to compare whether the posttest results were different among the 3 groups, analysis of covariance (ANCOVA) is a 1010 f Physical Therapy Volume 92 more suitable statistical method than repeated-measures ANOVA to compare the intervention main effect (ie, posttest score) by holding the pretest score constant in the former method.30 For the ANCOVA, pretest performance was the covariate, group was the independent variable, and posttest performance was the dependent variable. To index the magnitude of group differences in performance, 2⫽SSb/SStotal was calculated for each outcome variable, where SS is the sum of squares and b represents between-groups. The value of 2 is independent of sample size and represents the variability in the dependent variable (posttest performance) that can be explained by group.31 A large effect is represented by an 2 of at least .14, a moderate effect by an 2 of .06, and a small effect by an 2 of .01.32 Least significant difference was used to determine the post hoc significance of pair-wise comparisons of adjusted group mean via ANCOVA. Level of statistical significance (␣) was set at .05 for all comparisons and was not adjusted because of the preliminary nature and size of the study. Number 8 Role of the Funding Source This project was supported, in part, by the National Health Research Institutes (NHRI-EX100-9920PI and NHRI-EX100-10010PI), the National Science Council (NSC 97-2314-B-002008-MY3 and NSC 99-2314-B-182014-MY3), and the Healthy Aging Research Center at Chang Gung University (EMRPD1A0891). The mean age of the participants was 54.49 years (SD⫽9.69), and they were at an average of 17.62 months (SD⫽10.50) after stroke onset. The demographic and clinical characteristics of participants in the 3 groups (Tab. 1) did not differ significantly. Tables 2 and 3 present the descriptive statistics and inferential statistics for the kinematic variables and clinical measures. Two participants in the RBAT group and 1 participant in the CT group did not complete the bimanual task. No adverse events of pain were reported among the participants. Kinematic Measures For kinematic variables in the unilateral task, the ANCOVA results revealed significant differences among the 3 groups in NMT (F2,38⫽3.79, P⫽.032, 2⫽.17), NMUs (F2,38⫽3.95, P⫽.028, 2⫽.17), trunk NTD (F2,38⫽3.82, P⫽.031, 2⫽.17), trunk contribution slope for the middle part (F2,38⫽5.51, P⫽.008, 2⫽.23), and angular change of shoulder joints (F2,38⫽ 4.77, P⫽.014, 2⫽.20). Post hoc analyses revealed that the TBAT group, but not the RBAT group, demonstrated a significant decrease on NMT (P⫽.011), NMUs (P⫽.009), and trunk NTD (P⫽.009) compared with the CT group. Compared with the CT and RBAT groups, the TBAT group produced greater improvements in the trunk contribution slope for the middle part (TBAT group versus RBAT group, P⫽.008; TBAT group versus CT group, August 2012 Therapist-Based Versus Robotic Bilateral Arm Training Table 2. Descriptive and Inferential Statistics for Analysis of Reaching Kinematicsa Pretreatment (XⴞSD) Variable Unilateral task Posttreatment (XⴞSD) ANCOVA RBAT Group TBAT Group CT Group RBAT Group TBAT Group CT Group (n⫽14) (n⫽14) (n⫽14) (n⫽14) (n⫽14) (n⫽14) F 2 P NMT (s/mm) 0.008 (0.0045) 0.008 (0.0058) 0.0065 (0.0049) 0.0078 (0.0049) 0.0054 (0.0025) 0.0081 (0.0042) 3.79 .03b .17 NMUs (unit/mm) 0.043 (0.026) 0.056 (0.064) 3.95 .03b .17 b .17 Trunk NTD (mm/mm) 0.033 (0.030) 0.046 (0.031) 0.033 (0.029) 0.049 (0.033) 1.22 (0.18) 1.31 (0.49) 1.58 (1.31) 1.23 (0.21) 1.13 (0.10) 1.52 (0.76) 3.82 .03 3.21 (4.08) 3.37 (3.35) 2.70 (3.96) 4.94 (5.45) 3.25 (4.47) 5.02 (5.62) 0.59 Trunk contribution (mm/mm) Slope: start Slope: mid .56 b .03 2.13 (2.15) 0.96 (1.35) 2.84 (3.75) 1.37 (2.07) 2.93 (3.31) 1.55 (2.30) 5.51 .01 nShoulder flexion 0.16 (0.058) 0.13 (0.034) 0.14 (0.045) 0.19 (0.073) 0.14 (0.025) 0.14 (0.039) 4.77 .01b .20 nElbow extension 0.10 (0.038) 0.061 (0.033) 0.094 (0.039) 0.098 (0.037) 0.078 (0.034) 0.098 (0.053) 0.15 .87 .004 (n⫽12) (n⫽14) (n⫽13) (n⫽12) 0.0033 (0.0032) 1.70 .20 .09 .23 Angular change (°/mm) Bimanual task NMT (s/mm) NMUs (unit/mm) (n⫽14) 0.0052 (0.0017) 0.007 (0.0032) 0.0059 (0.0044) 0.0048 (0.0014) 0.005 (0.003) (n⫽13) 0.022 (0.009) 0.033 (0.029) 0.037 (0.016) 0.023 (0.012) 0.026 (0.022) 0.048 (0.037) 3.09 .06 .15 1.21 (0.16) 1.51 (0.77) 2.06 (2.35) 1.24 (0.20) 2.35 (3.36) 1.24 (0.35) 1.85 .17 .10 Slope: start ⫺0.08 (6.28) 9.15 (13.61) 4.33 (9.34) 1.80 (6.83) 6.90 (9.89) 1.41 (9.75) 0.63 .54 .04 Slope: mid 4.94 (5.11) 4.12 (4.38) 4.70 (6.84) 6.27 (9.61) 8.13 (8.52) 2.12 (4.07) 3.44 .04b .16 nShoulder flexion 0.16 (0.029) 0.12 (0.035) 0.15 (0.063) 0.17 (0.028) 0.12 (0.045) 0.11 (0.064) 4.92 .01b .22 nElbow extension 0.062 (0.039) 0.025 (0.050) 0.048 (0.042) 0.074 (0.039) 0.062 (0.056) 0.049 (0.056) 1.23 .07 Trunk NTD (mm/mm) Trunk contribution (mm/mm) Angular change (°/mm) .31 a ANCOVA⫽analysis of covariance, RBAT⫽robot-assisted bilateral arm training, TBAT⫽therapist-based bilateral arm training, CT⫽control treatment, NMT⫽normalized movement time, NMU⫽normalized movement unit, trunk NTD⫽normalized trunk displacement, nShoulder flexion⫽normalized shoulder flexion, nElbow extension⫽normalized elbow extension. b P⬍.05, 2⫽SSb/SStotal. P⫽.005). The RBAT group engendered a larger improvement in the angular changes of shoulder flexion than the TBAT and CT groups (RBAT group versus TBAT group, P⫽.031; RBAT group CT group, P⫽.005). trunk contribution slope for the middle part (P⫽.013) than the CT group. In addition, higher gains in the angular changes of the shoulder flexion were produced in the RBAT group than in the CT group (P⫽.004). For kinematic variables in the bimanual task, the ANCOVA results showed differences among the 3 groups in trunk contribution slope for the middle part (F2,35⫽3.44, P⫽.043, 2⫽.16) and angular changes of the shoulder joint (F2,35⫽4.92, P⫽.013, 2⫽.22). Post hoc analyses revealed that the TBAT group, but not the RBAT group, demonstrated larger enhancement on Clinical Measures No group effect on the overall FMA score, proximal part score of the FMA, and AOU and QOM of the MAL was documented; however, performance on the distal part of the FMA was significantly different among the 3 groups (F2,38⫽3.84, P⫽.03, 2⫽.168). Post hoc analyses revealed that the score for the distal part of the FMA was higher in the TBAT August 2012 group than in the CT group (P⫽.012). Differences also were found in the SIS total score (F2,38⫽4.58, P⫽.017, 2⫽.19), strength subscale (F2,38⫽5.02, P⫽.012, 2⫽.21), and physical function domain (F2,38⫽4.54, P⫽.017, 2⫽.19). Post hoc analyses indicated that the RBAT group showed larger improvement in total score (P⫽.005), strength subscale (P⫽.003), and physical function domain (P⫽.005) of the SIS than the CT group. Discussion To our knowledge, this comparative efficacy study is the first to evaluate Volume 92 Number 8 Physical Therapy f 1011 Therapist-Based Versus Robotic Bilateral Arm Training Table 3. Descriptive and Inferential Statistics for Clinical Measuresa Pretreatment (XⴞSD) Posttreatment (XⴞSD) ANCOVA RBAT Group (nⴝ14) TBAT Group (nⴝ14) CT Group (nⴝ14) RBAT Group (nⴝ14) TBAT Group (nⴝ14) CT Group (nⴝ14) F2,38 P 2 Total 43.29 (10.09) 43.43 (10.63) 45.43 (11.42) 47.14 (10.97) 48.71 (10.39) 48.57 (12.32) 1.85 .17 .09 Proximal 31.43 (4.54) 29.57 (5.30) 30.93 (3.93) 33.07 (4.46) 32.14 (4.62) 33.14 (4.31) 0.32 .73 .02 Distal 11.86 (7.05) 13.86 (6.50) 13.40 (7.44) 14.07 (7.66) 16.57 (7.30) 15.43 (9.10) 3.84 .03b .17 AOU 0.53 (0.47) 0.68 (0.51) 0.87 (1.00) 0.82 (0.65) 1.03 (0.91) 1.25 (1.25) 0.01 .99 .001 QOM 0.66 (0.51) 0.78 (0.61) 0.97 (1.05) 1.03 (0.79) 1.18 (0.83) 1.59 (1.51) 0.40 .68 .02 Total 68.62 (7.62) 64.27 (5.26) 65.23 (11.19) 73.97 (8.68) 67.61 (5.72) 64.75 (12.94) 4.58 .02b .19 Strength 41.52 (9.99) 40.63 (12.91) 37.05 (12.37) 51.34 (14.75) 44.20 (10.53) 36.16 (14.54) 5.02 .01b .21 Memory 91.11 (13.70) 89.28 (7.78) 85.46 (15.18) 93.07 (9.04) 89.27 (9.72) 86.73 (14.72) 0.49 .61 .03 Emotion 59.50 (15.17) 60.72 (12.45) 51.19 (10.49) 60.32 (9.66) 62.31 (12.51) 55.76 (13.38) 0.07 .93 .004 Communication 94.48 (13.01) 90.55 (11.68) 85.97 (18.51) 96.23 (8.67) 94.63 (7.40) 87.23 (14.67) 1.76 .19 .09 ADL/IADL 82.38 (10.50) 74.79 (10.83) 77.77 (12.23) 85.64 (11.81) 73.29 (13.66) 73.50 (17.97) 1.90 .16 .09 Variable FMA MAL SIS Mobility 91.55 (7.93) 83.32 (7.55) 80.16 (17.02) 94.25 (3.98) 86.17 (7.83) 76.40 (23.75) 2.27 .11 .11 Hand function 40.20 (28.78) 34.86 (18.51) 47.86 (25.70) 53.84 (22.50) 48.36 (28.74) 50.57 (27.84) 1.05 .36 .05 Participation 48.23 (20.03) 40.00 (25.50) 56.37 (24.07) 57.09 (28.70) 42.67 (18.60) 51.66 (21.41) 1.08 .35 .05 Physical function 63.91 (11.17) 58.39 (7.07) 60.71 (12.73) 71.27 (9.43) 63.00 (10.07) 59.16 (17.08) 4.54 .02b .19 a ANCOVA⫽analysis of covariance, RBAT⫽robot-assisted bilateral arm training, TBAT⫽therapist-based bilateral arm training, CT⫽control treatment, FMA⫽Fugl-Meyer Assessment, MAL⫽Motor Activity Log, AOU⫽amount of use, QOM⫽quality of movement, SIS⫽Stroke Impact Scale, ADL/IADL⫽activities of daily living/instrumental activities of daily living. b P⬍.05, 2⫽SSb/SStotal. movement quality, trunk compensation, daily functions, and quality of life of TBAT, RBAT, and CT. Therapist-based BAT and RBAT demonstrated differential benefits on specific outcome measures compared with CT. The TBAT group showed better temporal efficiency (NMT), smoothness (NMUs), and straighter trunk motion (NTD) during the unilateral task than the CT group. The TBAT group also showed less trunk compensation (trunk contribution) than the CT group during the unilateral and bimanual tasks and the RBAT group in the unilateral task. In contrast, the RBAT group demonstrated specific benefits for increasing shoulder flexion (angular changes of shoulder joint) compared with the CT group during the unilateral and bimanual tasks and the 1012 f Physical Therapy Volume 92 TBAT group in the unilateral task. The TBAT group also achieved better performance in the distal part score of the FMA than the CT group, whereas the RBAT group had higher strength subscale, physical function domain, and total scores of the SIS than the CT group. In general, BAT based on therapist or robot demonstrated superior performance compared with the control intervention. Bilateral arm training seems to contradict the principles of unilateral training, such as constraint-induced therapy, where the movement of the unaffected limb is limited and intensive practice of the affected limb is required. However, BAT and unilateral training, including constraint-induced therapy, share a similar mechanism Number 8 of rebalanced interhemispheric inhibition and disinhibition. The mechanisms for BAT involve the generation of a “template” by the contralesional hemisphere and the activations in both hemispheres, leading to balanced inhibitory effects between hemispheres.33 The mechanism for unilateral training (eg, constraintinduced therapy) relates to the facilitation of ipsilesional hemisphere activation, resulting in a disinhibitory effect of the contralesional cortex to the ipsilesional side and, thus, rebalanced activation between the 2 hemispheres.34 Benefits of TBAT Over Other Interventions Generally consistent with a previous study,8 the TBAT group performed the reaching task more efficiently August 2012 Therapist-Based Versus Robotic Bilateral Arm Training (less NMT) and smoothly (less NMUs) with the affected arm and with straighter trunk motion (less trunk NTD) in the unilateral task than the CT group. The possible explanation for the superiority of TBAT may have been the KR and KP provided by therapists and the active problem-solving process when functional tasks were practiced. By being provided with KR and KP, participants were able to perceive information about movement outcome and process and make the next attempt more successful by trying to reduce movement errors.35,36 The feedback thus might have helped facilitate motor learning and lead to better movement quality for patients in the TBAT group. In contrast, the RBAT group practiced only forearm pronation-supination and wrist flexion-extension in passive or active modes provided by the Bi-ManuTrack, which enforced movements in designed and suitable trajectories. Participants in the RBAT group lacked patient-therapist interaction and experience in error-based learning in functional tasks, which did not lead to superior effects on arm and trunk performance. The TBAT group recruited less trunk involvement (greater value of trunk contribution slope for the middle part) than the RBAT and CT groups during unilateral reaching and the CT group during the bilateral reaching task. When both arms perform a similar spatiotemporal pattern simultaneously, the “template” generated by the undamaged hemisphere may provide normal motor plans (ie, reaching with minimal trunk displacement)2 to assist in restoring the movement pattern of the hemiplegic UL.33 Moreover, the motor system organizes the trunk and proximal part musculature of the UL on a bilateral basis.37 The functional tasks in the TBAT group involved ULs without constraining the trunk and then provided more opportunities to August 2012 practice arm-trunk coordination while performing the tasks. In contrast, the tasks in RBAT involved minimal trunk movement via the static position of both arms strapped to the Bi-Manu-Track, which offered less arm-trunk coordination than TBAT. Consequently, TBAT may better facilitate trunk-limb organization in a desirable or normal way and lead to fewer trunk compensatory movements than RBAT. The TBAT group improved arm and trunk movement quality only in the unilateral task, which might be explained by the nature of the tasks. Participants were asked to perform the unilateral task as fast as possible but to execute the bimanual task with comfortable self-speed, which may not have been sensitive enough to induce differences among the 3 groups. Moreover, the bimanual task used in this study (eg, pull a drawer with the affected hand and retrieve an eyeglass case with unaffected hand) involved bilateral, sequential reaching that was different from the bilateral, simultaneous movements practiced in TBAT. Partially consistent with a previous study,7 the TBAT group produced greater improvements in the distal part score of the FMA, but not in the overall and proximal part of the FMA. Simultaneously moving both arms may have rebalanced interhemispheric activation and inhibition,38 thus reducing the distal part of motor impairment of the affected UL.4,39,40 Furthermore, consistent with previous research,41,42 this study demonstrated no significant differences among the groups in daily functions as measured by the MAL. This result might be because the bilateral symmetrical activities of the TBAT program did not emphasize forced use of the affected UL. Most bimanual tasks in daily life require bilateral sequential movement, but not bilateral simultaneous movement.4 Therefore, practice of bilateral symmetric activities might not be able to incorporate gain in the distal part of motor function into daily use of the affected UL. Benefits of RBAT Over Other Interventions The RBAT group had larger improvements in angular changes of shoulder flexion compared with the TBAT and CT groups in unilateral reaching and with the CT group in bimanual reaching. The Bi-Manu-Track robot provides robot-assisted, distal movement training, characterized by a constant velocity and a high number of repetitions in passive or active mode, which reestablishes the normative movement pattern by increasing the quality and quantity of sensorimotor information.43 Thus, the range of motion was improved. The distal movement training provided by the Bi-Manu-Track in the present study demonstrated treatment effects on the proximal part of the UL such as shoulder joints. The distal approach may lead to a stronger activation in the sensorimotor cortex, given the larger cortical representation, than the proximal training and thus result in benefits to the proximal joints.6 Another explanation for the possible advantages may be that the proximal parts also were working intensely during distal training.15 Interestingly, the 3 groups differed significantly in shoulder flexion but not in elbow extension range of motion. Voluntary elbow extension is less amenable to change than shoulder flexion.44 It is difficult to generate elbow extension in the affected limb when reaching outward45 because of the strong synergistic joint torque coupling of shoulder abductor and elbow flexion.46 – 48 Direct comparisons between bilateral protocols of the present study and unilateral protocols of the previous studies49,50 might be arguable. A previous study50 suggested that Volume 92 Number 8 Physical Therapy f 1013 Therapist-Based Versus Robotic Bilateral Arm Training intensive unilateral arm training mediated by a therapist or a robot improved motor impairment of the proximal UL, but not motor function and quality of life. In contrast, another study49 showed that intensive, robot-assisted, unilateral therapy significantly improved quality of life, but not motor function, immediately after intervention compared with conventional intervention. Differences in the intensity of training and the type of robot may explain the differential effect in these 2 studies. Our study extended the study findings of Lo et al49 and showed that the group who underwent robotassisted training based on a bilateral protocol had larger gains in quality of life, as reflected by the strength subscale, physical function domain, and total score of the SIS, than the CT group. Even though our study recruited participants with moderateto-mild UL impairment and used bilateral protocols different from those of the study by Lo et al49 using patients with moderate-to-severe UL impairment and treatment approaches with unilateral protocols, both studies adopted intensive, robot-assisted therapy to enhance quality of life for patients with chronic stroke. In contrast, Volpe et al50 did not find significant changes in SIS scores after using a different robot (InMotion2 [Interactive Motion Technology Inc, Cambridge, Massachusetts], the commercial version of MIT-MANUS) for less intensive training (1 hour per session, 3 times a week for 6 weeks). The RBAT in this study involved moving the distal bilateral arm against initial resistance in mode 3 (ie, active-active), which is similar to a strength training program and, therefore, may enhance strength output. Accordingly, patients who receive RBAT may report higher quality of life in the strength subscale than those who receive CT. Moreover, distal paretic limb 1014 f Physical Therapy Volume 92 strength has a strong relationship with daily activity, and strengthrelated training might have enhanced the UL performance in daily living in individuals with chronic stroke.51,52 Robot-assisted BAT increases active range of motion, as evidenced in the present study, and possibly decreases spasticity of the wrist and forearm.43 It follows that improved physical conditions (self-perceived muscle strength and quantitative measures of range of motion) in daily living might lead to better perception of the physical function domain and overall quality of life.43 A limitation of this study was the lack of a follow-up assessment, which may limit the understanding of potential long-term benefits. Future research should examine the retention of therapeutic gains after TBAT and RBAT. In addition, appropriate methods for measuring real-world activity are a concern.53 The MAL exclusively measures the functional performance of the affected UL, which may not be the most suitable one for assessing the outcomes after bilateral training protocols. Future studies need to assess changes on outcome measures relevant to patients’ daily situations, including bilateral tasks (eg, the ABILHAND accelerometry55) questionnaire,54 for monitoring activity of the ULs in the community. Finally, the significant results should be considered with caution, as correction for multiple comparisons was not done due to the preliminary nature and size of the study. Conclusions This is the first study to compare bilateral arm training mediated by a therapist versus a robot in improving motor control, functional performance, and quality of life in patients with stroke. These findings suggest that TBAT might uniquely improve temporal efficiency, smoothness, Number 8 and trunk compensation of reaching movement and motor impairment of the distal part of the UL. Robotassisted BAT may be a more compelling approach to improve shoulder flexion range of motion and quality of life related to paretic UL function. Dr Wu provided concept/idea/research design. Dr Wu, Ms Yang, Dr Chuang, Dr Lin, and Dr Chen provided writing. Ms Yang, Dr Lin, and Ms Huang provided data collection. Ms Yang, Dr Chuang, Dr Chen, and Ms Huang provided data analysis. Dr Wu, Dr Chuang, and Dr Lin provided project management and fund procurement. Ms Yang provided participants. Dr Wu, Dr Lin, and Dr Chen provided facilities/equipment. Dr Wu and Dr Lin provided institutional liaisons. Dr Chuang and Ms Huang provided clerical support. Dr Wu, Dr Chuang, Dr Lin, Dr Chen, and Dr Chen provided consultation (including review of manuscript before submission). The institutional review boards of the participating sites approved this study. This project was supported, in part, by the National Health Research Institutes (NHRIEX100-9920PI and NHRI-EX100-10010PI), the National Science Council (NSC 97-2314B-002– 008-MY3 and NSC 99-2314-B-182014-MY3), and the Healthy Aging Research Center at Chang Gung University (EMRPD1A0891). This trial has been registered at Clinical Trials.gov; Identifier: NCT01525979. DOI: 10.2522/ptj.20110282 References 1 Levin MF, Kleim JA, Wolf SL. What do motor “recovery” and “compensation” mean in patients following stroke? Neurorehabil Neural Repair. 2009;23:313– 319. 2 Levin MF, Michaelsen SM, Cirstea CM, Roby-Brami A. Use of the trunk for reaching targets placed within and beyond the reach in adult hemiparesis. Exp Brain Res. 2002;143:171–180. 3 Fasoli SE, Krebs HI, Ferraro M, et al. Does shorter rehabilitation limit potential recovery poststroke? Neurorehabil Neural Repair. 2004;18:88 –94. 4 McCombe Waller S, Whitall J. Bilateral arm training: why and who benefits? Neuro Rehabilitation. 2008;23:29 – 41. 5 Stoykov ME, Lewis GN, Corcos DM. Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabil Neural Repair. 2009;23: 945–953. August 2012 Therapist-Based Versus Robotic Bilateral Arm Training 6 Hesse S, Werner C, Pohl M, et al. Computerized arm training improves the motor control of the severely affected arm after stroke: a single-blinded randomized trial in two centers. Stroke. 2005;36:1960 –1966. 7 Lin KC, Chang YF, Wu CY, Chen YA. Effects of constraint-induced therapy versus bilateral arm training on motor performance, daily functions, and quality of life in stroke survivors. Neurorehabil Neural Repair. 2009;23:441– 448. 8 Lin KC, Chen YA, Chen CL, et al. The effects of bilateral arm training on motor control and functional performance in chronic stroke: a randomized controlled study. Neurorehabil Neural Repair. 2010; 24:42–51. 9 Wu CY, Chuang LL, Lin KC, et al. Randomized trial of distributed constraint-induced therapy versus bilateral arm training for the rehabilitation of upper-limb motor control and function after stroke. Neurorehabil Neural Repair. 2011;25:130 – 139. 10 Burgar CG, Lum PS, Shor PC, et al. Development of robots for rehabilitation therapy: the Palo Alto VA/Stanford experience. J Rehabil Res Dev. 2000;37:663– 673. 11 Lum PS, Burgar CG, Shor PC, et al. Robotassisted movement training compared with conventional therapy techniques for the rehabilitation of upper-limb motor function after stroke. Arch Phys Med Rehabil. 2002;83:952–959. 12 Lum PS, Burgar CG, Van der Loos M, et al. MIME robotic device for upper-limb neurorehabilitation in subacute stroke subjects: a follow-up study. J Rehabil Res Dev. 2006;43:631– 642. 13 Prange GB, Jannink MJ, GroothuisOudshoorn CG, et al. Systematic review of the effect of robot-aided therapy on recovery of the hemiparetic arm after stroke. J Rehabil Res Dev. 2006;43:171–184. 14 Brewer BR, McDowell SK, WorthenChaudhari LC. Poststroke upper extremity rehabilitation: a review of robotic systems and clinical results. Top Stroke Rehabil. 2007;14:22– 44. 15 Krebs HI, Volpe BT, Williams D, et al. Robot-aided neurorehabilitation: a robot for wrist rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2007;15:327–335. 16 Sanford J, Moreland J, Swanson LR, et al. Reliability of the Fugl-Meyer Assessment for testing motor performance in patients following stroke. Phys Ther. 1993;73:447– 454. 17 Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987;67: 206 –207. 18 Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”: a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12: 189 –198. 19 Subramanian SK, Massie CL, Malcolm MP, Levin MF. Does provision of extrinsic feedback result in improved motor learning in the upper limb poststroke? A systematic review of the evidence. Neurorehabil Neural Repair. 2010;24:113–124. August 2012 20 Hesse S, Schulte-Tigges G, Konrad M, et al. Robot-assisted arm trainer for the passive and active practice of bilateral forearm and wrist movements in hemiparetic subjects. Arch Phys Med Rehabil. 2003;84:915– 920. 21 Hesse S, Schmidt H, Werner C. Machines to support motor rehabilitation after stroke: 10 years of experience in Berlin. J Rehabil Res Dev. 2006;43:671– 678. 22 Wu CY, Chen CL, Tang SF, et al. Kinematic and clinical analyses of upper-extremity movements after constraint-induced movement therapy in patients with stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2007;88:964 –970. 23 Wu CY, Lin KC, Chen HC, et al. Effects of modified constraint-induced movement therapy on movement kinematics and daily function in patients with stroke: a kinematic study of motor control mechanisms. Neurorehabil Neural Repair. 2007;21:460 – 466. 24 Michaelsen SM, Dannenbaum R, Levin MF. Task-specific training with trunk restraint on arm recovery in stroke: randomized control trial. Stroke. 2006;37:186 –192. 25 Kamper DG, McKenna-Cole AN, Kahn LE, Reinkensmeyer DJ. Alterations in reaching after stroke and their relation to movement direction and impairment severity. Arch Phys Med Rehabil. 2002;83:702– 707. 26 Michaelsen SM, Levin MF. Short-term effects of practice with trunk restraint on reaching movements in patients with chronic stroke: a controlled trial. Stroke. 2004;35:1914 –1919. 27 Fugl-Meyer AR, Jaasko L, Leyman I, et al. The post-stroke hemiplegia, I: a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7:13–31. 28 Uswatte G, Taub E, Morris D, et al. The Motor Activity Log–28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006;67:1189 –1194. 29 Lai SM, Studenski S, Duncan PW, Perera S. Persisting consequences of stroke measured by the Stroke Impact Scale. Stroke. 2002;33:1840 –1844. 30 Huck S, McLean R. Using a repeated measures ANOVA to analyze the data from a pretest-posttest design: a potentially confusing task. Psychol Bull. 1975;82:511– 518. 31 Carr JH, Shepherd RB. Reaching and manipulation. In: Carr JH, Shepherd RB , eds. Guidelines for Exercise and Training to Optimize Motor Skill. Edinburgh, United Kingdom: Butterworth-Heinemann; 2003: 159 –191. 32 Cohen J. Statistical Power Analysis for the Behavioral Sciences. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988. 33 Mudie MH, Matyas TA. Can simultaneous bilateral movement involve the undamaged hemisphere in reconstruction of neural networks damaged by stroke? Disabil Rehabil. 2000;22:23–37. 34 Liepert J, Miltner WHR, Bauder H, et al. Motor cortex plasticity during constraintinduced movement therapy in stroke patients. Neurosci Lett. 1998;250:5– 8. 35 Magill R. Motor Learning and Control: Concepts and Application. 8th ed. New York, NY: The McGraw-Hill Companies; 2007. 36 van Vliet PM, Wulf G. Extrinsic feedback for motor learning after stroke: what is the evidence? Disabil Rehabil. 2006;28: 831– 840. 37 Di Stefano M, Morelli M, Marzi CA, Berlucchi G. Hemispheric control of unilateral and bilateral movements of proximal and distal parts of the arm as inferred from simple reaction time to lateralized light stimuli in man. Exp Brain Res. 1980;38: 197–204. 38 Whitall J, McCombe-Waller S, Sorkin JD, et al. Bilateral and unilateral arm training improve motor function through differing neuroplastic mechanisms: a single-blinded randomized controlled trial. Neurorehabil Neural Repair. 2011;25:118 –129. 39 Cauraugh JH, Summers JJ. Neural plasticity and bilateral movements: a rehabilitation approach for chronic stroke. Prog Neurobiol. 2005;5:309 –320. 40 Stewart KC, Cauraugh JH, Summers JJ. Bilateral movement training and stroke rehabilitation: a systematic review and meta-analysis. J Neurol Sci. 2006;244:89 – 95. 41 Luft AR, McCombe-Waller S, Whitall J, et al. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004; 292:1853–1861. 42 Richards LG, Senesac CR, Davis SB, et al. Bilateral arm training with rhythmic auditory cueing in chronic stroke: not always efficacious. Neurorehabil Neural Repair. 2008;22:180 –184. 43 Kutner NG, Zhang R, Butler AJ, et al. Quality-of-life change associated with robotic-assisted therapy to improve hand motor function in patients with subacute stroke: a randomized clinical trial. Phys Ther. 2010;90:493–504. 44 Malcolm MP, Massie C, Thaut M. Rhythmic auditory-motor entrainment improves hemiparetic arm kinematics during reaching movements: a pilot study. Top Stroke Rehabil. 2009;16:69 –79. 45 Ellis MD, Sukal T, DeMott T, Dewald JP. Augmenting clinical evaluation of hemiparetic arm movement with a laboratorybased quantitative measurement of kinematics as a function of limb loading. Neurorehabil Neural Repair. 2008;22: 321–329. 46 Beer RF, Given JD, Dewald JP. Taskdependent weakness at the elbow in patients with hemiparesis. Arch Phys Med Rehabil. 1999;80:766 –772. 47 Dewald JP, Beer RF. Abnormal joint torque patterns in the paretic upper limb of subjects with hemiparesis. Muscle Nerve. 2001;24:273–283. 48 Ellis MD, Acosta AM, Yao J, Dewald JP. Position-dependent torque coupling and associated muscle activation in the hemiparetic upper extremity. Exp Brain Res. 2007;176:594 – 602. Volume 92 Number 8 Physical Therapy f 1015 Therapist-Based Versus Robotic Bilateral Arm Training 49 Lo AC, Guarino PD, Richards LG, et al. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010;362:1772–1783. 50 Volpe BT, Lynch D, Rykman-Berland A, et al. Intensive sensorimotor arm training mediated by therapist or robot improves hemiparesis in patients with chronic stroke. Neurorehabil Neural Repair. 2008;22:305–310. 51 Faria-Fortini I, Michaelsen SM, Cassiano JG, Teixeira-Salmela LF. Upper extremity function in stroke subjects: relationships between the International Classification of Functioning, Disability and Health domains. J Hand Ther. 2011;24:256 –264. 1016 f Physical Therapy Volume 92 52 Harris JE, Eng JJ. Paretic upper-limb strength best explains arm activity in people with stroke. Phys Ther. 2007;87:88 –97. 53 Uswatte G, Hobbs Qadri L. A behavioral observation system for quantifying arm activity in daily life after stroke. Rehabil Psychol. 2009;54:398 – 403. 54 Penta M, Tesio L, Arnould C, et al. The ABILHAND questionnaire as a measure of manual ability in chronic stroke patients: Rasch-based validation and relationship to upper limb impairment. Stroke. 2001;32: 1627–1634. Number 8 55 Uswatte G, Giuliani C, Winstein C, et al. Validity of accelerometry for monitoring real-world arm activity in patients with subacute stroke: evidence from the extremity constraint-induced therapy evaluation trial. Arch Phys Med Rehabil. 2006;87:1340 –1345. August 2012 Research Report Hui-fang Chen, PhD, Assessment Research Centre, Hong Kong Institute of Education, Hong Kong, People’s Republic of China. Dr Chen was affiliated with the Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan, at the time of the study. Rasch Validation of the Streamlined Wolf Motor Function Test in People With Chronic Stroke and Subacute Stroke Hui-fang Chen, Ching-yi Wu, Keh-chung Lin, Hsieh-ching Chen, Carl P-C. Chen, Chih-kuang Chen Background. The construct validity and reliability of the short form of the Wolf Motor Function Test (S-WMFT) in people with subacute stroke and chronic stroke (S-WMFT subacute stroke and chronic stroke versions) have not been investigated. Objective. The purpose of this study was to investigate the dimensionality, item difficulty hierarchy, differential item functioning (DIF), and reliability of the S-WMFT subacute stroke and chronic stroke versions in people with mild to moderate upper-extremity (UE) dysfunction. Design. This was a secondary study in which data collected from randomized controlled trials were used. Methods. Data were collected at baseline from 97 people with chronic stroke (⬎12 months after stroke) and 75 people with subacute stroke (3–9 months after stroke) at 3 medical centers in Taiwan. Test structure, hierarchical properties, DIF, and reliability were assessed with Rasch analysis. Results. The test structure for both versions was unidimensional. No DIF relevant to sex, age, or stroke location (hemispheric laterality) was detected. The tasks of moving a hand to a box and moving a hand to a table in the S-WMFT for subacute stroke showed a significantly high correlation. The reliability coefficients for both versions were approximately .90. Limitations. The findings were limited to people with stroke and mild to moderate impairment of UE function. Conclusions. The S-WMFT subacute stroke and chronic stroke versions are useful tools for assessing UE function in different subgroups of people with stroke and show evidence of construct validity and reliability. A high correlation between the tasks of moving a hand to a box and moving a hand to a table in the S-WMFT for subacute stroke suggests that the removal of 1 of these 2 items is warranted. C. Wu, ScD, OTR, Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, Chang Gung University. K. Lin, ScD, OTR, School of Occupational Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan, and Division of Occupational Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, F4, 17 Xu Zhou Rd, Taipei, Taiwan. Address all correspondence to Dr Lin at: [email protected]. Hsieh-ching Chen, PhD, Department of Industrial Engineering and Management, National Taipei University of Technology, Taipei, Taiwan. C.P-C. Chen, MD, PhD, Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital, Taoyuan, Taiwan. C. Chen, MD, Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital. [Chen H, Wu C, Lin K, et al. Rasch validation of the streamlined Wolf Motor Function Test in people with chronic stroke and subacute stroke. Phys Ther. 2012;92: 1017–1026.] © 2012 American Physical Therapy Association Published Ahead of Print: May 3, 2012 Accepted: April 27, 2012 Submitted: May 27, 2011 Post a Rapid Response to this article at: ptjournal.apta.org August 2012 Volume 92 Number 8 Physical Therapy f 1017 Rasch Validation of the S-WMFT M ore than 80% of people who have had a stroke have impaired function of the upper extremity (UE),1 and many do not regain full functional abilities of their arms and hands.2 An important issue in addressing these deficits after stroke and improving UE function after rehabilitation therapy is to identify reliable and valid outcome measures for examining UE motor function. The Wolf Motor Function Test (WMFT), which is used to measure the recovery of UE motor function after stroke, is such a test.3,4 The WMFT was originally designed to evaluate UE function in people with chronic stroke5 and was modified to examine the effects of constraint-induced movement therapy in the Extremity ConstraintInduced Therapy Evaluation (EXCITE) study.6,7 Researchers further extended its use to study the effects of electrical stimulation– assisted therapy8 and bilateral arm training.9 The current WMFT consists of 15 performance tasks and has a performance time scale for evaluating the time to complete a task and a 6-point functional ability scale (FAS) for evaluating the quality of UE function during a task. In previous research, classical test theory was extensively used to study the measurement properties of the WMFT. The findings indicated that the predictive and concurrent validity, reliability, and responsiveness of the performance time scale and the FAS were adequate to excellent in people after stroke.10 –14 Rasch analysis has several potential advantages over classical test theory in assessing UE function when an ordinal scale is used. In classical test theory, a total score is the sum of the scores for all items on an ordinal scale. Because the true distances 1018 f Physical Therapy Volume 92 between the items and between the rating categories of the items are unknown,15 the simple summation of scores can lead to imprecise conclusions about differences between people as well as about change.16 To address this limitation, Rasch analysis has been increasingly used in rehabilitation research to create sound measures. Rasch analysis transforms ordinal scores into interval data, which may yield more accurate estimates of test item information in parametric analyses. Also, Rasch analysis can explore the construct validity of a UE measure to determine whether the tasks reflect a single construct: the functional ability of the UE.17,18 The estimated hierarchy of item difficulty (from easy to difficult to perform) advances contemporary expectations of deficit, repair, and recovery after stroke. The targeting of item difficulty to UE motor ability specifies tasks that people can and cannot perform, quantifies motor impairment by locating an individual’s ability to function along a continuum of UE motor function, and informs progress in the recovery of functional status. Rasch analysis also enables the examination of differential item functioning (DIF). Differential item functioning is an indicator of biased items that have resulted in people from different subgroups within a population, but with similar UE motor function, having different responses to certain types of UE tasks. When DIF is present, task performance is affected by multiple factors that are not the focus of study, and the instrument may not be accurate for assessing UE motor function. Therefore, DIF analyses potentially can improve knowledge of whether observed differences in scores across groups represent a measurement problem, a true difference in UE function, or Number 8 both, and can provide evidence to support the validity of the WMFT.19 Woodbury et al20 conducted a Rasch analysis to validate the theoretic basis of the WMFT FAS. Their findings suggested that all items in the WMFT measure a single latent trait, UE motor function, and that the item difficulty hierarchy is consistent with the original item difficulty expectations. However, researchers have not documented any findings in DIF analyses to indicate, after controlling for people’s UE functional abilities, whether the relationships between item responses and UE motor function measured by the WMFT differ across groups with regard to demographic and stroke-related characteristics. To improve the efficiency of administration, Bogard et al21 evaluated the relative contributions of the 15 WMFT timed performance tasks to the overall change in the WMFT total score in EXCITE study participants and proposed 2 short forms of the WMFT (S-WMFT), one for people with subacute stroke (3–9 months after stroke)17,18,22 and one for people with chronic stroke (12 months or longer after stroke). The 2 versions share 4 common tasks (moving a hand to a box, lifting a can, lifting a pencil, and folding a towel), and each version has 2 distinct tasks (extending elbow 28 cm on tabletop [0.4536-kg (1-lb) weight] and turning a key in a lock for the chronic stroke version and moving a hand to a table and reaching and retrieving for the subacute stroke version). Bogard et al21 developed the S-WMFT to reflect differences in the progress of motor abilities in people at different stages of recovery after stroke.23 People show relatively fast recovery for performing simple arm movements early after stroke (eg, reaching) but slow recovery for performing complex movement tasks.24 August 2012 Rasch Validation of the S-WMFT At 1 year after stroke, people gain small improvements in movement skills and are aware of how these small changes may be related to functional gains in daily activities.25 These findings imply that various test items may be required to evaluate motor function in people at different stages of recovery. In 1 investigation,26 the validity of the S-WMFT subacute stroke version was studied, but no research to date has documented the measurement properties of the S-WMFT chronic stroke version. The performance time scale study of the S-WMFT subacute stroke version revealed comparable responsiveness and concurrent validity but slightly higher predictive validity relative to those of the WMFT. These findings indicated the clinical utility of the S-WMFT subacute stroke version in outcome evaluation and promise for further validation. However, no investigations of the test hierarchy, DIF, or test structure of the S-WMFT subacute stroke or chronic stroke version have been performed. Although previous studies investigated the measurement properties of the WMFT, the measurement properties of the S-WMFT may not be similar to those of the original scale. The removal of test items may jeopardize 1 or more important aspects of the performance of the original test and, as a result, the psychometric properties of a short form may be different from those of the original.27 Because the measurement properties of the WMFT may not be generalized to the S-WMFT, further study of the hierarchical properties of the S-WMFT in people with subacute or chronic stroke is warranted. The goal of the present study was to extend the previous findings for the S-WMFT and fill the knowledge gap about the measurement properties of the S-WMFT. Because the 2 verAugust 2012 sions of the S-WMFT are targeted to people with stroke at different stages of recovery (subacute and chronic), we examined the psychometric properties of the 2 versions for their targeted populations, including the item difficulty hierarchy, test structure, targeting, and reliability of the S-WMFT FAS. In addition, we investigated DIF to understand whether the test structure is the same for people with different clinical and demographic characteristics. The Rasch rating model was used for the study. Method Participants Ninety-seven people with stroke at the chronic stage were recruited to study the psychometric properties of the S-WMFT chronic stroke version, whereas data from 75 people with subacute stroke were used to investigate the measurement properties of the S-WMFT subacute stroke version. The sample size required to achieve stable item calibrations with dichotomous data ranges from 64 to 144 for an accuracy of ⫾0.5 logit at the 95% confidence interval; polytomous observations require a smaller sample size.28 Thus, the sample sizes in the present study (97 for people with chronic stroke and 75 for people with subacute stroke) were sufficient to achieve stable item calibrations. The inclusion criteria were first-ever stroke with onset between 3 and 9 months prior (subacute stroke group) or 12 months prior or longer (chronic stroke group), ability to understand the study and respond to questions (score of ⱖ22 on the Mini-Mental State Examination),29 demonstration of Brunnstrom stage III or higher for the proximal part of the affected arm,30 and no excessive spasticity at any joint of the arm (score of ⱕ2 on the Modified Ashworth Scale).31 Excluded were people with physician-determined major medical problems, such as poor physical condition. Participants were enrolled in an ongoing randomized controlled trial investigating the effects of motor rehabilitation after stroke. All participants provided written informed consent. Outcome Measure The S-WMFT chronic stroke and subacute stroke versions have 6 items. They share 4 common tasks, and each has 2 distinct tasks. Table 1 shows the contents of the 2 versions of the S-WMFT. For the present study, we used only FAS item ratings and not item performance time. The FAS is a 6-point scale ranging from 0 (no use) to 5 (normal). Detailed descriptions of the FAS ratings are given in Table 2. Procedure Three certified and trained occupational therapists administered the WMFT to participants before and after the rehabilitation programs. The administration took an average of 20 minutes. Every participant was instructed to execute all of the test tasks with the affected arm and, if necessary, with help from the unaffected arm. Data Analysis Because the focus of the present study was the S-WMFT, we analyzed only the baseline scores for certain tasks. For the subacute stroke group, these tasks were moving a hand to a table, moving a hand to a box, reaching and retrieving, lifting a can, lifting a pencil, and folding a towel; for the chronic stroke group, these tasks were extending elbow 28 cm on tabletop (0.4536-kg weight), moving a hand to a box, lifting a can, lifting a pencil, turning a key in a lock, and folding a towel. We examined the appropriateness of rating categories (ie, rating scale diagnostics), test structure, item difficulty hierarchy, DIF, and reliability using Winsteps software (version 3.70.0.5).32 Volume 92 Number 8 Physical Therapy f 1019 Rasch Validation of the S-WMFT Table 1. Item Statistics for the Chronic Stroke and Subacute Stroke Versions of the Streamlined Wolf Motor Function Testa Biserial Correlation Item Difficulty Measure (Logit) Item Difficulty (SE) Extending elbow 28 cm on tabletop (0.4536-kg [1-lb] weight) .72 ⫺1.56 .19 Test Version Chronic stroke Subacute stroke Item Infit Outfit MNSQ ZSTD MNSQ ZSTD 1.27 1.70 1.49 2.50 Moving hand to box .74 ⫺1.88 .19 0.95 ⫺0.30 1.40 1.90 Lifting can .84 0.98 .17 0.86 ⫺1.0 0.90 ⫺0.70 Lifting pencil .87 0.59 .17 0.99 0.00 1.01 ⫺0.10 Turning key in lock .87 1.15 .17 0.89 ⫺0.80 0.94 ⫺0.40 Folding towel .88 0.71 .17 0.67 ⫺2.60 0.69 ⫺2.40 Moving hand to table (front) .85 ⫺1.06 .21 0.65 ⫺2.10 0.66 ⫺1.80 Moving hand to box (front) .84 ⫺0.73 .20 0.73 ⫺1.60 0.72 ⫺1.60 Reaching and retrieving .75 ⫺1.24 .21 1.34 1.70 1.24 1.10 Lifting can .84 0.88 .18 1.04 0.30 1.04 0.30 Lifting pencil .80 1.14 .18 1.24 1.50 1.24 1.40 Folding towel .85 1.01 .18 0.80 ⫺1.30 0.86 ⫺0.80 a SE⫽standard error of measurement, MNSQ⫽mean square of the item residuals, ZSTD⫽transformation of the mean square of the residuals to the standardized form. Rating scale diagnostics were examined to ensure that people with a lower level of UE motor function received predominantly lower ratings and that people with a higher level of UE motor function received predominantly higher ratings. The criteria were as follows33: there were at least 10 responses per rating category; the average participant’s motor ability in each rating category increased as the rating value increased; and the outfit mean square, a type of goodness-of-fit statistic, of each rating category was less than 2. If a rating category failed to meet these criteria, then collapsing the rating category would be considered. To assess construct validity, we investigated dimensionality, DIF, and item difficulty hierarchy. Rasch principal components analysis of the Table 2. Functional Ability Scale 1020 f Original Rating Revised Rating 0 0 Does not attempt with the affected arm. 1 0 Attempts to use the involved arm, but it does not participate functionally. In unilateral tasks, the less affected arm may be used to move the affected arm. 2 1 Attempts to use the involved arm with assistance from the less affected arm for minor adjustments or change of positions, requiring more than 2 attempts to complete or completing a task slowly. In bilateral tasks, the affected arm serves only as a helper. 3 2 Only the affected arm is involved in the task, but movements are influenced to some degree by synergy or performed slowly, with effort, or both. 4 3 Only the affected arm is involved in the task; movements are close to normal, but slightly slower. In addition, movements may lack precision, fine coordination, or fluidity. 5 4 Only the affected arm is involved in the task, but movements appear to be normal. Physical Therapy Volume 92 Number 8 Description August 2012 Rasch Validation of the S-WMFT residuals was used to test against the hypothesis of unidimensionality. The variance in UE motor function explained by the S-WMFT was analyzed. Unidimensionality was supported when the variance explained by the first dimension exceeded 50% and an eigenvalue of the unexplained variance in the first residual factor was less than 2.32 Item difficulty and person UE function were simultaneously evaluated with Rasch analysis. We expected that less difficult tasks would be more likely to be accomplished by all participants than more difficult tasks and that participants with a low level of UE function would be more likely to do poorly on difficult items than participants with a high level of UE function. The mean square and standardized z score fit statistics were used together to examine whether an item deviated significantly from the expectation of the Rasch model (misfit). Two types of unexpected ratings were summarized: responses close to the difficulty of an item (infit) and responses far from the difficulty of an item (outfit). On the basis of recommendations in the Winsteps software, an item with a mean square of greater than 1.5 and a standardized z score outside the range of ⫺2.0 to 2.0 was considered to be misfit.32 The item-person map indicating the relationship between item difficulty and person UE motor function was examined. An ideal instrument is capable of targeting a wide range of people’s UE motor function; that is, the mean person UE motor function should be relatively close to the mean item difficulty, and the item difficulty range should cover a substantial range of people’s UE motor function.34 Differential item functioning analyses were conducted to examine whether responses to items were influenced by demographic or clinical characteristics after controlAugust 2012 Table 3. Demographic and Clinical Characteristics of the Participantsa Chronic Stroke Group (nⴝ97) Variable Subacute Stroke Group (nⴝ75) Sex Men 64 58 Women 33 17 56.6 (31.3–86.33) 55.6 (29.6–77) 20 (12–89) 7 (3–9) Right 50 40 Left 47 35 Age, y, median (range) Mo after stroke, median (range) Stroke location (hemispheric laterality) a Values are numbers of participants unless otherwise indicated. ling for person UE motor function. The 3 factors chosen in the present study were sex, age (ⱖ65 years old or ⬍65 years old), and hemispheric laterality. The DIF contrast was the difference in item difficulty between 2 groups and should have been at least 0.5 logit to be noticeable.32 A DIF contrast of 0.5 or higher with a probability of less than .05 was considered to be significant.32 Finally, correlations between items and reliability were assessed. A correlation of greater than .90 indicated that 2 tasks were highly related. Reliability was examined with the index of person separation, person reliability, and the Cronbach alpha. Person separation specified the number of significant strata into which the samples of participants were divided by UE motor function. A person separation value of greater than 1.5 indicated that the S-WMFT could distinguish people into at least 2 groups with different levels of motor function.35 The Winsteps person reliability was algebraically distinct but conceptually similar to the traditional internal consistency that is usually measured with the Cronbach alpha.36 For clinical application, a value of 0.7 represented an acceptable level of reliability, a value of 0.8 represented a good level, and a value of 0.9 represented an excellent level.37 Role of the Funding Source This project was supported, in part, by the National Health Research Institutes (NHRI-EX99-9920PI and NHRI-EX100-10010PI), the National Sciences Council (NSC 97-2314-B002-008-MY3 and NSC 99-2314-B182-014-MY3), and the Healthy Ageing Research Center at Chang Gung University (EMRPD1A0891) in Taiwan. Results The median ages of the participants in the chronic stroke and subacute stroke groups were 56.6 and 55.6 years, respectively. In the chronic stroke group, 64 of 97 participants were men, and the mean time since stroke onset was 20 months. In the subacute stroke group, 58 of 75 participants were men, and the mean time since stroke onset was 7 months. Table 3 shows the demographic and clinical characteristics of the participants. Rating Scale Diagnostics Except for the rating category “0,” the FAS met all of the criteria. The category “0” was given 9 times in the chronic stroke group and 7 times in the subacute stroke group. The sub- Volume 92 Number 8 Physical Therapy f 1021 Rasch Validation of the S-WMFT acute stroke group had disordered average person measures. Participants with subacute stroke and a rating of 0 on the FAS had –1.86 logits of motor ability across any item, but participants with a rating of 1 had ⫺1.88 logits. Thus, we collapsed the original category “0” with the category “1.” Reanalysis showed that the new 5-point rating scale met all of the essential criteria and functioned properly. The recoded data were used in the subsequent analyses. (The revised rating categories are shown in Tab. 2.) Dimensionality Rasch principal components analysis supported the assumption of unidimensionality. We found that 72.4% and 70.8% of the variance could be explained by the Rasch dimension in the S-WMFT chronic stroke and subacute stroke versions, respectively. The eigenvalues of the first contrast residuals were less than 2 in both versions. Rasch indexes suggested adequate fit of all tasks (Tab. 1). We concluded that the S-WMFT chronic stroke and subacute stroke versions were unidimensional. DIF No significant DIF by sex, age, and hemiplegia laterality was detected in either version (P⬎.05). The item difficulty of each task for the women was not significantly different from that for the men. Every item had the same difficulty for the older (ⱖ65 years old) and younger (⬍65 years old) groups of participants. The difficulty of individual items for participants with right-side lesions was equivalent to that for participants with left-side lesions. Figure 1. Item difficulty hierarchy of the streamlined Wolf Motor Function Test for participants with chronic stroke. The numbers at the left are logits. Plots of items along the center line are based on average difficulty. The most able people and the most difficult items are at the top, and vice versa. M⫽mean, S⫽standard deviation, T⫽2 standard deviations, X⫽participant’s upper-extremity motor function. 1022 f Physical Therapy Volume 92 Number 8 Item Difficulty Hierarchy For the S-WMFT chronic stroke version, the item difficulty hierarchy from low to high was moving a hand to a box, extending elbow 28 cm on tabletop (0.4536-kg weight), lifting a pencil, folding a towel, lifting a can, August 2012 Rasch Validation of the S-WMFT and turning a key in a lock (Fig. 1). The average UE function was ⫺0.31 logit (SD⫽2.57). For the S-WMFT subacute stroke version, lifting a pencil was the most difficult task, folding a towel and lifting a can were next, and reaching and retrieving was the easiest task (Fig. 2). The average UE function was 0.86 logit (SD⫽2.36). These findings suggest that the S-WMFT subacute stroke version did not target UE motor function as well as the S-WMFT chronic stroke version did. Item Correlations and Test Reliability In the 2 versions of the S-WMFT, all but 1 pair of items had correlations between .37 and .74, and the correlation between the tasks of moving a hand to a table and moving a hand to a box in the S-WMFT subacute stroke version was .93. This correlation indicated that these items may measure similar contents of UE motor function. The investigation of residual correlations between pairs of items revealed that all but 1 pair of items had correlations of less than .30. The tasks of moving a hand to a table and moving a hand to a box in the S-WMFT subacute stroke version were highly locally dependent, with a residual correlation of .70. These 2 items shared more than 50% of their random variance, suggesting that only 1 was needed32 for the S-WMFT subacute stroke version. The person separation values in the S-WMFT chronic stroke and subacute stroke versions were 3.19 and 2.78, the person reliability values were .91 and .89, and the Cronbach alpha values were .91 and .91, respectively. People with chronic stroke could be divided into 4.59 strata/groups, and people with subacute stroke could be divided into 4.04 strata/groups.35 August 2012 Figure 2. Item difficulty hierarchy of the streamlined Wolf Motor Function Test for participants with subacute stroke. The numbers at the left are logits. Plots of items along the center line are based on average difficulty. The most able people and the most difficult items are at the top, and vice versa. M⫽mean, S⫽standard deviation, T⫽2 standard deviations, X⫽participant’s upper-extremity motor function. Volume 92 Number 8 Physical Therapy f 1023 Rasch Validation of the S-WMFT Discussion The present study is the first to examine the test structure, DIF, item difficulty hierarchy, item characteristics, and reliability of the S-WMFT FAS for people with chronic stroke and people with subacute stroke. The 2 versions of the S-WMFT were unidimensional, as is the original WMFT. The results of DIF analyses and the expected item difficulty hierarchy further supported the construct validity. Both versions had high reliability and were capable of differentiating our samples into 4 distinct groups on the basis of UE motor ability. Evidence from the present study indicated differences between the 2 versions in the difficulty of the 4 common items. When the mean person ability was compared with the mean item difficulty, the average item difficulty in the S-WMFT subacute stroke version was lower than that in the S-WMFT chronic stroke version. The S-WMFT subacute stroke version may have a redundant item. The results of the present study supported the unidimensionality of both S-WMFT versions, implying that all of the items in the S-WMFT consistently measure UE motor function in people with stroke. In accordance with the findings of Woodbury et al,20 Rasch principal components analysis of residuals supported unidimensionality. We further validated the construct validity by investigating DIF in the S-WMFT chronic stroke and subacute stroke versions. No DIF relevant to sex, age, or hemiplegia laterality was detected; that is, the rating scores for individual tasks in the S-WMFT were determined by a participant’s UE motor ability, not by other factors, such as sex, age, or hemiplegia laterality. These findings indicate that both S-WMFT versions may exclusively measure motor ability. 1024 f Physical Therapy Volume 92 The Rasch analysis– derived item difficulty hierarchy depicted how the items in the S-WMFT chronic stroke and subacute stroke versions related to one another, and the findings were consistent with the motor control literature. Researchers have reported that increasing the amount of precision required for the action and the number of performance steps amplifies task difficulty. We found that the easiest items in both versions of the S-WMFT (eg, moving a hand to a box in the S-WMFT chronic stroke version and reaching and retrieving in the S-WMFT subacute stroke version) required the control of primarily 1 joint and involved 1-step actions, whereas the most difficult items required the control and coordination of multiple joints and involved multistep actions. The Rasch analysis–derived S-WMFT item difficulty hierarchy provided evidence of the construct validity of the 2 versions of the S-WMFT. Among the 4 tasks common to the 2 S-WMFT versions, the most difficult task in the chronic stroke version was lifting a can; folding a towel, lifting a pencil, and moving a hand to a box were next. People in the chronic stage of stroke regain some fine motor ability (eg, pinching) but still exhibit spasticity or the late development of spasticity 1 year after stroke.38,39 Without sufficient recovery of volitional control of finger and thumb extension, lifting a can may be more difficult for people with chronic stroke than lifting a pencil or folding a towel. In the subacute stroke version, the item difficulty hierarchy of the 4 common tasks was lifting a pencil, folding a towel, lifting a can, and moving a hand to a box. Previous studies suggested that people need to regain voluntary control of wrist and finger extension at the early stage after stroke to exhibit improved dexterity.40,41 As a result, tasks related to Number 8 dexterity, such as lifting a pencil and folding a towel, are considered to be more difficult than tasks related to voluntary control of wrist and finger extension, such as lifting a can. The order of difficulty for lifting a pencil and lifting a can was reversed in the 2 S-WMFT versions. However, it was impossible to directly compare the results obtained with the 2 versions because the item difficulty was estimated for 2 different samples with different scales. The item difficulty estimates were sample dependent, and further transformations were required for comparisons. Future studies can make additional efforts to identify items with similar difficulty estimates across samples by use of DIF analysis, to anchor the “common items” in a separate calibration for each version and, finally, to compare the hierarchies for the groups. The closeness of the average UE motor function and the average item difficulty suggested that both versions of the S-WMFT performed well in targeting UE motor ability in people with stroke. The gaps in the item hierarchies seemed to be large in Figures 1 and 2; adding more difficult items (eg, stacking checkers) and easier items (eg, moving a forearm to a table) might extend construct coverage. However, the gaps did not diminish the sensitivity of both versions of the S-WMFT to changes in UE motor ability. Because there were 5 points in the revised rating scale and 4 steps in the item calibrations, each point scored for an individual task could capture different levels of UE motor function in people with stroke. Items in both versions of the S-WMFT covered a substantial range of UE motor function. Sensitivity for detecting changes in ability provides useful information when clinical practitioners evaluate individual changes in UE motor function over time. August 2012 Rasch Validation of the S-WMFT All items in the S-WMFT chronic stroke version showed biserial correlations higher than .7, contrary to the findings of Morris et al,10 who reported a low item-total correlation for extending elbow 28 cm on tabletop (0.4536-kg weight) in the EXCITE study. The difference may be a result of methodology. In the present study, we used Rasch analysis to transform the WMFT FAS scores from ordinal data to interval data, possibly yielding unbiased estimates to support the adequate fit of items in the S-WMFT chronic stroke version. In contrast, Morris et al10 used classical test theory, which does not have the described advantage. An indication of the redundancy of items was found in the S-WMFT subacute stroke version. The tasks of moving a hand to a box and moving a hand to a table showed a significantly high correlation, indicating that these 2 items provide similar information about UE function. When either of the 2 tasks was removed from data analyses, the unidimensionality held, and the item difficulty hierarchy of the remaining 5 tasks remained the same. The person reliability and person separation values dropped slightly, from .89 to .88 and from 2.78 to 2.69, respectively. The removal of 1 of the 2 tasks did not seem to adversely affect the construct validity or reliability of the S-WMFT subacute stroke version; thus, the removal was warranted. The S-WMFT chronic stroke and subacute stroke versions had the precision to distinguish people with different levels of UE function after stroke and exhibited high person separation and person reliability values.15 Although the person separation values of the 2 versions of the S-WMFT were slightly lower than that of the WMFT,20 the 2 versions could be used to divide our samples into 4 groups according to the level August 2012 of UE function. These findings are consistent with those of a previous study of the S-WMFT in patients with subacute stroke,26 which found that the S-WMFT was sensitive and able to distinguish people.15,42 Study Limitations and Future Research Of note, the rating “0” revealed a low frequency of use in the S-WMFT for people with subacute stroke (2%) and people with chronic stroke (1%), consistent with the results found for the WMFT.21 In the present study and the study of Woodbury et al,20 the participants were people with stroke and mild to moderate impairment of motor ability. Future research might include people with severe deficits in motor ability to examine the appropriateness of the rating “0.” removed might still maintain similar Rasch analysis– derived validity and reliability. We conclude that the S-WMFT chronic stroke and subacute stroke versions are useful outcome measures for evaluating motor deficits during recovery or during a treatment course in people who have mild to moderate impairment after stroke and are at different stages of recovery. Dr Hui-fang Chen, Dr Wu, Dr Lin, and Dr Hsieh-ching Chen provided concept/idea/ research design. Dr Hui-fang Chen, Dr Wu, and Dr Lin provided writing. Dr Wu, Dr Lin, and Dr Hsieh-ching Chen provided data collection. Dr Hui-fang Chen provided data analysis. Dr Wu and Dr Lin provided project management, fund procurement, and institutional liaisons. Dr C.P-C. Chen and Dr C. Chen provided participants and facilities/ equipment. All authors provided consultation (including review of manuscript before submission). Other limitations might influence the generalizability of the results of the present study. First, future research with larger sample sizes is needed to validate our findings. Second, we did not conduct a longitudinal study to track the withinparticipant progress of motor ability after stroke. Additional research is needed to validate the findings for changes in the item difficulty hierarchy to understand the recovery process. Dr Hui-fang Chen and Dr Ching-yi Wu contributed equally to this work. Conclusion References Institutional review board approval for this study was obtained from the study sites. This project was supported, in part, by the National Health Research Institutes (NHRI-EX99-9920PI and NHRI-EX10010010PI), the National Sciences Council (NSC 97-2314-B-002-008-MY3 and NSC 99-2314-B-182-014-MY3), and the Healthy Ageing Research Center at Chang Gung University (EMRPD1A0891) in Taiwan. DOI: 10.2522/ptj.20110175 The S-WMFT chronic stroke and subacute stroke versions are unidimensional measurement scales that are efficiently administered and appropriately targeted for the assessment of UE motor function in people who have had a stroke. The S-WMFT subacute stroke version did not target the UE motor function of people with subacute stroke as well as the S-WMFT chronic stroke version did for people with chronic stroke. The S-WMFT subacute stroke version with 1 of 2 tasks (moving a hand to a box or moving a hand to a table) Volume 92 1 Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994;75:394 –398. 2 Lai SM, Studenski S, Duncan PW, Perera S. Persisting consequences of stroke measured by the Stroke Impact Scale. Stroke. 2002;33:1840 –1844. 3 Rowland TJ, Cooke DM, Gustafsson LA. Role of occupational therapy after stroke. Ann Indian Acad Neurol. 2008;11:99 – 107. 4 Kunkel A, Kopp B, Muller G, et al. Constraint-induced movement therapy for motor recovery in chronic stroke patients. Arch Phys Med Rehabil. 1999;80:624 – 628. Number 8 Physical Therapy f 1025 Rasch Validation of the S-WMFT 5 Wolf SL, Lecraw DE, Barton LA, Jann BB. Forced use of hemiplegic upper extremities to reverse the effect of learned nonuse among chronic stroke and head-injured patients. Exp Neurol. 1989;104:125–132. 6 Park SW, Butler AJ, Cavalheiro V, et al. Changes in serial optical topography and TMS during task performance after constraint-induced movement therapy in stroke: a case study. Neurorehabil Neural Repair. 2004;18:95–105. 7 Winstein CJ, Miller JP, Blanton S, et al. Methods for a multisite randomized trial to investigate the effect of constraintinduced movement therapy in improving upper extremity function among adults recovering from a cerebrovascular stroke. Neurorehabil Neural Repair. 2003;17: 137–152. 8 Kowalczewski J, Gritsenko V, Ashworth N, et al. Upper-extremity functional electric stimulation-assisted exercises on a workstation in the subacute phase of stroke recovery. Arch Phys Med Rehabil. 2007;88:833– 839. 9 Hayner K, Gibson G, Giles GM. Comparison of constraint-induced movement therapy and bilateral treatment of equal intensity in people with chronic upperextremity dysfunction after cerebrovascular accident. Am J Occup Ther. 2010;64:528 –539. 10 Morris DM, Uswatte G, Crago JE, et al. The reliability of the Wolf Motor Function Test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001;82:750 –755. 11 Fritz SL, Blanton S, Uswatte G, et al. Minimal detectable change scores for the Wolf Motor Function Test. Neurorehabil Neural Repair. 2009;23:662– 667. 12 Hsieh YW, Wu CY, Lin KC, et al. Responsiveness and validity of three outcome measures of motor function after stroke rehabilitation. Stroke. 2009;40:1386 – 1391. 13 Lin KC, Hsieh YW, Wu CY, et al. Minimal detectable change and clinically important difference of the Wolf Motor Function Test in stroke patients. Neurorehabil Neural Repair. 2009;23:429 – 434. 14 Whitall J, Waller SM, Sorkin JD, et al. Bilateral and unilateral arm training improve motor function through differing neuroplastic mechanisms: a single-blinded randomized controlled trial. Neurorehabil Neural Repair. 2011;25:118 –129. 15 Higgins J, Finch LE, Kopec J, Mayo NE. Development and initial psychometric evaluation of an item bank created to measure upper extremity function in persons with stroke. J Rehabil Med. 2010;42:170 – 178. 1026 f Physical Therapy Volume 92 16 Wright BD, Linacre JM. Observations are always ordinal; measurements, however, must be interval. Arch Phys Med Rehabil. 1989;70:857– 860. 17 Tennant A, Conaghan PG. The Rasch measurement model in rheumatology: what is it and why use it? When should it be applied, and what should one look for in a Rasch paper? Arthritis Rheum. 2007;57: 1358 –1362. 18 Duncan PW, Bode RK, Lai SM, Parera S. Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale. Arch Phys Med Rehabil. 2003;84:950 –963. 19 Nichols-Larsen DS, Clark PC, Zeringue A, et al. Factors influencing stroke survivors’ quality of life during subacute recovery. Stroke. 2005;36:1480 –1484. 20 Woodbury M, Velozo CA, Thompson PA, et al. Measurement structure of the Wolf Motor Function Test: implications for motor control theory. Neurorehabil Neural Repair. 2010;24:791– 801. 21 Bogard K, Wolf S, Zhang Q, et al. Can the Wolf Motor Function Test be streamlined? Neurorehabil Neural Repair. 2009;23: 422– 428. 22 Bond TG, Fox CM. Applying the Rasch Model: Fundamental Measurement in the Human Sciences. 2nd ed. Mahwah, NJ: Lawrence Erlbaum Associates; 2007. 23 Kwakkel G, Kollen B, Twisk J. Impact of time on improvement of outcome after stroke. Stroke. 2006;37:2348 –2353. 24 Skilbeck CE, Wade DT, Hewer RL. Recovery after stroke. J Neurol Neurosurg Psychiatry. 1983;46:5– 8. 25 Lang CE, Edwards DF, Birkenmeier RL, Dromerick AW. Estimating minimal clinically important differences of upperextremity measures early after stroke. Arch Phys Med Rehabil. 2008;89:1693– 1700. 26 Wu CY, Fu T, Lin KC, et al. Assessing the streamlined Wolf Motor Function Test as an outcome measure for stroke rehabilitation. Neurorehabil Neural Repair. 2010; 25:194 –199. 27 Friedman DS, Tielsch JM, Vitale S, et al. VF-14 item specific responses in patients undergoing first eye cataract surgery: can the length of the VF-14 be reduced? Br J Ophthalmol. 2002;86:885– 891. 28 Linacre JM. Sample size and item calibration stability. Rasch Measurement Transactions. 1994;7:328. 29 Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”: a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12: 189 –198. Number 8 30 Brunnstrom S. Movement Therapy in Hemiplegia. New York, NY: Harper & Row; 1970. 31 Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987;67: 206 –207. 32 Linacre JM. Winsteps® Rasch Measurement Computer Program User’s Guide. Beaverton, OR: Winsteps.com; 2010. 33 Linacre JM. Optimizing rating scale category effectiveness. J Appl Meas. 2002;3: 85–106. 34 Linder HYN, Linacre JM, Hermansson LMN. Assessment of capacity of myoelectric control: evaluation of construct and rating scale. J Rehabil Med. 2009;41:467– 474. 35 Fisher W Jr. Reliability statistics. Rasch Measurement Transactions. 1992;6:238. 36 Everett V, Smith J. Evidence for the reliability of measures and validity of measure interpretation: a Rasch measurement perspective. In: Everett V, Smith J, Smith RM, eds. Introduction to Rasch Measurement. Maple Grove, MN: JAM Press; 2004:93– 122. 37 Lohr KN. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res. 2002;11: 193–205. 38 Watkins CL, Leathley MJ, Gregson JM, et al. Prevalence of spasticity post stroke. Clin Rehabil. 2002;16:515–522. 39 Welmer AK, von Arbin M, Widén Holmqvist L, Sommerfeld DK. Spasticity and its association with functioning and health-related quality of life 18 months after stroke. Cerebrovasc Dis. 2006;21: 247–253. 40 Fritz SL, Light KE, Patterson TS, et al. Active finger extension predicts outcomes after constraint-induced movement therapy for individuals with hemiparesis after stroke. Stroke. 2005;36:1172–1177. 41 Kwakkel G, Kollen B. Predicting improvement in the upper paretic limb after stroke: a longitudinal prospective study. Restor Neurol Neurosci. 2007;25:453– 460. 42 Miller KJ, Slade AL, Pallant JF, Galea MP. Evaluation of the psychometric properties of the upper limb subscales of the Motor Assessment Scale using a Rasch analysis model. J Rehabil Med. 2010;42:315–322. August 2012 Research Report Repeated Measurements of Arm Joint Passive Range of Motion After Stroke: Interobserver Reliability and Sources of Variation Lex D. de Jong, Pieter U. Dijkstra, Roy E. Stewart, Klaas Postema Background. Goniometric measurements of hemiplegic arm joints must be reliable to draw proper clinical and scientific conclusions. Previous reliability studies were cross-sectional and based on small samples. Knowledge about the contributions of sources of variation to these measurement results is lacking. Objective. The aims of this study were to determine the interobserver reliability of measurements of passive range of motion (PROM) over time, explore sources of variation associated with these measurement results, and generate smallest detectable differences for clinical decision making. Design. This investigation was a measurement-focused study with a longitudinal design, nested within a 2-arm randomized controlled trial. Methods. Two trained physical therapists assessed 7 arm movements at baseline L.D. de Jong, PT, MSc, School of Physiotherapy, Hanze University of Applied Sciences, Eyssoniusplein 18, 9714 CE Groningen, the Netherlands, and Department of Rehabilitation Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. Address all correspondence to Mr de Jong at: [email protected]. P.U. Dijkstra, PT, PhD, Department of Rehabilitation Medicine and Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen. and after 4, 8, and 20 weeks in 48 people with subacute stroke using a standardized protocol. One physical therapist performed the passive movement, and the other read the hydrogoniometer. The therapists then switched roles. The relative contributions of several sources of variation to error variance were explored with analysis of variance. R.E. Stewart, PhD, Department of Health Sciences, Community and Occupational Medicine, University Medical Center Groningen, University of Groningen. Results. Interobserver reliability coefficients ranged from .89 to .97. The PROM K. Postema, MD, PhD, Department of Rehabilitation Medicine, University Medical Center Groningen, University of Groningen. measurements were influenced by error variance ranging from 31% to 50%. The participant ⫻ time interaction made the largest contribution to error variance, ranging from 59% to 81%. Smallest detectable differences were 6 to 22 degrees and were largest for shoulder movements. Limitations. Verification of shoulder pain and hypertonia as sources of error variance led to a substantial number of unstable variance components, necessitating a simpler analysis. Conclusions. The assessment of PROM with a standardized protocol, a hydrogoniometer, and 2 trained physical therapists yielded high interobserver reliability indexes for all arm movements. Error variance made a large contribution to the variation in measurement results. The resulting smallest detectable differences can be used to interpret future hemiplegic arm PROM measurements with more confidence. [de Jong LD, Dijkstra PU, Stewart RE, Postema K. Repeated measurements of arm joint passive range of motion after stroke: interobserver reliability and sources of variation. Phys Ther. 2012;92: 1027–1035.] © 2012 American Physical Therapy Association Published Ahead of Print: May 10, 2012 Accepted: April 27, 2012 Submitted: September 1, 2011 Post a Rapid Response to this article at: ptjournal.apta.org August 2012 Volume 92 Number 8 Physical Therapy f 1027 Repeated Measurements of Arm Joint Passive Range of Motion After Stroke O f the 15 million people who have a stroke each year worldwide, between 77% and 81% of the survivors have a motor deficit in the extremities.1 The affected arm remains without function in almost 66% of survivors,2,3 rendering it inactive and immobilized. In recent years, several interventions believed to improve motor recovery or limit the development of secondary impairments in the paretic or paralyzed arm after stroke have been evaluated.4,5 To assess the arm function of patients with stroke during rehabilitation and in clinical research, physical therapists regularly assess passive range of motion (PROM) of joints by means of goniometry. In particular, the degree of passive shoulder external rotation and abduction and wrist extension are commonly used as outcome measures to evaluate the effects of interventions.6 –13 Reliable measurement of PROM is therefore an important prerequisite for the interpretation of study results. The reliability of arm range-ofmotion measurements is good in people who are healthy14,15 and in patients with orthopedic conditions,16,17 but these findings cannot be generalized to patients with stroke because stroke-specific impairments may influence reliability. Over time, many patients develop contractures10,18 and hypertonia,19,20 especially in shoulder internal rotators and wrist flexors. Many patients also develop shoulder pain, a condition strongly associated with restricted range of motion.21,22 The aforementioned factors may hinder a therapist’s attempts to move the hemiplegic arm, hence increasing the chance of making measurement errors. Such errors also may be increased if PROM measurements are obtained by only 1 therapist because it is difficult to 1028 f Physical Therapy Volume 92 handle a paralyzed arm and the goniometer and read the measurement simultaneously. Goniometric measurements of arm joints reflect both the true range of motion of a joint and measurement errors caused by different sources of variation. Identifying and quantifying these sources are important for finding strategies to reduce their influence on outcomes.23 In addition, to ensure accurate clinical interpretation of joint PROM measurements and changes in these measurements over time during poststroke rehabilitation or research, PROM measurements should be studied in the context of these sources of variation. In previous studies of arm PROM reliability in patients with stroke, sample sizes have not exceeded 18 people.24,25 To our knowledge, research into factors that may influence hemiplegic arm PROM measurements is also lacking. During a randomized controlled trial (L. de Jong, P. Dijkstra, J. Gerritsen, et al, unpublished data, 2012), 2 physical therapists (hereafter referred to as “observers”) assessed arm joint PROM in 48 people on 3 occasions over 20 weeks. This design presented us with the opportunity to explore interobserver reliability, analyze the contributions of sources of variation to the measurement results, and calculate smallest detectable differences (SDDs). We chose to use 2 observers because we hypothesized that doing so would result in fewer measurement errors than using 1 observer only and because a similar measurement procedure previously yielded high reliability indexes.25 Method As part of a randomized clinical trial investigating an arm intervention for people with subacute stroke and poor arm recovery, we used an existing measurement protocol that was specifically designed for measuring the PROM of 7 arm movements. All Number 8 participants gave written informed consent before participation. Participants Participants were recruited from 3 Dutch rehabilitation centers between August 2008 and September 2010. All admitted participants were initially screened by a physician to check the following inclusion criteria: first-ever stroke or recurrent stroke (except for subarachnoid hemorrhages) between 2 and 8 weeks after the initial stroke, age of 18 years or older, paralysis or severe paresis of the involved upper limb (Brunnstrom stage of recovery of ⬍4,26 as judged by the physician), and no planned date of discharge within 4 weeks. Participants meeting these criteria were referred to a research physical therapist, who excluded those with any contraindications for electrical stimulation, preexisting impairments of the affected arm (eg, frozen shoulder), severe cognitive deficits or language comprehension difficulties or both (⬍3/4 correct verbal responses or ⬍3 correct visual analog scale scores on the AbilityQ27), and moderate to good arm motor control (scores of ⬎18/66 on the Fugl-Meyer Assessment arm section28). After eligibility was confirmed, half of the participants were randomized to an experimental group, and half were randomized to a sham intervention group (L. de Jong, P. Dijkstra, J. Gerritsen, et al, unpublished data, 2012). Observers The 2 observers (both senior physical therapists) had 14 and 27 years of experience, respectively, across a wide range of diagnoses, including stroke. Before the trial, the observers were trained in obtaining the measurements using a detailed measurement protocol (the protocol, in Dutch, is available from the first author). They pretested the protocol on 3 participants with stroke. The observers had no pretrial experience August 2012 Repeated Measurements of Arm Joint Passive Range of Motion After Stroke with a hydrogoniometer and were not involved in the design of the study or the treatment of the participants. PROM Measurement Procedure All PROM measurements were obtained with a masked fluid-filled hydrogoniometer (MIE Medical Research Ltd, Leeds, United Kingdom). The measurement procedure was similar to the one described in detail in an earlier publication25 but was expanded to include wrist extension assessments. Each participant was independently assessed by the 2 observers at baseline and after 4, 8, and 20 weeks. Each time, 1 observer carried out the passive movement, and the other observer read the goniometer. The observers then switched roles. They were unaware of each other’s results because they used separate score sheets and were instructed not to discuss or mention the values found. The measurement sequence was as follows: shoulder external rotation, shoulder flexion, and elbow extension with the participant in the supine position and then shoulder abduction, forearm supination, and wrist extension with and without finger flexion while the participant sat on an adjustable plinth with the back supported. The observers carried out all measurements in the same fixed order. Data Analysis The variance components and their 2-way interactions were calculated for the measurement conditions of participants (n⫽48), time (4 assessments over time), and observers (n⫽2) by analysis of variance (type III sum of squares). Initially, the allocated intervention was also included in the calculation of variance components. However, for shoulder PROM, the variance component for intervention could not be estimated, indicating a redundancy. We therefore decided not to include intervention August 2012 in the calculations of variance components. In case of missing data (eg, because of participant dropout or vacation taken by 1 of the observers), only data from participants who were assessed by both observers were used in the analysis. the 48 participants are shown in Table 1. In general, they had restrictions in PROM for all 7 arm movements, especially shoulder movements. They had a median score of 5.5 on the arm section of the FuglMeyer Assessment. Error variance was calculated as the sum of all variances minus participant variance. The relative contributions of the sources of variation to this error variance were expressed as percentages. The agreement between the PROM ratings of the observers was calculated (see Streiner and Norman23[p159] for formulas) by means of interobserver reliability coefficients and accompanying 95% confidence intervals (CIs). Because the reliability coefficients alone did not indicate the magnitude of disagreement between the observers, the standard errors of measurement (SEMs) [SD⫻公(1⫺r)] and SDDs (1.96⫻公2⫻SEM) also were calculated. First, for the disagreement between observers within a measurement occasion, we used the standard deviation of the mean difference in ratings between the observers per movement. Second, for the disagreement among all observations over time (“overall”), the standard deviation of all observations per movement was used. All analyses were performed with SPSS (version 18, SPSS Inc, Chicago, Illinois). Figure 2 shows the separate variance components for the results obtained from shoulder external rotation as an example. The contribution of error variance (Tab. 2) to total variance ranged from 31% (wrist extension with flexed fingers) to 50% (supination). The interaction of participant and time made the largest contribution to error variance, ranging from 59% (forearm supination) to 81% (elbow extension). Time made a smaller contribution to error variance, especially for shoulder movements (17%–24%) and forearm supination (19%). Time did not contribute to the variance in the elbow joint. The interaction between participants and observers contributed only marginally to error variance (0%– 4%); the same was true for the main effect of observers (0%–2%). Residual (unexplained) variance contributed between 7% and 17% to error variance, and this contribution was generally lowest for shoulder movements. Table 3 shows the overall interobserver reliability coefficients (and 95% CIs) and SEMs and SDDs in both single sessions (“observers”) and overall for the 7 arm movements. Role of the Funding Source This study was funded by a grant from Fonds Nuts Ohra (main study, project SNO-T-0702-72) and Stichting Beatrixoord Noord-Nederland. Both funding sources had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Results Figure 1 shows the flow of participants through each stage of the trial. The characteristics of Discussion When different observers independently assess a joint range that does not change over time, interobserver reliability generally will be good provided that standardized protocols17 are used and the observers are trained.29 In addition to common sources of measurement variation, the development of contractures, hypertonia, and shoulder pain may complicate and negatively influence the reliability of PROM measure- Volume 92 Number 8 Physical Therapy f 1029 Repeated Measurements of Arm Joint Passive Range of Motion After Stroke Assessed for eligibility (n=260) Excluded after initial screening* (n=180) No ischemic/hemorrhagic stroke (n=9) >8 weeks poststroke (n=28) Brunnstrom’s stage of recovery ≥4 (n=169) Pre-existing arm impairments (n=24) Planned date of of discharge (n=64) Refused to/could not participate (n=6) Other (eg, multiple sclerosis, Alzheimer disease, locked-in syndrome, participant in other trial, recurrent stroke) (n=8) Unknown/missing data (n=4) Excluded after inclusion testing (n=32) Unable to fill out/read/understand AbilityQ (n=9) Fugl-Meyer Assessment arm score >18 points (n=14) Contraindications for electrical stimulation (n=1) Other reasons (n=8) Baseline Analyzed (n=43 of 48)† Dropout due to readmission to hospital (n=2), discharge (n=1) At 4 weeks Analyzed (n=39 of 45)†,‡ Dropout due to death (n=1), too much shoulder pain (n=1) At 8 weeks Analyzed (n=38 of 43)§ Lost to follow-up due to severe subluxation (n=1), not willing (n=3) At 20 weeks Analyzed (n=38 of 39)ll Figure 1. Flow of participants through each stage of the trial from initial screening by physician to follow-up measurement. *If a participant was excluded for more than 1 reason, then all reasons were reported separately. †Five participants were assessed by 1 observer only. ‡ One participant missed the 4-week assessment because of poor weather conditions. §Four participants were assessed by 1 observer only, and 1 participant was not assessed at 8 weeks because of temporary admission to a hospital. 㛳One participant was assessed by 1 observer only. 1030 f Physical Therapy Volume 92 Number 8 August 2012 Repeated Measurements of Arm Joint Passive Range of Motion After Stroke ments in patients after stroke. We found that PROM assessment with a standardized protocol, a hydrogoniometer, and 2 trained observers yielded high interobserver reliability indexes (.89 –.97) for 7 arm movements. We also found that error variance made a large contribution (31%–50%) to the variation in measurement results, with the participant ⫻ time interaction being the largest source of variance. The SDDs ranged from 6 to 22 degrees and were largest for shoulder movements. Table 1. Baseline Characteristics of the 48 Participantsa Characteristic Values Age, y, X (SD) 57.8 (11.9) Days after stroke, X (SD) 44 (14.0) Sex, no. of men/women 28/20 Paretic side (left/right), no. of participants 21/27 Stroke type (ischemic/hemorrhagic), no. of participants 39/9 Fugl-Meyer Assessment arm section score, median (IQR) 5.5 (4–10.75) Shoulder PROM, degrees, X (SD) External rotation 31.7 (19.4) Flexion 126.7 (30.6) Abduction 101.7 (44.1) Elbow/forearm PROM, degrees, X (SD) Interobserver Reliability The interobserver reliability of the 2 observers was high for all 7 arm movements. These results are in concordance with previous findings.25,30 The reliability coefficient for shoulder abduction (.97) was higher than previously reported values (intraclass correlation coefficients⫽.84 –.87),25 and the reliability coefficient was lowest for forearm supination (.89). Supination intraclass correlation coefficients were higher than previously reported values (.94 –.98),25 but the accompanying 95% CIs were wider (.84 –.98). Because all of our measurements were obtained with the same measurement protocol,25 the values that we obtained may have resulted from the use of a larger sample. Differences in sample size may also explain the narrower 95% CIs (.89 – .95) for elbow extension measurements in the present study than in a recent study (.68 –.97)24 of 13 patients with stroke and elbow flexor spasticity. Because larger samples generally yield more precise estimates of reliability coefficients (indicated by narrower CIs and smaller SEMs), the results of the present study can be interpreted with more confidence than the results of previous studies. To our knowledge, the reliability of wrist movements has not been August 2012 Extension 2.5 (7.3)b Supination 77.3 (11.6) Wrist PROM, degrees, X (SD) a b Extension with fingers extended 55.7 (17.0) Extension with fingers flexed 63.1 (13.0) IQR⫽interquartile range, PROM⫽passive range of motion. A value of 2.5 degrees indicates elbow flexor contracture. reported in patients with stroke. We found that the assessment of wrist extension revealed slightly higher reliability coefficients and slightly lower SEMs when the fingers were flexed instead of extended. The long finger flexors typically show increased resistance to passive stretch (hypertonia), possibly partly because of the rapid development of wrist flexor contractures.10,31 This condition occurs especially in patients with limited arm function and clearly applied to our participants. Therefore, wrist flexor hypertonia or contracture may have had a slight negative influence on the reliability of the assessments of wrist extension with extended fingers. This hypothesis is supported by the fact that residual variance (to which wrist flexor hypertonia or contracture may also have been a contributing factor) accounted for 16% of the error variance of the PROM measurements; when the fingers were flexed, the value was 13%. In conclusion, the resulting high reliability coefficients suggested that our standardized measurement protocol may be of use for other observers under comparable circumstances. Variance Components While assessing 7 arm movements on 4 occasions during a 20-week time period, we found that the participants in our sample were the largest source of variance. This finding indicates that the participants could be distinguished on the basis of their arm PROM; they had a large variety of arm joint ranges. Error variance explained between 31% and 50% of total variance in the PROM values. Overall, time and the participant ⫻ time interaction were responsible for more than 78% of the variation in measurement results, with the participant ⫻ time interaction contributing the most. This interaction effect indicates that the effects of time on PROM of the arm were different in different participants, in accordance with clinical observations. In some participants, PROM Volume 92 Number 8 Physical Therapy f 1031 Repeated Measurements of Arm Joint Passive Range of Motion After Stroke Figure 2. Variance components of shoulder external rotation. Total variance (left circle) comprised participant variance (main effect) and error variance. Several sources contributed to error variance. These sources (right circle) comprised main effects (time and observer), interaction effects (participant ⫻ time, participant ⫻ observer, and time ⫻ observer), and residual variance, all expressed as percentages of error variance. increased over time probably as a result of natural neurological recovery or rehabilitation, whereas in other participants, PROM may have increased over time as a result of contracture formation. The main effects of time and observers did not contribute to the variation in the results for elbow extension PROM. For the latter, the participant ⫻ time interaction (81%) and random variance (17%) made large contributions to error variance. Clinically, this finding indicates that over time, elbow extension developed quite differently in the participants. Observers contributed only marginally to the variation in measurement results, with a maximum of 4% (forearm supination). This finding indicates that the differences between the values obtained by the 2 observers were small, resulting in high interobserver reliability coefficients. The fact that 1 observer performed the passive movement and the other positioned and read the goniometer may have led to this finding. On the 1032 f Physical Therapy Volume 92 basis of these results, we argue that arm PROM assessments with a hydrogoniometer in patients after stroke should be performed by 2 observers. Clinically and economically, assessments by 2 raters may not always be practical or feasible.25 Therefore, clinical and economic arguments must be weighed against scientific arguments (reliability) in each situation. Further research is needed to analyze the influence of the number of observers on measurement results. Residual variance in the PROM measurements in our sample may be explained partly by random variations in PROM over time within a participant but may also have been caused by random variations in the force applied by the observers or the alignment of the hydrogoniometer between measurements. SDDs Overall, the SDDs ranged from 3 degrees to 22 degrees and were largest for shoulder movements. Taking shoulder external rotation as an Number 8 example, these data mean that a change of 17 degrees or more over a period of 20 weeks (overall SDD) represents a change in PROM with 95% certainty. Physical therapists and clinicians can use the overall SDD to evaluate their patients’ changes in arm PROM between admission and discharge. Similarly, researchers can use them to interpret changes in participants in clinical trials. The SDDs obtained in single sessions by our 2 observers also may serve another purpose. Taking elbow extension as an example, our results show that a difference of more than 3 degrees between 2 observers in 1 session indicates a significant difference in their measurements with 95% certainty. In stroke research, the Modified Tardieu Scale32 is increasingly being used to differentiate muscle contracture from spasticity. Because this scale relies partly on PROM measurements, the SDD can be used as a threshold value that must be exceeded to ascertain with 95% conAugust 2012 Repeated Measurements of Arm Joint Passive Range of Motion After Stroke Table 2. Estimated Variance Components and Their Contributions (in Percentages) to the Error Variance of Repeated Measurements of 7 Arm Movements (n⫽48) Shoulder Wrist External Rotation Abduction Flexion Elbow Extension Forearm Supination Flexion With Extended Fingers Participant 385.0 1,234.8 641.2 45.3 118.0 197.0 174.4 Error variance 241.3 702.2 377.1 34.4 117.8 115.5 77.9 a 22.3 3.2 6.5 2.6 2.4 1.5 Variance Component Time 48.5 118.6 91.3 0.0 4.5 0.3 0.7 0.0a Observer Participant ⫻ observer Flexion With Flexed Fingers 4.1 6.8 4.0 0.1 4.1 2.8 0.2 154.8 524.1 244.6 27.7 69.6 88.7 59.4 Time ⫻ observer 0.4 3.8 0.6 0.8 0.4 Residual variance 28.9 48.7 36.5 5.9 18.4 18.1 10.3 626.4 1,937.0 1,018.4 79.7 235.8 312.5 252.3 38.5 36.3 37.0 43.1 50.0 37.0 30.9 20.1 16.9 24.2 0.0 18.9 2.8 8.3 Observer 1.9 0.0 0.2 0.0 2.2 2.1 1.9 Participant ⫻ observer 1.7 1.0 1.1 0.4 3.5 2.4 0.3 Participant ⫻ time Total variance % error varianceb 0.0a 0.0a % contribution to error variance of: Time Participant ⫻ time 64.2 74.6 64.9 80.6 59.1 76.8 76.2 Time ⫻ observer 0.2 0.5 0.0 1.8 0.7 0.3 0.0 Residual variance 12.0 6.9 9.7 17.2 15.6 15.6 13.3 Negative variance components (ranging from ⫺0.027 to ⫺0.517) were set to 0. Error variance expressed as a percentage of total variance. For example, for shoulder external rotation, the calculation would be as follows: total variance (626.4) minus participant variance (385.0) equals error variance (241.3); error variance therefore represents 38.6% of total variance. a b Table 3. Interobserver Reliability Coefficients (and 95% Confidence Intervals), Standard Errors of Measurement (SEMs), and Smallest Detectable Differences (SDDs)a Wrist Shoulder External Rotation Abduction Flexion Elbow Extension Forearm Supination Extension With Extended Fingers .94 (.91–.96) .97 (.95–.98) .96 (.93–.97) .92 (.89–.95) .89 (.84–.93) .93 (.90–.96) .96 (.93–.97) 2.0 1.9 1.9 1.0 2.2 1.7 1.0 SDD (observers) 5.4 5.2 5.2 2.7 6.2 4.7 2.6 SEM (overall) 5.9 7.6 6.6 2.4 4.9 4.6 3.3 SDD (overall) 16.3 21.2 18.3 6.8 13.8 12.8 9.1 Variable Overall reliability (95% confidence interval) SEM (observers) Extension With Flexed Fingers a “Overall” refers to the overall reliability, SEM, and SDD for the observers over time; “observers” refers to the SDD and SEM for a single measurement session. August 2012 Volume 92 Number 8 Physical Therapy f 1033 Repeated Measurements of Arm Joint Passive Range of Motion After Stroke fidence that the angles between R1 (“catch”) and R2 (“end range”) are significantly different and that spasticity is indeed present. Similarly, the overall SDD for elbow extension (7°) can be used to indicate significant changes in elbow PROM over longer periods of time. Comparing our SDDs with those reported in the literature24,25 is hindered partly by the influence of sample sizes on SEMs (larger samples produce smaller SEMs) and therefore SDDs (smaller SEMs produce smaller SDDs). Because of our larger sample, our data can be used to interpret differences or changes in PROM with more confidence. Limitations An important limitation of the present study is that half of our participants were allocated to a combination intervention consisting of static muscle stretch and electrical stimulation. Although the results of this intervention were not significantly different from those of a sham intervention and the variance component for intervention could not be estimated, we cannot rule out the possibility that the development of the outcomes over time was confounded by the intervention and therefore that the intervention contributed to residual variance. Initially, we also tried to verify whether shoulder pain and hypertonia of shoulder internal rotators, elbow flexors, and wrist flexors were sources of error variance. However, adding these variables to the statistical analysis led to a substantial number of unstable variance components. Therefore, we chose to analyze a simpler model. The bestfitting model was subsequently applied to all other arm movements by setting all negative variances to 0. Future research is needed to verify which factors are actually responsible for random variance, for example, by comparing patients with and without contractures, hypertonia, 1034 f Physical Therapy Volume 92 and pain. Another limitation is that, despite pretrial training, we cannot say for certain whether the competence of our 2 observers had any influence on the study results. We selected people with stroke and poor recovery of arm motor control. A median score of 5.5 on the Fugl-Meyer Assessment arm section at about 6 weeks after stroke means that a patient typically shows only hyperreflexia or (partial) mass synergy patterns, which are usually dominated by shoulder internal rotation and elbow and finger flexion, at best. Although our results can be generalized only to similar groups of patients, such patients represent about 36% to 52% of those with subacute stroke between 2 weeks and 3 months after stroke.19 Finally, our results may indicate reliability within observers because it is generally recognized that intraobserver reliability is bound to be higher than interobserver reliability.23 Mr de Jong and Dr Postema provided concept/idea/research design and fund procurement. All authors provided writing and data analysis. Mr de Jong provided data collection and project management. Dr Dijkstra and Dr Postema provided institutional liaisons. The authors thank all of the study participants. Special thanks go to observers Ank Mollema and Marian Stegink. This study was approved by the Medical Ethics Committee of the University Medical Center Groningen (project METc 2008.107). This study was funded by a grant from Fonds Nuts Ohra (main study, project SNOT-0702-72) and Stichting Beatrixoord Noord-Nederland. The main randomized controlled trial is registered at the Dutch Trial Register (Unique Identifier: NTR1748) (available at: http://www.trialregister.nl/trialreg/index.asp). DOI: 10.2522/ptj.20110280 References 2 Sunderland A, Tinson D, Bradley L, Hewer RL. Arm function after stroke: an evaluation of grip strength as a measure of recovery and a prognostic indicator. J Neurol Neurosurg Psychiatry. 1989;52:1267–1272. 3 Wade DT, Langton-Hewer R, Wood VA, et al. The hemiplegic arm after stroke: measurement and recovery. J Neurol Neurosurg Psychiatry. 1983;46:521–524. 4 Sirtori V, Corbetta D, Moja L, Gatti R. Constraint-induced movement therapy for upper extremities in stroke patients. Cochrane Database Syst Rev. 2009;(4): CD004433. 5 Ada L, Foongchomcheay A, Canning C. Supportive devices for preventing and treating subluxation of the shoulder after stroke. Cochrane Database Syst Rev. 2005;(1):CD003863. 6 Posteraro F, Mazzoleni S, Aliboni S, et al. Upper limb spasticity reduction following active training: a robot-mediated study in patients with chronic hemiparesis. J Rehabil Med. 2010;42:279 –281. 7 de Jong LD, Nieuwboer A, Aufdemkampe G. Contracture preventive positioning of the hemiplegic arm in subacute stroke patients: a pilot randomized controlled trial. Clin Rehabil. 2006;20:656 – 667. 8 Turton AJ, Britton E. A pilot randomized controlled trial of a daily muscle stretch regime to prevent contractures in the arm after stroke. Clin Rehabil. 2005;19: 600 – 612. 9 Ada L, Goddard E, McCully J, et al. Thirty minutes of positioning reduces the development of shoulder external rotation contracture after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2005; 86:230 –234. 10 Pandyan AD, Cameron M, Powell J, et al. Contractures in the post-stroke wrist: a pilot study of its time course of development and its association with upper limb recovery. Clin Rehabil. 2003;17:88 –95. 11 Woldag H, Hummelsheim H. Is the reduction of spasticity by botulinum toxin beneficial for the recovery of motor function of arm and hand in stroke patients? Eur Neurol. 2003;50:165–171. 12 Linn S, Granat M, Lees K. Prevention of shoulder subluxation after stroke with electrical stimulation. Stroke. 1999;30: 963–968. 13 Bhakta BB, Cozens JA, Bamford JM, Chamberlain MA. Use of botulinum toxin in stroke patients with severe upper limb spasticity. J Neurol Neurosurg Psychiatry. 1996;61:30 –35. 14 Valentine RE, Lewis JS. Intraobserver reliability of 4 physiologic movements of the shoulder in subjects with and without symptoms. Arch Phys Med Rehabil. 2006; 87:1242–1249. 15 Petherick M, Rheault W, Kimble S, et al. Concurrent validity and intertester reliability of universal and fluid-based goniometers for active elbow range of motion. Phys Ther. 1988;68:966 –969. 1 Barker W, Mullooly J. Stroke in a defined elderly population, 1967–1985: a less lethal and disabling but no less common disease. Stroke. 1997;28:284 –290. Number 8 August 2012 Repeated Measurements of Arm Joint Passive Range of Motion After Stroke 16 MacDermid JC, Chesworth BM, Patterson S, Roth JH. Intratester and intertester reliability of goniometric measurement of passive lateral shoulder rotation. J Hand Ther. 1999;12:187–192. 17 Armstrong AD, MacDermid JC, Chinchalkar S, et al. Reliability of range-ofmotion measurement in the elbow and forearm. J Shoulder Elbow Surg. 1998;7: 573–580. 18 Sackley C, Brittle N, Patel S, et al. The prevalence of joint contractures, pressure sores, painful shoulder, other pain, falls, and depression in the year after a severely disabling stroke. Stroke. 2008;39:3329 – 3334. 19 de Jong LD, Hoonhorst MH, Stuive I, Dijkstra PU. Arm motor control as predictor for hypertonia after stroke: a prospective cohort study. Arch Phys Med Rehabil. 2011;92:1411–1417. 20 van Kuijk AA, Hendricks HT, Pasman JW, et al. Are clinical characteristics associated with upper-extremity hypertonia in severe ischaemic supratentorial stroke? J Rehabil Med. 2007;39:33–37. 21 Rajaratnam BS, Venketasubramanian N, Kumar PV, et al. Predictability of simple clinical tests to identify shoulder pain after stroke. Arch Phys Med Rehabil. 2007;88: 1016 –1021. August 2012 22 Bohannon RW, Larkin PA, Smith MB, Horton MG. Shoulder pain in hemiplegia: statistical relationship with five variables. Arch Phys Med Rehabil. 1986;67:514 –516. 23 Streiner DL, Norman GR. Generalizability theory. In: Streiner DL, Norman GR, eds. Health Measurement Scales: A Practical Guide to Their Development and Use. 3rd ed. Oxford, United Kingdom: Oxford University Press; 2003:153–171. 24 Paulis WD, Horemans HL, Brouwer BS, Stam HJ. Excellent test-retest and interrater reliability for Tardieu Scale measurements with inertial sensors in elbow flexors of stroke patients. Gait Posture. 2011; 33:185–189. 25 de Jong LD, Nieuwboer A, Aufdemkampe G. The hemiplegic arm: interrater reliability and concurrent validity of passive range of motion measurements. Disabil Rehabil. 2007;29:1442–1448. 26 Brunnstrom S. Movement Therapy in Hemiplegia: A Neurophysiological Approach. Hagerstown, MD: Harper and Row; 1970. 27 Turner-Stokes L, Rusconi S. Screening for ability to complete a questionnaire: a preliminary evaluation of the AbilityQ and ShoulderQ for assessing shoulder pain in stroke patients. Clin Rehabil. 2003;17: 150 –157. 28 Fugl-Meyer AR, Jaasko L, Leyman I, et al. The post-stroke hemiplegic patient, 1: a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7: 13–31. 29 Chesworth B, MacDermid J, Roth J, Patterson S. Movement diagram and “end feel” reliability when measuring passive lateral rotation of the shoulder in patients with shoulder pathology. Phys Ther. 1998;78: 593– 601. 30 Andrews AW, Bohannon RW. Decreased shoulder range of motion on paretic side after stroke. Phys Ther. 1989;69:768 –772. 31 Malhotra S, Pandyan AD, Rosewilliam S, et al. Spasticity and contractures at the wrist after stroke: time course of development and their association with functional recovery of the upper limb. Clin Rehabil. 2011;25:184 –191. 32 Morris S. Ashworth and Tardieu Scales: their clinical relevance for measuring spasticity in adult and paediatric and neurological populations. Phys Ther Rev. 2002: 53– 62. Volume 92 Number 8 Physical Therapy f 1035 Research Report A. Cacchio, MD, PhD, Department of Health Sciences, Physical Medicine and Rehabilitation Unit, School of Medicine, University of L’Aquila, P.le S. Tommasi 1, 67100 L’Aquila, Italy, and Department of Physical and Rehabilitation Medicine, School of Medicine, “La Sapienza” University of Rome, Rome, Italy. Address all correspondence to Dr Cacchio at: angelo. [email protected]. S. Necozione, MD, PhD, Department of Internal Medicine and Public Health, Clinical Epidemiology Unit, School of Medicine, University of L’Aquila. J.C. MacDermid, PT, PhD, School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada, and Hand and Upper Limb Centre, St Joseph’s Health Centre, London, Ontario, Canada. Cross-Cultural Adaptation and Measurement Properties of the Italian Version of the Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire Angelo Cacchio, Stefano Necozione, Joy C. MacDermid, Jan Dirk Rompe, Nicola Maffulli, Ferdinando di Orio, Valter Santilli, Marco Paoloni Background. The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire is a tool designed for self-assessment of forearm pain and disability in patients with lateral elbow tendinopathy (LET). However, an Italian version of this questionnaire has not been available. J.D. Rompe, MD, Orthopedic Surgery, OrthoTrauma Evaluation Center, Mainz, Germany. Objective. The aims of this study were: (1) to translate and cross-culturally adapt N. Maffulli, MD, PhD, Center for Sports and Exercise Medicine, Barts and The London School of Medicine and Dentistry, London, United Kingdom. Design. This was a longitudinal, observational measurement study. F. di Orio, MD, Department of Internal Medicine and Public Health, Clinical Epidemiology Unit, School of Medicine, University of L’Aquila. V. Santilli, MD, Department of Physical Medicine and Rehabilitation, School of Medicine, “La Sapienza” University of Rome, Rome, Italy. M. Paoloni, MD, PhD, Department of Physical Medicine and Rehabilitation, School of Medicine, “La Sapienza” University of Rome. [Cacchio A, Necozione S, MacDermid JC, et al. Cross-cultural adaptation and measurement properties of the Italian version of the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire. Phys Ther. 2012;92:1036 –1045.] the PRTEE questionnaire into Italian and (2) to evaluate its measurement properties. Methods. The PRTEE questionnaire was cross-culturally adapted to Italian according to established guidelines. Ninety-five individuals (41 women, 54 men) with unilateral, imaging-confirmed, chronic LET were selected consecutively to assess the measurement properties of the PRTEE questionnaire. Internal consistency, test-retest reliability, construct validity, and responsiveness were estimated. Results. The Italian version of the PRTEE displayed a high degree of internal consistency, with a Cronbach alpha of .95. The test-retest reliability was high for both short-term and medium-term, with intraclass correlation coefficients (2,1) of .95 and .93, respectively. The PRTEE exhibited a strong correlation (r⫽.77–.91, P⬍.0001) with the Disabilities of the Arm, Shoulder and Hand (DASH) at the baseline and a moderate correlation (r⫽.58 –.74, P⬍.0001) at discharge. The responsiveness was higher for the PRTEE than for the DASH. Limitations. A methodological limitation of the study is that due to the small sample size, a factor analysis was not performed to assess convergent validity. Conclusions. The Italian version of the PRTEE questionnaire is internally consistent, demonstrates expected correlations with other measures, and is more responsive than the DASH in Italian patients with chronic LET. © 2012 American Physical Therapy Association Published Ahead of Print: May 10, 2012 Accepted: April 30, 2012 Submitted: November 14, 2011 Post a Rapid Response to this article at: ptjournal.apta.org 1036 f Physical Therapy Volume 92 Number 8 August 2012 Italian Version of the PRTEE Questionnaire C hronic lateral elbow tendinopathy (LET) caused by a failed healing response of the tendon of the extensor carpi radialis brevis muscle1 is a common cause of arm pain in sporting and working populations. The importance of monitoring the effectiveness of treatment is widely recognized, as is the need for evidence-based health care. Several instruments have been developed to determine the outcome of elbow conditions.2–9 However, the success or failure of treatment for LET is open to interpretation, given the lack of consensus on how to measure treatment outcome in a standardized fashion.3,4 Before being used in different regions of the world, outcome measures need to be translated, culturally adapted, and retested to ensure the validity of the revised instruments.10 –12 The cross-cultural adaptation guidelines described by Guillemin et al10 are widely accepted and used for the translation and adaptation of outcome measures. The term “cross-cultural adaptation” is used to describe a process that takes into account both language (translation) and cultural adaptation issues in the preparation of an outcome measure for use in another setting.10 An Italian version of a pain and functional status questionnaire for people with chronic LET has not been available. The aims of this study, therefore, were: (1) to perform a cross-cultural adaptation of the original English version of Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire into Italian and (2) to evaluate the measurement properties of the Italian version of the PRTEE in patients with imagingconfirmed chronic LET. Materials and Method The data were collected between March 2005 and September 2008 at our outpatient rehabilitation center August 2012 at the Department of Physical Medicine and Rehabilitation, School of Medicine, “La Sapienza” University of Rome. Informed consent was obtained from all patients prior to participation in the study. The Cross-Cultural Adaptation Process Guidelines developed by Guillemin and colleagues10,11 and Beaton et al12 were used for the cross-cultural adaptation and validation of the Italian version of the PRTEE. The English version of the PRTEE6 was independently translated into Italian by 2 non–medical professional translators and one physician whose native language was Italian. The 3 different Italian translations were analyzed by a health care committee (2 physiatrists, 2 epidemiologists, 1 orthopedist, 1 physical therapist), who first ensured that the translations took Italian cultural characteristics into consideration, and then selected a consensus version (version 1) of these translations. Discrepancies were resolved by consensus to achieve conceptual equivalence. This consensus version was translated back into English by 2 other non–medical professional translators whose native language was English. Neither of these translators was aware of the concepts being investigated or had a medical background. At the end of this phase, a new consensus version (version 2) was obtained and, when compared with the original version of the PRTEE,6 was found to be semantically and grammatically equivalent. At this stage, a meeting was held with the health care committee to finalize the Italian version of the PRTEE. After the committee had confirmed the equivalence of the original PRTEE and the Italian version, we commenced a pilot test on 10 patients (5 women, 5 men; mean age⫽40.2 years, range⫽18 –72) with chronic LET and on 10 sex- and age- matched individuals who were healthy. The main aim of this phase was to determine whether the participants understood the questions. After they had completed the questionnaire, each participant was asked whether there were any sentences that were difficult to understand. The participants were asked what they thought each question meant. The meaning of the items and tasks and the selected response were discussed. This process ensured that the pre-final version retained adequate equivalence in purpose. All of the questions were considered to be easy to understand by all of the participants who filled out the questionnaire. The reliability, validity, and responsiveness of the final Italian version of the PRTEE (eAppendix, available at ptjournal.apta.org) then were evaluated by means of psychometric tests. Participants Ninety-five people (41 women, 54 men) with unilateral (66 right, 29 left), imaging-confirmed, chronic LET were consecutively enrolled for the purposes of this study. The participants’ mean age was 38.8 years (SD⫽15.7, range⫽18 –75). At the beginning of the study, the mean elapsed time since onset of LET was 23 months (SD⫽9, range⫽8 – 43). The inclusion criteria were: clinical diagnosis of chronic LET (ie, persistent or recurrent local pain and muscle weakness that did not respond to conservative measures), confirmed by an imaging evaluation (eg, ultrasound, magnetic resonance imaging), and a pain score of ⱖ3 cm on a Volume 92 Available With This Article at ptjournal.apta.org • eAppendix: Patient-Rated Tennis Elbow Evaluation Questionnaire, Italian Version Number 8 Physical Therapy f 1037 Italian Version of the PRTEE Questionnaire visual analog scale, induced by 2 or more of the following tests: (1) palpation of the lateral epicondyle, (2) resisted wrist extension (Thomsen test), (3) resisted extension of the middle finger, and (4) a chair test, in which the participant was asked to lift a 3.5-kg chair. The exclusion criteria were: age below 18 years; inflammatory or neoplastic disorders; concomitant pathologies in the shoulder or wrist; cervical radiculopathy or thoracic outlet syndrome; history of fracture or dislocation at the elbow; history of elbow surgery; treatment with corticosteroid injections in the previous 6 months; and inability to complete a questionnaire due to cognitive impairment or language difficulties. Questionnaires PRTEE. The PRTEE questionnaire,6 which is an updated version of the Patient-Rated Forearm Evaluation Questionnaire (PRFEQ),7,13 is a 15-item questionnaire specifically designed for patients with LET. The items investigate pain (5 items) and the degree of difficulty in performing various activities (6 specific and 4 usual activity items) due to the elbow problem over the preceding week. Each item has 1 response option (0⫽no difficulty, 10⫽unable to perform). The scores for the various items are used to calculate an overall scale score ranging from 0 (best score) to 100 (worst score). The worst score is 100 points, and not 150 points, because the specific and usual activity items are first summarized and then divided by 2, which means they account for a maximum of 50 points, as opposed to 100 points, in the final score. The PRTEE questionnaire, which provides a very quick (it takes 5 minutes to complete), easy, and standardized quantitative description of pain and functional disability in patients with LET, was recently validated as a reliable means of assessing LET.14 1038 f Physical Therapy Volume 92 Disabilities of the Arm, Shoulder and Hand (DASH). The DASH questionnaire is an upper-extremity– specific outcome measure,8 which has been shown to be reliable and valid in people with elbow disorders.15 The core of the DASH (part B) is a 30-item disability/symptom scale concerning an individual’s upper extremity during the preceding week. The items investigate the degree of difficulty in performing different physical activities because of arm, shoulder, or hand problems (items 1–21); the severity of each of the symptoms of pain, activityrelated pain, tingling, weakness, and stiffness (items 24 –28); and the effect the symptoms have on social activities, work, and sleep (items 22, 23, and 29) and their psychological impact (item 30). Each item has 5 response options, ranging from “no difficulty or no symptom” to “unable to perform activity or very severe symptom,” and is scored on a 5-point scale. The scores for all the items are used to calculate a scale score ranging from 0 (no disability) to 100 (severest disability). For the purposes of this study, we used the cross-culturally adapted and validated Italian version of the DASH.16 Global rating of change. At the discharge assessment, 6 weeks after initial assessment, the physician and the participant independently completed a 7-point global rating of change form. “How is the patient today compared with his/her first visit?” and “How are you today compared with your first visit?” were the questions answered by the physiatrist and the patient, respectively. The participant and physiatrist were unaware of each other’s responses. The 7 response options were: (1) “very much worse,” (2) “much worse,” (3) “little worse,” (4) “no change,” (5) “little improved,” (6) “much improved,” and (7) “very much improved.” The physician’s and the participant’s global rating of Number 8 change scores were averaged to give an overall change score, which was used in this study as the criterion standard of change. This measure of change was used as our external criterion, in the absence of a “gold standard,” for the evaluation of responsiveness.17,18 For this purpose, we chose global rating of change scores of 3 or lower to classify a worsened participant, a score of 4 to classify a stable participant, and scores of 5 or higher to classify an improved participant. Procedure At baseline, participants were asked to complete the PRTEE and the DASH questionnaires together in a comfortable room. All participants then underwent the same shockwave treatment. Because this was not an intervention study, the shockwave treatment is summarized briefly: the shock-wave treatment was provided by a radial shock-wave generator. Radial shock-wave therapy was administered in 4 sessions, at the rate of 1 session per week. At each session, 2,500 shocks with a pressure of 4 bars (equal to an energy flux density of approximately 0.18 mJ/mm2) and a frequency of 8 shocks per second were applied. Upon discharge at the end of the shock-wave treatment, 6 weeks after the first administration of the PRTEE and DASH questionnaires, participants were asked to complete these questionnaires again. Data Analysis Parametric tests were used after using a Kolmogorov-Smirnov test to ensure that the data were normally distributed. The level of statistical significance was set at P⬍.05. All analyses were conducted using MedCalc, version 11.1.1.0 for Windows (MedCalc Software, Mariakerke, Belgium), GraphPad InStat, version 3.05 for Windows (GraphPad Software Inc, San Diego, California), and August 2012 Italian Version of the PRTEE Questionnaire STATA software, version 8.2 (Stata Corp, College Station, Texas). Psychometric Properties Reliability. “Reliability” is a generic term used to indicate both the homogeneity (internal consistency) of a scale and the reproducibility (testretest reliability) of scores.17 Internal consistency of the PRTEE was assessed using Cronbach alpha with 95% confidence intervals (95% CIs), using the data from the baseline questionnaire, and was considered acceptable when Cronbach alpha exceeded .70.19 To assess the test-retest reliability of the PRTEE, the intraclass correlation coefficient (ICC) and 95% CIs were calculated on the basis of a 2-way random-effects analysis of variance.17,20,21 Additionally, standard error of measurement (SEM⫽ SD[公 1 ⫺ ICC]) was calculated. The ICC value was interpreted as follows: ⬍.40⫽poor reliability, .40 –.74⫽ moderate to good reliability, and ⱖ.75⫽excellent reliability.20 To assess the short-term (first testretest) reproducibility of the PRTEE, the participants were asked to complete this questionnaire again 3 days after the first administration at baseline. To minimize the risk of shortterm clinical changes, participants did not receive any treatment during this 3-day interval. An interval of 3 days was chosen for 3 reasons: (1) it minimized the time elapsed between enrollment and the start of the rehabilitation program, (2) participants were unlikely to remember what they had answered 3 days before, and (3) in the absence of any intervention, it was assumed that the participants’ clinical situation would remain stable over 3 days. To assess the reproducibility of the PRTEE in an interval that more closely resembles that used for evalAugust 2012 uating individuals in a clinical study, the participants who were classified as stable (global rating of change score of 4) were asked to complete the PRTEE at the end of the shockwave treatment, 6 weeks after the first administration (second retest). Based on global rating of change scores, this second retest was performed by only 38 participants. Construct validity. Construct validity was tested by determining the relationship between the PRTEE questionnaire scores and the scores of the DASH questionnaire at both the baseline and discharge assessments. Pearson correlation coefficients (r values) with 95% CIs were calculated to examine the construct validity. The r values were interpreted as follows: .00 to .19⫽very weak correlation, .20 to .39⫽weak correlation, .40 to .69⫽moderate correlation, .70 to .89⫽strong correlation, and .90 to 1.00⫽very strong correlation.22 Because the correlation results in the German version of the PRTEE14 are given only as a coefficient of determination (r2), we also calculated this coefficient to make a direct comparison of our results with those of the German version. Responsiveness. Floor and ceiling effects are considered important for the analysis of responsiveness because they indicate limits to the range of detectable change. Floor and ceiling effects were determined by calculating the number of participants who had the best or worst scores possible at both the baseline and discharge assessments in all of the questionnaires. This number indicates the proportion of patients whose condition could not significantly improve or deteriorate because they were already at one end of the range. Floor or ceiling effects are considered to be present if more than 15% of respondents achieve the lowest or highest possible score, respectively.23 Although there is no consensus on the most suitable statistical analysis to assess responsiveness, we decided to use 3 distribution-based methods to assess the responsiveness of the PRTEE and DASH questionnaires— the effect size (ES),24 the standardized response mean (SRM),25 and the Guyatt responsiveness ratio (GRR)26—together with an anchorbased method (ie, the receiver operating characteristic [ROC] curve).17,18 Changes in the PRTEE and DASH measurements following shock-wave treatment in comparison with the baseline measurements were assessed using a paired t test. The values of the 3 distributionbased methods were based on the data of the participants (n⫽49) classified as improved according to the consensus judgment of both participants and physicians. The ES was calculated as the mean difference between the baseline and follow-up scores (ie, mean change scores) divided by the standard deviation of the baseline scores.24 The SRM was calculated as the mean change score divided by the standard deviation of the change scores.25 The ES and SRM scores were interpreted as follows: 0.2⫽small, 0.5⫽ moderate, and 0.8 or higher⫽ large.25,27 The GRR was calculated as the ratio of the mean change score of the PRTEE or DASH of participants clinically identified as improved divided by the standard deviation of the mean change score of participants clinically identified as unchanged based on the global rating of change.26 If the GRR is larger than 1, the mean change score in clinically improved individuals exceeds the measurement error, and the instrument may be considered to be responsive to an extent that is pro- Volume 92 Number 8 Physical Therapy f 1039 Italian Version of the PRTEE Questionnaire portional to the magnitude of the responsiveness ratio.26 The sensitivity (true positive rate) and specificity (true negative rate) of the PRTEE and DASH questionnaires were examined using the ROC curve method. The ROC curve was constructed by plotting the sensitivity values on the y-axis and 1 minus the specificity values on the x-axis for the different change scores values. The ROC curve was calculated on the basis of the questionnaire change score and the global rating of change score (obtained by averaging the participant’s and physician’s global rating of change scores). When plotting the ROC curve, the global rating of change, used as external criterion, was dichotomized to identify those participants who experienced a clinically meaningful reduction in symptoms.18,28 We chose global change scores of 5 or higher to represent important change and scores of 4 or lower to represent no change. Generally, the area under the ROC curve (AUC) is a measure of the ability of a questionnaire to distinguish between individuals who have and have not changed, according to an external criterion (ie, global rating change score).28 In this study, because for the ROC curve calculation the participants classified as stable were mixed with those who worsened, the AUC assessed the ability of the PRTEE and the DASH to distinguish participants who improved from those who did not improve, whereas the small sample of participants who worsened did not allow construction of an ROC curve to distinguish participants who worsened from those who did not worsen. An AUC of 1.0 indicates perfect discrimination between these 2 health states. A questionnaire that does not discriminate more effectively than chance will have an AUC of 0.5. As a general rule, AUC values between 1040 f Physical Therapy Volume 92 0.7 and 0.8 are considered to have acceptable discrimination, those from 0.8 to 0.9 are considered to have excellent discrimination, and those above 0.9 are considered to have outstanding discrimination.28 The point of the ROC curve on the upper-most left-hand corner was identified as the optimal cutoff change score and was used to estimate the minimal clinically important difference (MCID),29,30 although the baseline entry score may affect it.31,32 The MCID represents the point with equally balanced sensitivity (probability of the measure correctly classifying individuals who demonstrate change on the global rating of change) and specificity (probability of the measure correctly classifying individuals who have minimally or not changed on the global rating of change) in the ROC curve.33 Results The Cross-Cultural Adaptation Process The PRTEE for Italian patients was adapted using a systematic, standardized approach.10 –12 No difficulties were encountered in translating the questionnaire, and the back translation corresponded very well to the original version. The only real, albeit minor, problem we encountered was in the first and third questions in the functional disability subscale (specific activities). The first question in the English version was: “Turn a doorknob or key.” As “doorknobs” are not widely used in Italy, this term was translated as “door handle.” The third question in the English version was: “Lift a full coffee cup . . . to your mouth.” Because most Italians drink espresso coffee, which comes in a small cup, we preferred to translate “Lift a full coffee cup” as “Lift a full cappuccino cup.” However, conceptual equivalence was verified by checking the original Number 8 PRTEE and the back-translated questionnaires for all equivalences. The prefinal version performed well in the pilot test. The participants stated that the items were clear and that the majority were relevant to their chronic LET. The average time taken by the participants to answer all the items was approximately 5 minutes. No items were missing from the PRTEE and DASH scores at either the baseline or the discharge assessment. No individual scored the worst or best possible score (no floor or ceiling effects) in either the PRTEE questionnaire or the DASH questionnaire. On the basis of global rating of change scores, 49 participants improved, 38 remained stable, and 8 worsened. Reliability Internal consistency reached a Cronbach alpha of .95 (95% CI⫽.93–.98) (N⫽95) for the 15 items. When the alpha coefficient was calculated for the overall scale by eliminating each of the 15 items one at a time, the range was .89 to .98; no single item was found to change the internal consistency substantially. The test-retest reliability yielded an ICC (2,1) of .95 (95% CI⫽.90 –.97), with a SEM of 2.68 (95% CI⫽2.64 – 2.73) in the short term (3 days, 95 participants), and an ICC (2,1) of .93 (95% CI⫽.89 –.96), with a SEM of 3.25 (95% CI⫽3.12–3.47), in the medium term (6 weeks, 38 participants). Construct Validity In the evaluation of the correlation between the PRTEE and DASH questionnaires, we considered the overall scores of the 2 questionnaires as well as the pain subscale scores (questions 1–5) and functional activity subscale scores (questions 6 –15) for the PRTEE questionnaire and the August 2012 Italian Version of the PRTEE Questionnaire Table 1. Correlations Between the Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire and Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire Scores at the Baseline Assessment (N⫽95)a PRTEE Pain Subscale Score PRTEE Overall Score Measure DASH overall score a PRTEE Functional Ability Subscale Score r P r P r P .83 (.75–.89) ⬍.0001 .77 (.73–.82) ⬍.0001 .79 (.75–.85) ⬍.0001 DASH symptoms subscale score .80 (.73–.85) ⬍.0001 .79 (.74–.85) ⬍.0001 .81 (.76–.88) ⬍.0001 DASH function subscale score .88 (.83–.92) ⬍.0001 .83 (.76–.87) ⬍.0001 .89 (.82–.94) ⬍.0001 Values are expressed as Pearson correlation coefficient (r) (95% confidence interval). 95% CI⫽.48 –.75, P⬍.001). As regards the coefficient of determination (r2), our results showed an r2 of .7 (P⬍.0001) (Fig. 1) for the baseline data and an r2 of .4 (P⬍.001) for the pretreatment-posttreatment change scores. symptoms subscale scores (questions 24 –29) and function subscale scores (questions 1–21) for the DASH questionnaire. Correlations between the PRTEE overall and subscale scores and the DASH overall and subscale scores at the baseline and discharge assessments are summarized in Tables 1 and 2, respectively. The overall PRTEE and DASH scores for the whole group of participants at baseline (N⫽95) were strongly correlated with one another (r⫽.84, 95% CI⫽.75–.89, P⬍.0001) (Fig.1). The overall PRTEE and DASH scores for the group of participants who underwent the shock-wave therapy (N⫽95) at discharge were moderately, albeit still significantly, correlated with one another (r⫽.50, 95% CI⫽.30 –.65, P⬍.001) (Fig. 2). The pretreatment-posttreatment change scores for the PRTEE and DASH also were moderately, albeit significantly, correlated with one another (r⫽.64, Responsiveness The t tests showed statistically significant changes from baseline to discharge for the PRTEE (t⫽10.66, P⬍.0001) and the DASH (t⫽6.49, P⬍.0001). The mean baseline and discharge scores, as well as the magnitude of changes expressed by the ES, SRM, and GRR for the improved participants (n⫽49), are shown in Table 3. According to the interpretation of Liang et al,25 both the PRTEE and the DASH yield large ES and SRM values (PRTEE: ES⫽2.0, SRM⫽2.3; DASH: ES⫽1.4, SRM⫽1.5). The GRR values yielded by both the PRTEE (2.9) and the DASH (2.3) also were large, according to the interpretation of Guyatt et al.26 The ROC curve analysis revealed AUC values of .89 (95% CI⫽.80 – .95) for the PRTEE and .79 (95% CI⫽.68 –.87) for the DASH (Fig. 3). The SEM values were .03 for the PRTEE and .05 for the DASH. The AUC for both the PRTEE (P⬍.0001) and the DASH (P⬍.0001) far exceeded 0.5. These findings indicate that the change scores yielded by the PRTEE and the DASH were significantly better than chance in identifying an improved individual from randomly selected pairs of improved and unimproved individuals. The difference between the PRTEE and DASH AUC values was 0.10 (SEM⫽0.04, z score⫽2.1, P⫽.03). This finding indicates that the discriminative ability of the PRTEE is better than that of the DASH in this sample of outpatients with chronic LET treated with shock-wave therapy. The ROC curve also was used to provide an estimate of the MCID, taken as the point on the ROC curve nearest the Table 2. Correlations Between the Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire and Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire Scores at the Discharge Assessment (N⫽95)a PRTEE Overall Score Measure DASH overall score a r P .50 (.30–.65) ⬍.0001 PRTEE Functional Ability Subscale Score PRTEE Pain Subscale Score r .58 (.32–.63) P r P ⬍.0001 .60 (.44–.66) ⬍.0001 DASH symptoms subscale score .55 (.36–.67) ⬍.0001 .54 (.37–.66) ⬍.0001 .43 (.33–.62) ⬍.0001 DASH function subscale score .46 (.34–.63) ⬍.0001 .52 (.38–.68) ⬍.0001 .61 (.48–.79) ⬍.0001 Values are expressed as Pearson correlation coefficient (r) (95% confidence interval). August 2012 Volume 92 Number 8 Physical Therapy f 1041 Italian Version of the PRTEE Questionnaire Figure 1. Relationship between the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire and Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire scores at baseline for all participants. Regression plot, with 95% confidence interval for the mean and the slope. upper left-hand corner of the graph (cutoff score), which most effectively discriminates between individuals who have improved and those whose condition is unchanged. Assuming equivalent importance for sensitivity and specificity, the best cutoff scores (MCID) for predicting global outcome (“improved”/“not improved”) were 8 points for the PRTEE and 7.5 points for the DASH. The sensitivity and specificity values associated with the PRTEE cutoff point of 8 were 0.94 (95% CI⫽0.83– 0.98) and 0.78 (95% CI⫽0.58 – 0.91), respectively, and the positive and negative likelihood ratios were 4.2 (95% CI⫽3.4 –5.2) and 0.08 (95% CI⫽0.02– 0.3), respectively. The sensitivity and specificity values associated with the DASH cutoff point of 7.5 were ⫺.77 (95% CI⫽0.63– 0.88) and 0.74 (95% CI⫽0.54 – 0.89), respectively, and the positive and negative likelihood ratios were 2.9 Figure 2. Relationship between the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire and Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire scores at discharge for participants who underwent shock-wave therapy. Regression plot, with 95% confidence interval for the mean and the slope. 1042 f Physical Therapy Volume 92 Number 8 August 2012 Italian Version of the PRTEE Questionnaire Table 3. Baseline and Discharge Scores of the Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire and Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire in the Overall Study Sample (N⫽95) and in Participants Who Improved (n⫽49), Were Stable (n⫽38), and Worsened (n⫽8) and the Magnitude of the Changes After Shock-Wave Therapy in Participants Who Improved (n⫽49)a Questionnaire PRTEE Group of Participants Total (N⫽95) DASH PRTEE Improved (n⫽49) Stable (n⫽38) DASH PRTEE DASH a 3-Day Retest Score 27.5 (11.3) 27 (10.6) 29.2 (11.6) DASH PRTEE Baseline Score Worsened (n⫽8) Discharge Score 9.8 (8.9) 16.8 (12) Change Score t 17.5 (12.2) 11.9 ⬍.0001 7.2 ⬍.0001 12.4 (10) P ES SRM GRR 29.8 (11.5) 6.4 (4.4) 23.1 (10.2) 10.6 ⬍.0001 2.0 2.3 2.9 31.6 (11.2) 16.1 (11.5) 15.5 (10.2) 6.5 ⬍.0001 1.4 1.5 2.3 28.1 (10.3) 24.8 (10.4) 1.3 (2.3) 0.7 .58 28.9 (11.4) 27.8 (10.8) 1.1 (2.8) 0.4 .66 26.1 (10.2) 34.4 (11.7) ⫺8.3 (8.8) ⫺1.5 .22 27.8 (11.2) 33.4 (12.5) ⫺5.6 (7.2) ⫺0.9 .31 Values are expressed as mean (SD). ES⫽effect size, SRM⫽standardized response mean, GRR⫽Guyatt responsiveness ratio, t⫽value of paired t test. (95% CI⫽2.3–3.9) and 0.3 (95% CI⫽0.1– 0.6), respectively. Discussion This study cross-culturally adapted the PRTEE questionnaire using a systematic, standardized approach10 –12 and determined the measurement properties of the Italian version in individuals with chronic LET. With the exception of 2 terms in 2 different questions, no difficulties were encountered in translating the questionnaire, and the back translation corresponded very well to the original English version. Figure 3. Receiver operating characteristic curves illustrating the relationship between sensitivity and complement of specificity (1 ⫺ specificity) for the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire and the Disabilities of Arm, Shoulder and Hand (DASH) questionnaire. August 2012 The Cronbach alpha for the Italian version of the PRTEE was .95, which indicates excellent internal consistency, and exceeded .90, which is the recommended threshold when a questionnaire is used in a clinical setting.34 The Cronbach alpha for the Italian version of the PRTEE was equivalent to those of the German (.94)14 and Swedish (.94)35 versions of the PRTEE. The Italian version of the PRTEE showed high reliability for both short-term (3 days, 95 patients) and medium-term (6 weeks, 38 patients) test-retest assessments, with ICCs of .95 and .93, respectively. These values were higher than that of the original PRTEE (ICC⫽.89)7 and similar to that of the Swedish version.35 The test-retest reliability of the German version was .87.14 However, because test-retest reliability in the German version was assessed using the Pearson correlation coefficient, a direct comparison with our results is not possible. Our ICC values were similar to those reported by Newcomer et al36 for the English version of the PRFEQ, although slightly lower than those of the Hong Kong Chinese version of the PRFEQ.37 Volume 92 Number 8 Physical Therapy f 1043 Italian Version of the PRTEE Questionnaire Pearson correlation coefficients between the PRTEE and DASH displayed a strong correlation at the baseline assessment, whereas the correlation at discharge was moderate. The strongest correlation was found between the PRTEE functional ability subscale score and the DASH function subscale score at baseline (r⫽.89). The weakest correlation was found between the PRTEE functional ability subscale score and the DASH symptoms subscale score at discharge (r⫽.43). Our Pearson correlation coefficients at baseline were close to those of the Swedish version35 but higher than those reported by Newcomer et al.36 Conversely, our Pearson correlation coefficients at discharge were lower than those of the Swedish version35 and those reported by Newcomer et al.36 A Pearson correlation coefficient (.56) comparable to ours (.58) was observed between the DASH overall score and the pain subscale score in the English version of the PRFEQ. With regard to the coefficient of determination (r2), our results yielded an r2 value that was slightly lower than that reported by Rompe et al14 for the baseline data (.70 versus .75) and lower (.40 versus .66) for the pretreatmentposttreatment change values. Although the quality of measurement questionnaires usually has been evaluated by considering their reliability and validity, it has been suggested that responsiveness should be another criterion in the choice of a measurement questionnaire.39 Rompe et al14 were the first to determine the responsiveness of the PRTEE, but they used only a distribution-based method (ie, the SRM) for this purpose. Newcomer et al36 also analyzed the responsiveness of the PRFEQ using distributionbased methods alone (ie, ES and SRM). To our knowledge, this is the first study that has used all of the 1044 f Physical Therapy Volume 92 recommended statistical methods, including the ES, SRM, and GRR (distribution-based methods) and the ROC curve (anchor-based method), to determine the responsiveness of the PRTEE questionnaire. Our results demonstrated a high degree of responsiveness for both the PRTEE and the DASH. However, both the distribution-based methods and anchor-based method showed that the PRTEE was clearly more responsive than the DASH in our sample of outpatients with chronic LET treated with shock-wave therapy. We compared our ES and SRM results with those of the 2 previous studies that evaluated the responsiveness of the PRTEE and PRFEQ. We observed that our SRM value (2.3) was slightly higher than that reported by Rompe et al (2.0)14 and higher than that reported after 6 weeks (2.3 versus 1.0) and slightly higher than that reported after 12 weeks (2.3 versus 1.9) of treatment by Newcomer et al.36 Our ES value was higher than that reported by Newcomer et al36 both after 6 weeks (2.0 versus 1.0) and after 12 weeks (2.0 versus 1.6) of treatment. The MCID, defined as the magnitude of change that best distinguishes between patients who have improved and those whose condition remains unchanged, was calculated using the ROC curve analysis. The MCID was approximately 8 points for the PRTEE and approximately 7.5 points for the DASH. A comparison of the data yielded by the analysis of the ROC curve in our study with those of other studies is not possible because no other studies, to our knowledge, have appraised responsiveness of the PRTEE through the ROC curve. A methodological limitation of our study is that due to a small sample Number 8 size, we did not perform a factor analysis to assess convergent validity. Our sample of patients, however, may be considered representative of the general population that is normally referred to an outpatient rehabilitation center. The evidence presented in this article indicates that the PRTEE, a patient-rated, disease-specific questionnaire, was a valid and reliable means of measuring change in pain and function over time in our sample of outpatients with chronic LET treated with shock-wave therapy and that it was significantly more responsive than the DASH, a patient-rated, generic questionnaire. This observation is in keeping with those reported in other studies that showed patient-rated, diseasespecific questionnaires were more responsive to the target condition than patient-rated, generic questionnaires.40 – 42 As the PRTEE is, unlike the DASH, a disease-specific questionnaire, we suggest that the PRTEE can be used as a standard outcome measure in Italian outpatients who undergo therapy for chronic LET. Our data indicate that the Italian version of the PRTEE questionnaire is a valid, reliable, and responsive tool that can be used to quantitatively measure outcome in Italian patients with chronic LET, in both clinical and research settings. Further research is warranted to determine the measurement properties of the Italian version of the PRTEE in people with acute LET and other elbow diseases, as well as to compare the measurement properties of the Italian version of the PRTEE with other disease- and organspecific questionnaires. Prof Cacchio, Prof Necozione, Prof Rompe, Prof di Orio, Prof Santilli, and Prof Paoloni provided concept/idea/research design. Prof Cacchio, Prof MacDermid, Prof Maffulli, and Prof Paoloni provided writing. Prof Cacchio, August 2012 Italian Version of the PRTEE Questionnaire Prof Necozione, Prof Maffulli, Prof di Orio, Prof Santilli, and Prof Paoloni provided data collection. All authors provided data analysis. Prof Cacchio and Prof Paoloni provided project management. Prof Cacchio, Prof Necozione, Prof MacDermid, Prof Maffulli, Prof di Orio, Prof Santilli, and Prof Paoloni provided consultation (including review of manuscript before submission). Prof MacDermid is the developer of the Patient-Rated Tennis Elbow Evaluation (PRTEE). This study was approved by the local ethics committee and complied with the Declaration of Helsinki. DOI: 10.2522/ptj.20110398 References 1 Regan W, Wold LE, Coonrad R, Morrey BF. Microscopic histopathology of chronic refractory lateral epicondylitis. Am J Sports Med. 1992;20:746 –749. 2 Longo UG, Franceschi F, Loppini M, et al. Rating systems for evaluation of the elbow. Br Med Bull. 2008;87:131–161. 3 MacDermid JC. Outcome evaluation in patients with elbow pathology: issues in instrument development and evaluation. J Hand Ther. 2001;14:105–114. 4 Sathyamoorthy P, Kemp GJ, Rawal A, et al. Development and validation of an elbow score [erratum in: Rheumatology (Oxford). 2005;44:1081]. Rheumatology (Oxford). 2004;43:1434 –1440. 5 King GJ, Richards RR, Zuckerman JD, et al; for the Research Committee, American Shoulder and Elbow Surgeons. A standardized method for assessment of elbow function. J Shoulder Elbow Surg. 1999;8:351– 354. 6 MacDermid J. Update: the patient-rated forearm evaluation questionnaire is now the patient-rated tennis elbow evaluation. J Hand Ther. 2005;18:407– 410. 7 Overend TJ, Wuori-Fearn JL, Kramer JF, MacDermid JC. Reliability of a patientrated forearm evaluation questionnaire for patients with lateral epicondylitis. J Hand Ther. 1999;12:31–37. 8 Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (Disabilities of the Arm, Shoulder and Hand) [erratum in: Am J Ind Med. 1996;30:372]. Am J Ind Med. 1996;29:602– 608. 9 Pransky G, Feuerstein M, Himmelstein J, et al. Measuring functional outcomes in work-related upper extremity disorders: development and validation of the upper extremity function scale. J Occup Environ Med. 1997;39:1195–1202. 10 Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993;46:1417–1432. August 2012 11 Guillemin F. Cross-cultural adaptation and validation of health status measures. Scand J Rheumatol. 1995;24:61– 63. 12 Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000; 25:3186 –3191. 13 Wuori JL, Overend TJ, Kramer JF, MacDermid J. Strength and pain measures associated with lateral epicondylitis bracing. Arch Phys Med Rehabil. 1998;79:832– 837. 14 Rompe JD, Overend TJ, MacDermid JC. Validation of the Patient-Rated Tennis Elbow Evaluation questionnaire. J Hand Ther. 2007;20:3–10. 15 Turchin DC, Beaton DE, Richards RR. Validity of observer-based aggregate scoring systems as descriptors of elbow pain, function, and disability. J Bone Joint Surg Am. 1998;80:154 –162. 16 Padua R, Padua L, Ceccarelli E, et al. Italian version of the Disability of the Arm, Shoulder and Hand (DASH) questionnaire: cross-cultural adaptation and validation. J Hand Surg Br. 2003,28:179 –186. 17 Deyo RA, Diehr P, Patrick DL. Reproducibility and responsiveness of health status measures: statistic and strategies for evaluation. Control Clin Trials. 1991;12:142S– 158S. 18 Stratford PW, Binkley JM, Riddle DL. Health status measures: strategies and analytic methods for assessing change scores. Phys Ther. 1996;76:1109 –1123. 19 Streiner DL, Norman GR. Health Measurement Scales: A Practical Guide to Their Development and Use. Oxford, United Kingdom: Oxford University Press; 2003. 20 Fleiss JL. Reliability of measurement. In: Fleiss JL. The Design and Analysis of Clinical Experiments. New York, NY: John Wiley & Sons Inc; 1986:1–32. 21 Ottenbacher KJ, Tomchek SD. Reliability analysis in therapeutic research: practice and procedures. Am J Occup Ther. 1992; 47:10 –16. 22 Fowler J, Jarvis P, Chevannes M. Practical Statistics for Nursing and Health Care. West Sussex, United Kingdom: John Wiley & Sons Ltd; 2002. 23 McHorney CA, Tarlov AR. Individualpatient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res. 1995;4:293–307. 24 Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care. 1989;27(3 suppl):S178 – S189. 25 Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments for orthopedic evaluation. Med Care. 1990; 28:632– 642. 26 Guyatt G, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis. 1987;40:171–178. 27 Cohen JW. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988. 28 Hosmer DW, Lemeshow S, eds. Applied Logistic Regression. 2nd ed. New York, NY: John Wiley & Sons Inc; 2000. 29 Farrar JT, Portenoy RK, Berlin JA, et al. Defining the clinically important difference in pain outcome measures. Pain. 2000;88:287–294. 30 Beaton DE, Boers M, Wells GA. Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr Opin Rheumatol. 2002;14:109 –114. 31 Riddle DL, Stratford PW, Binkley JM. Sensitivity to change of the Roland-Morris Back Pain Questionnaire: part 2. Phys Ther. 1998;78:1197–1207. 32 Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003;56:395– 407. 33 Stratford PW, Binkley JM, Solomon P, et al. Assessing change over time in patients with low back pain. Phys Ther. 1994;74: 528 –533. 34 Bland JM, Altman DG. Cronbach’s alpha. BMJ. 1997;314:572. 35 Nilsson P, Baigi A, Marklund B, Månsson J. Cross-cultural adaptation and determination of the reliability and validity of PRTEE-S (Patientskattad Utvärdering av Tennisarmbåge), a questionnaire for patients with lateral epicondylalgia, in a Swedish population. BMC Musculoskelet Disord. 2008;9:79. 36 Newcomer KL, Martinez-Silvestrini JA, Schaefer MP, et al. Sensitivity of the Patient-Rated Forearm Evaluation questionnaire in lateral epicondylitis. J Hand Ther. 2005;18:400 – 406. 37 Leung HB, Yen CH, Tse PY. Reliability of Hong Kong Chinese version of the PatientRated Forearm Evaluation questionnaire for lateral epicondylitis. Hong Kong Med J. 2004;10:172–177. 38 Guyatt GH, Kirshner B, Jaeschke R. Measuring health status: what are the necessary measurement properties? J Clin Epidemiol. 1992;45:1341–1345. 39 Kopec JA. Measuring functional outcomes in persons with back pain: a review of back-specific questionnaires. Spine (Phila Pa 1976). 2000;25:3110 –3114. 40 Stucki G, Liang MH, Fossel AH, Katz JN. Relative responsiveness of conditionspecific and generic health status measures in degenerative lumbar spinal stenosis. J Clin Epidemiol. 1995;48:1369 –1378. 41 Wiebe S, Guyatt G, Weaver B, et al. Comparative responsiveness of generic and specific quality-of-life instruments. J Clin Epidemiol. 2003;56:52– 60. Volume 92 Number 8 Physical Therapy f 1045 Italian Version of the PRTEE Questionnaire eAppendix. Patient-Rated Tennis Elbow Evaluation Questionnaire, Italian Versiona QUESTIONARIO DI VALUTAZIONE DA PARTE DEL PAZIENTE DELL’EPICONDILITE O“GOMITO DEL TENNISTA” Le seguenti domande ci aiuteranno a capire la difficoltà che Lei ha avuto ad usare il suo braccio nella scorsa settimana. Lei dovrà dare una singola risposta per ciascuna domanda indicando il punteggio, su una scala da 0 a 10, che ritiene meglio descriva i Suoi sintomi al braccio relativi alla settimana scorsa. Se Lei non ha svolto una delle sottostanti attività a causa del dolore o perché le era impossibile, Lei dovrebbe cerchiare il “10”. Se Lei non è sicuro/a indichi il punteggio che meglio esprime il massimo della Sua capacità possibile ad usare il braccio. Se Lei non compie mai una delle sottostanti attività non risponda alla relativa domanda e tracci una linea sulla domanda relativa all’attività che non compie mai. 1. DOLORE nel braccio infortunato Quantifichi il dolore medio del suo braccio durante la scorsa settimana cerchiando il numero che meglio descrive il Suo dolore su una scala da 0–10. Dove zero (0) indica che Lei non aveva alcun dolore, mentre dieci (10) indica che Lei aveva il peggior dolore immaginabile. QUANTIFICHI IL SUO DOLORE Peggior No Dolore Dolore A riposo 0 1 2 3 4 5 6 7 8 9 10 Durante un movimento ripetitivo del braccio 0 1 2 3 4 5 6 7 8 9 10 Trasportando le buste della spesa 0 1 2 3 4 5 6 7 8 9 10 Quando il suo dolore era minimo 0 1 2 3 4 5 6 7 8 9 10 Quando il suo dolore era massimo 0 1 2 3 4 5 6 7 8 9 10 2. DISABILITÀ FUNZIONALE A. ATTIVITÀ SPECIFICHE Quantifichi la difficoltà che Lei ha provato nel compiere ciascuno dei compiti indicati in basso, durante la scorsa settimana, cerchiando il numero che meglio descrive la Sua difficoltà su una scala da 0 a 10. Dove zero (0) indica nessuna difficoltà, mentre dieci (10) indica che il compito era cosı̀ difficile da non poterlo svolgere. Peggior No Dolore Dolore Aprire una maniglia o girare una chiave 0 1 2 3 4 5 6 7 8 9 10 Portare una borsa o una busta della spesa per i manici 0 1 2 3 4 5 6 7 8 9 10 Portare alla bocca una tazza di cappuccino o un bicchiere di latte 0 1 2 3 4 5 6 7 8 9 10 Aprire un barattolo 0 1 2 3 4 5 6 7 8 9 10 Indossare i pantaloni 0 1 2 3 4 5 6 7 8 9 10 Strizzare uno straccio o un asciugamano bagnato 0 1 2 3 4 5 6 7 8 9 10 B. ATTIVITÀ ABITUALI Quantifichi la difficoltà che Lei ha provato nel compiere le sue attività abituali in ciascuno delle aree indicate, durante la scorsa settimana, cerchiando il numero che meglio descrive la Sua difficoltà su una scala da 0 a 10. Per “attività abituali” si intendono quelle attività che Lei svolgeva prima che iniziasse il dolore al braccio. Un valore pari a zero (0) indica nessuna difficoltà, mentre un valore pari a dieci (10) indica che il compito era cosı̀ difficile da rendere impossibile ogni forma di attività abituale. Peggior No Dolore Dolore Cura della persona (vestirsi, lavarsi) 0 1 2 3 4 5 6 7 8 9 10 Lavori domestici (pulizia, manutenzione) 0 1 2 3 4 5 6 7 8 9 10 Attività lavorativa 0 1 2 3 4 5 6 7 8 9 10 Attività ricreative o sportive 0 1 2 3 4 5 6 7 8 9 10 Commenti: (Continued) August 2012 (eAppendix, Cacchio et al) Volume 92 Number 8 Physical Therapy f 1 Italian Version of the PRTEE Questionnaire eAppendix. Continued ISTRUZIONI PER IL PUNTEGGIO Ridurre al massimo le non-risposte controllando il questionario quando i pazienti hanno terminato di completarlo. Assicurarsi che il paziente non abbia lasciato una domanda in bianco solo perché non era in grado di svolgere quel compito, ricordandogli che in questo caso avrebbe dovuto cerchiare il “10” e non lasciarla in bianco. Se i pazienti sono incerti perché hanno compiuto raramente una delle attività durante la scorsa settimana, dovrebbero essere incoraggiati a dare comunque una valutazione media della loro difficoltà. Questo sarà più accurato che lasciare la domanda in bianco. Se i pazienti non compiono mai una delle attività, non saranno capaci di valutare la difficoltà e quindi dovrebbero lasciare in bianco la domanda. Se tutte le domande di una sottoscala sono state lasciate in bianco, si può attribuire a quella sottoscala il risultato medio ottenuto dalle altre sottoscale. a 2 Sottoscala Dolore – Somma di 5 domande. Miglior punteggio ⫽ 0; peggior punteggio ⫽ 50 Attività Specifiche – Somma di 6 domande. Miglior punteggio ⫽ 0; peggior punteggio ⫽ 60 Attività Abituali – Somma di 4 domande. Miglior punteggio ⫽ 0; peggior punteggio ⫽ 40 Sottoscala Funzione – (Attività Specifiche ⫹ Attività Abituali)/2 Miglior punteggio ⫽ 0; peggior punteggio ⫽ 50 Punteggio Totale ⫽ Sottoscala Dolore ⫹ Sottoscala Funzione Miglior punteggio ⫽ 0; peggior punteggio ⫽ 100 (Il dolore e la disabilità contribuiscono in egual misura alla determinazione del punteggio totale) The Patient-Rated Tennis Elbow Evaluation questionnaire, Italian version, may not be reproduced without written permission from the authors. f Physical Therapy Volume 92 Number 8 August 2012 (eAppendix, Cacchio et al) Research Report The ABLE Scale: The Development and Psychometric Properties of an Outcome Measure for the Spinal Cord Injury Population E.M. Ardolino, PT, PhD, Department of Physical Therapy, University of St. Augustine, Austin Campus, 5401 LaCrosse Ave, Austin, TX 78739 (USA). Address all correspondence to Dr Ardolino at: [email protected]. K.J. Hutchinson, PT, DPT, PhD, Department of Physical Therapy and Athletic Training, Sargent College, Boston University, Boston, Massachusetts. G. Pinto Zipp, PT, EdD, Department of Health Sciences, Seton Hall University, South Orange, New Jersey. M. Clark, EdD, School of Health Professions and Nursing, Long Island University, Brookville, New York. S.J. Harkema, PhD, Department of Neurological Surgery, University of Louisville, Louisville, Kentucky; Kentucky Spinal Cord Injury Research Center, Louisville, Kentucky; and Frazier Rehabilitation, Louisville, Kentucky. [Ardolino EM, Hutchinson KJ, Pinto Zipp G, et al. The ABLE scale: the development and psychometric properties of an outcome measure for the spinal cord injury population. Phys Ther. 2012;92: 1046 –1054.] © 2012 American Physical Therapy Association Published Ahead of Print: May 10, 2012 Accepted: May 3, 2012 Submitted: August 12, 2011 Elizabeth M. Ardolino, Karen J. Hutchinson, Genevieve Pinto Zipp, MaryAnn Clark, Susan J. Harkema Background. A paucity of information exists on the psychometric properties of several balance outcome measures. With the exception of the Modified Functional Reach Test, none of these balance outcome measures were developed specifically for the population with spinal cord injury (SCI). A new balance assessment tool for people with SCI, the Activity-based Balance Level Evaluation (ABLE scale), was developed and tested. Objective. The purposes of this study were: (1) to develop a scale capturing the wide spectrum of functional ability following SCI and (2) to assess the initial psychometric properties of the scale using a Rasch analysis. Design. A methodological research design was used to test the initial psychometric properties of the ABLE scale. Methods. The Delphi technique was used to establish the original 28-item ABLE scale. People with SCI at each of 4 centers (n⫽104) were evaluated using the ABLE scale. A Rasch analysis was conducted to test for targeting, item difficulty, item bias, and unidimensionality. An analysis of variance was completed to test for discriminant validity. Results. The Rasch analysis revealed a scale with minimal floor and ceiling effects and a wide range of item difficulty capturing the large scope of functional capacity after SCI. Multiple redundancies of item difficulty were observed. Limitations. All raters were experienced physical therapists, which may have skewed the results. The sample size of 104 participants precluded a principal component analysis. Conclusion. Development of an all-inclusive clinical instrument assessing balance in the SCI population was accomplished using the Delphi technique. Modifications of the ABLE scale based on the Rasch analysis yielded a 28-item scale with minimal floor or ceiling effects. Larger studies using the revised scale and factor analyses are necessary to establish unidimensionality and reduction of the total item number. Post a Rapid Response to this article at: ptjournal.apta.org 1046 f Physical Therapy Volume 92 Number 8 August 2012 Development and Psychometric Properties of the ABLE Scale A spinal cord injury (SCI) is a sudden, catastrophic, lifechanging event. An estimated 12,000 new cases of SCI occur each year in the United States,1 and more than 1.2 million individuals are living with an SCI in the United States.2 An SCI results in some degree of sensation or motor loss below the level of the lesion, producing a balance impairment that affects the injured individual’s ability to participate in functional activities and activities of daily living.3 Balance is difficult to assess, yet it is essential to the evaluation process. Few quantitative measures exist to adequately capture balance assessment in SCI. Studies utilizing forceplates and electromyography (EMG) capture changes in center of pressure and muscle activation patterns.4 –7 Although these measures provide precise and quantitative data, time, equipment costs, and expertise needed for reliable use and interpretation of such data preclude their widespread utilization in the physical therapy clinic.8 Clinicians often turn to clinical outcome measures such as the Modified Functional Reach Test (MRFT)9 and the Berg Balance Scale (BBS)10 as indexes of balance and postural control post-SCI.11 The MFRT9 was adapted from the standing Functional Reach Test12 in an effort to differentiate levels of injury severity in nonambulatory individuals following SCI. Reliability of this outcome measure has been established in both the motor complete9,13 and incomplete14 SCI populations. The MFRT is easy and quick to administer, requires minimal equipment and training to perform accurately, and can be used in both ambulatory and nonambulatory people. The test assesses sitting balance only in the anterior-posterior plane and thus does not provide a complete assessment of functional sitting August 2012 abilities. Further research is needed to establish the interrater reliability, validity, and minimal detectable change in the SCI population. The BBS is a 14-item scale originally designed to assess fall risk in the elderly population.10 Although the psychometric properties of the BBS have been established for a wide range of neurologic populations, only 2 studies have examined its reliability and validity in the SCI population.11,15 Although these studies correlated the BBS with several walking indexes, both studies demonstrated a ceiling effect with the BBS. Another drawback to the BBS in this population is that there is only one sitting balance item. Therefore, for people with SCI who are unable to stand and walk, a floor effect will be observed. The Functional Independence Measure (FIM) is an 18-item test used to assess the amount of assistance a person requires with transfers, walking, and several activities of daily living.16,17 The FIM is widely used in inpatient rehabilitation settings to measure burden of care and improvement in functional mobility in the SCI population.16 Although balance is a component of functional mobility tasks, the FIM does not specifically test balance. A person can improve in the functional mobility items on the FIM by compensating for paralyzed body parts or using adaptive equipment. Knowing only that a person requires a certain amount of assistance to transfer, or walk 45.7 m (150 ft) does not provide the clinician with useful information for evaluating balance deficits. Therefore, the FIM is not a sensitive measure for assessing balance in the SCI population. There currently are no outcome measures specifically developed and validated to assess balance abilities in the SCI population throughout the full spectrum of functional recovery. Clinical outcome measures that are currently utilized are limited in scope and present significant ceiling and floor effects. Therefore, there is a need for the development of a new balance outcome measure specific to the SCI population. The purposes of this study were: (1) to develop an all-inclusive clinical instrument, the Activity-based Balance Level Evaluation (ABLE scale), to assess balance across the full spectrum of recovery in the SCI population and (2) to determine the initial psychometric properties of the ABLE scale using a Rasch analysis. Method Scale Development The initial ABLE scale was written by the primary authors (E.M.A., K.J.H., and G.P.Z.) based upon an extensive review of the literature in conjunction with clinical experience in administering the BBS and the MFRT to clients with SCI. The initial ABLE scale consisted of 30 items, which tested balance in the domains of sitting, standing, and walking. This initial ABLE scale was further developed and refined through the use of a Delphi technique that seeks consensus among a group of experts using a series of questionnaires.18 There were 2 rounds of the Delphi In summary, forceplates and EMG recordings for the measurement of balance are not available for use in the typical physical therapy clinic. Volume 92 Available With This Article at ptjournal.apta.org • eAppendix: The Activity-based Balance Level Evaluation (ABLE Scale) • Demonstration Video of Selected Items From the Activitybased Balance Level Evaluation (ABLE Scale) Number 8 Physical Therapy f 1047 Development and Psychometric Properties of the ABLE Scale technique plus a round of advanced critique by a panel of SCI researchers and educators. Experts in all 3 rounds were physical therapists who had at least 5 years of physical therapist practice, at least 2 years of evaluating and treating people with SCI, and at least 2 years of administering the BBS. Twenty-four experts participated in rounds 1 and 2 and were recruited anonymously from the 14 Model SCI Systems and from the 7 centers of the NeuroRecovery Network (NRN) and the NeuroPT listserve, an electronic mailing list operated by the Neurology Section of the American Physical Therapy Association. In round 1 of the Delphi study, the experts were presented with the initial ABLE scale online via Seton Hall University’s ASSET survey program. All experts recruited for the study were given instructions on how to access the survey via the ASSET platform and were given 2 weeks to complete the survey. The experts were presented with each item of the ABLE scale and were asked several questions regarding the item, including the importance of including the item, clarity of the wording, appropriateness of the scoring, and feasibility of administering the item in a physical therapy clinic. Experts also were provided with the opportunity to offer suggestions on improving each item and the scale as a whole. Through this process, content validity, which ensures that the test is free from the influences of factors that are irrelevant to the purpose of the measurement,19 and item reliability (internal consistency), which reflects the extent to which items measure various aspects of the same characteristic and nothing else,19 were established. The results from the first round were reviewed by the research team. Although there is no universally agreed-upon percentage of agree1048 f Physical Therapy Volume 92 ment for consensus, the literature suggests that 70% to 80% is considered a reasonable guideline, and it is highly recommended that this level be set prior to the data analysis.20,21 Using an 80% agreement requirement for an item to be modified or deleted, the ABLE scale was revised. Nineteen of the 30 items reached an 80% consensus, 8 items were modified, and 3 items were deleted. The revised scale, noting the items modified or deleted, was posted online via ASSET. Experts were contacted again through either the supervisors at the Model SCI Systems centers and the NRN centers or through the NeuroPT listserve. The second survey presented each item of the scale, and the experts were asked to answer the questions following any item that had been modified. Once the ABLE scale had gone through a 2-round Delphi review process with the clinical expert panel, a final review was conducted by an additional panel of 7 SCI researchers and educators to ensure that the scale would be appropriate for use in a clinical research setting. The latter panel of experts was asked to offer feedback on the clinical expert version of the scale developed via the Delphi process by responding to the relative importance and feasibility questions posed in the Delphi review process via ASSET. This final round resulted in what we considered a final Delphi review. As a result of the 3 rounds of the Delphi technique, 3 items were removed from the scale, 1 item was added, and minor editorial changes were made. This process resulted in an ABLE scale with 28 items across the 3 functional domains of sitting, standing, and walking (Tab. 1). Number 8 Table 1. Functional Activity Associated With Each Item of the Activity-based Balance Level Evaluation (ABLE Scale) Item Task 1 Sitting 2 Seated forward reach 3a Seated lateral reach (right) 3b Seated lateral reach (left) 4 Pick up object in sitting position 5 Scooting forward in chair 6 Seated external perturbations 7 Transfers 8 Wheelchair perturbations 9 Sit to stand 10 Standing 11 Stand to sit 12 Stand with eyes closed 13 Standing with feet together 14 External perturbations in standing 15 Standing forward reach 16 Pick up object from standing 17 Look over shoulder in standing 18 Turn 180° 19 Alternate step-ups 20 Tandem stance 21a Standing on one leg (right) 21b Standing on one leg (left) 22 Walking over level surface 23 Walking with head turns 24 Walking with change in direction 25 Stepping over object while walking 26 Walking with object in 2 hands 27 Walking up/down stairs 28 Walking up/down incline Participants One hundred fifty-seven people were screened for inclusion, and a total of 104 individuals with SCI were included in this study.22 This was a sample of convenience, and participants were recruited from the inpatient and outpatient settings of Magee Rehabilitation Hospital, Philadelphia, Pennsylvania; Shepherd Center, Atlanta, Georgia; Kessler Research Center, West Orange, New August 2012 Development and Psychometric Properties of the ABLE Scale Jersey; and Frazier Rehabilitation Institute, Louisville, Kentucky. Inclusion criteria specified that participants be at least 16 years of age and have a traumatic or nonprogressive, complete or incomplete SCI. Exclusion criteria, which disqualified 53 potential participants, included: inability to follow 2-step commands, need for a spinal stabilization device, spinal precautions that limit the ability to bend or rotate the thoracic or lumbar spine, and inability to tolerate upright supported sitting for at least 1 minute. We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during the course of this research. Procedure To ensure standardization of the scoring and administration of the ABLE scale across the data collection centers, the primary investigator (E.M.A.) provided an in-person instructional session and responded via telephone call or e-mail to any concerns the therapists had regarding the administration and scoring of the ABLE scale. All participants were asked for their consent to participate by the primary investigator or one of the designated physical therapists at the 4 data collection sites. Participants were tested on the ABLE scale in a single session in a quiet, designated area in each of the data collection sites. The ABLE scale was administered to each participant based upon the instructions for each item (eAppendix, available at ptjournal.apta.org). The equipment used for testing was standardized across all centers according to the directions noted at the beginning of the scale. Participants were not allowed to use their personal wheelchair for items 7 and 8 and were asked to sit in a standard manual wheelchair provided by the clinic. Participants were positioned August 2012 with their hips, knees, and ankles at 90 degrees in a wheelchair with a sling back to approximately scapular height and a solid seat. This positioning was done to prevent the influence of a participant’s customized seating system on his or her balance. Participants who could complete only the sitting balance subscale were finished within 15 minutes, whereas those who could complete all 3 subscales required up to 45 minutes. The data for each individual were recorded in a standardized Excel spreadsheet (Microsoft Corporation, Redmond, Washington) and sent to the primary investigator. Data collection took place between May 2009 and November 2009. All participants were blinded as to the other participants in the study. Data Analysis After reaching consensus via the Delphi process, a Rasch analysis of scale scores was completed to further assess and develop the scale. Rasch analysis is a statistical model that can estimate the person “ability” and item “difficulty” of a measurement tool by comparing the responses of individuals with those of the entire sample.23 This model provides a method to analyze and improve a rating scale.24 Rasch analysis uses 2 values: the logit, which is the natural logarithm of the odds of a person being successful on a particular item, and fit statistics.23 Infit and outfit statistics determine how well raw data meet the requirements of the Rasch model.23 In the Rasch model, we would expect people with higher abilities to achieve higher scores on difficult items. People with lower abilities would be expected to score lower on difficult items. A Rasch analysis is used to test specific properties of a rating scale, including unidimensionality, item bias, targeting, and item difficulty. Unidimensionality, as measured by fit statistics, is the concept that all items on the scale are measuring the same construct, in this case, balance. Differential item functioning (DIF) tests for item bias by examining the estimates, or ability levels, for different groups of individuals.23 In this study, we tested for item bias across sex, age, and American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification.25 Targeting reveals the range of difficulty of the items that correspond to the range in ability noted in the study population. It ensures that there are items that are appropriate to test every level of person ability. Testing the item difficulty may reveal redundant items or items that appear to have the same level of difficulty.23 Using a Rasch analysis to test item difficulty allows for the items to be placed in a hierarchy.23 Furthermore, to determine whether any changes needed to be made to any items, each item’s rating scale categories, or scoring levels, were examined using threshold ordering. Each item on the ABLE scale has distinct definitions for each rating scale category, so that a score of 1 on one item is not equal to a score of 1 on a different item.26 In order to correctly place the items on the scale according to level of difficulty, the rating scale categories need to be aligned. Pivot anchoring is a process of aligning these differently worded rating scale categories to assist in defining the difficulty of each item. Pivot anchoring consists of first assigning a point in each item’s rating scale in which the categories represent passing or failing an item. For the ABLE scale, passing was defined as the ability to complete the specified task according to the item’s instruction, without physical assistance or supervision. For example, passing item 1 was defined as “able to sit with posterior pelvic tilt for 2 minutes, independently,” or a score of 3, whereas passing item 6 was determined to be a score of 4. Using these definitions, pivot points were defined for each item’s rating scale and are boldfaced Volume 92 Number 8 Physical Therapy f 1049 Development and Psychometric Properties of the ABLE Scale Table 2. Table 3. Demographic Characteristics of the Participants With Spinal Cord Injury (SCI) (n⫽104) Items With Disordered Thresholdsa Characteristic Values Age, y, X⫾SD (median) Item 38.63⫾14.98 (36) 4 Sex, n (%) Male 79 (76) Female 25 (24) Mean time since injury, mo, X⫾SD 44.8⫾68.1 Type of SCI, n (%) Motor complete 10 17 (16) Motor incomplete 87 (84) Tetraplegia 59 (57) Paraplegia 45 (43) Functional level, n (%) Wheelchair dependent 42 (40) Able to stand for ⱖ10 s with or without minimal assistance 30 (29) Able to ambulate ⱖ6.1 m (20 ft) without an assistive device 32 (31) 11 13 in the ABLE scale (eAppendix). These passing points then are anchored to a common value for all items on the scale, and the item difficulties are recalibrated across the scale.26 A one-way analysis of variance (ANOVA) was performed to test the hypothesis that the person ability levels, or estimates, for 3 functional groups of wheelchair users, standers, and walkers were equal. Multiple comparisons were completed using the Bonferroni procedure. Descriptive statistics were used to analyze the demographic data, including age, sex, time since injury, severity of SCI, and functional level. All demographic data and the ANOVA results were analyzed with Statistical Software for the Social Sciences (SPSS), version 14.0 (SPSS Inc, Chicago, Illinois). The Rasch analysis was completed using WINSTEPS software, version 3.68.2 (Winsteps, Chicago, Illinois). 1050 f Physical Therapy Volume 92 Results Demographics One hundred four participants were tested once on the ABLE scale. Table 2 summarizes the demographic characteristics. Participants were stratified into 3 distinct categories based upon functional ability. Individuals who were unable to stand or walk (n⫽42) were classified as “wheelchair users,” those who could stand for at least 10 seconds with minimal to no physical assistance (n⫽30) were classified as “standers,” and those who could ambulate at least 6.1 m (20 ft) without an assistive device or physical assistance (n⫽32) were classified as “walkers.” Threshold Ordering An examination of the category threshold measures, in logits, was made to identify any disordered thresholds (ie, response categories that were utilized in a manner inconsistent with the trait being measured). On the ABLE scale, response category 3 should have a higher logit value than response category 2, indi- Number 8 14 a Response Category Category Measure (Logits) 0 ⫺6.90 1 ⫺5.71 2 ⫺2.41 3 ⫺4.24* 4 1.65 0 ⫺4.94 1 ⫺2.21 2 ⫺0.56 3 ⫺0.86* 4 2.67 0 ⫺3.65 1 ⫺0.76 2 ⫺2.08* 3 0.08 4 2.97 0 ⫺3.40 1 ⫺0.19 2 0.21 3 ⫺0.08* 4 3.06 0 ⫺4.48 1 ⫺0.15 2 0.82 3 0.20* 4 3.62 Asterisk indicates disordered category. cating that category 3 is more difficult than category 2. Table 3 displays the 5 items with disordered thresholds. In items 4, 10, 13, and 14, category 2 had a higher measure than category 3. In item 11, category 1 had a higher measure than category 2. Consequently, we reviewed these disordered thresholds to see what changes could be made. The response categories of 2 and 3 for item 4 were reversed, as this made sense clinically. This change resulted in an improved fit of item 4, as the August 2012 Development and Psychometric Properties of the ABLE Scale outfit value improved from 0.50 to 0.85. Review of the other items with disordered thresholds determined that reversing the response categories did not make sense clinically. Therefore, we rewrote these response categories, and we are retesting these items in a follow-up study. The revised version of the ABLE scale is presented in the eAppendix. (See a video demonstrating selected items from the ABLE scale, available at ptjournal.apta. org.) Unidimensionality Although recent studies suggest that unidimensionality should be determined through a combination of Rasch fit statistics and principal component analysis (PCA) residuals, our sample size was too small to conduct a PCA.27,28 The fit statistics reported here are rudimentary analyses of the unidimensionality of this scale. Table 4 shows the infit and outfit mean square values for all of the items of the ABLE scale. Two items, 7 (transfers) and 8 (seated wheelchair perturbations), were determined to have infit mean square values of ⬎1.4, suggesting that these items may be measuring a construct other than functional balance. Items with an outfit mean square value of ⬍0.6 are considered to be less efficient in measuring the construct. Although these items are not a threat to the validity of the scale, they may produce deceptively high reliability estimates. Seventeen items had outfit values of ⬍0.6: 2 (seated forward reach), 4 (pick up object in sitting), 6 (posterior external perturbations in sitting), 9 (sit to stand), 11 (stand to sit), 13 (standing with feet together), 15 (standing forward reach), 18 (turn 180°), 19 (alternate step test), 21b (left single-leg stance), 22 (walking over level surface), 23 (walking with head turns), 24 (walking with change in direction), 25 (stepping over object while walking), 26 (walking with object in 2 hands), 27 August 2012 (walking up/down stairs), and 28 (walking up/down incline). Items with an outfit value of ⬎1.4 are a greater threat to validity and represent outliers. Four items had an outfit value of ⬎1.4: 3a and 3b (seated lateral reach to the right and left), 7 (transfers), and 8 (seated wheelchair perturbations). Therefore, these items should be tested further using a factor analysis with a larger sample size. Table 4. Mean Square Values for Each Item of the Activity-based Balance Level Evaluation (ABLE Scale) Item Targeting and Item Difficulty Rasch analysis places item difficulty and person ability along the linear continuum of a logit scale. The Figure is a person-item map that displays the item difficulty and person ability of the ABLE scale for 104 participants with SCI after pivot anchoring was applied. To the left of the dashed line are the person ability measures, and to the right of the dashed line are the item measures placed longitudinally by degree of difficulty in “passing” the item (see “Method” section). Each item is represented by its corresponding number on the ABLE scale (Tab. 1). The participants with the lowest balance ability are located at the bottom of the scale, whereas those with the highest ability are located at the top of the scale. Similarly, the easiest items are located at the bottom of the scale and the most difficult items are positioned at the top of the scale. Targeting compares the range of item difficulties with the range of person abilities. An extremely large range of abilities were identified in this sample, which reflects the wide range in abilities observed following SCI. A slight ceiling effect still existed, as there were no items to measure the one subject with abilities greater than 6 logits (Figure). There also was a slight floor effect, as there were no items to measure the one participant with an ability of less than ⫺7 logits. Infit Outfit 1 1.11 1.32 2 0.78 0.30 3a 1.03 2.44 3b 1.01 2.98 4 0.78 0.50 5 1.07 0.79 6 1.33 0.50 7 1.66 1.85 8 3.05 9.90 9 0.53 0.41 10 1.13 0.76 11 0.68 0.36 12 1.14 0.80 13 0.57 0.40 14 1.03 0.60 15 0.59 0.50 16 1.16 1.28 17 0.79 0.76 18 0.59 0.24 19 0.75 0.41 20 0.71 0.74 21a 1.22 0.78 21b 0.74 0.51 22 0.41 0.25 23 0.66 0.30 24 0.49 0.19 25 0.84 0.29 26 0.60 0.24 27 0.76 0.50 28 0.51 0.22 Analysis of item difficulty revealed that the most difficult item is 21a (right single-leg stance). The easiest item is 5 (scooting forward in a chair), which is located on the ⫺7 logit. Several item redundancies were noted at the ⫺1, 0, 2, and 3 logits (eg, 7 different items had a similar level of difficulty located on logit 0). Volume 92 Number 8 Physical Therapy f 1051 Development and Psychometric Properties of the ABLE Scale was to determine what modifications needed to be made to the scale based upon the initial properties of unidimensionality, targeting, item difficulty, and item bias identified with the Rasch analysis. We also tested the scale’s ability to discriminate among the 3 groups of participants stratified across functional ability. Analysis of the fit statistics suggests that 2 items (7 and 8) measure a construct other than balance. These 2 items, along with items 3a and 3b, also had a high outfit value, which implies that they are outliers. Our small sample size precluded performing a PCA, and a follow-up study on a larger sample is warranted to determine whether these items should be removed from the scale. Figure. Person-item map for the 28 items of the Activity-based Balance Level Evaluation (ABLE scale) as tested on 104 individuals with spinal cord injury. Each “.” is one participant, each “#” is 2 participants. DIF We used DIF to determine whether any items were biased according to sex, age, or AIS classification. The DIF effect sizes for sex and age were negligible and did not reach statistical significance for any item. When DIF was examined by AIS classification, 2 items (7 and 8) showed significant bias for the AIS C group (P⬍.05). Discriminant Validity A one-way ANOVA was conducted on the person estimates to assess whether the ABLE scale differentiates among the 3 distinct functional groups. The average person estimates were found to be different across groups (F2,101⫽258.37, P⬍.0001). Bonferroni post hoc com1052 f Physical Therapy Volume 92 parisons performed at the .05 level of significance showed that the mean person ability for the “walker” group (X⫽3.64, SD⫽1.66, n⫽32) was significantly higher than for the “stander” group (X⫽⫺0.13, SD⫽1.04, n⫽30) and for the “wheelchair-user” group (X⫽⫺4.08, SD⫽1.54, n⫽42). The mean person ability for the stander group also was found to be significantly higher compared with the wheelchair-user group at the .05 level of significance. Discussion The purpose of this study was 2-fold. First, our goal was to develop an allinclusive clinical instrument to assess balance in the SCI population, which was accomplished via the Delphi technique. The second purpose Number 8 Analysis of the item map (Figure) shows that the ABLE scale has an appropriate targeting range, with minimal floor and ceiling effects. In an attempt to further minimize the ceiling effect, an additional walking item (walking during perturbations) was added following this analysis. An appropriate targeting range is important, as there currently is no outcome measure that can capture the full spectrum of recovery in the SCI population. Datta et al29 found floor and ceiling effects with the BBS and suggested the development of a new balance scale for this population. The large spread of item difficulty will allow a clinician to use a single outcome measure with a patient throughout his or her entire recovery. For example, a patient in the acute phase of recovery who may just be regaining sitting balance can be assessed using the sitting balance subscale. As he or she progresses, not only can progression of sitting balance be tested, but standing or walking items, scored specifically for people recovering from SCI, also can be incorporated into testing. August 2012 Development and Psychometric Properties of the ABLE Scale The analysis of item difficulty revealed 4 logits in which there were multiple redundancies. Some of these redundancies may have been caused by disordered thresholds of 5 items, as well as by a decreased ability to discriminate among scoring criteria in several of the items. Upon completion, scoring criteria were revised for the items with disordered thresholds, as well as for the items with outfit values of ⬍0.6, to improve separation, clarity, and accuracy in scoring. Given the large number of items on the scale, we were not surprised to see some overlap in item difficulty levels. To address this overlap, further testing is needed on a larger sample to conduct a factor analysis, which would allow for reduction in number of items. There were several limitations to this study. First, all of the participants were tested by raters who were experienced in administering balance assessments to the SCI population. It is unclear how these individuals might have been rated by physical therapists with less experience in balance assessment or the rehabilitation of people with SCI. The use of less experienced raters may have resulted in increased difficulty in distinguishing among the different rating scale categories for each item. As the purpose of this study was to determine what changes need to be made to the ABLE scale, experienced raters were specifically chosen so that reliable assessments of the participants could be made and would not influence the outcome of the study. Analysis of item bias through DIF revealed only 2 items (7 and 8) with significant bias in individuals with AIS C classification. These 2 items may be unfairly difficult for this group of individuals. It is unclear whether the problem lies with the items themselves, as individuals with AIS C classification often have a complicated pattern of recovery and may be inconsistent in performance of functional tasks. However, as these items also had high infit and outfit statistics, they may be removed from a future version of the scale, after a PCA is completed. A second limitation was the sample size of 104 participants. Although this sample size has been shown to be appropriate for conducting a Rasch analysis of an outcome measure with 20 items, it precluded performing a PCA.22,26,27 Therefore, this study was only the first step in assessing the validity of this new instrument. In the future, a PCA will be completed on a larger sample of participants to further develop the unidimensionality of the scale and to ensure that all of the items on the ABLE scale measure balance, and not another related construct. One major strength of the ABLE scale is its ability to discriminate among individuals, not based on injury severity (eg, AIS classification), but by functional mobility levels. Several studies of the MFRT showed that it is able to discriminate among injury severities, but does not differentiate or correlate with functional mobility.9,13,30 The use of the ABLE scale will provide the clinician with a more detailed assessment of a client’s balance abilities. This study identified several weaknesses of the initial ABLE scale, and several of the redundant and poorly fitting items were rewritten to improve their clarity. This modified version of the ABLE scale is currently being tested on a larger sample in a multicenter format in order to conduct a PCA and reduce the total number of items of the scale. Once the PCA is completed, further research should be conducted to examine other psychometric properties. Intrarater and interrater reliability August 2012 should be established for the ABLE scale in the SCI population using both experienced and novice clinicians. Concurrent validity of the ABLE scale with other currently utilized outcome measures, including the BBS and the MFRT, should be assessed. Finally, fall incidence and performance on the ABLE scale should be correlated to determine whether the ABLE scale has the sensitivity or specificity needed to predict fallers in the SCI population. Conclusion Currently, there is no clinical outcome measure that has been designed specifically to assess balance in the SCI population. This study was the first step in developing a scale that can assess balance across the full spectrum of recovery in this population. Although the Rasch analysis showed that the ABLE scale has an appropriate targeting range and discriminate ability, further study is needed to ensure that it is a unidimensional and valid scale. Dr Ardolino, Dr Hutchinson, Dr Pinto Zipp, and Dr Harkema provided concept/idea/ research design. Dr Ardolino, Dr Hutchinson, Dr Pinto Zipp, and Dr Clark provided writing and data analysis. Dr Ardolino and Dr Harkema provided data collection. Dr Ardolino provided project management. Dr Harkema provided study participants. Dr Clark and Dr Harkema provided institutional liaisons. Dr Hutchinson and Dr Clark provided consultation (including review of manuscript before submission). The authors thank the staff and patients at Magee Rehabilitation, the Shepherd Center, Kessler Rehabilitation, and Frazier Rehabilitation for their time and participation in this study. They also thank the Balance Committee of the NeuroRecovery Network for their assistance in initiating the development of the ABLE scale. Approval for the study was granted by the institutional review boards of Magee Rehabilitation Hospital, Shepherd Center, Kessler Research Center, Frazier Rehabilitation Institute, and Seton Hall University. DOI: 10.2522/ptj.20110257 Volume 92 Number 8 Physical Therapy f 1053 Development and Psychometric Properties of the ABLE Scale References 1 Spinal cord injury: facts and figures at a glance. J Spinal Cord Med. 2008;31:357– 358. 2 One Degree of Separation: Paralysis and Spinal Cord Injury in the United States. 2009. Available at: http://www.spinal cordinjuryzone.com/info/8995/onedegree-of-separation-paralysis-and-spinalcord-injury-in-the-united-states. Accessed March 18, 2012. 3 Somers MF. Spinal Cord Injury: Functional Rehabilitation. 2nd ed. Upper Saddle River, NJ: Prentice Hall; 2000:458. 4 Grigorenko A, Bjerkefors A, Rosdahl H, et al. Sitting balance and effects of kayak training in paraplegics. J Rehabil Med. 2004;36:110 –116. 5 Janssen-Potten YJM, Seelen HA, Drukker J, et al. The effect of footrests on sitting balance in paraplegic subjects. Arch Phys Med Rehabil. 2002;83:642– 648. 6 Kamper D, Parnianpour M, Barin K, et al. Postural stability of wheelchair users exposed to sustained, external perturbations. J Rehabil Res Dev. 1999;36:121– 132. 7 Middleton JW, Sinclair PJ, Smith RM, Davis GM. Postural control during stance in paraplegia: effects of medially linked versus unlinked knee-ankle-foot orthoses. Arch Phys Med Rehabil. 1999;80:1558 –1565. 8 Monsell EM, Furman JM, Herdman SJ, et al. Computerized dynamic platform posturography. Otolaryngol Head Neck Surg. 1997;117:394 –398. 9 Lynch SM, Leahy P, Barker SP. Reliability of measurements obtained with a modified Functional Reach Test in subjects with spinal cord injury. Phys Ther. 1998; 78:128 –133. 10 Berg K, Wood-Dauphinée S, Williams JI, Gayton D. Measuring balance in the elderly: preliminary development of an instrument. Physiother Can. 1989;41:304 –311. 1054 f Physical Therapy Volume 92 11 Wirz M, Müller R, Bastiaenen C. Falls in persons with spinal cord injury: validity and reliability of the Berg Balance Scale. Neurorehabil Neural Repair. 2010;24: 70 –77. 12 Duncan PW, Weiner DK, Chander J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990; 43:M192–M197. 13 Adegoke BOA, Ogwumike OO, Olatemiju A. Dynamic balance and level of lesion in spinal cord injured patients. Afr J Med Sci. 2002;31:357–360. 14 Field-Fote EC, Ray SS. Seated reach distance and trunk excursion accurately reflect dynamic postural control in individuals with motor-incomplete spinal cord injury. Spinal Cord. 2010;48:745–749. 15 Lemay J, Nadeau S. Standing balance assessment in ASIA D paraplegic and tetraplegic participants: concurrent validity of the Berg Balance Scale. Spinal Cord. 2010;48:245–250. 16 Hall KM, Cohen ME, Wright J, et al. Characteristics of the Functional Independence Measure in traumatic spinal cord injury. Arch Phys Med Rehabil. 1999;80:1471– 1476. 17 Granger CV, Hamilton BB, Linacre JM, et al. Performance profiles of the Functional Independence Measure. Arch Phys Med Rehabil. 1993;72:84 – 89. 18 Hasson F. Research guidelines for the Delphi survey technique. J Adv Nurs. 2000; 32:1008 –1015. 19 Portney LG, Watkins MP. Foundations of Clinical Research: Applications to Practice. 3rd ed. Upper Saddle River, NJ: Prentice Hall Health; 2008. 20 Biondo PD, Nekolaichuk CL, Stiles C, et al. Applying the Delphi process to palliative care tool development: lessons learned. Support Care Cancer. 2008;16:935–942. Number 8 21 Keeney S, Hasson F, McKenna H. Health care assistants: the views of managers of health care agencies on training and employment. J Nurs Manag. 2005;13:82– 92. 22 Wang W, Chen C. Item parameter recovery, standard error estimates, and fit statistics of the Winsteps program for the family of Rasch models. Educ Psychol Meas. 2005;65:376 – 404. 23 Bond TG, Fox CM. Applying the Rasch Model: Fundamental Measurement in the Human Sciences. Mahweh, NJ: Lawrence Erlbaum Associates Publishers; 2001:255. 24 Linacre JM. Investigating rating scale category utility. J Outcome Meas. 1999;3:103– 122. 25 Reference Manual for the International Standards for Neurological Classification of Spinal Cord Injury. Chicago, IL: American Spinal Injury Association; 2003. 26 Bode RK. Partial credit model and pivot anchoring. J Appl Meas. 2001;2:78 –95. 27 Linacre JM. Structure in Rasch residuals: why principal components analysis? Rasch Measurement Transactions. 1998; 12:636. 28 Linacre JM. Detecting multidimensionality: which residual data-type works best? J Outcome Meas. 1998; 2:266 –283. 29 Datta S, Lorenz DJ, Morrison S, et al. A multivariate examination of temporal changes in berg balance scale items for patients with ASIA impairment scale C and D spinal cord injuries. Arch Phys Med Rehabil. 2009;90:1208 –1217. 30 Forrest GF, Lorenz DJ, Hutchinson K, et al. Ambulation and balance activities measure different aspects of recovery in individuals with chronic incomplete spinal cord injury. Arch Phys Med Rehabil. In press. August 2012 Development and Psychometric Properties of the ABLE Scale eAppendix. The Activity-based Balance Level Evaluation (ABLE Scale)a Purpose: to assess changes in balance across the full spectrum of recovery in the spinal cord injury population. General Instructions: • The scale consists of 3 subscales: sitting, standing, and walking. The scale may be administered in full, or each subscale may be administered and scored separately. • The participant may be given the option to attempt each task twice. Score the higher of the 2 attempts. • The participant may not use an assistive device or bracing for any item on the test, except for items 6 and 21, which allow the participant to use an assistive device only. • The items should be done in the order listed. • The examiner must adhere to the instructions provided. • The examiner must use the equipment as described below. • If a participant attempts an item, but is unable to perform the activity as per the scoring specifications, the examiner may choose to use the comment box to remark on the participant’s performance for future reference. Equipment: • 1 standard-height (18- to 19-in) chair without armrests (size appropriate for participant to be seated with hips, knees, and ankles at 90°) • 1 standard-sized manual wheelchair with removable armrests • 1 meter stick/yardstick • 1 large plastic cup (12–16 oz) • 1 6- to 8-in step stool • 1 2- ⫻ 4-in block of wood at least 15 in long • 1 inflatable beach ball (12-in diameter) • 1 stopwatch • 1 ADA ramp • At least 8 standard-height (6- to 8-in) steps • 3 cones or tape to mark walkway General Definitions: Safely: The participant performs the task without loss of balance or risk of falling Loss of balance: The participant shifts weight out of BOS and is unable to recover/return to within BOS. Physical assistance: The examiner places his/her hands on the participant during an activity in order to provide support, or in some instances, to lift the participant. Minimal physical assistance: The examiner places his/her hands on the participant during an activity in order to steady the participant. Moderate physical assistance: The examiner places his/her hands on the participant in order to prevent the participant from falling or to help the participant initiate a lift. Maximal physical assistance: The examiner places his/her hands on the participant in order to lift the participant through the majority of the range of motion. Supervision: The participant completes the task while the examiner purposefully stands within an arm’s reach of the participant, but does not actually touch the participant during the activity. (Continued) August 2012 (eAppendix Ardolino et al) Volume 92 Number 8 Physical Therapy f 1 Development and Psychometric Properties of the ABLE Scale eAppendix. Continued Independent: The participant safely and successfully completes the task and does not require any physical assistance, and the examiner can stand more than an arm’s reach away from the participant. Demographic and Self-Report Items: The purpose of these items is to provide the clinician and researcher with demographic information, as well as to help the examiner determine which subscales may be needed for testing. A. What is your date of birth? B. What is your sex? C. What was the date of your injury? D. What is the level of your injury? E. Is your injury complete or incomplete? • Complete • Incomplete • Unsure F. Do you have sensation below the level of your injury? • Yes • No G. Do you have voluntary movement below the level of your injury? • Yes • No H. Can you feel when you go to the bathroom? • Yes • No I. What percentage of your day do you use a wheelchair to get around your home and/or community? Please choose one: a. b. c. d. e. I use a wheelchair all of the time, in both my home and community I use a wheelchair sometimes at home, always in my community I use a wheelchair sometimes at home and sometimes in my community I never use a wheelchair at home and only occasionally in my community (for long distances) I never use a wheelchair at home or in my community J. Are you able to stand for at least 10 s, with a little assistance from a caregiver or therapist, without bracing and without an assistive device? • Yes • No • Unsure (Continued) 2 f Physical Therapy Volume 92 Number 8 August 2012 (eAppendix Ardolino et al) Development and Psychometric Properties of the ABLE Scale eAppendix. Continued K. Can you walk 20 ft, with an assistive device if needed, but without bracing and without help from a caregiver? • Yes • No • Unsure L. How many times have you fallen in the past month __________ and/or past 12 mo ___________ (or since your injury if less than 12 mo since injury)? A fall is an event that results in a person coming to rest inadvertently on the ground or other lower level (World Health Organization). If you have fallen on multiple occasions, please respond with the most frequent scenario surrounding your fall episodes. Please provide us with the following information: a. What were you doing when you fell? b. What time of day did you fall? c. Where were you when you fell? Sitting Balance Subscale: 1. Sitting with back unsupported but feet supported on the floor or on a foot stool Administration of item: The participant should be seated in a standard-height chair without armrests. The participant should be positioned on the chair so that his/her back is not touching the back of the chair and his/her lower extremities have 90° of flexion in the hips, knees, and ankles. If the participant cannot achieve a full neutral pelvis due to an orthopedic condition (eg, lumbar stenosis, fusion of vertebrae), have the participant sit as upright as possible and score appropriately. Instruction to participant: Please sit up as straight as you can, with a slight arch in your low back and with your arms folded or resting in your lap for 2 min. Scoring: 4. 3. 2. 1. 0. Able to sit with a neutral pelvis (neither anteriorly nor posteriorly tilted) independently, 2 min Able to sit 2 min with posterior pelvic tilt, independently Able to sit ⱖ30 s with posterior pelvic tilt, with supervision Only able to sit with posterior pelvic tilt, 10 to 29 s, with supervision Unable to sit without support ⱖ10 s Comments: 2. Seated forward reach Administration of item: The participant should be seated in a standard-height chair without armrests, leaning against the back of the chair, with his/her sacrum approximately 3 in from the back of the chair, so that his/her back is on an 80° incline. The participant should have 90° of flexion in the knees and ankles, with both feet resting on the floor. A meter stick will be held by another examiner at the height of the participant’s shoulder. The participant will flex one shoulder to 90°; the other upper extremity may rest in the participant’s lap, but cannot provide support. The ulnar styloid process should be used as a bony landmark for measurement. If the participant is unable to flex either upper extremity to 90°, then both upper extremities can rest in the participant’s lap but may not be used for support. In this case, the acromion can be used as the bony landmark for measurement. At no point should the participant touch or rest against the meter stick. (Continued) August 2012 (eAppendix Ardolino et al) Volume 92 Number 8 Physical Therapy f 3 Development and Psychometric Properties of the ABLE Scale eAppendix. Continued Instruction to participant: Please raise your preferred arm up to the height of your shoulder. Reach forward as far as possible, and then return to an upright position without using your hands for support. Do not twist your trunk as you reach. Scoring: Upper extremity used (please circle): 4. 3. 2. 1. 0. Right Left Able to reach forward ⬎15 in independently Able to reach forward 10 to 15 in independently Able to reach forward 5 to 10 in but needs supervision Reaches forward ⬍5 in and needs supervision Loses balance when trying, requires physical assistance Comments: 3. Seated lateral reach Administration of item: The participant should begin while seated in the same position as for the seated forward reach test, in a chair without armrests. Prior to reaching laterally, the participant should sit upright so that his/her trunk is no longer touching the back of the chair. When reaching to the right, the participant should abduct the right shoulder to 90°, and the ulnar styloid process should be used as the bony landmark for measurement. The left upper extremity may rest in the participant’s lap, but cannot be used for support. If the participant is unable to abduct the shoulder to 90°, then the acromion may be used as the bony landmark. Repeat with the left upper extremity. Score each upper extremity separately. The participant’s hips may come up on the opposite side of the reach. Instruction to participant: Please raise one arm up to the height of your shoulder. Reach out to the right as far as possible and return to the middle. Wait 5 s, then reach out to the left as far as possible and return to the middle. Do not twist your trunk while you reach, and keep your feet flat on the floor. Scoring: Please mark score in the box provided Right Left 4. 3. 2. 1. Able to reach >6 in independently Able to reach 2 to 6 in with supervision Able to reach ⬍2 in with supervision Able to turn head in direction of reach and uses contralateral limb in lap to assist during reach with supervision 0. Loses balance when trying, requires physical assistance Comments: 4. Pick up/touch an object from the floor from a seated position Administration of the item: The participant should begin while seated in the same position as for the seated forward reach test in a chair without arm rests. A 12- to 16-oz plastic cup should be placed on the floor between the participant’s feet. Any strategy may be used to pick up the cup, including the use of 2 hands on the cup. If the participant is unable to pick up the cup because of impaired hand function, he/she may just touch the cup. (Continued) 4 f Physical Therapy Volume 92 Number 8 August 2012 (eAppendix Ardolino et al) Development and Psychometric Properties of the ABLE Scale eAppendix. Continued Instruction to participant: Please pick up the cup placed in front of your feet any way you like. Try to use your arms for balance as little as possible. Scoring: 4. Able to pick up/touch cup independently without using arms to maintain balance. 3. Unable to pick up/touch the cup but comes within 1 to 2 in of the cup and keeps balance independently without using arms 2. Able to pick up/touch the cup independently but uses arms for support 1. Reaches halfway to cup and needs supervision while trying 0. Loses balance when trying, requires physical assistance to keep from falling Comments: 5. Scooting forward in a chair Administration of the item: The participant should be seated in a standard-height chair without arm rests with his/her feet in contact with the floor, sitting back as far as possible in the chair so that his/her back is against the backrest. In order to move forward, the participant may scoot the buttocks forward either unilaterally or bilaterally. The participant should not push against the back of the chair to slide the buttocks forward. The examiner may demonstrate segmentally moving each buttock forward. Instruction to participant: Please move your bottom forward to the edge of the chair, using your arms if necessary. Do not push against the back of the chair. Scoring: 4. 3. 2. 1. 0. Able to move one buttock forward at a time without assistance, without upper extremities Able to move both buttocks forward simultaneously, with or without upper extremities Able to lift buttocks off of chair, but unable to move forward, with or without upper extremities Requires minimal assistance to lift buttocks and move forward, with or without upper extremities Requires moderate to maximal assistance to lift buttocks and move forward, with or without upper extremities Comments: 6. Wheelchair-to-chair transfers Administration of item: The participant should be seated in a standard-height chair without armrests. Arrange a standard-height/standard-width manual wheelchair with a solid seat and no back cushions (use chair size to keep hip and knee flexion roughly at 90° perpendicular to each other for a stand or squat pivot/lateral transfer). The participant may use a sliding board if necessary, but cannot score higher than 2. The left armrests and footrests may be removed prior by the examiner prior to the transfer. Instruction to participant: Please transfer from the chair you are sitting in, to the wheelchair next to you, using your hands as little as possible. Then, when you are ready, please transfer back into the other chair. You may use a sliding board if you need one. (Continued) August 2012 (eAppendix Ardolino et al) Volume 92 Number 8 Physical Therapy f 5 Development and Psychometric Properties of the ABLE Scale eAppendix. Continued Scoring: 4. Able to independently perform a stand pivot/stand step transfer without use of hands 3. Able to perform a stand pivot/stand step transfer with use of hands as a guide, with no weight bearing through upper extremities, requires supervision 2. Able to perform a squat pivot/lateral transfer with use of upper-extremity weight bearing without a sliding board 1. Able to perform a squat pivot/lateral transfer with use of upper-extremity weight bearing with a sliding board 0. Needs physical assist with or without a sliding board Comments: 7. Support surface displacement while seated in a wheelchair Administration of the item: The participant should be seated in a standard-height/standard-width manual wheelchair, as described in item 6. The participant holds a 12-in-diameter inflatable beach ball with both hands and/or wrists, while his/her feet are supported on wheelchair footrests. The brake on the left wheel should be locked. Facing the participant, the examiner contacts the top of the propulsion rim on the right side of the wheelchair with his/her left hand, while guarding the individual with his/her right arm. The chair is then turned one eighth of a circle (or 45°) forward in 1 s by pulling the hand down toward the floor. After a balance response is made or once the participant is returned to an upright sitting posture, the examiner returns the propulsion rim rapidly back (45° in 1 s) to the starting position. The trunk is unsupported during this test, and the participant is not allowed to bear weight through the hands on the lap during the test. Instruction to participant: Hold the ball with both hands and raise it as high as you can. Keep your trunk still while I turn your chair. Try not to lean against the back of the chair. Scoring: 4. Able to raise ball to 90° shoulder flexion with elbows extended and maintain or recover balance during turns in both directions 3. Able to raise ball 3 in off lap and maintain or recover balance while turning one direction only 2. Keeps hands on ball in lap but does not bear weight through the upper extremities and trunk remains steady during turns in both directions 1. Keeps hands on ball in lap and upper-extremity weight bearing is used to recover trunk balance during turns in both directions 0. Unable to sit unsupported for 30 s, unable to attempt or tolerate perturbations Comments: Standing Subscale: All individuals who are unable to stand would score a zero on items 9 through 28. 8. Arising from a chair Administration of item: The participant should begin while seated in a standard-height chair without armrests, with back of the knees 6 in from the edge of the chair. Instruction to participant: Please stand up without using your arms for support. (Continued) 6 f Physical Therapy Volume 92 Number 8 August 2012 (eAppendix Ardolino et al) Development and Psychometric Properties of the ABLE Scale eAppendix. Continued Scoring: 4. Arises from chair to full upright standing position without use of arms on first attempt 3. Arises from chair to full upright standing position with use of arms for momentum, requires >1 attempt 2. Arises from chair with use of arms for weight bearing, requires ⬎1 attempt 1. Able to arise from chair with minimal assistance 0. Unable or needs moderate to maximal assist to stand Comments: 9. Static standing balance Administration of item: Once in a standing position on a level surface, the participant is instructed to stand with eyes open, without holding on to any devices or people. Instruction to participant: Please stand for as long as you can without holding on to anything. Scoring: 4. 3. 2. 1. 0. Able to stand ⱖ1 min independently Able to stand ⱖ30 s on first attempt with supervision Able to stand ⱖ15 s on first or second attempt with supervision Able to stand ⱖ10 s on first or second attempt with minimal assistance Unable to stand, or stands ⬍10 s with minimal or greater assistance Comments: 10. Stand to sit Administration of item: The participant should transition from a full standing position to a seated position in a standard-height chair without armrests. Instruction to participant: Please sit down, trying not to use your hands for support. Scoring: 4. 3. 2. 1. 0. Sits independently, controls descent without use of hands Sits independently, with use of hands to control descent Requires supervision and/or uses back of legs against chair to control descent Requires minimal assistance to sit safely Needs moderate or maximal assistance to sit Comments: (Continued) August 2012 (eAppendix Ardolino et al) Volume 92 Number 8 Physical Therapy f 7 Development and Psychometric Properties of the ABLE Scale eAppendix. Continued 11. Static standing balance with eyes closed Administration of item: The participant should stand on a level surface, with feet hip width apart, without leaning or holding on to any surface and with eyes closed. Instruction to participant: Please close your eyes and stand still for 30 s. Scoring: 4. Able to stand >30 s independently with normal sway (uses ankle strategies only) 3. Able to stand ⱖ30 s safely with minimal excess sway (uses ankle and hip strategies), requires supervision 2. Able to stand ⱖ10 s with moderate excess sway (uses upper extremities to counteract balance), requires supervision 1. Tolerates eyes closed for ⬍10 s but remains standing with supervision 0. Unable to stand or needs help to keep from falling Comments: 12. Static standing balance with feet together Administration of item: The participant should stand on a level surface without leaning or holding on to any surface and with feet touching so that the medial malleoli of his/her ankles are in contact with each other. If the participant is unable to place the feet completely together due to a biomechanical constraint (eg, extreme genu valgum or obesity), he/she may stand with the medial aspect of the knees touching. The participant begins with eyes open. If the participant can maintain independent standing with feet together and eyes open for 30 s, ask him/her to stand in this position with eyes closed for 10 s. Instruction to participant: Please move your feet so they are touching each other and stand without holding on to anything. Begin with your eyes open. If the participant stands with eyes open for 30 s, then say “Please close your eyes and remain standing with your feet together for 10 s.” Scoring: 4. 3. 4. 1. 0. Moves feet together and stands independently ⱖ10 s with eyes closed Moves feet together and stands independently >30 s Requires supervision to move feet together and remain standing for ⱖ30 s Needs minimal assistance to assume the position but can stand for 10 s, with supervision Unable to stand or requires moderate or maximal assistance to assume or hold the position Comments: 13. External perturbations in standing Administration of item: The examiner gently nudges the participant from the front with one hand on the sternum 3 times while standing on a level surface with feet a shoulder width apart, ensuring that the participant is displaced no more than 3 in. The examiner should apply each nudge 5 s apart. If the participant uses an ankle or hip strategy to independently maintain balance during displacement in this position, have him/her stand with feet together, as in item 13, and repeat the perturbations. (Continued) 8 f Physical Therapy Volume 92 Number 8 August 2012 (eAppendix Ardolino et al) Development and Psychometric Properties of the ABLE Scale eAppendix. Continued Instruction to participant: Stand with your feet shoulder width apart (or feet together, as indicated). I am going to challenge your balance 3 times. Try to keep your balance while I nudge you. Scoring: 4. 3. 2. 1. Utilizes ankle and hip strategies to maintain balance, with feet together Utilizes hip and ankle strategies to maintain balance, with feet a shoulder width apart Steps backward and uses legs against chair to maintain balance, with feet a shoulder width apart Maintains balance after first push but falls into chair after second or third push, with feet a shoulder width apart 0. Unable to stand or maintain balance/falls into chair after first push, with feet shoulder width apart Comments: 14. Standing forward reach Administration of item: The participant should raise his/her preferred arm to 90°; however, he/she should be cued to avoid trunk rotation. The ulnar styloid process is used by the primary examiner as the bony landmark for measurement. If the participant is unable to raise either upper extremity to 90°, the acromion can be used as the bony landmark for measurement. A ruler should be held by a second examiner at the height of the participant’s shoulders on his/her preferred side. The participant must keep his/her feet still, with heels maintaining contact with the ground while returning to an upright/erect posture, and may not use an assistive device. Instruction to participant: Raise your preferred arm to the height of your shoulder. Reach forward as far as you can without falling and without twisting your trunk. Then return to full upright standing. Do not move your feet. Scoring: 4. 3. 2. 1. 0. Able to reach forward ⱖ12 in independently Able to reach forward ⱖ6 in independently Able to reach forward >2 in independently Able to reach forward ⱖ2 in with supervision Reaches ⬍2 in or unable to attempt or requires physical assistance to prevent loss of balance Comments: 15. Pick up/touch object from the floor from a standing position Administration of the item: A 12- to 16-oz plastic cup should be placed 6 in in front of the participant’s feet. The participant must begin from a standing position and must return to a full standing position. Any strategy may be utilized to pick up the cup. If the participant is unable to pick up the cup because of impaired hand function, he/she may just touch the cup. Instruction to participant: Pick up the cup that is in front of your feet any way you like and stand up with it. Try not to use your hands for support. (Continued) August 2012 (eAppendix Ardolino et al) Volume 92 Number 8 Physical Therapy f 9 Development and Psychometric Properties of the ABLE Scale eAppendix. Continued Scoring: 4. Able to pick up/touch the cup independently, without using arms for balance 3. Able to pick up/touch the cup, but uses hands for balance and/or requires supervision 2. Able to bend down to pick up/touch the cup, but requires minimal assistance to return to full standing position 1. Reaches halfway to cup and needs supervision while trying 0. Unable to try or loses balance when trying Comments: 16. Standing trunk rotation Administration of item: The participant should stand without leaning or holding on to any surface. A second examiner should stand centered 6 in behind the participant’s shoulder, opposite to the side of rotation, to encourage a better weight shift. The participant is tested in both directions, but scored only once. Note any cervical or thoracolumbar fusion under the comment section. Instruction to participant: Turn and look at the other examiner over your left shoulder, while keeping your feet planted. Repeat by looking over your right shoulder. Scoring: 4. 3. 2. 1. 0. Independently rotates shoulders and cervical spine each to 90°, in both directions Independently rotates shoulders and cervical spine each to 90°, in one direction only Independently rotates shoulders or cervical spine separately to <90°, in both directions Requires supervision during rotation Requires physical assistance during rotation Comments: 17. Turn 180° Administration of item: The participant may not hold on to anything and must complete a half-circle turn in each direction. The time stops once the participant’s feet face exactly opposite to the start position. The participant is tested in both directions, but scored only once. The participant can start turning in whatever direction he/she chooses. Instruction to participant: While standing, turn around in a half circle, pause for 5 s, then turn a half circle back in the other direction. Scoring: 4. 3. 2. 1. 0. Able to turn 180° independently in ⱕ2 s, in each direction Able to turn 180° independently in ⱕ4 s, in each direction Able to turn 180° independently in each direction, in >4 s Needs close supervision or verbal cuing during turning in both directions Unable to attempt or needs assistance while turning Comments: (Continued) 10 f Physical Therapy Volume 92 Number 8 August 2012 (eAppendix Ardolino et al) Development and Psychometric Properties of the ABLE Scale eAppendix. Continued 18. Alternating step test Administration of item: Place a 6- to 8-in step/stool 4 to 6 in in front of the participant’s feet. The participant must alternate placing his/her entire foot on the step while maintaining standing. The participant may not hold on to anything. The examiner counts how many times the participant can place his/her foot on the step in 15 s. Instruction to participant: Without holding on to anything, alternate tapping each foot on the step/stool as many times as you can in 15 s, with the goal of getting 15 foot taps. Do not step up on to the stool. Scoring: 4. 3. 2. 1. 0. Able to complete 15 foot taps in 15 s independently Able to complete 8 foot taps in 15 s independently Able to complete ⱖ4 foot taps in 15 s, but requires supervision Able to complete ⱖ2 foot taps in 15 s, but requires minimal assistance Unable to attempt, needs moderate or maximal assistance to keep from falling, or steps with one limb only Comments: 19. Balance in tandem/stride stance Administration of item: The examiner should demonstrate the tandem stance position and alternate stance foot position (step forward with feet shoulder width apart) for the participant. If the participant attempts the tandem stance and cannot hold the position, he/she may attempt the alternate position. The participant chooses which limb to place forward and is scored only on this one position. The participant is allowed at most 2 attempts to achieve the highest scoring foot position possible, starting each attempt from normal stance position. Instruction to participant: Please stand with the heel of one foot directly in front of the toes of the other foot. If you cannot keep your balance in this position, you can take a step forward with one foot, keeping your feet about a hip width apart. Scoring: Forward limb (please circle): Right Left 4. Able to independently achieve and maintain tandem stance >30 s 3. Requires minimal assistance to achieve tandem stance, but can maintain this position for ⱖ15 seconds with supervision 2. Able to step forward and maintain stride stance, feet shoulder width apart, ⱖ30 s independently 1. Requires minimal assistance to step but can maintain this position ⱖ15 s with supervision 0. Unable to attempt or requires moderate or maximal assistance to complete Comments: 20. Single-leg stance Administration of item: The participant must be tested on each leg and will be scored separately for each leg. The participant may not lean or hold on to any surface during testing. (Continued) August 2012 (eAppendix Ardolino et al) Volume 92 Number 8 Physical Therapy f 11 Development and Psychometric Properties of the ABLE Scale eAppendix. Continued Instruction to participant: Stand on your right leg as long as you can without holding on to anything. Please lift your left leg at least 2 in off of the ground. Repeat standing on your left leg, lifting your right leg at least 2 in off of the ground. Scoring: Please mark score in the box provided. Right Left 4. Able to lift leg at least 2 in independently and hold ⱖ10 s 3. Able to lift leg at least 2 in independently and hold 5 s, no contact of weight-bearing limb with non–weight-bearing limb 2. Able to lift leg at least 2 in and hold 5 s, with contact of weight-bearing limb with non–weight-bearing limb, requires supervision 1. Attempts task but is unable to lift ⱖ2 in and/or holds ⬍5 s 0. Unable to try or needs physical assistance to prevent fall Comments: Walking Subscale: For items 22 to 26, the examination should take place on the same 20-ft level walkway surface consisting of tile or low-pile carpeting. The walkway should be cleared of all obstacles. The participant is not allowed physical assistance or use of bracing during these tasks, but may use an assistive device on item 22 only. The start and finish of the walkway should be clearly marked with tape or cones. 21. Walking over level surface Administration of item: The participant should walk 20 ft over a level surface. The participant may NOT receive physical assistance from the examiner. The participant may use an assistive device as necessary, but cannot score higher than a 2. No bracing is allowed during testing. Instruction to participant: Walk at your normal speed from here to the end of the walkway. Scoring: 4. Able to walk 20 ft without an assistive device, independently; no loss of balance and maintains constant speed 3. Able to walk 20 ft without an assistive device while maintaining constant speed, with supervision; regains balance easily using abducted arms 2. Able to walk 20 ft without an assistive device, with supervision, but does not maintain constant speed 1. Able to walk 20 ft with an assistive device and supervision 0. Unable to walk 20 ft with an assistive device without physical assistance Comments: 22. Walking with horizontal head turns Administration of item: The participant should ambulate on the same walkway as in the previous item. The participant is asked to turn his/her head 90° (or to the point of cervical range restriction), maintaining each head position for 3 steps. The examiner is encouraged to demonstrate this item. The participant may not use an assistive device or physical assistance from the examiner. (Continued) 12 f Physical Therapy Volume 92 Number 8 August 2012 (eAppendix Ardolino et al) Development and Psychometric Properties of the ABLE Scale eAppendix. Continued Instruction to participant: Begin walking at your normal pace. When I tell you “look right,” keep walking straight, but turn your head to the right. Keep looking to the right until I tell you “look straight,” then keep walking straight, but return your head to the center. When I tell you “look left,” keep walking straight, but turn your head to the left. Keep your head to the left until I tell you “look straight,“ then keep walking straight, but return your head to the center. Scoring: 4. Able to maintain constant gait speed while turning head in both directions, independently 3. Hesitates slightly while turning head, but does not lose balance or deviate inside a 15-in-wide path 2. Hesitates considerably and/or laterally deviates within a 15-in-wide path with head turns, requires supervision 1. Laterally deviates outside a 15-in-wide path while turning head, requires supervision 0. Unable to try/requires physical assistance to prevent a fall Comments: 23. Walking with change in direction Administration of item: The participant should ambulate on the same walkway as in the previous item. The participant may not use an assistive device or physical assistance from the examiner. Place a cone halfway down the walkway. The examiner may demonstrate a smooth turn around the cone. The participant may turn around the cone in either direction. Document the direction of turn in the comment box for reference for future testing. Instruction to participant: Please walk to the cone, turn around it without hesitation, and return to the starting position. Scoring: 4. 3. 2. 1. 0. Able to turn direction without hesitation and without loss of balance, independently Able to turn direction with minimal hesitation and without loss of balance, independently Approaches cone, stops, slowly turns around cone, without loss of balance, requires supervision Approaches cone, stops, loses balance when turning, but does not need physical assistance to prevent fall Unable to try/requires physical assistance to prevent fall Comments: 24. Stepping over object while walking Administration of item: The participant should ambulate on the same walkway as in the previous item. The participant may not use an assistive device or physical assistance from the examiner. Place a 2- ⫻ 4-in piece of wood halfway down the walkway, perpendicular to the walkway. The examiner may demonstrate stepping over the 2- ⫻ 4-in piece of wood. Instruction to participant: Begin walking at your normal speed. When you come to the piece of wood, please step over it, not around it or on it. (Continued) August 2012 (eAppendix Ardolino et al) Volume 92 Number 8 Physical Therapy f 13 Development and Psychometric Properties of the ABLE Scale eAppendix. Continued Scoring: 4. 3. 2. 1. 0. Able to maintain constant speed while stepping over 2- ⫻ 4-in piece of wood. Stops, steps over 2- ⴛ 4-in piece of wood, does not lose balance Able to clear 2- ⫻ 4-in piece of wood, loses balance but does not need physical assistance to recover Stops, unable to clear 2- ⫻ 4-in piece of wood, but does not lose balance Unable to try/requires physical assistance to prevent falling Comments: 25. Walking while carrying an object with 2 hands Administration of item: The participant should ambulate the full length of the walkway used for the previous items. The participant may not use an assistive device or physical assistance from the examiner. The object should be a 12-in inflatable beach ball, or an object of similar size and weight. The participant must carry the ball with both hands (clenched fists are acceptable for participants with impaired hand function). Instruction to participant: Walk down the walkway at your normal pace while holding this ball with both of your hands. Scoring: 4. 3. 2. 1. Maintains consistent speed while holding object, ambulates independently, Cadence slows slightly while holding object, but ambulates independently Laterally deviates within a 15-in-wide path while holding object, requires supervision Laterally deviates outside a 15-in-wide path while holding object or drops object ⬎2 times during one pass, requires supervision 0. Unable to try/needs physical assistance or an assistive device to a prevent fall Comments: 26. Walking up/down stairs Administration of item: At least 8 standard-height (6- to 8-in) steps should be used. The participant may not use an assistive device to complete the task. If more than 10 steps are used, note the total number of steps that the participant was able to negotiate. Instruction to participant: Walk up the stairs with your typical pattern using the rails if you need to for safety. At the top of the stairs, turn around and walk down. Scoring: 4. Able to walk up and down steps without rail, with reciprocal pattern, independently 3. Able to walk up and/or down steps with rail with reciprocal pattern, with supervision, or able to walk up/down stairs without rail, with step-to pattern, independently 2. Able to walk up and down steps with or without rail, with step-to pattern, with supervision 1. Able to walk up and down steps with rail, with step-to pattern, with minimal physical assistance in each direction 0. Unable to try/requires moderate or maximal physical assistance Total no. of steps: ________ Comments: (Continued) 14 f Physical Therapy Volume 92 Number 8 August 2012 (eAppendix Ardolino et al) Development and Psychometric Properties of the ABLE Scale eAppendix. Continued 27. Walking up/down an incline Administration of item: An ADA graded ramp (1 ft of length for every 1 in of rise), such as an entrance ramp into a building, should be used. The participant is not allowed to use an assistive device. Instruction to participant: Please walk up and down the ramp without holding on. Scoring: 4. 3. 2. 1. Able to walk both up and down ramp, independently, at or close to normal walking speed Able to walk both up and down ramp, independently, but one direction is at a slower speed Able to walk both up and down ramp slowly, with minimal path deviations, independently Able to walk both up and down ramp slowly, with large path deviations (outside 15-in-wide path) and requires supervision 0. Unable to try/requires an assistive device and/or physical assistance to walk up/down ramp Comments: 28. Reactive balance testing during walking Administration of the item: The participant should walk the entire 20 ft of the walkway. The examiner displaces the participant at the level of the pelvis as he/she walks along the 20-ft walkway. On the start of the third stride, the participant is displaced laterally 3 in in 1 s to the contralateral side. Instruction to the participant: We are going to challenge your balance while you walk; try to keep walking straight ahead at your normal pace. Scoring: 4. 3. 2. 1. 0. Makes appropriate postural adjustments, safely maintains gait speed without loss of balance Produces a lateral stepping strategy to maintain balance, but continues walking Stops with or without stepping strategy before continuing down the walkway Participant requires minimum/moderate assistance after perturbation to prevent a fall Unable to safely attempt/unable to ambulate Comments: a Pivot points were defined for each item’s rating scale and are boldfaced. 1 in⫽2.54 cm, 1 ft⫽0.3048 m, 1 oz⫽28 g. BOS⫽base of support, ADA⫽Americans With Disabilities Act. The Activity-based Balance Level Evaluation (ABLE scale) may not be used or reproduced without written permission of the authors. August 2012 (eAppendix Ardolino et al) Volume 92 Number 8 Physical Therapy f 15 Case Report Cervical Disk Pathology in Patients With Multiple Sclerosis: Two Case Reports Ann E. Mullen, Mary Ann Wilmarth, Sue Lowe Background and Purpose. A patient with multiple sclerosis (MS) may be seen by a physical therapist for evaluation before the MS diagnosis is definitively made, after a relapse, or during a progression. The diagnosis of MS should be part of the differential diagnosis if the symptoms of a patient with neurological issues fit the pattern of a progressive disease. Multiple sclerosis can affect any part of the central nervous system. Cervical pathology can be confused with relapsing symptoms of MS. The purpose of this case report is to demonstrate how easily cervical pathology can be overlooked in a patient with MS. Case Description. Two case reports of patients with relapsing MS are presented. Both patients were referred for physical therapy after not responding to standard treatment with intravenous methylprednisolone. One patient reported multiple falls and complained of increasing cervical pain and spasm, fatigue, bouts of diplopia, and difficulty ambulating. The other patient complained of headaches, visual disturbances, and cervical pain with radicular symptoms. Contrast magnetic resonance imaging (MRI) did not reveal new MS lesions or the extension of old MS lesions. The cervical herniations in the first patient, not previously documented, were old. The bulging disks in the second patient, seen in a previous study, were unchanged. The MRI findings did not support the diagnosis of acute inflammatory MS or acute cervical pathology. Outcomes. Both patients responded to physical therapy intervention once the cervical symptoms were directly addressed. As the cervical pain and spasm decreased, the relapsing MS symptoms of dysmetria, balance disturbance, and ataxic gait began to diminish. In both patients, eye function was slow to recover, with persistent impairment. Both patients returned to their premorbid activity and socialization level. Discussion. Cervical disk disease should be considered in the differential diagnosis when a patient with MS has a history of trauma and displays abnormal postures, spastic weakness, and changes in pain complaints. In these 2 cases, treating the cervical pathology in addition to the MS symptoms provided the most effective approach for functional improvement. A.E. Mullen, PT, DPT, College of Professional Studies, Bouvé College of Health Sciences, Northeastern University, Boston, Massachusetts. Mailing address: 845 Karen St, Palm Harbor, FL 34684 (USA). Address all correspondence to Dr Mullen at: annemullen@ verizon.net. M.A. Wilmarth, PT, DPT, MS, OCS, MTC, CertMDT, Adjunct Faculty, College of Professional Studies, Bouvé College of Health Sciences, Northeastern University, and Harvard University Health Services, Cambridge, Massachusetts. Dr Wilmarth also is owner of Back2back Physical Therapy, Andover, Massachusetts. S. Lowe, PT, DPT, GCS, CEEAA, Transitional DPT Program, College of Professional Studies, Bouvé College of Health Sciences, Northeastern University. [Mullen AE, Wilmarth MA, Lowe S. Cervical disk pathology in patients with multiple sclerosis: two case reports. Phys Ther. 2012;92:1055– 1064.] © 2012 American Physical Therapy Association Published Ahead of Print: April 19, 2012 Accepted: April 11, 2012 Submitted: January 11, 2011 Post a Rapid Response to this article at: ptjournal.apta.org August 2012 Volume 92 Number 8 Physical Therapy f 1055 Cervical Disk Pathology in Multiple Sclerosis T he patient with multiple sclerosis (MS) is frequently encountered in physical therapist practice. There are 25,000 newly diagnosed cases of MS in the United States.1 There is strong evidence that MS is an autoimmune disease, although there is controversy as to whether the invasive elements that trigger the immune response are viral or bacterial.2 This inflammatory response to an invasive agent is responsible for disrupting the bloodbrain barrier and allowing the destruction of primarily white matter and, to a lesser degree, gray matter. Susceptibility to MS is considered multifactorial. Other factors that may disrupt the blood-brain barrier include trauma, environmental pollutants,3 and vaccinations. Genetic disposition4 can influence a person’s vulnerability to MS. Lifestyle factors such as inactivity, stress,5 and diet6 can influence susceptibility to MS relapse and the course of the disease. Multiple sclerosis is a poorly understood disease process that dismantles the myelin and myelinproducing cells, leaving lesions or plaques in the central nervous system (CNS). Gray matter destruction is associated with physical disability, fatigue, and cognitive impairment.7 Prinster et al8 were able to correlate regional loss of gray and white matter with indexes of clinical and radiological severity, Expanded Disability Status Scale scores, and lesion load in people with relapsing-remitting MS. The McDonald diagnostic criteria are now being used to diagnose MS, but there is still a degree of ambiguity and confusion as to the definition of terms.9 The diagnostic criteria define an exacerbation, time between attacks, requirement of magnetic resonance imaging (MRI) findings, cerebral spinal fluid and evoked potential abnormalities, cri- 1056 f Physical Therapy Volume 92 teria of follow-up MRIs, and progression characteristics. Although late onset of symptoms and early presentation of optic neuritis are favorable predictors of outcome, multiplicity of symptoms and frequency of relapse suggest a poor outcome. Prediction of relapse using MRI loading, or factoring the number and location of lesions, is becoming more promising to diagnose exacerbations.10 Signs and symptoms of MS depend on the area of CNS involvement and can result in a plethora of symptoms. Patients with MS have sensorimotor and balance impairments, ataxia, tremor, seizures, cranial motor impairments, cognitive deficits, and behavioral disorders. Cervical myelopathic and radicular symptoms are seen in active MS involvement of the spinal cord. Magnetic resonance imaging with gadolinium contrast has been the conventional method to confirm new active lesions at the spinal cord or new spinal pathology, or as a process of elimination to differentiate them from mechanical derangement of old cervical pathology. The physical therapist may encounter a patient with MS early in the disease process before a definitive diagnosis is made or after a relapse or progression. Although it is important for the physical therapist to be aware of MS as a differential diagnosis in the patient with neurological disease,11 it also is important that there be a high level of suspicion for comorbid cervical disease or pathology that may confuse the clinical picture or response to treatment.12 It has been suggested that patients with MS having spastic weakness or postural deformities are more susceptible to spinal abnormalities and infections because of the abnormal compressive forces on the vertebra.2 Number 8 Both diseases are common, their coexistence is not unusual,13 and multilevel disease can coexist in MS and confuse the diagnosis.14 The most common symptoms found during a retrospective study of 14 people with definite MS who were scheduled for cervical decompression surgery were progressive myelopathy and radiculopathy.15 Important clinical considerations for cervical disease include the following: the age of the patient, a history of falls or trauma, repetitive activities, deconditioning, and comorbid diseases such as osteoporosis and diabetes that place the patient at risk.16 Correctly identifying spinal abnormalities will determine effective strategies, physical therapy interventions, goals, and optimal outcome for rehabilitation. Discussing the clinical radiological paradox, Dousset et al17 noted that acute MS lesions most often can be detected on T2-weighted images based on the water content. Gadolinium crosses an open blood-brain barrier and reveals acute inflammatory lesions. Gadolinium studies are not foolproof in that chronic lesions can show up as acute lesions or new lesions may be completely missed; thus, adjunct MRI studies are being developed.17 Most centers do not perform these expensive batteries of tests. Most of the MS trauma-related research has focused on injury as a cause of MS and not on investigating the effect of trauma on definitive cases of MS.18 Patient History and Review of Systems This case report describes 2 patients who were referred for home health care with a diagnosis of relapsing MS. Both patients were referred for physical therapy by nursing staff after completing the standard treatment of IV methylprednisolone with only marginal resolution of their August 2012 Cervical Disk Pathology in Multiple Sclerosis Table 1. Medications and Dosages for Patients 1 and 2a Patient 1 Medication Dosage Medication Dosage Advair Diskus (GlaxoSmithKline, Research Triangle Park, NC) 250 mcg Crestor (AstraZeneca LP, Wilmington, DE) 10 mg po qd INH bid D3 6,000 mg po qd Advil (Pfizer Inc, Kings Mountain, NC) 200 mg po qod Lyrica (Pfizer Inc) 100 mg po qd Betaseron (Bayer HealthCare Pharmaceuticals, Berlin, Germany) 0.3 mg subcutaneously qod Nexium (AstraZeneca LP) 40 mg po qd Carbamazepine 200 mg po bid Nortriptyline hydrochloride 10 mg po qd Citalopram 20 mg po qd Singulair (Merck & Co Inc, West Point, PA) 10 mg po qd Symbicort (AstraZeneca LP) 160 mcg INH bid Tizanidine hydrochloride 2 mg po qd Patient 2 Medication a Dosage Medication Dosage Advair Diskus 250 mcg INH bid Crestor 10 mg po qd Advil 200 mg po qod D3 6,000 mg po qd Betaseron 0.3 mg subcutaneously qod Lyrica 100 mg po qd Carbamazepine 200 mg po bid Nexium 40 mg po qd Citalopram 20 mg po qd Nortriptyline hydrochloride 10 mg po qd Singulair 10 mg po qd Symbicort 160 mcg INH bid Tizanidine hydrochloride 2 mg po qd INH⫽isoniazid, po⫽orally, qd⫽every day, qod⫽every other day, bid⫽twice a day, D3⫽cholecalciferol. symptoms. The patients demonstrated exacerbation of previous MS symptoms, particularly complaints of severe cervical pain, spasm, weakness of the upper extremities, and gait instability. No new MS lesions or extension of old lesions were noted in either case when gadolinium contrast MRI was done; however, old cervical pathology was noted at multiple levels. The patient in the first case described her cervical pain as “different pain and spasms than I had before.” The slow resolution of cervical symptoms after IV steroids prompted the physician to diagnose the patient with secondary progressive MS. An MRI was done to confirm suspected new lesions. The MRI did not support the diagnosis; however, it did confirm old cervical pathology that was previously unsuspected. August 2012 The patient in the second case complained of an exacerbation of previous MS symptoms, as well as new radicular pain in the left upper extremity. This patient previously had an abnormal MRI with known cervical bulging at 4 levels. The more recent MRI with contrast, however, showed no new MS lesions or change in cervical pathology. Patient 1 The patient was a 41-year-old woman who was first diagnosed with fibromyalgia, but 10 years later was confirmed by McDonald criteria to have MS.9 The patient was referred for home health care physical therapy with a diagnosis of relapsing MS. The patient was referred for physical therapy after IV steroid infusion, which slightly resolved her symptoms. The patient’s past history was significant for seizure disorder, migraine headaches, visual loss, depressive disorder, hyperlipidemia, asthma, gastroparesis, a right ankle fracture 1 year previously requiring a bone graft, and multiple falls. Her past cortical and spinal MRIs had demonstrated MS plaques but no bony changes. During the physical therapist’s evaluation, the patient complained of headaches, cervical pain and spasm that were “different,” and diplopia. There was dysmetria, weakness and tremor of both arms, and increased impairment of balance and ataxia. The patient also complained of an increase in Uhthoff’s phenomenon, or worsening of her MS symptoms with elevation of body temperature after exercise. Patient 1’s medications and dosages are listed in Table 1. Volume 92 Number 8 Physical Therapy f 1057 Cervical Disk Pathology in Multiple Sclerosis Patient 2 The patient was a 45-year-old woman who also was referred for home health care physical therapy for relapsing MS 1 month after returning from a vacation trip to Panama. She also received IV steroid medication, with some resolution of her symptoms. She was first diagnosed with MS 5 years ago using the McDonald criteria. She initially was seen in the emergency department with symptoms of feeling detached and smelling foul, unusual odors. She was admitted to a psychiatric unit until experiencing optic neuritis, which prompted a thorough neurological examination and MRI. She was diagnosed with MS and a urinary tract infection. The patient’s past history was significant for migraine, vertigo, depressive disorder, and urinary tract infections. An MRI done 5 years ago showed demyelinating disease in 2 cortical areas and fluid surrounding the optic nerve. The cervical MRI showed a possible MS lesion in the cervical cord at the C5 level and in the T1–2 interspace. There also was mild posterior degenerative annular bulging at 4 cervical levels. She had recently taken a vacation and rode a cable suspended over the rain forest holding on to a pulley slide. She was taking Provigil (Cephalon Inc, Frazer, Pennsylvania) medication to boost endurance and stated “I may have pushed too hard.” She experienced worsening of MS symptoms, including cervical pain, within 24 hours after returning home. She also had swelling of the right jaw, which a dentist diagnosed as failure of a previous bone graft with infection. She complained of patchy visual loss, headaches, severe cervical pain with radicular symptoms down the C5– 6 distribution, sensory loss, increased tremor and dysmetria of both of her 1058 f Physical Therapy Volume 92 upper extremities, twitching of her thumb and index fingers bilaterally, and left arm weakness. The most recent MRI showed confirmation of the old cervical spine plaque, with no active cortical lesions or changes in the bulging disks. Patient 2’s medications and dosages are listed in Table 1. Examination The patients initially received a physical therapist evaluation that included assessment of the cardiovascular and pulmonary system, including vital signs; auscultation of the lungs; girth measurements; tests of gait, locomotion, and balance, including the Timed “Up & Go” Test (TUG),19 the Tinetti PerformanceOriented Mobility Assessment (POMA),20 and gait analysis; assessment of activities of daily living (ADL) and range of motion (ROM); manual muscle testing; reflex testing; the Modified Fatigue Impact Scale21; and special tests such as the Spurling test, Lhermitte sign, Babinski test, Hoffman test, distraction test, compression test,22 cranial nerve testing, smooth eye pursuit, finger-to-nose testing, and clonus testing. The physical therapist outlined short-term and long-term goals, including interventions. A prognosis to reach the stated goals also was included. The format of the home care progress notes included goals and interventions that were evaluated on each note. Significant findings are listed in Tables 2 and 3, and measurements are shown in Table 4. Patient 1 The patient complained of severe cervical and bilateral arm pain that was “different than before” and rated the pain as 10/10, where a rating of 10 represents “worst pain imaginable.” Cervical ROM was limited in all planes by 50%. Her sensation in Number 8 the hands was diminished and did not appear to follow a dermatome. Her reflexes were ⫹1 throughout both upper extremities. The lower extremities revealed clonus in both ankles, to a greater degree on the right. Tremor in the upper extremities was greater on the right and was more noticeable with fatigue. Strength of her right side was ⫹3/5 compared with strength of 4/5 on the left side. Dysmetria appeared greater in her right upper extremity. Her dynamic sitting balance was 4/5, and her dynamic standing balance was ⫹3/5. She required a roller walker to ambulate. She scored 10/28 on the POMA, indicating that she was at high risk for falls.23 Her TUG score was 28. Her gait was ataxic and staggering. She required assistance for dressing, bathing, and all household activities. Patient 2 The patient complained of cervical and radicular pain of 10/10 down the left upper extremity. During examination, radicular symptoms were immediately relieved after performing the distraction test. This is one of the positive tests for radiculopathy and indicated that manual traction could be effective.20 There was numbness in her C5– 6 distribution. Her cervical ROM was limited in all planes by 40%, except cervical rotation to the left, which was 50%. Muscle strength of her left arm was grossly ⫹3/5. There were decreased reflexes of the left upper extremity. Reflexes in her right upper extremities and both lower extremities were within normal limits. Her dynamic sitting balance was 5/5, and her dynamic standing balance was 4/5. She refused to use an assistive device, although her POMA score was 18/28 and her TUG score was 18. Clinical Impression According to the Guide to Physical Therapist Practice,24 the treatment August 2012 Cervical Disk Pathology in Multiple Sclerosis Table 2. Differential Diagnosis: Symptoms in Multiple Sclerosis That Are Also Found in Disk Pathologya Radiculopathy Symptoms Myelopathy Patient 1 Patient 2 Patient 1 Patient 2 Decreased cervical ROM x L cervical rotation 40° x x Postural deformity x Pain Headaches x x x LUE C5–6 Cervical Cervical x x x LUE R side ⬎ L side Reflex changes Decreased LUE Decreased BUE, increased BLE Sensory changes Decreased LUE All 4 extremities Muscle weakness Dysmetria x x Dizziness x x x x Positive Lhermitte sign Positive Spurling test x Positive distraction test x x Fasciculations x x Babinski sign R x, L x Bladder/bowel incontinence x Clonus x Unsteady gait x x Romberg sign x x a ROM⫽range of motion, LUE⫽left upper extremity, BUE⫽bilateral upper extremities, BLE⫽bilateral lower extremities, R⫽right, L⫽left. “x” indicates presence of symptom. of MS is within the scope of a physical therapist’s practice. Multiple sclerosis is classified into pattern 5E: Impaired Motor Function and Sensory Integrity Associated With Progressive Disorders of the Central Nervous System. Cervical disk disease is classified into pattern 4F: Impaired Joint Mobility, Motor Function, Muscle Performance, Range of Motion, and Reflex Integrity Associated With Spinal Disorders.24 This clinical pattern was obvious in patient 2, but not confirmed in patient 1 until after the contrast MRI. Intervention Cervical pathology was addressed using cryotherapy for pain and spasm for patient 1. Soft tissue mobilization, graded manual traction, ROM exercises, deep flexor stabilization, and proprioceptive neuromuscular facilitation (PNF) exercises were performed on her cervical regions. General strengthening exercises for her trunk and lower extremities and balance-based torso weighting techniques were used. Her ambulation progressed from a roller walker to a quad cane. A home exercise program was devised for her, and a cervical home traction unit was provided. Both patients were treated for exacerbation of their MS symptoms in addition to their functional cervical disk pathology. Treatment time was 1 hour or longer, according to the patients’ tolerance. Not all of the modalities could be used at once. Cryotherapy, ultrasound, and soft tissue mobilization were utilized for pain and spasm for patient 2. Graded manual traction, ROM exercises, deep flexor exercises, and PNF exercises were directed to her cervical August 2012 regions and upper extremities. A home program for general conditioning using her pool was added. She was shown how to use a cervical home traction device. The interventions utilized with both patients are summarized in Table 5. Cryotherapy was effective for them. The patient in the first case was familiar with cooling body jackets that are designed for patients with MS. Both patients kept the environmental temperatures in their homes at 65° to 70°F. Soft tissue mobilization, graded manual traction, a home cervical traction unit, and balancebased torso-body weighting were utilized. The patient in case 2 ambulated throughout the home while wearing a diving belt. The patient in case 1 was encouraged to start a walking Volume 92 Number 8 Physical Therapy f 1059 Cervical Disk Pathology in Multiple Sclerosis Table 3. Symptoms of Multiple Sclerosis in Patients 1 and 2a Symptoms Patient 1 Patient 2 x x Migraine type headache x x Trigeminal neuralgia x Stabbing aching pain x Secondary pain due to muscle weakness, spasticity, or rigidity x Fatigue ⬎ 6.5 on the Fatigue Severity Scale program, and pool exercises were shown to the patient in the second case. Physical therapy was scheduled twice a week for 6 weeks for both patients. Pain x Eyes Diplopia (especially lateral gaze) x Partial vision, pain in one eye x x Abnormal smooth eye pursuit x x Uhthoff syndrome, heat sensitivity with visual symptoms x x Sensorimotor system Incoordination/ataxia LEs Decreased sensation UE/LEs LUE Dysmetria BUE BUE Tingling or burning BUE LUE Hyperactive reflexes below the level of active lesion BLE Clonus BLE Tremor BUE Spasticity BUE BLE Muscle weakness Lhermitte sign R side ⬎ L side LUE x x Babinski sign BLE Hoffman sign No test RUE Romberg sign x x Autonomic disturbances Sexual dysfunction Urinary incontinence x Gastroparesis x Bowel constipation Cortex Seizures x Aphasia x Speech hesitancy x Emotional disturbances Dx/bipolar Depression x Dizziness/vertigo x x Dementia a LE⫽lower extremity, UE⫽upper extremity, LUE⫽left upper extremity, BUE⫽bilateral upper extremities, BLE⫽bilateral lower extremities, R⫽right, L⫽left, Dx⫽diagnosis. “x” indicates presence of symptom. 1060 f Physical Therapy Volume 92 Number 8 Outcomes Patient 1 Upon treatment completion, the patient reported her pain at 4/10 daily, but not constantly. Diplopia occurred only with fatigue. Her cervical ROM was within normal limits except for left cervical rotation that was 10 degrees less than on the right side. Strength of her cervical muscles increased one grade within range. Weakness of her right side was one grade less than that of her left side and persisted. Her POMA score was 21/28. Her TUG score was 18. She continued to use the home cervical traction unit and followed through with the home exercise program. Her level of independence improved, with the Outcome and Assessment Information Set (OASIS)– based ADL scores as follows: M1820⫽2/0, M1830⫽3/0, and M1860⫽2/1.25 She continued to complain of fatigue; however, her level of social participation improved so that she was able to enjoy dinners or family outings with proper pacing. An improved gait pattern allowed her to use a quad cane. There were no reported falls in the home. She was able to take public transportation and use air travel to visit her family. Patient 2 The patient’s cervical pain completely resolved. Cervical ROM had improved to within normal limits. There was resolution in her fasciculations bilaterally. Strength in the left upper extremity increased by half a grade in all muscle groups. Her POMA score was 21/28. Her TUG score was 15. Her ADL scores as defined in the OASIS had improved: August 2012 Cervical Disk Pathology in Multiple Sclerosis Table 4. Clinical Findings in Patients 1 and 2a Before Treatment After Treatment Patient 1 Patient 2 Patient 1 Patient 2 Pain 10/10 cervical and bilateral arm pain 10/10 left C5–6 radicular pain 4/10 Resolved WNL except left external rotation, which was 10% less than right external rotation WNL Resolved None Strength was improved 1 grade, but the right side persisted weaker than the left LUE increased 1⁄2 grade ROM Decreased 50% in all planes Decreased 40% in all planes except external rotation 50% Both upper extremities, greater on right None RUE ⫹3, LUE 4 RLE ⫹3, LLE 4 LUE ⫹3 Tremor Strength Tinetti Performance-Oriented Mobility Assessment 10/28 18/28 21/28 21/28 20 15 TUG 28 18 a ROM⫽range of motion, WNL⫽within normal limits, RUE⫽right lower extremity, LUE⫽left upper extremity, RLE⫽right lower extremity, LLE⫽left lower extremity, TUG⫽Timed “Up & Go” Test. M1860⫽1/0, M1130⫽3/0, and M1880⫽1/0. Vision in her right eye was slow to detect light. She was beginning to see some light. More visual studies were planned for the future. She returned to her premorbid activity level and was able to accompany her son in college selection. Discussion Two patients with MS, who were taking disease-modifying drugs, were referred for home health care physical therapy with complaints of relapsing MS symptoms. A relapse is a clinical diagnosis characterized by signs of MS, which are either new or old and last for a few days or months. Both patients fit this description clinically; however, when MRIs with gadolinium contrast were done, no new lesions or extension of old lesions were seen in either patient. Magnetic resonance imaging with gadolinium contrast has been considered the gold standard for determinAugust 2012 ing new MS activity. A series of specific tests for MS have a sensitivity of 94% and a specificity of 55%.26 Work has shown that gadolinium crosses the blood-brain barrier and detects active lesions in people with MS.27 This activity persists for 4 weeks, on average, and at most 8 weeks. In both patients presented here, the gadolinium MRI was done within a 2to 4-week period of symptoms. The MRI should have detected new lesions but did not. New inflammation was not perceptible on the MRI. Corticosteroids can diminish or resolve active MS lesions on MRI, but the MS symptoms did not quickly resolve as expected with administration of IV steroids. The gold standard MRI was done appropriately with gadolinium during the appropriate time period, after IV steroids that marginally resolved relapse symptoms. A study by Merwick and Sweeney28 showed that relapses may not be easily linked to a particular lesion on MRI, and can be pseudo-relapses. If there are no MRI changes, these relapses may be attributed to physiologic changes such as those due to infection, fever, medications, or electrolytes. The first patient was treated for an upper-respiratory infection, and the second patients was treated for a dental infection, but neither patient had improvement of her MS symptoms when treated with antibiotics. These 2 cases do not fit the definition of pseudo-relapse. There is another concept that may explain the discrepancy between clinical presentation and MRI findings. This concept is called the “clinical-radiological paradox,” which is described as a lack of clinical symptoms when the MRI is abnormal. These MS lesions are “silent” because neuroplastic processes may have occurred at the cor- Volume 92 Number 8 Physical Therapy f 1061 Cervical Disk Pathology in Multiple Sclerosis Table 5. Evidence-Based Treatmenta a Intervention Rationale Study Cryotherapy, ultrasound, soft tissue mobilization Acute onset pain and spasm reduction. Heat therapy is indicated in acute muscle pain and spasm, to a minimum due to heat insensitivity. Cryotherapy reduces inflammation, edema, and muscle spasm and decreases conduction velocity of nociceptors to block pain impulses. Practice for health professionals: pain and multiple sclerosis. Available at: http://www.msaustralia.org.au/ documents/ms-Practice/pain.pdf. PNF to the cervical muscles To improve proprioceptive joint sense of deep flexors, eye-head control, and relocation of head on the trunk. Jull G, Falla D, Treleaven J, et al. Retraining cervical joint position sense: the effect of two exercise regimes. J Orthop Res. 2007;25:404–412. Strengthening exercises Patients with mild to moderate fatigue levels, if exercising at proper intensities, can improve strength without increasing or accelerating the disease process. DeBolt LS, McCubbin JA. The effects of home-based resistance exercise on balance, power, and mobility in adults with multiple sclerosis. Arch Phys Med Rehabil. 2004;85:290–297. Dalgas U, Stenager E, Jakobsen J, et al. Resistance training improves muscle strength and functional capacity in multiple sclerosis. Neurology. 2009;73:1478–1484. Balance-based torso-body weighting Torso weighting is used to counteract directional balance loss in a patient with MS. Gibson-Horn C. Balance-based torso weighting in a patient with ataxia and MS: a case report. J Neurol Phys Ther. 2008;32:139–146. Specific cervical deep flexor exercises Pain impairs deep flexor cervical muscles that stabilize the neck. Jull GA, Falla D, Vincenzino B, Hodges PW. The effect of therapeutic exercise on activation of the deep muscle in people with chronic neck pain. Man Ther. 2009;14:696– 701. Cervical traction Treatment of cervical radiculopathy using a multimodal technique. Cervical traction can be used for cases of herniated disks with mild compressive myelopathy. Waltrop M. Diagnosis and treatment of cervical radiculopathy using a clinical prediction rule and multimodal intervention approach: a case series. J Orthop Sports Phys Ther. 2006;36:152–159. Browder DA, Erhard RE, Piva SR. Intermittent cervical traction and thoracic manipulation for management of mild compressive myelopathy attributed to cervical herniated disc: a case series. J Orthop Sports Phys Ther. 2004;43:701–712. Aquatic therapy Patients with MS can participate in aquatic therapy without increase in fatigue level or heat intolerance and improve their functional scores. Petersen C. Exercise in 94°F water for a patient with multiple sclerosis. Phys Ther. 2001;81:1049–1058. Pariser G, Madras E, Weiss E. Outcomes of an aquatic exercise program including aerobic capacity, lactate threshold, and fatigue in two individuals with multiple sclerosis. J Neurol Phys Ther. 2006;30:82–90. Aerobic exercise program Aerobic training partially affected the health-related quality of life of patients with MS. Rampello A, Franceschini M, Piepoli M, et al. Effect of aerobic training on walking capacity and maximal exercise tolerance in patients with multiple sclerosis: a random crossover controlled study. Phys Ther. 2007;87: 545–555. PNF⫽proprioceptive neuromuscular facilitation, MS⫽multiple sclerosis. tical and spinal cord levels, resulting in functional reorganization.29 There also can be clinical neurological deficits without MRI findings. After an inflammatory process, the destructive process that occurs to axons and myelin takes time to degenerate, phagocytize, and produce symptoms. For that reason, demyelination must be studied at the molecular level. Vascular adhesions 1062 f Physical Therapy Volume 92 and transmigration of mononuclear cells are key prerequisites in new lesion formation in people with MS. Magnetic resonance molecular imaging and nanotechnology have been proposed to increase the potential of MRI analysis.30 Abnormalities can be missed in normal-appearing cervical cord tissue. There is a strong correlation between cervical cord area, a measure of atrophy, and clinical presentation. However, the frequency at Number 8 which spinal cord MRI should be performed to track lesion load and atrophy has not been fully determined. Diffusion tensor imaging is being investigated as an adjunctive technique.31 One common denominator in both patients was trauma with previous cervical pathology. In the first case, the patient had one serious fall in the previous year but had multiple August 2012 Cervical Disk Pathology in Multiple Sclerosis minor falls just preceding the exacerbation of symptoms. The cervical herniations were not suspected and were undetected until the last MRI. In the second case, the cervical pathology was unchanged. Although trauma was less clear, patient 2 could have aggravated her preexisting cervical pathology during the recreational pulley ride over the forest, resulting in functional exacerbation of symptoms. tion after soft tissue injury of the cervical spine, which they concluded was likely due to dysfunction of the proprioceptive system in the cervicocranial area. There are some other possible explanations for the exacerbation of the other MS symptoms without acute MRI findings. Multiple sclerosis is characterized by demyelination. Conduction velocity and amplitude of nerve transmission are suboptimal to begin with in patients with MS. Trauma may further weaken an impaired nervous system. The most reliable correlation between clinical status of the patient with MS and spinal cord lesions is cord atrophy. Although these articles are not strong evidence, they do seem to support the importance of cervical function, vision, and balance. In the 2 cases presented in this case report, once the cervical dysfunction was treated, there was decrement of pain, improvement of head and eye coordination, and correction of cervical alignment. Treatment to the cervical region improved coordination of the upper extremities and steadiness of gait. There may be other factors that explain the improvement in gait and coordination, such as amelioration of deconditioning effects, improvement of cardiopulmonary status, and an improved sense of independence and well-being. A corresponding study offers an explanation for the appearance of diplopia, dysmetria, balance disturbance, and ataxia seen in patients with cervical pain. These symptoms are seen in people with MS and may be exacerbated by trauma and pain. A study by Krisjansson and Treleaven32 looked at the effect of 2 physical therapy techniques—proprioceptive training and craniocervical flexion exercises—in the rehabilitation of patients with cervical pain. They suggested that pain afferents disrupt the proprioceptive afferents into the dorsal horn, resulting in abnormal position sense. Abnormal stresses on the vertebral joint may alter cervical afferent firing.32 In summary, 2 patients with a diagnosis of relapsing MS were referred for home health care physical therapy. Both cases showed no new MS lesions on contrast MRIs. This finding could have been a limitation of the MRI technique; however, improved sensitivity and specificity of 94% and 55%, respectively, have been reported.35 Corticosteroids could have diminished acute findings on the MRIs; however, many of the MS symptoms, although diminished, persisted for weeks afterwards. The steroids may have had an anti-inflammatory effect on some of the soft tissue structures and connective tissue, which may explain some of the initial improvement. In one case report, a patient with cervical cord injury and myelopathy had bilateral upper-extremity dysmetria and ataxic gait.33 The symptoms subsided after surgical intervention. Hildingsson et al34 studied 38 patients with eye motility dysfunc- Both patients had chronic cervical disk pathology shown by MRI, which could account for a functional exacerbation of symptoms. Both patients had sustained trauma prior to the exacerbation of symptoms. Both patients had evidence of severe cer- August 2012 vical spasm, scapular malalignment, and kyphoscoliosis because of the muscle imbalance. Derangement can place abnormal stresses on the nerve roots, as they exit the spine. Cervical pain and spasm can affect the proprioceptive input to the CNS, in turn, affecting coordination of the extremities and trunk. When the appropriate physical therapy intervention was instituted, the cervical symptoms decreased and coordination and proprioception improved, with reduction in motor impairment and disability. Cervical disk disease should be considered in the differential diagnosis in a patient with MS if he or she complains of cervical symptoms. The symptoms of cervical disk pathology can easily be confused with symptoms of relapsing MS. When the patient in the first case had suboptimal responses to IV steroids, the physician ordered a new MRI with contrast, suspecting secondary progressive MS requiring methotrexate, a more aggressive pharmacological treatment. When the MRI findings showed no new lesions, the physical therapy treatment was modified to treat the cervical pathology. The cervical radicular symptoms in the second case were more obvious, and the diagnosis of radiculopathy was made. Physical therapy treatment was directed to the cervical region early, based on clinical examination. The MRI results confirmed old cervical pathology and no new MS lesions shortly thereafter. Patients with MS are referred for physical therapy with a diagnosis of relapsing MS. It is important that the clinician do a thorough review of the patient’s medical history, establish a time line of progression, review pertinent diagnostic studies that are available, and perform a comprehensive systems review during the physical therapist evaluation. Patterns of Volume 92 Number 8 Physical Therapy f 1063 Cervical Disk Pathology in Multiple Sclerosis diagnoses are important to recognize, as well as which signs and test results may be clinically significant. Clinical improvement in response to cervical treatment potentially indicates that trauma may have been the catalyst to exacerbate previous cervical symptoms and weaken neurological areas that were already weakened in these 2 cases. The physical therapist must screen for spinal abnormalities when presented with a middle-aged patient with MS and a history of trauma showing abnormal postures or spastic weakness with complaints of changes in pain. Dr Mullen and Dr Wilmarth provided concept/idea/project design, project management, and clerical support. All authors provided writing and consultation (including review of manuscript before submission). Dr Mullen provided data collection/analysis and patients. Dr Wilmarth provided institutional liaisons. The manuscript was written in partial fulfillment of Dr Mullen’s Doctor of Physical Therapy degree at Bouvé Institute, Northeastern University. DOI: 10.2522/ptj.20110004 References 1 Luzzio C, Dangond F; Keegan BM, ed. Multiple sclerosis: differential diagnoses & workup. Available at: http://emedicine. medscape.com / article / 793013 -differential. Published July 22, 2010. Updated June 11, 2010. 2 Burks J, Johnson K. Multiple Sclerosis: Diagnosis, Medical Management and Rehabilitation. New York, NY: Demos Medical Publishing Inc; 2000. 3 Poser CM. The role of trauma in the pathogenesis of multiple sclerosis: a review. Clin Neurol Neurosurg. 1994;96:103– 110. 4 Cassetta I, Granieri E. Prognosis of multiple sclerosis: environmental factors. Neurol Sci. 2000;21(suppl 2):S839 –S842. 5 Brown RF, Tennant CC, Sharrock M, et al. Relationship between stress and relapse in multiple sclerosis, part 1: important features. Mult Scler. 2006;12:453– 464. 6 Martinelli V. Trauma, stress and multiple sclerosis. Neurol Sci. 2000;21(4 suppl 2):S849 –S852. 1064 f Physical Therapy Volume 92 7 Pirko I, Lucchinetti CF, Sriram S, Bakshi R. Gray matter involvement in multiple sclerosis [erratum in: Neurology. 2008;71: 2021]. Neurology. 2007;68:634 – 642. 8 Prinster A, Quarantelli M, Lanzillo R, et al. A voxel-based morphometry study of disease severity correlates in relapsingremitting multiple sclerosis. Mult Scler. 2010;16:45–54. 9 National MS Society of America. Diagnostic criteria for multiple sclerosis. Available at: http://www.mult-sclerosis.org/Diagnos ticCriteria.html. Published April 2001. Revised June 29, 2011. Accessed April 29, 2012. 10 Gurevich M, Tuller T, Rubinstein U, et al. Prediction of acute multiple sclerosis relapses by transcription of peripheral blood cells. BMC Med Genomics. 2009;2: 46. 11 Trojano M, Paolicelli D. The differential diagnosis of multiple sclerosis: classification and clinical features of relapsing and progressive neurological syndromes. Neurol Sci. 2001;22(suppl 2):S98 –S102. 12 Luzzio C, Dangond F; Keegan BM, ed. Multiple sclerosis: clinical presentation. Available at: http://emedicine.medscape.com/ article/1146199-clinical. Published 2011. Updated February 16, 2012. 13 Ronthal M. On the coincidence of cervical spondylosis and multiple sclerosis. Clin Neurol Neurosurg. 2006;108:275–277. 14 Korovessis P, Maraziotis M, Stamatakis M, Balkousis A. Simultaneous three-level disc herniation in a patient with multiple sclerosis. Eur Spine J. 1996;5:278 –280. 15 Bashir K, Cai CY, Moore TA Jr, et al. Surgery for cervical spine cord compression in patients with multiple sclerosis. Neurosurgery. 2000;47:637– 643. 16 Osteoarthritis. Family Practice Notebook. com. Available at: http://www.fpnotebook. com/Rheum/OA/Ostrthrts.htm. Accessed April 29, 2012. 17 Dousset V, Brochet B, Deloire MS, et al. MR imaging of relapsing multiple sclerosis patients using ultra-small-particle iron oxide and compared with gadolinium. ANJR Am J Neuroradiol. 2006;27:1000 – 1005. 18 Siva A, Radhakrishnan K, Kurland LT, et al. Trauma and multiple sclerosis: a population-based cohort study from Olmsted County, Minnesota. Neurology. 1993; 43:1878 –1882. 19 Posiadlo D, Richardson S. The timed “Up and Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39:142–148. 20 Kegelmeyer DA, Kloos AD, Thomas KM, Kostyk SK. Reliability and validity of the Tinetti Mobility Test for individuals with Parkinson disease. Phys Ther. 2007;87: 1369 –1378. 21 Fatigue severity scale. Available at: http:// www.mult-sclerosis.org/fatigueseverity scale.html. Updated June 29, 2011. Accessed April 29, 2012. Number 8 22 Cook C, Hegedus E. Orthopedic Physical Examination Tests: An Evidence-Based Approach. Upper Saddle River, NJ: Prentice Hall; 2008. 23 Waldrop MA. Diagnosis and treatment of cervical radiculopathy using a clinical prediction rule and a multimodal intervention approach: a case series. J Orthop Sports Phys Ther. 2006;36:152–159. 24 Guide to Physical Therapist Practice. Revised 2nd ed. Alexandria, VA: American Physical Therapy Association; 2003. 25 OASIS based home health agency patient outcome and case mix reports. Centers for Medicare and Medicaid Services website. Available at: http://www.cms.gov/ OASIS/09b_hhareports.asp#TopOfPage. Accessed April 29, 2012. 26 Tas MW, Barkhol F, van Walderveen MA, et al. The effect of gadolinium on the sensitivity and specificity of MR in the initial diagnosis of multiple sclerosis. ANJR Am J Neuroradiol. 1995;16:259 –264. 27 Petrella JR Grossman RI, McGowan JC, et al. Multiple sclerosis lesions: relationship between MR enhancement pattern and magnetization transfer effect. ANJR: Am J Neuroradiol. 1996;17:1041–1049. 28 Merwick A, Sweeney BJ. Functional symptoms in clinically definite MS: pseudorelapse syndrome. Int MS J. 2008:15:47– 51. 29 Pelletier J, Audoin B, Reuter F, Ranjeva J. Plasticity in MS: from functional imaging to rehabilitation. Int MS J. 2009;16:26 –31. 30 Wu X. Multiple Sclerosis: MRI Diagnosis, Potential Treatment and Future Potential for Nanoparticle Applications [doctoral thesis]. Stockholm, Sweden: Karolinska Institute; 2005. 31 Rovira A. MRI as a biomarker: advances in multiple sclerosis. Presented at: 2010 Annual Meeting of the International Society for Magnetic Resonance in Medicine; May 1–7, 2010; Stockholm, Sweden. 32 Kristjansson E, Treleaven J. Sensorimotor function and dizziness in neck pain: implications for assessment and management. J Orthop Sports Phys Ther. 2009;39:364 – 377. 33 Lin HC, Chen CH, Khor GT, Huang P. Upper limb-dysmetria caused by cervical spinal cord injury: a case report. BMC Neurol. 2009:9:50. 34 Hildingsson C, Wenngren BI, Toolanen G. Eye motility dysfunction after soft-tissue injury of the cervical spine: a controlled prospective study of 38 patients. Acta Orthop Scand. 1993;64:129 –132. 35 Silver NC, Good CD, Barker GJ, et al. Sensitivity of contrast enhanced MRI in multiple sclerosis: effects of gadolinium dose, magnetization transfer contrast and delayed imaging. Brain. 1997;120 (pt 7):1149 –1161. August 2012 Case Report Patient-Centered Integrated Motor Imagery Delivered in the Home With Telerehabilitation to Improve Walking After Stroke Judith E. Deutsch, Inbal Maidan, Ruth Dickstein Background and Purpose. This case report describes the clinical reasoning process used to examine a person after stroke and intervene with a novel integrated motor imagery treatment designed for the rehabilitation of walking and delivered in the home through telerehabilitation. The integrated motor imagery treatment consisted of patient-centered goal setting and physical practice combined with motor and motivational imagery. Case Description. The patient was a 38-year-old woman who had had a diffuse left subarachnoid hemorrhagic stroke 10 years earlier. She lived independently in an assisted living complex and carried a straight cane during long walks or in unfamiliar environments. Examination revealed a slow gait speed, reduced walking endurance, and decreased balance confidence. Although she was in the chronic phase, patientcentered integrated motor imagery was predicted to improve her community mobility. Treatment sessions of 45 to 60 minutes were held 3 times per week for 4 weeks. The practiced tasks included transitioning from sitting to standing, obstacle clearance, and navigation in interior and exterior environments; these tasks were first executed and then imagined at ratios of 1:5. Task execution allowed the creation of a scene based on movement observation. Imagery scenarios were customized to address the patient’s goals and observed movement problems. Motivational elements of arousal, problem solving, and reward were embedded in the imagery scenarios. Half of the sessions were provided on site, and the remaining sessions were delivered remotely. Seven sessions were delivered by the clinician in the home, and 5 sessions were delivered using telerehabilitation. Outcomes. Improvements in motor imagery ability, gait parameters, and balance were observed after training. Most gains were retained at the 3-month follow-up. Compared with on-site delivery, the telerehabilitation sessions resulted in less therapist travel time and cost, as well as shorter therapy sessions. J.E. Deutsch, PT, PhD, Department of Rehabilitation and Movement Science, University of Medicine and Dentistry of New Jersey, 65 Bergen St, SSB 723, Newark, NJ 07101 (USA). Address all correspondence to Dr Deutsch at: [email protected]. I. Maidan, PT, MS, Department of Rehabilitation and Movement Science, University of Medicine and Dentistry of New Jersey. R. Dickstein, PT, DSc, Department of Physical Therapy, Faculty of Social Welfare and Health Sciences, University of Haifa, Mount Carmel, Haifa, Israel. [Deutsch JE, Maidan I, Dickstein R. Patient-centered integrated motor imagery delivered in the home with telerehabilitation to improve walking after stroke. Phys Ther. 2012;92:1065–1077.] © 2012 American Physical Therapy Association Published Ahead of Print: April 12, 2012 Accepted: April 5, 2012 Submitted: August 31, 2011 Discussion. The delivery of integrated motor imagery practice for walking recovery was feasible both on site and remotely. Post a Rapid Response to this article at: ptjournal.apta.org August 2012 Volume 92 Number 8 Physical Therapy f 1065 Integrated Motor Imagery at Home to Improve Walking After Stroke M otor imagery (MI) practice, either alone or in combination with physical practice, has been applied for the movement rehabilitation of people after stroke.1,2 Substantial gains attributed to MI practice in combination with physical practice were reported for upper-extremity use,3,4 performance of activities of daily living,5,6 foot sequence learning, and transitioning from sitting to standing.7,8 Studies of rehabilitation of walking after stroke with imagery alone9 –11 and with a combination of imagery and physical practice12 yielded promising results as well. A recent review indicated that locomotor activities either performed physically or imagined can be used to promote ambulation.13 Generally, it is believed that the overlap of neural substrates between movement imagination and execution explains some of the positive effects of MI practice on motor performance. The mechanism and neural basis of MI were reviewed extensively by Lotze et al,14 Munzert et al,15 and Guillot and Collet.16 Reports of the use of MI in the stroke rehabilitation literature have focused on skills without the incorporation of a motivational component. Motivational imagery has been explained with an attention-arousal theory.17 It is postulated that imagery places the system in an optimal state of arousal, allowing the learner to focus on taskrelevant cues.17 A second explanation is that imagery builds psychological skills, such as increased confidence and decreased anxiety, which are critical for performance enhancement. Thus, motivational imagery is used to imagine arousal and affect.18 It has been associated with improvements in self-efficacy19 by increasing attention and arousal.20 Evidence from the sports literature has suggested that incorporating motivational strategies into imagery may improve outcomes, 1066 f Physical Therapy Volume 92 such as confidence, self-efficacy, and performance.19,21,22 The delivery of MI in the home increases compliance and facilitates a patient-centered intervention. The rationale for a patient-centered intervention is based on the accumulating evidence that successful rehabilitation focuses on the patient and the attainment of goals rather than on the resolution of problems.23 Patientcentered therapy is important both for goal setting and for the delivery of rehabilitation because it promotes active involvement with therapy.24,25 In addition, MI provided in the home enables a patient to train in the relevant environment and to encounter specific difficulties that interfere with goal attainment.26,27 It is known that home-based exercises for people in the chronic stage after stroke result in larger intervention effects28,29 and substantial reductions in dropouts, which are common in group therapy.30 Although delivery in the home has benefits, it also has challenges, including therapist travel time and lack of access to care for people in remote areas. One solution to these challenges is remote delivery. Telerehabilitation has been implemented in stroke rehabilitation primarily for upper-extremity recovery31,32 but also for lower-extremity training.33,34 To date, however, MI has not been provided in a telerehabilitation model. In previous work, we showed that a home-based MI intervention improved walking for people in the chronic stage after stroke.10 The purpose of this case report is to describe the implementation of an integrated MI intervention including patientcentered goals, motivation aspects of imagery, and the delivery of therapy both on site and through telerehabilitation. These innovations were used for a woman who was in the chronic Number 8 phase after stroke and who experienced walking restrictions and apprehension about walking in the community. The clinical decisionmaking process described by Schenkman et al35 was used to frame the case. Patient History and Review of Systems The patient was a 38-year-old woman who had sustained a diffuse left subarachnoid hemorrhagic stroke 10 years earlier. Before her stroke, she worked as an art therapist and led an active lifestyle with no physical or cognitive limitations. On the day of the stroke, she experienced nausea and vomiting. A computed axial tomography scan revealed a clinical grade 1 or 2 hemorrhage caused by a terminal bifurcation aneurysm. The patient underwent a left-side peritoneal craniotomy, clipping of the bifurcation aneurysm, and placement of a spinal drain. Although she tolerated the initial procedure well, she developed hydrocephalus and remained for approximately 40 days in a surgical intensive care unit, where she received an emergency ventriculoperitoneal shunt. She completed 4 weeks of inpatient rehabilitation consisting of physical therapy and speech therapy. At discharge, she had regained gross function of the right upper extremity; however, she continued to demonstrate weakness of the right lower extremity, difficulty with fine motor movements, and problems with word finding and sentence completion. For several months, she continued physical therapy, occupational therapy, and cognitive therapy, including several sessions of vestibular rehabilitation to address complaints of dizziness upon standing. At the completion of therapy, she was independent in the performance of activities of daily living, ambulation, and communication and was living with her parents. August 2012 Integrated Motor Imagery at Home to Improve Walking After Stroke Two years before the current episode of care, she was living independently in her own apartment in an assisted living complex. She reported carrying a straight cane for occasional use during long walks or in unfamiliar environments because they made her feel anxious and fearful. These concerns limited her community mobility. Before her first evaluation, she signed an informed consent statement, in accordance with the guidelines of the institutional ethics review board. Examination The examination approach, which was based on an integrated model for decision making in neurologic physical therapist practice,35 had 3 main objectives: assessment of imagery ability, measurement of motor behavior outcomes, and movement assessment for selecting and guiding the intervention. Because there is no definitive test of imagery ability for people after stroke, imagery ability was measured through complementary assessments of imagery modalities (Kinesthetic and Visual Imagery Questionnaire [KVIQ]),36 temporal congruence (mental chronometry),37 and spatial working memory38 (we used the Wechsler test component, which is not validated to be used individually). Motor behavior outcomes were selected on the basis of the patient’s mobility goals and represented motor recovery (FuglMeyer Test),39,40 temporal features of walking (10-m and 6-minute walk tests),41,42 balance confidence,43,44 and cognition and self-efficacy (Timed “Up & Go” Test [TUG],45 TUG with dual tasks,46,47 and Activities-specific Balance Confidence Scale [ABC]). Movement was assessed by observing executed tasks, which were performed (as a form of ongoing examination) during every intervention session. Examinations of imagery ability and motor behavior outcomes were conAugust 2012 ducted in the Rivers Laboratory (University of Medicine and Dentistry of New Jersey, Newark, New Jersey) at 3 time points: before therapy, after therapy, and 3 months after the end of therapy. For the purpose of increasing internal validity, the examiner was blinded to the intervention.48 Implementation of the telerehabilitation technology was tracked during training, and costs were calculated after the intervention. At the conclusion of the intervention, both the patient and the clinician completed the Post-Study System Usability Questionnaire. It consists of 19 items rated on a scale from 1 to 7 (where 1⫽strongly agree and 7⫽strongly disagree). It contains 3 domains: system usefulness, information quality, and interface quality. The clinician completed the entire questionnaire. The patient completed the questionnaire without the information quality domain.49 The complete test is available online (http://drjim.0catch. com/usabqtr.pdf). The examination tools, relevant psychometric information, and findings of the first examination are summarized in Table 1. Clinical Impression The initial examination identified walking limitations that could partially explain the patient’s identified problems with walking in unfamiliar environments, outdoors, and crowded places.35 The limitations included slow speed and loss of balance. These limitations were compounded by vision problems such as diplopia and dizziness, which led to apprehension and fear that affected the patient’s walking ability, reduced her confidence and motivation for community mobility, and restricted her participation in social activities. The examination results indicated slow gait speed, reduced walking endurance, and decreased balance confidence. These findings were consistent with a physical therapist diagnosis of impaired motor function and sensory integrity associated with a nonprogressive disorder of the central nervous system acquired in adulthood (Guide to Physical Therapist Practice Pattern 5D50). The corresponding diagnosis in the International Statistical Classification of Diseases, 9th Revision, Clinical Modification (code 781.2), was abnormality of gait. Scores on the tests of imagery ability (KVIQ, mental chronometry, and Wechsler) indicated that the patient had the ability to imagine. Furthermore, because of her premorbid role as a recreational therapist, she was familiar with imagery practice as a practitioner and as an instructor. Imagery scenarios were constructed to address the patient’s goals by remediating motor behaviors observed in the examination. The imagery scripts were further refined through movement observation and assessments of the executed tasks during the intervention. Prognosis Even though the patient was in the chronic phase after stroke, which is associated with a lack of change in walking function at home and in the community, we predicted that she would benefit from the therapy. This prediction was based on the patient’s measured imagery ability and premorbid experience with imagery and on our plan of care. We planned to combine mental practice with a small amount of physical practice for relearning motor strategies. The addition of physical practice to imagery practice has been shown to produce a better result than imagery practice alone.51,52 Furthermore, because we planned to include motivational aspects of imagery, we anticipated a good outcome on the basis of evidence from the sports field of the impact of MI on affective Volume 92 Number 8 Physical Therapy f 1067 Integrated Motor Imagery at Home to Improve Walking After Stroke Table 1. Testsa Test Purpose and Description Measurement Scores 5–25 for each modality Psychometric Cutoff Scores Initial Examination Scores Kinesthetic and Visual Imagery Questionnaireb Visual (V) and kinesthetic (K) imagery modalities measured on a 5-point ordinal scale Test-retest reliability (ICC⫽.8–.9), construct validity (V⫽0.89, K⫽0.87)36 V⫽16, K⫽18 Mental chronometryb Comparison of imagined and real walking times at 5- and 10-m intervals Test-retest reliability (ICC⫽.81–.90)37 5 m⫽0.01 s, 10 m⫽3.02 s Spatial working memory (Wechsler and Hartogs38)b 2-dimensional stimulus response cards of Wechsler Memory Scale 0–12 for each spatial span Fugl-Meyer Test (lower extremity [LE])c Sensorimotor recovery of patients with hemiplegia after stroke Total⫽56, LE⫽0–32, sensory⫽0–24 Test-retest reliability (ICC⫽.81),40 criterion validity (r⫽.61 with gait speed)39 LE⫽20, sensory⫽12 10-m timed walk testc Measurement of comfortable walking speed (average of 3 trials) Middle 6-m data collected by GAITRite Systemd Test-retest reliability (ICC⫽.95–.99),65 cutoff (speeds of ⬎0.8 m/s indicate community ambulation)41 0.6 m/s 6-minute walk test (6MWT)c Assessment of distance walked over 6 min for endurance estimation (performed at fastest speed possible) Distance Test-retest reliability (ICC⫽.96),66 criterion validity (high correlation with gait speed and leg strength),42 minimal detectable change (36.6 m)45 257 m Timed “Up & Go” Test (TUG)c Assessment of mobility, balance, and fall risk (patient rises from a chair, walks 3 m at a comfortable pace, turns, walks back to the chair, and sits) (average of 3 trials) Time to complete task Test-retest reliability (ICC⫽.96), criterion validity (r⬎.86 with CGS, FGS, SCas, SCde, and 6MWT),45 cutoff (times of ⬎13.5 s are associated with fall risk)47 13.4 s TUG with dual tasksc Same as TUG, except that patient concurrently counted backward by fives, starting at 100 (average of 3 trials) Time to complete task Test-retest reliability (ICC⫽.98), criterion validity (r⫽⫺.66 with BBS),46 cutoff (times of ⱖ15 s are associated with fall risk)47 14.6 s Activities-specific Balance Confidence Scalec 16-item self-report measure of balance confidence in performing various ambulatory activities without falling Items are rated from 0 to 100, added, and divided by 16 Test-retest reliability (ICC⫽.85), construct validity (r⫽.36 with BBS and r⫽.48 with gait speed),43 cutoff (scores of ⬍67% indicate risk for falling)44 65% Post-Study System Usability Questionnaire (ease-of-use questionnaire)e Evaluation of use of telerehabilitation system (1 questionnaire each was administered to patient and clinician) 12–84 for patient, 19–133 for clinician Instrument was adapted from existing indexes for this case report Discharge only Costse Assessment of costs related to remote sessions Travel and time costs Forward⫽10, backward⫽7 Discharge only a ICC⫽intraclass correlation coefficient; CGS⫽comfortable gait speed; FGS⫽fast gait speed; SCas⫽stair climb, ascending; SCde⫽stair climb, descending; BBS⫽Berg Balance Scale. b Imagery or memory measure. c Motor test. d CIR Systems Inc, Sparta, New Jersey. e Technology test. 1068 f Physical Therapy Volume 92 Number 8 August 2012 Integrated Motor Imagery at Home to Improve Walking After Stroke Table 2. Interventions Technology Management, Therapy Progression, and Caregiver Instruction Mode of Delivery During Session: a Tasks (Sequences)a 2 3 1 Sit-walk (E, I⫻5, E), obstacle course (E, I⫻5, E), and walk interior (I) Local Local Local Familiarization with computer, camera; clinician on site (local clinician) responsible for making sure the patient knew how to handle the software 2 Sit-walk (E, I⫻5), obstacle course (E, I⫻5), walk interior (E, I⫻5, E), and walk exterior (I) Local Local Remote Practice logging in outside of session 3 Sit-walk (E, I⫻5), obstacle course (E, I⫻5), walk community interior (I), and walk community exterior (I) Local Remote Remote Progression of speed and endurance, addition of real-world or ecologically valid obstacles 4 Sit-walk (E, I⫻5, E), obstacle course (E, I⫻5, E), walk community interior (I), and walk community exterior (I) Local Remote Remote Checking computer competency, walking goal different from that in week 3 Week 1 E⫽physically executed, I⫻5⫽imagined 5 times. deficits.19 The goal of the intervention was to improve the patient’s community mobility and balance confidence. Intervention Dose and Structure The intervention consisted of 12 sessions of 45 to 60 minutes each 3 times per week for 4 weeks.53 As indicated in Table 2, each week contained 3 core tasks: sit-walk, obstacle course, and walking in different environments. These tasks were selected because they form the basis for mobility and represent the repertoire of real exercises used in the rehabilitation of people after stroke, who are prone to falls.54,55 On the basis of previous research,53 each practice session, guided by the clinician, was composed of the following 6 elements: (1) execution of the task; (2) relaxation for 1 to 2 minutes; (3) provision of explicit information on characteristics of the task and the environment; (4) imagining walking with different imagery modalities (kinesthetic and visual), perspectives (first and third persons), and cognitive and motivational cues; (5) repeat execution of the task; and (6) debriefing of the August 2012 patient. The task was executed to ensure that the patient understood the imagery task and to help the trainer create a scene based on the observation of real movement. The ratio of executed tasks to imagined tasks was 1:5.51,52 Execution could be performed only for a subset of tasks. The selection of imagery perspectives and modalities and the addition of cognitive challenges and affective cues were based on observed motor behaviors, mental chronometry, and the patient’s report of engagement. The therapy was delivered either on site (Tab. 2, “local”) or through telerehabilitation (Tab. 2, “remote”). Table 2 also shows technology management and therapy progression. Movement Assessment and Integrated MI Practice The plan of care was implemented by integrating the intervention with the movement assessment. At each session, the patient’s movement during the executed tasks was observed. In accordance with the patientcentered therapy approach, the patient set goals for the tasks and environments that were relevant to her. Specifically, she wanted to walk quickly in the hallway, walk in the parking lot, walk in the street leading out from her housing complex, and walk in the mall. Tasks in environments where she often was unable to physically practice, such as the mall, were only imagined. Therapy progression was based on the ongoing movement assessment conducted in the home according to the taxonomy of Gentile56 to classify environments and tasks and the temporal sequence of movement of Hedman et al57 to analyze tasks, as interpreted in the integrated model of Schenkman et al.35 Movements in the patient’s apartment, common spaces, grounds, and neighborhood were observed. Table 3 shows the environment and task categories based on the 4 conditions adapted from Gentile56 and observations of the patient’s performance. Thus, the intervention was based on recurring examination and evaluation of the patient’s goals and observed motor behaviors. Specifically, we observed that she had difficulties with tasks when she was moving and the environment was either “stationary” (walking in the hallway) or “moving” Volume 92 Number 8 Physical Therapy f 1069 Integrated Motor Imagery at Home to Improve Walking After Stroke Table 3. Environment and Task Categories Based on the Taxonomy of Gentile56 Environment (Gentile Taxonomy) Task Observations of Movement and Confidence Stationary individual, stationary environment Sitting on all surfaces in the apartment Independent and confident Moving individual, stationary environment Walking in the apartment Independent; movements were slow and halting and became slower when the patient spoke to someone in the room or when someone crossed her path Stationary individual, moving environment Sitting on all surfaces with people moving around in the apartment or outside on the grounds Independent and confident Moving individual, moving environment Walking from the apartment to the hallway, to the parking lot, and along the street with unpredictable perturbations from people and cars Close supervision to contact guard; movements became slower as the patient transitioned from the apartment to the hallway and then from the hallway to outside; the patient stopped when she encountered people walking in her vicinity (not necessarily to speak with them but just to let them go by); while walking outside, the patient needed minimal assistance when a car approached her in the parking lot; she reported a high level of fatigue and feeling nervous after walking outside (walking on the sidewalk with cars passing by). Each task was analyzed according to the temporal sequence of Hedman et al57 with 5 stages of movement. Table 4 shows an analysis of 3 tasks (sitting, walking in the hallway, and walking in the parking lot) performed by the patient. Her preparation for movement always involved seeking an external source of support (the wall as a reference point or a person nearby). She showed a consistent delay or hesitation in preparation for all movements. Her execu- tion was slow and uncoordinated. On the basis of her report, these movement difficulties were a result of poststroke sequelae and discomfort with movement. For task practice, the integrated imagery approach, combining cogni- Table 4. Task Analysis of the Patient’s Performance According to the Temporal Sequence of Movement of Hedman et al57 Task Initial Conditions Preparation Initiation Execution Termination Sitting Posture unremarkable; patient was able to interact with the environment No delay Unremarkable Unremarkable Unremarkable Walking in the hallway when it was empty Patient oriented herself toward the walls or banister Delay Head was fixated, gaze was on the floor, and movement direction was lateral rather than forward Direction was forward, step length was reduced, step length was longer on the left, and speed was slow and became slower as the patient intended to terminate movement Movement continued after intended stop, with oscillation of trunk and repositioning of feet Walking in the parking lot with cars pulling in and out Patient oriented herself close to the person guarding Delay Head was fixated, gaze was on the floor, base of support was wide, direction of movement was lateral rather than forward, and amplitude was reduced Direction was forward, step length was reduced, step length was longer on the left, speed was slow, and movements were halting and uncoordinated with perturbations Movement appeared to be premature relative to target destination, with oscillation of trunk and repositioning of feet 1070 f Physical Therapy Volume 92 Number 8 August 2012 Integrated Motor Imagery at Home to Improve Walking After Stroke tive rehearsal of motor tasks with motivational components, was used. This concept was adapted from sports to create a structure for delivering imagery practice; the components were arousal-attention, problem solving, and a sense of accomplishment. This approach was selected to motivate and engage the patient in a manner consistent with motor learning principles requiring problem solving for learning. Through imagery, feelings of confidence were reinforced for both task performance and successful accomplishment of the practiced tasks.58,59 Reinforcement was accomplished by devising imagery scripts tailored to the patient’s goals and movement problems.60 The Appendix shows an imagery script illustrating all of the components of integrated MI tailored to address the patient’s goal of walking in the parking lot. Telerehabilitation All of the practice sessions were conducted by the same physical therapist. Seven practice sessions were carried out at the patient’s home, and 5 practice sessions were directed remotely. During the remote sessions, 1 researcher (the local therapist) was on site ensuring that the technology was working and that the patient was safe. The local therapist was never required for patient safety but assisted with the technology setup. Another researcher (the remote therapist) delivered the therapy remotely from her home. The remote sessions were conducted with the patient’s computer. A camera for tracking the patient’s movements was installed in her home, and a headset, which included a microphone and earphones, was used to ensure better engagement in imagery practice. The patient had a desktop computer with an Internet connection, and she was comfortable using the computer. The remote therapist used her lapAugust 2012 top, which had a built-in camera. Communication between the patient’s site and the remote therapist’s site was accomplished through a videoconference conducted with Blackboard Collaborate communication software (Blackboard Inc, Washington, DC). There was 2-way audiovisual communication. The remote therapist could observe the patient during the delivery of instructions, imagery, and debriefing but only partially during execution. For this reason, the patient did not execute the external walking tasks during the remote sessions. The remote sessions were, on average, 15 minutes shorter than the on-site sessions. Outcome Response to Intervention The patient was able to imagine the scripts, as confirmed by comparison of the executed task times and the imagined task times. Adjustments were made in the instructions when the congruence decreased. The patient attended all of the planned sessions. In the debriefing that occurred after each script, she provided information on how she felt about the imagined walking experience, what obstacles she encountered, and how she solved them. Representative comments were “I could see myself in the rain, walking safely; it felt good” and “I was nervous, but then I felt my leg and it was strong.” walking speed changed from that of household ambulation to that of limited community ambulation.61 Her walking distance on the 6-minute walk test increased from 257 m before the intervention to 277 m after the intervention and to 282 m at the retention test. Balance, Cognition, and Balance Confidence The TUG time decreased from the initial examination to discharge, and further decreases were seen at follow-up for both the TUG and the TUG with dual tasks (Fig. 2). After training, the TUG time was below the cutoff for fall risk.47 The ABC scores increased from 65 points before the intervention to 76 points at discharge and to 69 points at the retention test. A 10-point change is considered clinically meaningful.44 Motor Imagery Ability The KVIQ scores changed from 16 points to 24 points in the visual domain and from 18 points to 24 points in the kinesthetic domain, and these gains were retained at followup. Chronometry was not used as an outcome measure. Telerehabilitation The patient’s score on the Post-Study System Usability Questionnaire for telerehabilitation technology was 23 of 84. The clinician’s score was 34 of 133 (the scores on the domains were as follows: 13/56 for system usefulness, 14/49 for quality of information, and 7/28 for quality of interface). Lower numbers indicated that the system was comfortable and easy to use. The patient’s score for most items was 1 or 2; the highest score was seen for “the system has all the functions and capabilities I expect it to have.” The patient’s comment relative to this item was that she preferred having the second therapist on site. The patient also commented that therapy delivered through telerehabilitation was fine if it was “in addition” to physical therapy delivered in person. Gait Parameters Gait speeds at discharge increased 57% for self-selected speed and 37% for fast speed, and these increases were maintained at the 3-month follow-up (Fig. 1). The patient’s There were some technical challenges. Both the patient and the clinician reported noise and audio lag during audio communication. The clinician complained that the camera had a limited field of view. For exam- Volume 92 Number 8 Physical Therapy f 1071 Integrated Motor Imagery at Home to Improve Walking After Stroke Figure 1. Gait speed. Gait speeds of less than 0.4 m/s indicate household ambulation, gait speeds of 0.4 to 0.8 m/s indicate limited ambulation in the community, and gait speeds of greater than 0.8 m/s indicate full ambulation in the community.61 ple, it captured only a small part of the walking path, and observing small movements, such as breathing and facial expression, was difficult. Costs were defined as travel time, travel cost, and session time. The average travel time in each direction for the therapist was 30 minutes (1 hour for a session), and the travel cost per session was $15 (30-mile round trip reimbursed at $0.50 per mile). Five sessions were conducted remotely, resulting in savings of 5 hours of travel time and $75 of travel cost. Remote therapy sessions lasted 45 to 60 minutes, and on-site therapy sessions lasted 60 to 75 minutes; thus, remote therapy resulted in a savings of 75 minutes of therapy time. Figure 2. Times on the Timed “Up & Go” Test (TUG) and the TUG with dual tasks (TUG-DT). Times of 13.5 seconds or greater were associated with fall risk.47 1072 f Physical Therapy Volume 92 Number 8 August 2012 Integrated Motor Imagery at Home to Improve Walking After Stroke Additional costs related to telerehabilitation technology, such as a computer and Internet access, were not relevant in this case because the patient had her own computer and connection to the Internet. The camera and the headset were provided by a researcher. Discussion We described the clinical reasoning process that led to an integrated imagery intervention, delivered on site and remotely, for gait and balance confidence training for a person after stroke. This case report illustrates how to design a patientcentered intervention after careful examination and customization of an intervention based on patient goals and the results of a movement analysis. In this single case, providing integrated MI training remotely was feasible. Furthermore, the patient showed changes in mobility and balance confidence outcomes that were specifically selected as outcome measures relevant to her goals. The examination yielded the relevant therapy outcomes for mobility and balance confidence, and the movement assessment during the intervention allowed for customization of the therapy. Furthermore, we involved the patient in setting the goals for therapy because doing so has been linked to increased adherence to therapy tasks, greater goal attainment and satisfaction, facilitation of a person’s sense of control over rehabilitation, and improved therapy outcomes.24,62 For this patient, the construction of integrated MI emphasized the affective domain because she reported apprehension with walking. Although one cannot attribute causality in a single case report, we believe that changes in the mobility and balance confidence measures suggested the specificity of imagery training. The patient showed August 2012 improvements in walking speed (10-m walk test) and endurance (6-minute walk test). Both speed and endurance were trained only by imagery and not by physical execution. During imagery training, the patient was instructed to walk fast, and imagery scenarios for community mobility that required imagining walking long distances were used. The patient also showed improvements in balance and balance confidence. The intervention was specifically designed to address these issues through imagining problem solving and emotions connected to a task. During imagery training, the patient succeeded (by her report) in overcoming some of her feelings of discomfort. We speculate that problem solving difficult situations and imagining being satisfied were captured by the improvements measured on the TUG with dual tasks and the ABC. The patient often reported feeling more comfortable executing movements after she had imagined them. We speculate that improvements in balance self-efficacy may have been related to increasing attention and arousal during the intervention.20 The motivational component of the imagery intervention is novel. This approach emphasized difficulties of an affective-cognitive nature, such as fear of falling, poor attention, organizational problems, and difficulty problem solving.63 These difficulties could be a source of subsequent losses of autonomy. The MI scenes incorporated elements of attention, problem solving, and sense of accomplishment in accordance with the patient’s goals. We speculate that the MI training enabled repeated practice of both physically and affectively challenging scenes to overcome fears and address problems during practice. Thus, the motivational aspect of the imagery was related to both patient-centered goals and customization of scripts with the appropriate cognitive and affective cues. It is important that we relied on patient report and did not specifically measure motivation. The validity of imagery training is often questioned on the basis of the difficulty in determining whether people are really imagining. During training, the patient was asked how she performed the imagery training and about any difficulties that she had. In addition, we measured the congruency between imagined tasks and executed tasks. We often found that if the scripts were too openended, then the imagined task times were shorter than the executed task times. We learned that it was better to provide instruction, give the person time to imagine walking to a specific destination, ask the person to signal arrival, and then continue the script. This strategy increased the congruence between imagined and executed task times. A second source of evidence for engagement in imagery was the improvement in KVIQ scores. We suggest that improvements in imagery skill were attributable to imagery practice. We found similar imagery improvements in people after stroke involved in a Feldenkrais training program in which they were directed to feel the movements demonstrated improved kinesthetic imagery scores after training.64 To our knowledge, this is the first attempt to deliver MI therapy via telerehabilitation. The patient was able to access the software and communicate with the remote therapist. The delivery of therapy remotely required less time (an average of 45 minutes) than the delivery of therapy on site (an average of 65 minutes), in part because of less socializing between the clinician and the patient and because exterior walking tasks were not executed in the absence of the therapist. Also, in an earlier on-site visit, time was spent Volume 92 Number 8 Physical Therapy f 1073 Integrated Motor Imagery at Home to Improve Walking After Stroke ensuring that the technology was operational and understood by the patient. However, time was spent on setting up the telecommunication, and there were occasional interruptions in the communication. Importantly, the patient lived alone and functioned at a sufficiently high level to execute the tasks without the assistance of a caregiver. Possible challenges in implementing the intervention remotely with other people after stroke include a requirement for comfort and competence with the technology and a requirement for physical assistance with executed tasks. We anticipate that training of both patients and caregivers with the technology may be required. Whether the costs of implementing the intervention outweigh the benefits in savings of travel time and cost needs to be determined. In summary, this case report described the clinical reasoning process of designing an examination and an intervention based on patientcentered goals and movement observations. The intervention was refined by observing performance during executed movements and then was implemented with imagined movement practice. The novelty of this case is that the imagery practice had a motivational component, which included affective and cognitive additions to MI scripts that were designed to promote arousal, attention, and problem solving and to provide reward. Because both the patient-centered approach to therapy design and the motivational components of imagery were believed to increase motivation, it is impossible to separate the possible contributions of these factors to the improvements in mobility and balance confidence. However, this case report provides a guideline for the application of MI to practice. The delivery of integrated MI training 1074 f Physical Therapy Volume 92 remotely was demonstrated to be feasible. Further research is needed to parse the motivational components of integrated imagery and to characterize the benefits and disadvantages of the remote delivery of integrated MI training. Dr Deutsch and Dr Dickstein provided concept/idea/project design. Dr Deutsch and Ms Maidan provided writing and data collection. Dr Deutsch provided data analysis, project management, fund procurement, patient, facilities/equipment, and institutional liaisons. Dr Dickstein provided consultation (including review of the manuscript before submission). The authors acknowledge Michal Kafri, PT, PhD, who served as a masked assessor. This work was supported by the National Institute of Child Health and Human Development. DOI: 10.2522/ptj.20110277 References 1 Jackson PL, Lafleur MF, Malouin F, et al. Potential role of mental practice using motor imagery in neurologic rehabilitation. Arch Phys Med Rehabil. 2001;82: 1133–1141. 2 Johnson SH. Imagining the impossible: intact motor representations in hemiplegics. Neuroreport. 2000;11:729 –732. 3 Page SJ, Levine P, Sisto SA, Johnston MV. Mental practice combined with physical practice for upper-limb motor deficit in subacute stroke. Phys Ther. 2001;81: 1455–1462. 4 Yoo E, Park E, Chung B. Mental practice effect on line-tracing accuracy in persons with hemiparetic stroke: a preliminary study. Arch Phys Med Rehabil. 2001;82: 1213–1218. 5 Liu KP, Chan CC, Lee TM, Hui-Chan CW. Mental imagery for promoting relearning for people after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2004; 85:1403–1408. 6 Page SJ, Levine P, Leonard A. Mental practice in chronic stroke: results of a randomized, placebo-controlled trial. Stroke. 2007;38:1293–1297. 7 Jackson PL, Doyon J, Richards CL, Malouin F. The efficacy of combined physical and mental practice in the learning of a footsequence task after stroke: a case report. Neurorehabil Neural Repair. 2004;18: 106 –111. 8 Malouin F, Richards CL, Doyon J, et al. Training mobility tasks after stroke with combined mental and physical practice: a feasibility study. Neurorehabil Neural Repair. 2004;18:66 –75. Number 8 9 Dickstein R, Dunsky A, Marcovitz E. Motor imagery for gait rehabilitation in poststroke hemiparesis. Phys Ther. 2004;84: 1167–1177. 10 Dunsky A, Dickstein R, Arjav C, et al. Motor imagery practice in gait rehabilitation of chronic post-stroke hemiparesis: four case studies. Int J Rehabil Res. 2006; 29:351–356. 11 Lamontagne A, Fung J. Faster is better: implications for speed-intensive gait training after stroke. Stroke. 2004;35:2543– 2548. 12 Hwang S, Jeon HS, Yi CH, et al. Locomotor imagery training improves gait performance in people with chronic hemiparetic stroke: a controlled clinical trial. Clin Rehabil. 2010;24:514 –522. 13 Malouin F, Richards CL. Mental practice for relearning locomotor skills. Phys Ther. 2010;90:240 –251. 14 Lotze M, Heymans U, Birbaumer N, et al. Differential cerebral activation during observation of expressive gestures and motor acts. Neuropsychologia. 2006;44: 1787–1795. 15 Munzert J, Lorey B, Zentgraf K. Cognitive motor processes: the role of motor imagery in the study of motor representations. Brain Res Rev. 2009;60:306 –326. 16 Guillot A, Collet C. The Neurophysiological Foundation of Mental and Motor Imagery. Oxford, NY: Oxford University Press; 2010. 17 Weinberg RS, Gould D. Foundations of Sport and Exercise Psychology. 5th ed. Champaign, IL: Human Kinetics Inc; 2011: 293–316. 18 Paivio A. Cognitive and motivational functions of imagery in human performance. Can J Appl Sport Sci. 1985;10:22S–28S. 19 Short SE, Tenute A, Feltz DL. Imagery use in sport: mediational effects for efficacy. J Sports Sci. 2005:23:951–960. 20 Cumming J, Hall C. Athletes’ use of imagery in the off-season. Sport Psychologist. 2002;16:160 –172. 21 Beauchamp MR, Bray SR, Albinson JG. Precompetition imagery, self-efficacy and performance in collegiate golfers. J Sports Sci. 2002;20:697–705. 22 Salmon J, Hall CR. The use of imagery by soccer players. J Appl Sport Psychology. 1994;6:116 –133. 23 Glazier SR, Schuman J, Keltz E, et al. Taking the next steps in goal ascertainment: a prospective study of patient, team, and family perspectives using a comprehensive standardized menu in a geriatric assessment and treatment unit. J Am Geriatr Soc. 2004;52:284 –289. 24 Cott CA. Client-centred rehabilitation: client perspectives. Disabil Rehabil. 2004; 26:1411–1422. 25 Locke EA, Latham GP. Building a practically useful theory of goal setting and task motivation: a 35-year odyssey. Am Psychol. 2002;57:705–717. August 2012 Integrated Motor Imagery at Home to Improve Walking After Stroke 26 von Koch L, de Pedro-Cuesta J, Kostulas V, et al. Randomized controlled trial of rehabilitation at home after stroke: one-year follow-up of patient outcome, resource use and cost. Cerebrovasc Dis. 2001;12: 131–138. 27 von Koch L, Wottrich AW, Holmqvist LW. Rehabilitation in the home versus the hospital: the importance of context. Disabil Rehabil. 1998;20:367–372. 28 Dijkerman HC, Ietswaart M, Johnston M, MacWalter RS. Does motor imagery training improve hand function in chronic stroke patients? A pilot study. Clin Rehabil. 2004;18:538 –549. 29 Rodriquez AA, Black PO, Kile KA, et al. Gait training efficacy using a home-based practice model in chronic hemiplegia. Arch Phys Med Rehabil. 1996;77:801– 805. 30 Morgan RO, Virnig BA, Duque M, et al. Low-intensity exercise and reduction of the risk for falls among at-risk elders. J Gerontol A Biol Sci Med Sci. 2004;59: 1062–1067. 31 Holden MK. Virtual environment-based telerehabilitation in patients with stroke. Presence: Teleoperators Virtual Environments. 2005;14:214 –233. 32 Piron L, Turolla A, Agostini M, et al. Exercises for paretic upper limb after stroke: a combined virtual-reality and telemedicine approach. J Rehabil Med. 2009;41:1016 – 1102. 33 Carey JR, Durfee WK, Bhatt E, et al. Comparison of finger tracking versus simple movement training via telerehabilitation to alter hand function and cortical reorganization after stroke. Neurorehabil Neural Repair. 2007;21:216 –232. 34 Lewis JA, Boian RF, Burdea G, Deutsch JE. Remote console for virtual telerehabilitation. Stud Health Technol Inform. 2005; 111:294 –300. 35 Schenkman M, Deutsch JE, Gill-Body KM. An integrated framework for decision making in neurologic physical therapist practice. Phys Ther. 2006;86:1681–1702. 36 Malouin F, Richards CL, Jackson PL, et al. The Kinesthetic and Visual Imagery Questionnaire (KVIQ) for assessing motor imagery in persons with physical disabilities: a reliability and construct validity study. J Neurol Phys Ther. 2007;31:20 –29. 37 Malouin F, Richards CL, Durand A, Doyon J. Reliability of mental chronometry for assessing motor imagery ability after stroke. Arch Phys Med Rehabil. 2008;89: 311–319. 38 Wechsler D, Hartogs R. The clinical measurement of anxiety: an experimental approach. Psychiatr Q. 1945;19:618 – 635. 39 Nadeau S, Arsenault AB, Gravel D, Bourbonnais D. Analysis of the clinical factors determining natural and maximal gait speeds in adults with a stroke. Am J Phys Med Rehabil. 1999;78:123–130. August 2012 40 Platz T, Pinkowski C, van Wijck F, et al. Reliability and validity of arm function assessment with standardized guidelines for the Fugl-Meyer Test, Action Research Arm Test and Box and Block Test: a multicentre study. Clin Rehabil. 2005;19: 404 – 411. 41 Bowden MG, Balasubramanian CK, Behrman AL, Kautz SA. Validation of a speed-based classification system using quantitative measures of walking performance poststroke. Neurorehabil Neural Repair. 2008;22:672– 675. 42 Patterson SL, Forrester LW, Rodgers MM, et al. Determinants of walking function after stroke: differences by deficit severity. Arch Phys Med Rehabil. 2007;88:115– 119. 43 Botner EM, Miller WC, Eng JJ. Measurement properties of the Activities-specific Balance Confidence Scale among individuals with stroke. Disabil Rehabil. 2005; 27:156 –163. 44 Lajoie Y, Gallagher SP. Predicting falls within the elderly community: comparison of postural sway, reaction time, the Berg balance scale and the Activitiesspecific Balance Confidence (ABC) scale for comparing fallers and non-fallers. Arch Gerontol Geriatr. 2004;38:11–26. 45 Flansbjer UB, Holmback AM, Downham D, et al. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005;37:75– 82. 46 Hofheinz M, Schusterschitz C. Dual task interference in estimating the risk of falls and measuring change: a comparative, psychometric study of four measurements. Clin Rehabil. 2010;24:831– 842. 47 Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000; 80:896 –903. 48 McEwen I. Writing Case Reports. 3rd ed. Alexandria, VA: American Physical Therapy Association; 2009. 49 Lewis JR. IBM computer usability satisfaction questionnaires: psychometric evaluation and instructions for use. Int J Hum Comput Interact. 1995;7:57–78. 50 Guide to Physical Therapist Practice. 2nd ed. Phys Ther. 2001;81:9 –746. 51 Allami N, Paulignan Y, Brovelli A, Boussaoud D. Visuo-motor learning with combination of different rates of motor imagery and physical practice. Exp Brain Res. 2008;184:105–113. 52 Malouin F, Richards CL, Durand A, et al. Effects of practice, visual loss, limb amputation, and disuse on motor imagery vividness. Neurorehabil Neural Repair. 2009; 23:449 – 463. 53 Dunsky A, Dickstein R, Marcovitz E, et al. Home-based motor imagery training for gait rehabilitation of people with chronic poststroke hemiparesis [erratum in: Arch Phys Med Rehabil. 2008;89:2223]. Arch Phys Med Rehabil. 2008;89:1580 –1588. 54 Nelson ME, Layne JE, Bernstein MJ, et al. The effects of multidimensional homebased exercise on functional performance in elderly people. J Gerontol A Biol Sci Med Sci. 2004;59:154 –160. 55 Salbach NM, Mayo NE, RobichaudEkstrand S, et al. The effect of a taskoriented walking intervention on improving balance self-efficacy poststroke: a randomized, controlled trial [erratum in: J Am Geriatr Soc. 2005;53:1450]. J Am Geriatr Soc. 2005;53:576 –582. 56 Gentile AM. Skill acquisition: action, movement, and neuromotor processes. In: Carr JH, Shepard RB, eds. Movement Science: Foundations for Physical Therapy. Rockville, MD: Aspen Publishers; 2000: 93–154. 57 Hedman LD, Rogers MW, Hanke TA. Neurologic professional education: lining the foundation science of motor control with physical therapy interventions for movement dysfunction. J Neurologic Phys Ther. 1996;20:9 –13. 58 Green L. The use of imagery in the rehabilitation of injured athletes. In: Sheikh AA, Korn ER, eds. Imagery in Sport and Physical Performance. New York, NY: Baywood Publishing Co; 1994:157–174. 59 Riccio CM, Nelson DL, Bush MA. Adding purpose to the repetitive exercise of elderly women through imagery. Am J Occup Ther. 1990;44:714 –719. 60 Scully D, Kremer J. Imagery, mental rehearsal and visualization. In: Butler R, ed. Sports Psychology in Performance. Oxford, United Kingdom: Butterworth Heinemann; 1997:158 –162. 61 Perry J, Garrett M, Gronley JK, Mulroy SJ. Classification of walking handicap in the stroke population. Stroke. 1995;26:982– 989. 62 Leach E, Cornwell P, Fleming J, Haines T. Patient centered goal-setting in a subacute rehabilitation setting. Disabil Rehabil. 2010:159 –172. 63 Talbot LR, Viscogliosi C, Desrosiers J, et al. Identification of rehabilitation needs after a stroke: an exploratory study. Health Qual Life Outcomes. 2004;2:53. 64 Batson G, Deutsch JE. Use of Feldenkrais to improve balance in individuals poststroke. Complement Health Pract Rev. 2005;10:203–210. 65 Collen FM, Wade DT, Bradshaw CM. Mobility after stroke: reliability of measures of impairment and disability. Int Disabil Stud. 1990;12:6 –9. 66 Eng JJ, Dawson AS, Chu KS. Submaximal exercise in persons with stroke: test-retest reliability and concurrent validity with maximal oxygen consumption. Arch Phys Med Rehabil. 2004;85:113–118. Volume 92 Number 8 Physical Therapy f 1075 Integrated Motor Imagery at Home to Improve Walking After Stroke Appendix. Script Goal: To safely walk from her apartment to the parking lot while it is raining. You are standing at the hallway next to your apartment door, holding an umbrella in one hand and your handbag in the other hand. Visual cue: See yourself starting to walk toward the entrance of the building. Kinesthetic cue: Feel your right heel as it touches the floor and your weight as it shifts forward toward your right leg. Feel your right foot push against the floor and advance forward. Pause (the clinician stopped the script and gave the patient time to imagine) Visual cue: Notice that you pass the last door before the hallway opening next to the building entrance. Kinesthetic cue: Continue walking, feeling the weight of the umbrella on one hand and the heaviness of the handbag on the other hand. Pause Visual cue: See that you are approaching the front door of the building. You open the door by pressing the “open” button. The door is opening, and you see that it is raining outside. You feel nervous because you are concerned that the sidewalks are slippery. Problem solving: You take a deep breath, stop, open your umbrella, and plan your route to the car. Pause You start walking carefully toward your car. The sidewalk is slippery. Problem solving: You keep your balance and continue walking. Kinesthetic cue: Feel your right heel touch the floor carefully but securely and your weight shift forward on your foot. You are confident with your steps and feel safe. Pause You keep walking on the sidewalk toward your car. Notice that there is someone running toward you trying to get into the building to avoid getting wet. You are worried that he will bump into you. Problem solving: You pause and wait for him to pass. You feel happy that you avoided a collision. Pause (Continued) 1076 f Physical Therapy Volume 92 Number 8 August 2012 Integrated Motor Imagery at Home to Improve Walking After Stroke Appendix. Continued You continue walking; you pass the first car, and your car is the next one. You are approaching your car. You are about to step down from the curb to the road to open your car’s door. The water is running as a stream by the edge of the road. Problem solving: You step carefully. Pause Problem solving: You take out your keys and open the door while managing the bag and the umbrella. Now you are pleased that you got into the car, and you feel relieved and satisfied to be inside it. You are so happy to be in the car dry and safe. Debriefing (statements made by patient): “I was afraid about slipping and managing the umbrella and the bag. . . .” “It helped to pause and plan my walk. . .this way I did not panic. . .I was paying attention.” August 2012 Volume 92 Number 8 Physical Therapy f 1077 Health Policy in Perspective Rothstein Roundtable Podcast—“Medical Homes, PACA, IFDS—Where Do Physical Therapists Fit in a Reforming Health Care Environment? ” Panelists: Stacey Cochran-Comstock, Anthony Delitto, Carolyn Oddo. Moderator: Everette James. A t PT 2012 in Tampa, Florida, on June 8, 2012, the Rothstein Roundtable featured frontline physical therapists who are defining the role of the physical therapist—and demonstrating the value of physical therapy services—in innovative environments consistent with health care reform initiatives, such as medical homes and integrated financial delivery systems. They discussed challenges and opportunities, barriers to success, and strategies to overcome those barriers. As former Pennsylvania Secretary of Health, Moderator Everette James oversaw the regulation of all of the hospitals, nursing homes, and managed care plans in Pennsylvania and brought a broad scope to the roundtable. Cochran-Comstock, Delitto, and Oddo discussed their innovations in incorporating physical therapy in the management of acute and outpatient care services in disadvantaged populations and in managing high-cost conditions such as low back pain. The podcast is available at: http://ptjournal.apta.org/content/92/8/1078/suppl/DC1 S. Cochran-Comstock, PT, DPT, CSCS, Physical Therapist, Providence Portland Medical Center, Portland, Oregon. A. Delitto, PT, PhD, FAPTA, PTJ’s Chair of the Rothstein Roundtable, Professor and Associate Dean for Research, School of Health and Rehabilitation Sciences, and Director of Research Comprehensive Spine Center, University of Pittsburgh; and Vice President for Education and Research Centers for Rehabilitation Services (formerly CORE Network), Pittsburgh, Pennsylvania. C. Oddo, PT, FACHE, Vice President for Operations Support/Associate Administrator, Harris County Hospital District, Houston, Texas. E. James, JD, MBA, Associate Vice Chancellor for Health Policy and Planning, Schools of the Health Sciences, and Professor of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh. [DOI: 10.2522/ptj.2012.92.8.1078]. 1078 f Physical Therapy Volume 92 Number 8 August 2012 Corrections Kersten RF, Stevens M, van Raay JJAM, et al. Habitual physical activity after total knee replacement: analysis in 830 patients and comparison with a sex- and age-matched normative population. Phys Ther. doi: 10.2522/ptj.20110273. On May 24, 2012, “Habitual Physical Activity After Total Knee Replacement: Analysis in 830 Patients and Comparison With a Sex- and Age-Matched Normative Population” by Kersten RF, Stevens M, van Raay JJAM, et al1 was published online ahead of print in Physical Therapy (PTJ). In the June 2012 issue of Journal of Physiotherapy, “After Total Knee Arthroplasty, Many People Are Not Active Enough to Maintain Their Health and Fitness: An Observational Study” by Groen J-W, Stevens M, Kersten RFMR, et al2 was published. These two related articles, both of which reported on the same sample of subjects, were written and published each without recognizing the other. The first article aims to report the habitual physical activity behavior of patients with total knee arthroplasty and provides detailed data on number of minutes of activity per week spent in total, on different intensity categories, on different activity categories, and on separate activities (walking and cycling). These data were reported for male and female patients separately and for different age categories. Moreover, these data were compared with a normative group. The second article focuses on the adherence to different health and fitness guidelines and which factors contribute to these. Although two different research questions are addressed in both articles, it is relevant for the reader to know that these two papers are related. We regret omitting this information from our articles. Martin Stevens, PhD Department of Orthopedics Univesity Medical Center Groningen University of Groningen Inge van den Akker-Scheek, PhD Department of Orthopedics Martini Hosptial Groningen Department of Orthopedics University Medical Center Groningen Unviersity of Groningen Groningen, The Netherlands References 1 Kersten RF, Stevens M, van Raay JJAM, et al. Habitual physical activity after total knee replacement: analysis in 830 patients and comparison with a sex- and age-matched normative population [published online ahead of print May 24, 2012]. Phys Ther. doi: 10.2522/20110273. 2 Groen J-W, Stevens M, Kersten RFMR, et al. After total knee arthroplasty, many people are not active enough to maintain their health and fitness: an observational study. Journal of Physiotherapy. 2012;58:113–116. [DOI: 10.2522/ptj.20110273.cx] Niemeijer AS, Reinders-Messelink HA, Disseldorp LM, et al. Feasibility, reliability, and agreement of the WeeFIM instrument in Dutch children with burns. Phys Ther. 2012;92:958–966. In the July 2012 article by Niemeijer et al titled “Feasibility, Reliability, and Agreement of the WeeFIM Instrument in Dutch Children With Burns,” the equation for calculation of minimal or least detectable difference (LDD) was presented incorrectly in the “Method” and “Results” sections as ξʹ ൈ ͳǤͻ ൈ rather than ξʹ × 1.96 × SEM. The statements, with corrected equation, in those sections should be: Taking .05 as the significance level, the LDD equaled ξʹ × 1.96 × SEM. The LDD on the total score between 2 raters was ξʹ × 1.96 × 3.7=10.3 points. The Journal regrets the errors. [DOI: 10.2522/ptj.20110419.cx] August 2012 Erratum 8.12.indd 1079 Volume 92 Number 8 Physical Therapy ■ 1079 7/18/12 3:43 PM Assessing Competence: A Resource Manual An Invaluable Tool for Employers and Clinicians Designed to help both employers and physical therapists, this resource manual features reviews of nine of the most common methods for measuring competence: Order No. E-60 Regular Price: $87.00 APTA Member price: $51.95 To order, call APTA’s Member Services Department at 800/999-APTA (2782), ext 3395, Mon-Fri, 8:30 am-6:00 pm, EST or order online at www.apta.org. • Case report • Chart review • Outcome measurements • Employee performance appraisal • Portfolio review • Key-feature problems/examinations • Self-assessment • Competence checklists • Proficiency testing Assessing Competence provides samples and updated references and resources. Employers can use the manual to develop methods for assessing their employees’ performance. Clinicians can use it to evaluate the strengths and weaknesses of their practices. As a self-assessment tool, it can help guide your professional development now and in the future. My APTA Brings More Patients to My Practice With Find a PT. When health care consumers need physical therapy, they rely on APTA’s Find a PT. This searchable database connects patients with clinicians who fit their needs. To register and reach prospective patients: • Specify one or more locations and areas of expertise • Describe your educational background and accomplishments • Clarify which types of insurance your practice accepts, and more! Visit www.apta.org/findapt to register or update your profile. Not a Member Yet? Visit www.apta.org/join or call 800/999-2782, ext 3395 to join. Scholarships, Fellowships, and Grants News from the Foundation for Physical Therapy Foundation Alumni Publications “A Three-Compartment Muscle Fatigue Model Accurately Predicts Joint-Specific Maximum Endurance Times for Sustained Isometric Tasks,” by Frey-Law LA, Looft JM, and Heitsman J, was published online in the Journal of Biomechanics on May 9, 2012. Laura A. Frey-Law, PT, PhD, was awarded a Mary McMillan Doctoral Scholarship in 2000, a Promotion of Doctoral Studies (PODS) I scholarship in 2001, and a PODS II scholarship in 2002. “Tibiofemoral and Patellofemoral Mechanics Are Altered at Small Knee Flexion Angles in People With Patellofemoral Pain,” by Salsich GB and Perman WH, was published online in the Journal of Sports Science and Medicine on May 9, 2012. Gretchen B. Salsich, PT, PhD, was awarded a New Investigator Fellowship Training Initiative (NIFTI) in 1999. “Early Complexity Supports Development of Motor Behaviors in the First Months of Life,” by Dusing SC, Thacker LR, Stergiou N, and Galloway JC, was published online in Developmental Psychobiology on May 9, 2012. Stacey C. Dusing, PT, PhD, was awarded a Mary McMillan Doctoral Scholarship in 2002 and a PODS II scholarship in 2005. “Improvements in Balance in Older Adults Engaged in a Specialized Home Care Falls Prevention Program,” by Whitney SL, Marchetti GF, Ellis JL, and Otis L, was published online in the Journal of Geriatric Physical Therapy on May 8, 2012. Susan L. Whitney, PT, DPT, PhD, NCS, ATC, FAPTA, was awarded a Doctoral Training Research Grant in 1989. August 2012 Foundation 8.12.indd 1081 “Quadriceps Muscle Weakness, Activation Deficits, and Fatigue With Parkinson Disease,” by Stevens-Lapsley J, Kluger BM, and Schenkman M, was published in Neurorehabilitation and Neural Repair (2012;26:533–541). Jennifer E. Stevens-Lapsley, PT, MPT, PhD, was awarded a PODS I scholarship in 2000, a PODS II scholarship at 2001, and a Pittsburgh–Marquette Challenge Research Grant in 2007. Margaret L. Schenkman, PT, PhD, FAPTA, was awarded a Doctoral Training Research Grant in 1990 and a Orthopaedic Section Research Grant in 2001. “Rehabilitation and Parkinson’s Disease,” by Earhart GM, Ellis T, Nieuwboer A, and Dibble LE, was published online in the Journal of Parkinson’s Disease on April 5, 2012. Gammon M. Earhart, PT, PhD, was awarded a PODS II scholarship in 1999. Leland E. Dibble, PT, PhD, ATC, was awarded a Geriatric Section Research Grant in 2004. Foundation Announces Winning Schools of Pittsburgh–Marquette Challenge The Foundation announced the winners of the Pittsburgh–Marquette Challenge at its annual gala on June 7 in Tampa, Florida. Physical therapist and physical therapist assistant students from 65 schools across the country raised $240,201 to support physical therapy research. In 24 years, the Challenge has raised more than $2,000,000 to benefit the Foundation. Congratulations to the winners of the Pittsburgh–Marquette Challenge: • 1st Place: University of Pittsburgh ($50,000) • 2nd Place: Virginia Commonwealth University ($14,288.18) • 3rd Place: Sacred Heart University ($13,822.60). The Foundation would also like to recognize the Marquette University students for their financial commitment to the Challenge in donating $20,000. Award of Excellence (donating $10,000 or more): The University of Oklahoma Health Sciences Center. Award of Merit (donating $6,000 or more): Mayo School of Health Sciences, New York University, Quinnipiac University, Rosalind Franklin University of Medicine & Science, and University of Alabama at Birmingham. Honorable Mention (donating $3,000 or more): Arcadia University, Boston University, Creighton University, Emory University, Indiana University, Massachusetts College of Pharmacy & Health Science–Worcester, MGH Institute of Health Professions, Midwestern University, Northeastern University, Northwestern University, Somerset Community College, UMDNJ and Rutgers–Camden, University of Colorado–Denver, University of Delaware, University of Iowa, University of Miami, University of North Carolina–Chapel Hill, University of St Augustine, and Washington University in St Louis. Special Awards: • Most Successful Newcomer: Massachusetts College of Pharmacy & Health Science–Worcester • Biggest Stretch School: Quinnipiac University • Most Successful PTA School: Somerset Community College. Volume 92 Number 8 Physical Therapy ■ 1081 7/13/12 4:21 PM Scholarships, Fellowships, and Grants We’d also like to thank the rest of the participating schools: The Foundation alumni 2012 Fellows include: A.T. Still University, Clarkson University, Cleveland State, Concordia University Wisconsin, Daemen College, Elon University, George Washington University, Governors State University, Hardin-Simmons University, Jefferson Community & Technical College, Long Island University, Louisiana State University Health Science Center in Shreveport, Marymount University, Nazareth College of Rochester, Ohio University, Ohio State University, Pennsylvania State University, Simmons College, St Ambrose University, Temple University, Texas Woman’s University–Houston, Thomas Jefferson University, University of Evansville, University of Findlay, University of Hartford, University of Nebraska, University of Nevada Las Vegas, University of Saint Francis, University of South Dakota, University of Southern California, University of the Sciences, University of Wisconsin–Madison, Walsh University, Western University of Health Science, Wichita State University, and Youngstown State University. • Janet L. Gwyer, PT, PhD, FAPTA (1980 Doctoral Training Research Grant [DTRG]) The 2012–2013 Pittsburgh–Marquette Challenge kicks off at the National Student Conclave in Arlington, Virginia, on November 2, 2012. Foundation Alumni Honored at PT 2012 Congratulations to the Foundation alumni named as 2012 Catherine Worthingham Fellows of APTA. The FAPTA designation is the highest honor among APTA’s membership categories and is given to physical therapist members of the association whose contributions to the physical therapy profession through leadership, influence, and achievements have demonstrated frequent and sustained efforts to advance the profession. • Ellen Hillegass, PT, EdD, CCS, FAACVPR, FAPTA (1995 DTRG) • Wayne A. Stuberg, PT, PhD, PCS, FAPTA (1987 DTRG, 2003 Pediatric Research Grant) • Rita Wong, PT, EdD, FAPTA (1988 DTRG). Congratulations to the Foundation alumni who received other awards at APTA’s annual conference. • Edelle Field-Fote, PT, PhD (1994 DTRG)—Chattanooga Research Award • Kathryn E. Roach, PT, PhD (1987, 1994 DTRG)—Chattanooga Research Award • Lynn Snyder-Mackler, PT, ScD, SCS, FAPTA (1988, 1991 DTRG)— Helen J. Hislop Award for Outstanding Contributions to Professional Literature • Allison Hyngstrom, PT, PhD (2003 PODS I, 2004 PODS II)— Eugene Michels New Investigator Award • Robert Palisano, PT, ScD, FAPTA (1984 DTRG)—Marian Williams Award for Research in Physical Therapy. Congratulations and Kudos Jonathan Dropkin, PT, ScD (2010 PODS II), successfully defended his dissertation and received his post-professional doctoral degree in May from the University of Massachusetts, Lowell. Share Your Research News and Announcements To have your information posted in the Foundation’s section of Physical Therapy, please e-mail Rachael Crockett at RachaelCrockett@ Foundation4PT.org. Stay Connected in 3 Easy Ways 1. www.facebook.com/foundation 4PT. 2. Check out our Foundation4PT.org. website: 3. Subscribe to our monthly newsletter for updates on our donors, Foundation alumni, events, and much more! E-mail Rachael [email protected] to sign up today. [DOI: 10.2522/ptj.2012.92.8.1081] Keith Avin, PT, PhD (2008 Kendall Doctoral Scholarship, 2009 PODS I, 2010 PODS II) received his post-professional doctoral degree in May from the University of Iowa after successfully defending his dissertation. His training will continue at the University of Pittsburgh through a T32 post-doctoral training award. 1082 ■ Physical Therapy Volume 92 Number 8 Foundation 8.12.indd 1082 Andrew Littmann, PT, PhD (2006 Kendall, 2007, 2008 PODS I, 2009 PODS II) successfully defended his dissertation and graduated from the University of Iowa in May. Dr. Littmann will be joining the faculty at Regis University in Denver, Colorado. August 2012 7/13/12 4:21 PM Product Highlights BROAD SPECTRUM POWER A powerful disinfectant safe for sensitive equipment... That’s Protex Disinfectant Spray is a powerful one step disinfectant effective against a broad spectrum of pathogens, including Influenza Type A (H1N1), MRSA, Staph, HIV, and many others. Protex is ideal for disinfecting nonporous athletic/ wrestling mats, exercise equipment, training tables, stainless steel as well as vinyl and plastic upholstery. www.parkerlabs.com (Continued) Index to General Information Found at: www.apta.org Physical Therapy (PTJ) Accredited Education Programs ............http://www.capteonline.org/Programs/ Awards ..................... http://www.apta.org/HonorsAwards/ Bylaws ................................. http://www.apta.org/Policies/ Call for Nominations .......... http://www.apta.org/Elections/ Code of Ethics .................................... http://www.apta.org/ CoreDocuments/ Abstracts of Papers Accepted for Presentation at Annual Conference (added every May) ............................ ptjournal.apta.org/ site/misc/annualcon.xhtml Submission Guidelines .......................... ptjournal.apta.org/ site/misc/ifora.xhtml In Memoriam............................................................March Mary McMillan Lecture ......................................September Membership Statistics ..................................................June Presidential Address ...........................................September Statement of Ownership .....................................December August 2012 Product_8.12.indd 1083 Volume 92 Number 8 Physical Therapy ■ 1083 7/13/12 4:22 PM Product Highlights Visit Pfizerpro.com/thermacare to register for samples. Want to give your patients up to 1 ThermaCare® provides 8 hours of relief while your patients are wearing the HeatWrap, plus an additional 8 hours of relief after they take it off.1-3 Use as directed. References: 1. Nadler SF, Steiner DJ, Erasala GN, et al. Continuous low-level heat wrap therapy provides more efficacy than ibuprofen and acetaminophen for acute low back pain. Spine. 2002;27(10):10121017. 2. Nadler SF, Steiner DJ, Erasala GN, Hengehold DA, Abeln SB, Weingand KW. Continuous low-level heatwrap therapy for treating acute nonspecific low back pain. Arch Phys Med Rehabil. 2003;84(3):329-334. 3. Nadler SF, Steiner DJ, Petty SR, Erasala GN, Hengehold DA, Weingand KW. Overnight use of continuous low-level heatwrap therapy for relief of low back pain. Arch Phys Med Rehabil. 2003 ;84 ( 3 ):335-342. ©2012 Pfizer Inc. 05/12 THC041215 ThermaCare.com Ad Index Interacoustics................................................ Cover 3 Parker Laboratories ....................................... Cover 4 ThermaCare.................................................. Cover 2 APTA Products and Services APTA Marketplace ............................................... 981 Assessing Competence: A Resource Manual .......... 1080 Guidelines for Clinicians ........................................ 986 Membership ..................................................... 1080 Request FREE Product Information on products advertised in PTJ. Go to APTA’s online resource at: http://www.apta.org/freeproductinfo 1084 ■ Physical Therapy Volume 92 Number 8 Product_8.12.indd 1084 August 2012 7/18/12 3:27 PM