Study Summary
This trial will explore whether a condensed version of CI therapy can be just as effective as the original protocol while being more time/resource friendly.
Eligible Conditions
- Stroke
- Weakness of the Upper Extremity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 2 Secondary · Reporting Duration: 3 months after the end of the treatment.
Month 3
Canadian Occupational Performance Measure (COPM)
Motor Activity Log (MAL)
Stroke Impact Scale (SIS)
Wolf Motor Function Test (WMFT)
Zung Self-Rating Depression Scale
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Keys intervention
1 of 1
Experimental Treatment
16 Total Participants · 1 Treatment Group
Primary Treatment: Keys Constraint-induced Movement Therapy protocol · No Placebo Group · N/A
Keys intervention
Behavioral
Experimental Group · 1 Intervention: Keys Constraint-induced Movement Therapy protocol · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months after the end of the treatment.
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,446 Previous Clinical Trials
2,235,630 Total Patients Enrolled
33 Trials studying Stroke
47,513 Patients Enrolled for Stroke
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are able to move your more affected arm and hand to certain positions, like extending your wrist, moving your thumb away from your hand, and straightening some of your fingers.
Your test score on the MAL indicates that you have significant difficulties using your more affected arm/hand.
You have had a stroke at least 6 months ago.
Who else is applying?
What state do they live in?
| Alabama | 50.0% |
| Maine | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Alabama at Birmingham | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Typically responds via
| Phone Call | 100.0% |
Most responsive sites:
- University of Alabama at Birmingham: < 24 hours
Average response time
- < 2 Days
References
- Virani, Salim S., Alvaro Alonso, Emelia J. Benjamin, Marcio S. Bittencourt, Clifton W. Callaway, April P. Carson, Alanna M. Chamberlain, et al.. 2020. “Heart Disease and Stroke Statistics—2020 Update: A Report from the American Heart Association”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0000000000000757.
- Wolf, Steven L, Carolee J Winstein, J Phillip Miller, Paul A Thompson, Edward Taub, Gitendra Uswatte, David Morris, Sarah Blanton, Deborah Nichols-Larsen, and Patricia C Clark. 2008. “Retention of Upper Limb Function in Stroke Survivors Who Have Received Constraint-induced Movement Therapy: The EXCITE Randomised Trial”. The Lancet Neurology. Elsevier BV. doi:10.1016/s1474-4422(07)70294-6.
- Uswatte, G., E. Taub, D. Morris, K. Light, and P. A. Thompson. 2006. “The Motor Activity Log-28: Assessing Daily Use of the Hemiparetic Arm After Stroke”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/01.wnl.0000238164.90657.c2.
- Brogårdh, Christina, and Bengt H Sjölund. 2006. “Constraint-induced Movement Therapy in Patients with Stroke: A Pilot Study on Effects of Small Group Training and of Extended Mitt Use”. Clinical Rehabilitation. SAGE Publications. doi:10.1191/0269215506cr937oa.
- Taub, Edward, Gitendra Uswatte, Victor W. Mark, David M. Morris, Joydip Barman, Mary H. Bowman, Camille Bryson, Adriana Delgado, and Staci Bishop-McKay. 2013. “Method for Enhancing Real-world Use of a More Affected Arm in Chronic Stroke”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/strokeaha.111.000559.
- Morris, David M., Gitendra Uswatte, Jean E. Crago, Edwin W. Cook III, and Edward Taub. 2001. “The Reliability of the Wolf Motor Function Test for Assessing Upper Extremity Function After Stroke”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1053/apmr.2001.23183.
- Morris, David M., Edward Taub, David M. Macrina, Edwin W. Cook, and Brian F. Geiger. 2009. “A Method for Standardizing Procedures in Rehabilitation: Use in the Extremity Constraint Induced Therapy Evaluation Multisite Randomized Controlled Trial”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2008.09.576.
- Taub, Edward, Jean E. Crago, Louis D. Burgio, Thomas E. Groomes, Edwin W. Cook III, Stephanie C. DeLuca, and Neal E. Miller. 1994. “An Operant Approach to Rehabilitation Medicine: Overcoming Learned Nonuse by Shaping”. Journal of the Experimental Analysis of Behavior. Wiley. doi:10.1901/jeab.1994.61-281.
- Viana, Ricardo, and Robert Teasell. 2012. “Barriers to the Implementation of Constraint-induced Movement Therapy into Practice”. Topics in Stroke Rehabilitation. Informa UK Limited. doi:10.1310/tsr1902-104.
- Andrabi, Mudasir, Edward Taub, Staci Mckay Bishop, David Morris, and Gitendra Uswatte. 2021. “Acceptability of Constraint Induced Movement Therapy: Influence of Perceived Difficulty and Expected Treatment Outcome”. Topics in Stroke Rehabilitation. Informa UK Limited. doi:10.1080/10749357.2021.1956046.
- Shi, Yue X., Jin H. Tian, Ke H. Yang, and Yue Zhao. 2011. “Modified Constraint-induced Movement Therapy Versus Traditional Rehabilitation in Patients with Upper-extremity Dysfunction After Stroke: A Systematic Review and Meta-analysis”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2010.12.036.
- Fleet, Alana, Marion Che, Marilyn MacKay-Lyons, Diane MacKenzie, Stephen Page, Gail Eskes, Alison McDonald, Joy Boyce, and Shaun Boe. 2014. “Examining the Use of Constraint-induced Movement Therapy in Canadian Neurological Occupational and Physical Therapy”. Physiotherapy Canada. University of Toronto Press Inc. (UTPress). doi:10.3138/ptc.2012-61.
- Woodbury, Michelle L., Dena R. Howland, Theresa E. McGuirk, Sandra B. Davis, Claudia R. Senesac, Steve Kautz, and Lorie G. Richards. 2008. “Effects of Trunk Restraint Combined with Intensive Task Practice on Poststroke Upper Extremity Reach and Function: A Pilot Study”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968308318836.
- ZUNG, WILLIAM W. K.. 1965. “A Self-rating Depression Scale”. Archives of General Psychiatry. American Medical Association (AMA). doi:10.1001/archpsyc.1965.01720310065008.
- Thrasher, T. Adam, Vera Zivanovic, William McIlroy, and Milos R. Popovic. 2008. “Rehabilitation of Reaching and Grasping Function in Severe Hemiplegic Patients Using Functional Electrical Stimulation Therapy”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968308317436.
- Toomey, Moira, Donna Nicholson, and Anne Carswell. 1995. “The clinical utility of the canadian occupational performance measure”. Canadian journal of occupational therapy. SAGE Publications. doi:10.1177/000841749506200503.
- Duncan, Pamela W., Dennis Wallace, Sue Min Lai, Dallas Johnson, Susan Embretson, and Louise Jacobs Laster. 1999. “The Stroke Impact Scale Version 2.0”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.str.30.10.2131.
- Pedlow, Katy, Sheila Lennon, and Colin Wilson. 2014. “Application of Constraint-induced Movement Therapy in Clinical Practice: An Online Survey”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2013.08.240.
- Andrabi M, Taub E, Mckay Bishop S, Morris D, Uswatte G. Acceptability of constraint induced movement therapy: influence of perceived difficulty and expected treatment outcome. Top Stroke Rehabil. 2022 Oct;29(7):507-515. doi: 10.1080/10749357.2021.1956046. Epub 2021 Aug 23.
- Viana R, Teasell R. Barriers to the implementation of constraint-induced movement therapy into practice. Top Stroke Rehabil. 2012 Mar-Apr;19(2):104-14. doi: 10.1310/tsr1902-104.
- Toomey M, Nicholson D, Carswell A. The clinical utility of the Canadian Occupational Performance Measure. Can J Occup Ther. 1995 Dec;62(5):242-9. doi: 10.1177/000841749506200503.
- Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.
- Duncan PW, Wallace D, Lai SM, Johnson D, Embretson S, Laster LJ. The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Stroke. 1999 Oct;30(10):2131-40. doi: 10.1161/01.str.30.10.2131.
- Shi YX, Tian JH, Yang KH, Zhao Y. Modified constraint-induced movement therapy versus traditional rehabilitation in patients with upper-extremity dysfunction after stroke: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2011 Jun;92(6):972-82. doi: 10.1016/j.apmr.2010.12.036.
- Wolf SL, Winstein CJ, Miller JP, Thompson PA, Taub E, Uswatte G, Morris D, Blanton S, Nichols-Larsen D, Clark PC. Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. Lancet Neurol. 2008 Jan;7(1):33-40. doi: 10.1016/S1474-4422(07)70294-6.
- Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.
- ZUNG WW. A SELF-RATING DEPRESSION SCALE. Arch Gen Psychiatry. 1965 Jan;12:63-70. doi: 10.1001/archpsyc.1965.01720310065008. No abstract available.
- Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.
- Sarah Monteiro Dos Anjos, PhD 2022. "Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05311384.
Frequently Asked Questions
What is the upper limit to the number of people who can join this research project?
"That is correct, a quick glance at the information provided on clinicaltrials.gov reveals that this trial is still recruiting patients. The first posting was on 4/20/2022 and the most recent update was on 5/6/2022. Presently, the trial needs 16 patients from 1 locations." - Anonymous Online Contributor
Unverified Answer