Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
Constraint-Induced Therapy (CI Therapy) is a behavioral approach to neurorehabilitation and consists of multi-components that have been applied in a systematic method to improve the use of the limb or function addressed in the intensive treatment. CI Therapy for the more-affected upper extremity (UE) post-stroke is administered in daily treatment sessions over consecutive weekdays. Sessions include motor training with repeated, timed trials using a technique called shaping, a set of behavioral strategies known as the Transfer Package (TP) to improve the use of the more-affected hand in the life situation, and strategies to remind participants to use the more-affected UE including restraint. Robust improvements in the amount and qualify of use have been realized with stroke participants from mild-to-severe UE impairment.
Eligible Conditions
- CVA (Cerebrovascular Accident)
- Stroke
- Paresis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 5 Secondary · Reporting Duration: At follow-up at 3 months following the end of treatment.
Month 3
Beck Depression Inventory (BDI)
Month 3
45-Item Motor Activity Log (MAL)
Month 3
Stroke Impact Scale (SIS)
Month 3
Canadian Occupational Performance Measure (COPM)
Week 2
Wolf Motor Function Test (WMFT)
Week 2
9 Hole Peg Test (9HPT)
Revised Nottingham Sensory Assessment (rNSA)
Semmes-Weinstein Monofilament Test (SWMT)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Grade 1 CI Therapy + Sensory Components
1 of 1
Experimental Treatment
12 Total Participants · 1 Treatment Group
Primary Treatment: Grade 1 CI Therapy +Sensory Components · No Placebo Group · N/A
Grade 1 CI Therapy + Sensory Components
Behavioral
Experimental Group · 1 Intervention: Grade 1 CI Therapy +Sensory Components · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at follow-up at 3 months following the end of treatment.
Closest Location: University of Alabama at Birmingham · Birmingham, AL
1991First Recorded Clinical Trial
26 TrialsResearching Stroke
1070 CompletedClinical Trials
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,402 Previous Clinical Trials
2,211,051 Total Patients Enrolled
33 Trials studying Stroke
47,559 Patients Enrolled for Stroke
David Morris, PhDStudy ChairUniversity of Alabama at Birmingham
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Stroke
12 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 have had a stroke at least 6 months ago.
You have the ability to perform the minimum active movement criteria of 20 degrees of wrist extension from a fully flexed position, 10 degrees of thumb extension or abduction, and 10 degrees of extension of all finger joints.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- 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.
- 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.
- Wu, Ching-yi, I-ching Chuang, Hui-ing Ma, Keh-chung Lin, and Chia-ling Chen. 2016. “Validity and Responsiveness of the Revised Nottingham Sensation Assessment for Outcome Evaluation in Stroke Rehabilitation”. The American Journal of Occupational Therapy. AOTA Press. doi:10.5014/ajot.2016.018390.
- 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.
- Patel, Prakruti, Sarthak R. Kaingade, Anthony Wilcox, and Neha Lodha. 2020. “Force Control Predicts Fine Motor Dexterity in High-functioning Stroke Survivors”. Neuroscience Letters. Elsevier BV. doi:10.1016/j.neulet.2020.135015.
- 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.
- 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.
- 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.
- Tsao, Connie W., Aaron W. Aday, Zaid I. Almarzooq, Alvaro Alonso, Andrea Z. Beaton, Marcio S. Bittencourt, Amelia K. Boehme, et al.. 2022. “Heart Disease and Stroke Statistics—2022 Update: A Report from the American Heart Association”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0000000000001052.
- Serrada, Ines, Brenton Hordacre, and Susan L. Hillier. 2019. “Does Sensory Retraining Improve Sensation and Sensorimotor Function Following Stroke: A Systematic Review and Meta-analysis”. Frontiers in Neuroscience. Frontiers Media SA. doi:10.3389/fnins.2019.00402.
- 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.
- Suda, Mabu, Michiyuki Kawakami, Kohei Okuyama, Ryota Ishii, Osamu Oshima, Nanako Hijikata, Takuya Nakamura, Asako Oka, Kunitsugu Kondo, and Meigen Liu. 2021. “Validity and Reliability of the Semmes-weinstein Monofilament Test and the Thumb Localizing Test in Patients with Stroke”. Frontiers in Neurology. Frontiers Media SA. doi:10.3389/fneur.2020.625917.
- 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.
- Wang, Yuan-Pang, and Clarice Gorenstein. 2013. “Psychometric Properties of the Beck Depression Inventory-ii: A Comprehensive Review”. Revista Brasileira De Psiquiatria. EDITORA SCIENTIFIC. doi:10.1590/1516-4446-2012-1048.
- Oxford Grice, Kimatha, Kimberly A. Vogel, Viet Le, Ana Mitchell, Sonia Muniz, and Mary Ann Vollmer. 2003. “Adult Norms for a Commercially Available Nine Hole Peg Test for Finger Dexterity”. The American Journal of Occupational Therapy. AOTA Press. doi:10.5014/ajot.57.5.570.
- 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.
- Mary H Bowman 2022. "Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05492513.
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