Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment

NCT05492513 | Recruiting

• 2 other identifiers: IRB-300008653UAB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CVA (Cerebrovascular Accident); Stroke; Upper Extremity Paresis

Outcome Measures

Primary Outcomes (5)

• 45-Item Motor Activity Log (MAL)

  The 45-Item MAL is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 45 activities of daily living. The use of this test is to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting. It is administered before and after treatment. The score is derived from a 0-5 scale and reported as a mean for the Amount of Use (AOU) and the Quality of Use (QOM).

  At post treatment after 2 weeks of intervention

• 45-Item Motor Activity Log (MAL)

  The 45-Item MAL is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 45 activities of daily living. The use of this test is to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting. It is administered before and after treatment. The score is derived from a 0-5 scale and reported as a mean for the Amount of Use (AOU) and the Quality of Use (QOM).

  At 3 months after the end of the treatment

• Wolf Motor Function Test (WMFT)

  The WMFT is a standardized test that measures the motor ability of the upper extremities of a participant. The performance time by stopwatch is recorded and functional ability (quality) score is provided for each item tested. It is administered before treatment and after treatment. The quality of movement is rated by the therapist on a scale from 0-5 with 0 representing the participant's inability to perform the task, and 5 representing normal movement or as good as before the stroke, such that a higher functional ability score is better. A lower performance represents a better performance.

  At post treatment after the 2 weeks of intervention

• Canadian Occupational Performance Measure (COPM)

  The COPM is a semi structured interview in which the participant is asked to rate desired occupational performance areas for activities of daily living and instrumental activities of daily living. The COPM is used to show changes in performance and satisfaction in desired areas of occupational performance. There are three scales used in the COPM administration one for importance, performance, and satisfaction. The scales range from 1-10 with the higher score indicating an improvement in the score.

  At post-treatment after the 2 weeks of intervention

• Canadian Occupational Performance Measure (COPM)

  The COPM is a semi structured interview in which the participant is asked to rate desired occupational performance areas for activities of daily living and instrumental activities of daily living. The COPM is used to show changes in performance and satisfaction in desired areas of occupational performance. There are three scales used in the COPM administration one for importance, performance, and satisfaction. The scales range from 1-10 with the higher score indicating an improvement in the score.

  At follow-up at 3 months following the end of treatment.

Secondary Outcomes (7)

• Beck Depression Inventory (BDI)

  At post- treatment following the 2 weeks of treatment

• Beck Depression Inventory (BDI)

  At 3 month follow up from the end of the 2 weeks of treatment.

• Stroke Impact Scale (SIS)

  At post-treatment following the 2 weeks of treatment

• Stroke Impact Scale (SIS)

  At 3 months following the end of the 2 weeks of treatment.

• 9 Hole Peg Test (9HPT)

  At post-treatment after the 2 weeks of intervention

Study Arms (1)

Grade 1 CI Therapy + Sensory Components

EXPERIMENTAL

All participants will receive the Grade 1 CI Therapy + Sensory Components administered over a two-week period of time.

Behavioral: Grade 1 CI Therapy +Sensory Components

Interventions

Grade 1 CI Therapy +Sensory Components BEHAVIORAL

All participants will receive Grade 1 CI Therapy + Sensory Components over a two-week period of time. The treatment intervention will include all CI Therapy treatment strategies including: 1) supervised motor training in the form of shaping with repeated trials and task practice for 1.5 hours per day for 5 weekdays for 2 weeks 2) a behavioral Transfer Package (TP) will be employed to aid carry-over of skills gained by the participant in the laboratory to the life situation 3) each participant will wear a mitt on the less-affected hand for most of their waking hours to encourage use of the more-affected hand 4) participants will be given home assignments to be carried out for at least 30 minutes each day. Sensory component strategies will be added to stimulate sensory input through the more-affected arm and hand as well as to train sensory discrimination skills.

Grade 1 CI Therapy + Sensory Components

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 6 months post stroke
• The ability to demonstrate the minimum UE 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.
• Mean score of \>2.5 on the Motor Activity Log indicating the participant's use of the more-affected UE.

You may not qualify if:

• Score\< 24 on the Mini Mental State Exam
• Inability to answer the MAL questions and/or provide informed consent
• The inability to come in to the laboratory setting for treatment.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Related Publications (16)

• Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.

  PMID: 35078371 BACKGROUND

• Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.

  PMID: 8466415 BACKGROUND

• Morris DM, Taub E, Mark VW. Constraint-induced movement therapy: characterizing the intervention protocol. Eura Medicophys. 2006 Sep;42(3):257-68.

  PMID: 17039224 BACKGROUND

• Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.

  PMID: 17039223 BACKGROUND

• 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.

  PMID: 17030751 BACKGROUND

• 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.

  PMID: 11387578 BACKGROUND

• 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.

  PMID: 10152880 BACKGROUND

• 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.

  PMID: 10512918 BACKGROUND

• Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.

  PMID: 24402217 BACKGROUND

• Oxford Grice K, Vogel KA, Le V, Mitchell A, Muniz S, Vollmer MA. Adult norms for a commercially available Nine Hole Peg Test for finger dexterity. Am J Occup Ther. 2003 Sep-Oct;57(5):570-3. doi: 10.5014/ajot.57.5.570.

  PMID: 14527120 BACKGROUND

• Serrada I, Hordacre B, Hillier SL. Does Sensory Retraining Improve Sensation and Sensorimotor Function Following Stroke: A Systematic Review and Meta-Analysis. Front Neurosci. 2019 Apr 30;13:402. doi: 10.3389/fnins.2019.00402. eCollection 2019.

  PMID: 31114472 BACKGROUND

• Wu CY, Chuang IC, Ma HI, Lin KC, Chen CL. Validity and Responsiveness of the Revised Nottingham Sensation Assessment for Outcome Evaluation in Stroke Rehabilitation. Am J Occup Ther. 2016 Mar-Apr;70(2):7002290040p1-8. doi: 10.5014/ajot.2016.018390.

  PMID: 26943116 BACKGROUND

• Suda M, Kawakami M, Okuyama K, Ishii R, Oshima O, Hijikata N, Nakamura T, Oka A, Kondo K, Liu M. Validity and Reliability of the Semmes-Weinstein Monofilament Test and the Thumb Localizing Test in Patients With Stroke. Front Neurol. 2021 Jan 27;11:625917. doi: 10.3389/fneur.2020.625917. eCollection 2020.

  PMID: 33584520 BACKGROUND

• 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.

  PMID: 34425065 BACKGROUND

• Taub E, Uswatte G, Mark VW, Morris DM, Barman J, Bowman MH, Bryson C, Delgado A, Bishop-McKay S. Method for enhancing real-world use of a more affected arm in chronic stroke: transfer package of constraint-induced movement therapy. Stroke. 2013 May;44(5):1383-8. doi: 10.1161/STROKEAHA.111.000559. Epub 2013 Mar 21.

  PMID: 23520237 BACKGROUND

• Patel P, Kaingade SR, Wilcox A, Lodha N. Force control predicts fine motor dexterity in high-functioning stroke survivors. Neurosci Lett. 2020 Jun 11;729:135015. doi: 10.1016/j.neulet.2020.135015. Epub 2020 Apr 30.

  PMID: 32360934 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Morris, PhD

  University of Alabama at Birmingham

  STUDY CHAIR

Central Study Contacts

Mary H Bowman, BS OT

CONTACT

2059340069; mbowman@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: December 8, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)