Constraint-Induced Movement Therapy Plus Sensory Components After Stroke

NCT05515237 | Recruiting

• 1 other identifier: IRB-300009729
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Constraint-Induced Movement Therapy or CI Therapy is a form of treatment that systematically employs the application of selected behavioral techniques delivered in intensive treatment over consecutive day with the following strategies utilized: behavioral strategies are implemented to improve the use of the more- affected limb in life situation called a Transfer Package (TP), motor training using a technique called shaping to make progress in successive approximations, repetitive, task oriented training, and strategies to encourage or constrain participants to use the more-affected extremity including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining the application of CI therapy with UE rehabilitation after stroke have demonstrated strong evidence for improving the amount of use and the quality of the more-affected UE functional use in the participant's daily life situation. CI Therapy studies with adults, to date, have explored intensive treatment for participants with a range from mild-to-severe motor impairment following stroke with noted motor deficits and limited use of the more-affected arm and hand in everyday activities. Each CI Therapy protocol was designed for the level of impairment demonstrated by participants recruited for the study. However, often following stroke, patients not only have motor deficits but somatosensory impairments as well. The somatosensory issues have not, as yet, been systematically measured and trained in CI Therapy protocols with adults and represent an understudied area of stroke recovery. We hypothesize that participants with mild-to-severe motor impairment and UE functional use deficits can benefit from CI therapy protocols that include somatosensory measurement and training components substituted for portions of motor training without loss in outcome measure gains. Further, we hypothesize that adults can improve somatosensory outcomes as a result of a combined CI therapy plus somatosensory component protocol.

Conditions

CVA (Cerebrovascular Accident); Stroke; Upper Extremity Paresis

Outcome Measures

Primary Outcomes (8)

• Motor Activity Log

  The Motor Activity Log is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 30 activities of daily living. This test is used to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting and in the life situation. It is administered before and after treatment. The score is derived from two scales that are each 0-5 and reported as a mean for the Amount of Use (AOU) and mean for the Quality of Use (QOM).

  At post treatment after 2 weeks of intervention for participants with mild-moderate UE impairment

• Motor Activity Log

  The Motor Activity Log is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 30 activities of daily living. This test is used to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting and in the life situation. It is administered before and after treatment. The score is derived from two scales that are each 0-5 and reported as a mean for the Amount of Use (AOU) and mean for the Quality of Use (QOM).

  At 3 month follow up after the end of treatment

• G4/5 Motor Activity Log

  The G4/5 Motor Activity Log is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 30 activities of daily living. This test is used to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting and in the life situation. It is administered before and after treatment. The score is derived from two scales that are each 0-5 and reported as a mean for the Amount of Use (AOU) and mean for the Quality of Use (QOM).

  At post treatment after 3 weeks of intervention for participants with severe UE impairment

• G4/5 Motor Activity Log (G4/5 MAL)

  The G4/5 Motor Activity Log is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 30 activities of daily living. This test is used to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting and in the life situation. It is administered before and after treatment. The score is derived from two scales that are each 0-5 and reported as a mean for the Amount of Use (AOU) and mean for the Quality of Use (QOM).

  At 3 month follow up after the end of treatment

• Wolf Motor Function Test(WMFT)

  The WMFT is a standardized performance capacity test that measures the motor ability of the upper extremities of a participant. The performance time is measured using a stopwatch and a functional ability (quality) score is provided for each item tested. This test 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 time represents a better performance.

  At post treatment after the 2 weeks of intervention for mild to moderately impaired participants

• Grade 5 Graded Wolf Motor Function Test (G5 GWMFT)

  The G5 Graded WMFT is a standardized motor performance test that measures the motor ability of the upper extremities of a participant. The performance time is measured using a stopwatch and the 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 0-7 with 0 representing the participant's inability to perform the task, and 7 representing normal movement or as good as before the stroke, such that a higher functional ability score is better. A lower performance time represents a better performance.

  At post treatment after the 3 weeks of intervention for severely impaired participants

• Canadian Occupational Performance Measure (COPM)

  The COPM is a semi-structured interview in which the participant is asked to rate their desired occupational performance areas in activities of daily living and instrumental activities of daily living. The COPM is used to show changes in the 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 2-3 weeks of intervention, depending on the severity of the impairment.

• Canadian Occupational Performance Measure (COPM)

  The COPM is a semi-structured interview in which the participant is asked to rate their desired occupational performance areas in activities of daily living and instrumental activities of daily living. The COPM is used to show changes in the 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 3 month follow up after the end of treatment

Secondary Outcomes (7)

• Zung Depression Scale (ZDS)

  At post treatment after 2-3 weeks of treatment, depending on the severity of the impairment

• Zung Depression Scale (ZDS)

  At 3 month followup after the end of treatment.

• Stroke Impact Scale (SIS)

  At post-treatment following the 2-3 weeks of treatment, depending on severity of the impairment.

• Stroke Impact Scale (SIS)

  At 3 months follow-up after the end of treatment.

• Revised Nottingham Sensory Assessment (rNSA)

  At post-treatment after 2-3 weeks of treatment, depending in the severity of the impairment

Study Arms (1)

Grade 2-5 CI Therapy + Sensory Components

EXPERIMENTAL

All participants will receive CI Therapy + Sensory Components administered over the specific time frame of 2-3 weeks.

Behavioral: Grade 2-5 CI Therapy + Sensory Components

Interventions

Grade 2-5 CI Therapy + Sensory Components BEHAVIORAL

All participants will receive CI Therapy + Sensory Components over a 2-3 weeks time frame. The treatment intervention will apply all CI Therapy treatment components to include: 1) a behavioral set of techniques called the Transfer Package (TP) to promote carry-over of skills that were gained in the laboratory into the participant's life situation, 2) the use of motor training called shaping to make progress in small approximations 3) the use by the participant of a mitt on the less-affected hand to encourage use of the more-affected hand and 4) home skills and home work will be provided each day for at least 30 minutes. Sensory component training strategies will be added to stimulate sensory input through the more-affected arm an dhand as well as to train sensory discrimination skills.

Grade 2-5 CI Therapy + Sensory Components

Eligibility Criteria

• Age: 18 Years - 89 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 shoulder ≥ 30 toward flexion or abduction, initiate movement at the elbow for flexion and extension, and initiate movement at the wrist, fingers, or thumb.
• Mean score of \<2.5 on the Motor Activity Log/ G4/5 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/ G4/5 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

• 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

• Jokelainen J, Timonen M, Keinanen-Kiukaanniemi S, Harkonen P, Jurvelin H, Suija K. Validation of the Zung self-rating depression scale (SDS) in older adults. Scand J Prim Health Care. 2019 Sep;37(3):353-357. doi: 10.1080/02813432.2019.1639923. Epub 2019 Jul 9.

  PMID: 31286810 BACKGROUND

• Uswatte G, Taub E, Bowman MH, Delgado A, Bryson C, Morris DM, Mckay S, Barman J, Mark VW. Rehabilitation of stroke patients with plegic hands: Randomized controlled trial of expanded Constraint-Induced Movement therapy. Restor Neurol Neurosci. 2018;36(2):225-244. doi: 10.3233/RNN-170792.

  PMID: 29526860 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 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 23, 2022
• First Posted: August 25, 2022
• Study Start: March 30, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)