Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity

Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity Recovery Following Stroke: A Pilot Study

CI therapy is a family of techniques that has systematically applied intensive treatment daily over consecutive days, supervised motor training using a technique called shaping, behavioral strategies to improve the use of the more- affected limb in real life situations called a Transfer Package (TP), and strategies to remind participants to use the more-affected extremity; including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining use of CI therapy with UE rehabilitation have demonstrated robust evidence for increasing the amount and the quality of the paretic UE functional use in daily situations of individuals recovering from stroke.

Previous studies have explored the barriers for clinical implementation of the approach, including the amount of time needed by therapists, other resources required and lack of payment for the services. With regards to therapists' time/resources, in the signature CI therapy protocol, therapists supervised movement training for 3 hours daily (except for weekends) for a 12 consecutive-day period. This level of supervision in highly unusual for traditional rehabilitation clinical settings. The treatment schedule is also incompatible with most insurance reimbursement policies in the US. As such, most CI therapy clinics require patients to pay privately with little or no insurance reimbursement. Such practices severely limit the number of patients who can afford to receive CI therapy. Two lines of evidence have suggested that an alternative CI therapy protocol may allow for the essential (or "Key") CI therapy elements to be delivered in a schedule that better utilizes therapist time/resources and is compatible with payment policies of many US insurance companies. One line of evidence comes from findings that indicate that the original 6-hour supervised training schedule could be shortened to as little as 2-hours/daily without a reduction in outcomes. Additional evidence comes from a study exploring the systematic addition and deletion of the signature CI therapy protocol elements indicated that when the transfer package was omitted, outcomes related to functional use were reduced by 50%. These findings were also verified by brain imaging studies conducted concurrently that revealed a much-reduced level of brain remodeling in those not receiving the transfer package. These findings highlight the potential effectiveness of the transfer package and continued movement training by the patient while away from clinical supervision. The hypothesis of this study is that the amount of supervised training could be reduced further and delivered in a distributed schedule (1 to 4 times/ week over an 8-week period) instead of consecutively over a 12-day treatment period. This modification could be possible by adapting and strengthening the transfer package component of the protocol. In order to investigate if all of the Keys intervention protocol is necessary for producing optimal outcomes, the delivery of specific protocol elements will be also explored. Additionally, another round of testing at the 4-week point of the 8-week intervention will be administered to investigate the need for the final 4 weeks of the intervention.

Study Overview

• Status: Completed
• Conditions: Stroke; Upper Extremity Paresis; CVA (Cerebrovascular Accident)
• Intervention / Treatment: Behavioral: Keys Constraint-induced Movement Therapy protocol

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 6 months after stroke
• Ability to demonstrate minimum movement criteria of more-affected UE including 10 degrees of wrist extension (starting from a fully flexed position), 10 degrees of thumb abduction, and 10 degrees of extension of two additional fingers at all joints
• Score <2.5 on the MAL indicating significant functional deficits of the more-affected UE

Exclusion Criteria:

• Inability to answer the MAL questions and/or provide informed consent
• Score <24 on the Mini-Mental State Examination
• No availability to come to the clinic for the sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Keys intervention; All participants will receive the Keys CI Therapy protocol over an 8-week intervention period.

Behavioral: Keys Constraint-induced Movement Therapy protocol; All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. Specific CI therapy strategies will be delivered, including: 1) supervised movement training will be carried out for 1 hour for 4 days/week for the first 4 weeks, 2 days/week for weeks 5 and 6, and 1 day/week for weeks 7 and 8; 2) participants will use the restraint mitt on their less-affected UE for most of their waking hours for an 8 week period; 3) transfer package methods will be modified to accommodate the longer time period between clinic visits; and 4) participants will be asked to independently perform additional movement training for 30 minutes each day at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Activity Log (MAL)	The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment. The assessment is scored from 0-10, and higher scores denote more frequent spontaneous use and quality of movement of the affected arm.	4 weeks after starting the intervention (middle of the protocol)
Motor Activity Log (MAL)	The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity comparing the scores collected before and in the middle of the treatment.The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change in spontaneous use of the affected upper extremity before and after the treatment. The assessment is scored from 0-10, and higher scores denote more frequent spontaneous use and quality of movement of the affected arm.	after the intervention (8 weeks after starting the protocol)
Motor Activity Log (MAL)	The MAL assesses how much and how well the individuals uses the affected upper extremity in 30 different daily activities. It will be used to investigate the change and retention of spontaneous use of the affected upper extremity right after the treatment and 3 months after the end of the treatment. The assessment is scored from 0-10, and higher scores denote more frequent spontaneous use and quality of movement of the affected arm.	3 months after the end of the treatment.
Canadian Occupational Performance Measure (COPM)	The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before and in the middle of the treatment. The assessment is scored from 0-10, and higher scores denote higher satisfaction, importance, and quality of performance.	4 weeks after starting the intervention (middle of the protocol)
Canadian Occupational Performance Measure (COPM)	The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes in occupational performance comparing the scores collected before and after the treatment. The assessment is scored from 0-10, and higher scores denote higher satisfaction, importance, and quality of performance.	after the intervention (8 weeks after starting the protocol)
Canadian Occupational Performance Measure (COPM)	The COPM is a self-reported measure regarding the individual's occupational performance in self-care, productivity, and leisure activities. The COPM will be administered to explore the changes and retention of occupational performance right after the treatment and 3 months after the end of the treatment. The assessment is scored from 0-10, and higher scores denote higher satisfaction, importance, and quality of performance.	3 months after the end of the treatment.
Wolf Motor Function Test (WMFT)	The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and in the middle of the treatment. The functional scale ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.	4 weeks after starting the intervention (middle of the protocol)
Wolf Motor Function Test (WMFT)	The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected before and after the treatment. The functional scale ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.	after the intervention (8 weeks after starting the protocol)
Wolf Motor Function Test (WMFT)	The WMFT measures upper extremity motor function in terms of quality of movement and performance time. The WMFT will be administered to investigate changes in motor function of the affected arm comparing the scores collected right after the treatment and 3 months after the end of the treatment. The functional scale ranges from 0-5, in which 0 represents inability to perform the task, and 5 is given for performances close o before the stroke. The tasks are also timed with a stopwatch and lower performance time denotes better motor function.	3 months after the end of the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Impact Scale (SIS)	The SIS is a self-reported measure of disability and quality of life after stroke. The score ranges from 0-100, where lower score mean more difficulty in doing and remembering things. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and in the middle of the treatment.	4 weeks after starting the intervention (middle of the protocol)
Stroke Impact Scale (SIS)	The SIS is a self-reported measure of disability and quality of life after stroke. The score ranges from 0-100, where lower score mean more difficulty in doing and remembering things. The SIS will be administered to investigate changes in quality of life comparing the scores collected before and after the treatment.	after the intervention (8 weeks after starting the protocol)
Stroke Impact Scale (SIS)	The SIS is a self-reported measure of disability and quality of life after stroke. The score ranges from 0-100, where lower score mean more difficulty in doing and remembering things. The SIS will will be administered to investigate changes and retention of quality of life comparing the scores collected right after of the treatment and 3 months after the end of the treatment.	3 months after the end of the treatment.
Zung Self-Rating Depression Scale	The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected before and in the middle of the treatment.	4 weeks after starting the intervention (middle of the protocol)
Zung Self-Rating Depression Scale	The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected before and after the treatment.	after the intervention (8 weeks after starting the protocol)
Zung Self-Rating Depression Scale	The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The ZDS is a self-reported outcome that measures the presence of specific symptoms related to depression. The final score ranges from 20-80, where scores are classified as normal (<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (>70). The ZDS will be administered to investigate changes in depressive symptoms comparing the scores collected right after of the treatment and 3 months after the end of the treatment.	3 months after the end of the treatment.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Publications and helpful links

General Publications

• Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.
• 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.
• 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.
• Morris DM, Taub E, Mark VW. Constraint-induced movement therapy: characterizing the intervention protocol. Eura Medicophys. 2006 Sep;42(3):257-68.
• 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.
• Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.
• 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.
• 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, 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.
• 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.
• 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.
• 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.
• 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.
• Pedlow K, Lennon S, Wilson C. Application of constraint-induced movement therapy in clinical practice: an online survey. Arch Phys Med Rehabil. 2014 Feb;95(2):276-82. doi: 10.1016/j.apmr.2013.08.240. Epub 2013 Sep 8.
• 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.
• Fleet A, Che M, Mackay-Lyons M, Mackenzie D, Page S, Eskes G, McDonald A, Boyce J, Boe S. Examining the use of constraint-induced movement therapy in canadian neurological occupational and physical therapy. Physiother Can. 2014 Winter;66(1):60-71. doi: 10.3138/ptc.2012-61.
• Morris DM, Taub E, Macrina DM, Cook EW, Geiger BF. A method for standardizing procedures in rehabilitation: use in the extremity constraint induced therapy evaluation multisite randomized controlled trial. Arch Phys Med Rehabil. 2009 Apr;90(4):663-8. doi: 10.1016/j.apmr.2008.09.576.
• Uswatte G, Taub E, Morris D, Barman J, Crago J. Contribution of the shaping and restraint components of Constraint-Induced Movement therapy to treatment outcome. NeuroRehabilitation. 2006;21(2):147-56.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 27, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: IRB-300008977

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No