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

Study Overview
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Brief Summary
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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.

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

Conditions
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CVA (Cerebrovascular Accident), Stroke, Upper Extremity Paresis

Intervention / Treatment
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* Behavioral: Keys Constraint-induced Movement Therapy protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Keys intervention<br>All participants will receive the Keys CI Therapy protocol over an 8-week intervention period. | Behavioral: Keys Constraint-induced Movement Therapy protocol<br>* 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.<br>|

What is the study measuring?
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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. |