To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients

Study Overview
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Brief Summary
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The investigators are trying to determine the therapeutic effect of the music glove and conventional hand exercise program to the subacute stroke patients. All participants will be randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with a minimal 3 hours exercise time per week. Participants will receive the other intervention at 3-month post stroke date. Clinical evaluations will be performed at baseline, post therapy after first intervention, 3-week post intervention follow up, 3-month post stroke, post therapy after second intervention, 3-week post second intervention follow up, and 6-month post stroke follow up visits.

Official Title
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Influence of Timing on Motor Learning

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Device: Music Glove
* Other: Conventional Hand Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of a single stroke at least 1 week prior to enrollment Upper Extremity weakness measured on a standard clinical scale No active major psychiatric problems, or neurological/orthopedic problems affecting the stroke affected upper extremity No active major neurological disease other than the stroke Absence of pain in the affected upper extremity Exclusion Criteria: Severe tone at the affected upper extremity as measured on a standard clinical scale Severe aphasia as measured on a standard clinical scale Severe reduced level of consciousness Severe sensory/proprioception deficit at the affected upper extremity as measured on a standard clinical scale Currently pregnant Difficulty in understanding or complying with instructions given by the experimenter Inability to perform the experimental task that will be studied Increased pain with movement of the affected upper extremity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Glove<br>Music Glove is a glove with sensors attached to the tips of all 5 fingers. The glove is connected to a software musical program like guitar hero. Participants will follow the rhythm or musical notes of the songs and move their fingers accordingly. Participants are reinforced with biofeedback that includes visual and auditory cues when the correct sequences are achieved. | Device: Music Glove<br>* Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimal of 3 hours per week.<br>|
| Active Comparator: Conventional Hand Exercise Program<br>Conventional Hand Exercise Program includes range of motion exercises, strengthening exercises, coordinating exercises of the hand and fingers. This exercise program is designed by an occupational therapist and is a general exercise program that a stroke patient will receive when he/she is being discharged from the hospital. | Other: Conventional Hand Exercise Program<br>* Participants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimal of 3 hours per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Block Test | We compared the change of Box and Block Test scores from baseline evaluation to the end of 3-week of therapy (Intervention 1), and from 12-week post-stroke to end of 3-week therapy (Intervention 2). Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicates a better outcome. | From baseline to end of therapy (3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Motor Assessment of the Upper Extremity | We measure the change of the Fugl-Meyer Motor Assessment scores from the baseline evaluation to 3-week therapy (intervention 1) and 12-week post-stroke to end of 3-week therapy (Intervention 2). Fugl-Meyer is a 66-point scale measuring the movement pattern of upper extremities. For this study, we analyze total score only. The higher scores indicate a better outcome. | From baseline to end of therapy (3 weeks) | 
| Action Research Arm Test | We compared the change in Action Research Arm Test (ARAT) scores from the baseline evaluation to 3-week therapy (Intervention 1) and 12-week post-stroke to 3-week therapy (Intervention 2). The ARAT is a 57-point scale which measures upper extremity function, coordination, and dexterity. The higher scores indicate a better outcome. | From baseline to end of therapy (3 weeks) | 
| 9-Hole Peg Test | We compared the change in 9-Hole Peg Test scores from the baseline evaluation to 3-week therapy (Intervention 1) and 12-week post-stroke to 3-week therapy (Intervention 2). The 9-Hole Peg Test is a timed test that measures the time it takes to place, and remove 9 pegs. The maximum allowed time for the test is 60 seconds. The more number of pegs placed and removed indicate a better outcome. The shorter time it takes to complete the task indicates a better outcome. | From baseline to end of therapy (3 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke