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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Glove | Experimental | 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. |
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| Conventional Hand Exercise Program | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Glove | Device | 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. |
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| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| An Do, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Music Glove First Then Conventional Hand Exercise Program | 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. Music Glove: 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. |
| FG001 | Conventional Hand Exercise Program First Then Music Glove | 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. Conventional Hand Exercise Program: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Music Glove First - Conventional Second | 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. Music Glove: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | blocks | From baseline to end of therapy (3 weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Music Glove First - Conventional Second | 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. Music Glove: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr An Do | University of California Irvine | (714) 456-2332 | and@uci.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Conventional Hand Exercise Program | Other | 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. |
|
| 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) |
| Subject moved back to home country |
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| Subject underwent heart surgery |
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| BG001 | Conventional Hand Exercise Program First - Music Glove Second | 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. Conventional Hand Exercise Program: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Conventional Hand Exercise Program First Then Music Glove | 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. Conventional Hand Exercise Program: 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. |
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale | From baseline to end of therapy (3 weeks) |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale | From baseline to end of therapy (3 weeks) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | From baseline to end of therapy (3 week) |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Conventional Hand Exercise Program First - Music Glove Second | 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. Conventional Hand Exercise Program: 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Change in 16-week post cross over evaluation |
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| Change in 16-week post cross over evaluation |
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| Change in 16-week post cross over evaluation |
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