Cerebrovascular Accident
Conditions
Keywords
Stroke
Brief summary
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.
Interventions
DEVICEMusic 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.
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.
Sponsors
David Reinkensmeyer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test | From baseline to end of therapy (3 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Motor Assessment of the Upper Extremity | From baseline to end of therapy (3 weeks) | 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. |
| Action Research Arm Test | From baseline to end of therapy (3 weeks) | 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. |
| 9-Hole Peg Test | From baseline to end of therapy (3 week) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 5 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Family cannot commit to the study | 2 | 1 |
| Overall Study | Subject moved back to home country | 0 | 1 |
| Overall Study | Subject returned to work | 1 | 0 |
| Overall Study | Subject underwent heart surgery | 0 | 1 |
Baseline characteristics
| Characteristic | Music Glove First - Conventional Second | Conventional Hand Exercise Program First - Music Glove Second | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 17 | 59 years STANDARD_DEVIATION 13 | 62 years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 4 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 2 Participants | 8 Participants |
| Region of Enrollment United States | 6 participants | 5 participants | 11 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
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.
Time frame: From baseline to end of therapy (3 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Glove First Then Conventional Hand Exercise Program | Box and Block Test | Baseline evaluation | 21 blocks | Standard Deviation 14 |
| Music Glove First Then Conventional Hand Exercise Program | Box and Block Test | Change in Post therapy evaluation (Intervention 1) | 12 blocks | Standard Deviation 4 |
| Music Glove First Then Conventional Hand Exercise Program | Box and Block Test | Change in 16-week post cross over evaluation | 19 blocks | Standard Deviation 16 |
| Conventional Hand Exercise Program First Then Music Glove | Box and Block Test | Baseline evaluation | 33 blocks | Standard Deviation 15 |
| Conventional Hand Exercise Program First Then Music Glove | Box and Block Test | Change in Post therapy evaluation (Intervention 1) | 7 blocks | Standard Deviation 5 |
| Conventional Hand Exercise Program First Then Music Glove | Box and Block Test | Change in 16-week post cross over evaluation | 12 blocks | Standard Deviation 11 |
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.
Time frame: From baseline to end of therapy (3 week)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Glove First Then Conventional Hand Exercise Program | 9-Hole Peg Test | Baseline 9-Hole Peg Test Scores | 55 seconds | Standard Deviation 12 |
| Music Glove First Then Conventional Hand Exercise Program | 9-Hole Peg Test | Change in post therapy score (Intervention 1) | -5 seconds | Standard Deviation 8 |
| Music Glove First Then Conventional Hand Exercise Program | 9-Hole Peg Test | Change in 16-week post cross over evaluation | -9 seconds | Standard Deviation 12 |
| Conventional Hand Exercise Program First Then Music Glove | 9-Hole Peg Test | Baseline 9-Hole Peg Test Scores | 47 seconds | Standard Deviation 15 |
| Conventional Hand Exercise Program First Then Music Glove | 9-Hole Peg Test | Change in post therapy score (Intervention 1) | -7 seconds | Standard Deviation 4 |
| Conventional Hand Exercise Program First Then Music Glove | 9-Hole Peg Test | Change in 16-week post cross over evaluation | -5 seconds | Standard Deviation 8 |
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.
Time frame: From baseline to end of therapy (3 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Glove First Then Conventional Hand Exercise Program | Action Research Arm Test | Baseline evaluation | 42 scores on a scale | Standard Deviation 14 |
| Music Glove First Then Conventional Hand Exercise Program | Action Research Arm Test | Change in Post therapy evaluation | 9 scores on a scale | Standard Deviation 9 |
| Music Glove First Then Conventional Hand Exercise Program | Action Research Arm Test | Change in 16-week post cross over evaluation | 13 scores on a scale | Standard Deviation 14 |
| Conventional Hand Exercise Program First Then Music Glove | Action Research Arm Test | Baseline evaluation | 47 scores on a scale | Standard Deviation 12 |
| Conventional Hand Exercise Program First Then Music Glove | Action Research Arm Test | Change in Post therapy evaluation | 7 scores on a scale | Standard Deviation 13 |
| Conventional Hand Exercise Program First Then Music Glove | Action Research Arm Test | Change in 16-week post cross over evaluation | 7 scores on a scale | Standard Deviation 13 |
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.
Time frame: From baseline to end of therapy (3 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Glove First Then Conventional Hand Exercise Program | Fugl-Meyer Motor Assessment of the Upper Extremity | Baseline evaluation | 44 scores on a scale | Standard Deviation 13 |
| Music Glove First Then Conventional Hand Exercise Program | Fugl-Meyer Motor Assessment of the Upper Extremity | Change in Post therapy evaluation | 4 scores on a scale | Standard Deviation 5 |
| Music Glove First Then Conventional Hand Exercise Program | Fugl-Meyer Motor Assessment of the Upper Extremity | Change in 16-week post cross over evaluation | 9 scores on a scale | Standard Deviation 8 |
| Conventional Hand Exercise Program First Then Music Glove | Fugl-Meyer Motor Assessment of the Upper Extremity | Baseline evaluation | 42 scores on a scale | Standard Deviation 9 |
| Conventional Hand Exercise Program First Then Music Glove | Fugl-Meyer Motor Assessment of the Upper Extremity | Change in Post therapy evaluation | 7 scores on a scale | Standard Deviation 11 |
| Conventional Hand Exercise Program First Then Music Glove | Fugl-Meyer Motor Assessment of the Upper Extremity | Change in 16-week post cross over evaluation | 9 scores on a scale | Standard Deviation 10 |