To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Music Glove 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
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.
|
Active Comparator: Conventional Hand Exercise Program 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
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of California, Irvine | Irvine | California | United States | 92697 |
Sponsors and Collaborators
- University of California, Irvine
Investigators
- Principal Investigator: An Do, MD, University of California, Irvine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2R44HD074331- 02 [2008-6432]
- 2R44HD074331-02
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Music Glove First Then Conventional Hand Exercise Program | Conventional Hand Exercise Program First Then Music Glove |
---|---|---|
Arm/Group Description | 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. | 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. |
Period Title: Overall Study | ||
STARTED | 8 | 9 |
COMPLETED | 5 | 6 |
NOT COMPLETED | 3 | 3 |
Baseline Characteristics
Arm/Group Title | Music Glove First - Conventional Second | Conventional Hand Exercise Program First - Music Glove Second | Total |
---|---|---|---|
Arm/Group Description | 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. | 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. | Total of all reporting groups |
Overall Participants | 6 | 5 | 11 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
2
33.3%
|
3
60%
|
5
45.5%
|
>=65 years |
4
66.7%
|
2
40%
|
6
54.5%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
64
(17)
|
59
(13)
|
62
(15)
|
Sex: Female, Male (Count of Participants) | |||
Female |
3
50%
|
4
80%
|
7
63.6%
|
Male |
3
50%
|
1
20%
|
4
36.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
0
0%
|
1
20%
|
1
9.1%
|
Not Hispanic or Latino |
6
100%
|
4
80%
|
10
90.9%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
1
20%
|
1
9.1%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
1
20%
|
1
9.1%
|
White |
6
100%
|
2
40%
|
8
72.7%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
1
20%
|
1
9.1%
|
Region of Enrollment (participants) [Number] | |||
United States |
6
100%
|
5
100%
|
11
100%
|
Outcome Measures
Title | Box and Block Test |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Music Glove First Then Conventional Hand Exercise Program | Conventional Hand Exercise Program First Then Music Glove |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 6 | 5 |
Baseline evaluation |
21
(14)
|
33
(15)
|
Change in Post therapy evaluation (Intervention 1) |
12
(4)
|
7
(5)
|
Change in 16-week post cross over evaluation |
19
(16)
|
12
(11)
|
Title | Fugl-Meyer Motor Assessment of the Upper Extremity |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Music Glove First Then Conventional Hand Exercise Program | Conventional Hand Exercise Program First Then Music Glove |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 6 | 5 |
Baseline evaluation |
44
(13)
|
42
(9)
|
Change in Post therapy evaluation |
4
(5)
|
7
(11)
|
Change in 16-week post cross over evaluation |
9
(8)
|
9
(10)
|
Title | Action Research Arm Test |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Music Glove First Then Conventional Hand Exercise Program | Conventional Hand Exercise Program First Then Music Glove |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 6 | 5 |
Baseline evaluation |
42
(14)
|
47
(12)
|
Change in Post therapy evaluation |
9
(9)
|
7
(13)
|
Change in 16-week post cross over evaluation |
13
(14)
|
7
(13)
|
Title | 9-Hole Peg Test |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Music Glove First Then Conventional Hand Exercise Program | Conventional Hand Exercise Program First Then Music Glove |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 6 | 5 |
Baseline 9-Hole Peg Test Scores |
55
(12)
|
47
(15)
|
Change in post therapy score (Intervention 1) |
-5
(8)
|
-7
(4)
|
Change in 16-week post cross over evaluation |
-9
(12)
|
-5
(8)
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Music Glove First - Conventional Second | Conventional Hand Exercise Program First - Music Glove Second | ||
Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
Music Glove First - Conventional Second | Conventional Hand Exercise Program First - Music Glove Second | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/8 (0%) | 0/9 (0%) | ||
Serious Adverse Events |
||||
Music Glove First - Conventional Second | Conventional Hand Exercise Program First - Music Glove Second | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/8 (0%) | 0/9 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Music Glove First - Conventional Second | Conventional Hand Exercise Program First - Music Glove Second | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/8 (0%) | 0/9 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr An Do |
---|---|
Organization | University of California Irvine |
Phone | (714) 456-2332 |
and@uci.edu |
- 2R44HD074331- 02 [2008-6432]
- 2R44HD074331-02