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

Sponsor
University of California, Irvine (Other)
Overall Status
Completed
CT.gov ID
NCT02410629
Collaborator
(none)
17
1
2
16
1.1

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
  • Device: Music Glove
  • Other: Conventional Hand Exercise Program
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Influence of Timing on Motor Learning
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Jul 1, 2016

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

  1. 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

  1. 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.

  2. 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.

  3. 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

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

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.
Responsible Party:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT02410629
Other Study ID Numbers:
  • 2R44HD074331- 02 [2008-6432]
  • 2R44HD074331-02
First Posted:
Apr 7, 2015
Last Update Posted:
Jun 22, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University of California, Irvine
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Secondary Outcome
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)
3. Secondary Outcome
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)
4. Secondary Outcome
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

[Not Specified]

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
Email and@uci.edu
Responsible Party:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT02410629
Other Study ID Numbers:
  • 2R44HD074331- 02 [2008-6432]
  • 2R44HD074331-02
First Posted:
Apr 7, 2015
Last Update Posted:
Jun 22, 2021
Last Verified:
Jun 1, 2021