Back to resultsTo Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients
Primary Purpose
Cerebrovascular Accident
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Glove
Conventional Hand Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Stroke
Eligibility 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
Sites / Locations
- University of California, Irvine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Music Glove
Conventional Hand Exercise Program
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02410629
Brief Title
To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients
Official Title
Influence of Timing on Motor Learning
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Reinkensmeyer
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music Glove
Arm Type
Experimental
Arm 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.
Arm Title
Conventional Hand Exercise Program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Music Glove
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Hand Exercise Program
Intervention Description
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.
Primary Outcome Measure Information:
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)
Secondary Outcome Measure Information:
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)
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)
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
An Do, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients
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