Trial Outcomes & Findings for Influence of Timing on Motor Learning (NCT NCT01769326)
NCT ID: NCT01769326
Last Updated: 2017-07-02
Results Overview
The primary end point was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 secons, from baseline to 1 month posttherapy. The higher the scores, the better arm and hand function indicated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
From baseline to 1 month post therapy
Results posted on
2017-07-02
Participant Flow
Participant milestones
| Measure |
MusicGlove Group
Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program
MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
|
Control Group for Music Glove
Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
|
Resonating Arm Exerciser (RAE)
Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program
Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.
|
Control Group for RAE
Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
9
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
0
|
Reasons for withdrawal
| Measure |
MusicGlove Group
Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program
MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
|
Control Group for Music Glove
Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
|
Resonating Arm Exerciser (RAE)
Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program
Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.
|
Control Group for RAE
Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
0
|
|
Overall Study
unrelated injry
|
1
|
1
|
0
|
0
|
|
Overall Study
got a job
|
0
|
1
|
0
|
0
|
|
Overall Study
Got sick and could not complete study
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Influence of Timing on Motor Learning
Baseline characteristics by cohort
| Measure |
MusicGlove Group
n=9 Participants
Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program
MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
|
Control Group for Music Glove
n=8 Participants
Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
|
Resonating Arm Exerciser (RAE)
n=8 Participants
Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program
Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.
|
Control Group for RAE
n=8 Participants
Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
59 years
n=7 Participants
|
61 years
n=5 Participants
|
54 years
n=4 Participants
|
60 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
33 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From baseline to 1 month post therapyPopulation: Number of blocks participants able to pick up and place in a box in 60 seconds at one month follow up minus the number of blocks participants able to pick up and place in a box in 60 seconds at baseline. Please note that box and block test was the primary outcome measure for the Music Glove part of the study.
The primary end point was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 secons, from baseline to 1 month posttherapy. The higher the scores, the better arm and hand function indicated.
Outcome measures
| Measure |
MusicGlove Group
n=9 Participants
Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program
MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
|
Control Group for Music Glove
n=8 Participants
Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
|
|---|---|---|
|
Motor and Strength Outcome Measure Using Box and Block Test
|
2.3 blocks
Standard Deviation 6.2
|
4.3 blocks
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: From baseline to 1 month post therapyPopulation: Fugl-Meyer score at one month post therapy minus Fugl-Meyer score at baseline on a 66 point scale. Please note that Fugl-Meyer UE motor score is the primary outcome measure for RAE part of the study.
The primary outcome measure was the change in Upper Extremity FM score on a scale of 0 to 66 at one month post therapy. The higher the scores, the better arm and hand function indicated.
Outcome measures
| Measure |
MusicGlove Group
n=8 Participants
Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program
MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
|
Control Group for Music Glove
n=8 Participants
Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
|
|---|---|---|
|
Motor and Strength Outcome Measure Using Fugl-Meyer Score
|
2.88 units on a scale
Standard Deviation 4.68
|
1.31 units on a scale
Standard Deviation 2.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthOutcome measures
Outcome data not reported
Adverse Events
MusicGlove Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group for Music Glove
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resonating Arm Exerciser (RAE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group for RAE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place