Trial Outcomes & Findings for Efficacy Study of the Music Glove Patients With Spinal Cord Injuries (NCT NCT02473614)
NCT ID: NCT02473614
Last Updated: 2021-06-07
Results Overview
We compared the change of Box and Blocks Test (BBT) scores from baseline evaluation to the end of 3-week of therapy, and from 1-month post first intervention to the end of the second 3-week therapy. 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 indicate better outcomes.
COMPLETED
NA
11 participants
Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.
2021-06-07
Participant Flow
34 subjects were screened for eligibility
11 of the 34 participants were randomized.
Participant milestones
| Measure |
Music Glove First, Then Conventional Hand Exercise Program
Participants first participated in Music Glove therapy intervention for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, they participated in a conventional hand therapy program for 3 weeks with a minimum of 3 hours per week.
|
Conventional Hand Exercise Program First, Then Music Glove
Participants first participated in conventional hand therapy for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, then they participated in the Music Glove therapy intervention for 3 weeks with a minimum of 3 hours per week.
|
|---|---|---|
|
First Intervention (3 Weeks)
STARTED
|
6
|
5
|
|
First Intervention (3 Weeks)
COMPLETED
|
5
|
5
|
|
First Intervention (3 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Wash Out Period (3 Weeks)
STARTED
|
5
|
5
|
|
Wash Out Period (3 Weeks)
COMPLETED
|
5
|
5
|
|
Wash Out Period (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (3 Weeks)
STARTED
|
5
|
5
|
|
Second Intervention (3 Weeks)
COMPLETED
|
5
|
5
|
|
Second Intervention (3 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Music Glove First, Then Conventional Hand Exercise Program
Participants first participated in Music Glove therapy intervention for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, they participated in a conventional hand therapy program for 3 weeks with a minimum of 3 hours per week.
|
Conventional Hand Exercise Program First, Then Music Glove
Participants first participated in conventional hand therapy for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, then they participated in the Music Glove therapy intervention for 3 weeks with a minimum of 3 hours per week.
|
|---|---|---|
|
First Intervention (3 Weeks)
Job duties/lack of transportation
|
1
|
0
|
Baseline Characteristics
Efficacy Study of the Music Glove Patients With Spinal Cord Injuries
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
Participants who were randomized to participate in Music Glove or Conventional Hand Exercise Program for 3 weeks, then after a three-week washout period they participated in either Music Glove or Conventional Hand Exercise Program for 3 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.We compared the change of Box and Blocks Test (BBT) scores from baseline evaluation to the end of 3-week of therapy, and from 1-month post first intervention to the end of the second 3-week therapy. 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 indicate better outcomes.
Outcome measures
| Measure |
Music Glove First, Then Conventional Hand Exercise Program
n=5 Participants
Participants first participated in Music Glove therapy intervention for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, they participated in a conventional hand therapy program for 3 weeks with a minimum of 3 hours per week.
|
Conventional Hand Exercise Program First, Then Music Glove
n=5 Participants
Participants first participated in conventional hand therapy for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, then they participated in the Music Glove therapy intervention for 3 weeks with a minimum of 3 hours per week.
|
|---|---|---|
|
Box and Blocks Test
Baseline
|
40.6 blocks
Standard Deviation 1.7
|
40 blocks
Standard Deviation 18.0
|
|
Box and Blocks Test
EOT 1st Intervention (3 weeks)
|
44.8 blocks
Standard Deviation 7.0
|
39.0 blocks
Standard Deviation 19.6
|
|
Box and Blocks Test
1Month Post 1st Intervention
|
46.4 blocks
Standard Deviation 1.7
|
41.0 blocks
Standard Deviation 22.2
|
|
Box and Blocks Test
EOT 2nd Intervention
|
43.0 blocks
Standard Deviation 4.8
|
43.2 blocks
Standard Deviation 20.9
|
|
Box and Blocks Test
1-month Post 2nd Intervention
|
46.6 blocks
Standard Deviation 6.1
|
40.4 blocks
Standard Deviation 22.0
|
SECONDARY outcome
Timeframe: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.We used the GRASSP to capture information on upper limb impairment from the SCI population through three domains: Strength, Sensibility, and Prehension. We focused on the Prehension section of the test. The prehension ability domain consists of three different tasks 1) Cylindrical Grasp, 2) Lateral Key Pinch, \& 3) Tip to Tip Pinch and one can score 0-4 for each task for a total of 12 points for this section. The prehension performance domain consists of 1) pour water from a bottle, 2) open jars, 3) pick up \& turn a key, 4) transfer 9 pegs board to board, 5) pick up 4 coins \& place in the slot, 6) screw 4 nuts onto bolts and one can score 0-5 for each task for a total of 30 points. The score for each domain of the prehension test is totaled for each of the upper extremities with ranges from 0 to 42. The higher scores indicate better functional outcomes.
Outcome measures
| Measure |
Music Glove First, Then Conventional Hand Exercise Program
n=5 Participants
Participants first participated in Music Glove therapy intervention for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, they participated in a conventional hand therapy program for 3 weeks with a minimum of 3 hours per week.
|
Conventional Hand Exercise Program First, Then Music Glove
n=5 Participants
Participants first participated in conventional hand therapy for 3 times a week for 3 weeks with a minimum of 3 hours per week. After a washout period of 3 weeks, then they participated in the Music Glove therapy intervention for 3 weeks with a minimum of 3 hours per week.
|
|---|---|---|
|
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Baseline
|
18.6 points
Standard Deviation 3.0
|
18.6 points
Standard Deviation 6.1
|
|
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
EOT 1st Intervention
|
20.0 points
Standard Deviation 5.1
|
19.0 points
Standard Deviation 6.4
|
|
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
1-month post 1st Intervention
|
19.6 points
Standard Deviation 4.2
|
20.6 points
Standard Deviation 4.4
|
|
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
EOT 2nd Intervention
|
20.2 points
Standard Deviation 3.8
|
21.1 points
Standard Deviation 4.8
|
|
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
1-month post 2nd Intervention
|
20.8 points
Standard Deviation 4.1
|
20.2 points
Standard Deviation 5.7
|
Adverse Events
Music Glove
Conventional Hand Exercise Program
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