Spinal Cord Injuries
Conditions
Brief summary
Investigators are trying to determine the therapeutic effect of the music glove and conventional hand exercise program to patients with spinal cord injuries. 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 minimum of 3 hours of exercise time per week. Participants will receive the other intervention at their 3 week post-therapy follow-up visits. Clinical evaluations will be performed at baseline 1 and 2 (3 to 10 days apart), post-therapy after the first intervention, 3-week post-therapy follow up, post-therapy after the second intervention, and 3-week post-second intervention follow up visits.
Interventions
DEVICEMusic Glove
Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimum of 3 hours per week.
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 minimum of 3 hours per week.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* History of spinal cord injury affecting the arm and hand functions, at least 6 months prior to enrollment * Upper extremity weakness as measured on a standard clinical scale * No active major psychiatric problems, or neurological/orthopedic problems affecting the training upper extremity * No active major neurological disease other than the spinal cord injury * 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 sensory/proprioception deficit at the affected upper extremity as measured on a standard clinical scale * 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 training upper extremity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and Blocks Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | 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. |
Countries
United States
Participant flow
Recruitment details
34 subjects were screened for eligibility
Pre-assignment details
11 of the 34 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| All Study 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. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (3 Weeks) | Job duties/lack of transportation | 1 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 51.3 years STANDARD_DEVIATION 15.7 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Box and Blocks Test
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.
Time frame: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Glove First, Then Conventional Hand Exercise Program | Box and Blocks Test | EOT 1st Intervention (3 weeks) | 44.8 blocks | Standard Deviation 7 |
| Music Glove First, Then Conventional Hand Exercise Program | Box and Blocks Test | EOT 2nd Intervention | 43.0 blocks | Standard Deviation 4.8 |
| Music Glove First, Then Conventional Hand Exercise Program | Box and Blocks Test | 1Month Post 1st Intervention | 46.4 blocks | Standard Deviation 1.7 |
| Music Glove First, Then Conventional Hand Exercise Program | Box and Blocks Test | 1-month Post 2nd Intervention | 46.6 blocks | Standard Deviation 6.1 |
| Music Glove First, Then Conventional Hand Exercise Program | Box and Blocks Test | Baseline | 40.6 blocks | Standard Deviation 1.7 |
| Conventional Hand Exercise Program First, Then Music Glove | Box and Blocks Test | 1-month Post 2nd Intervention | 40.4 blocks | Standard Deviation 22 |
| Conventional Hand Exercise Program First, Then Music Glove | Box and Blocks Test | Baseline | 40 blocks | Standard Deviation 18 |
| Conventional Hand Exercise Program First, Then Music Glove | Box and Blocks Test | EOT 1st Intervention (3 weeks) | 39.0 blocks | Standard Deviation 19.6 |
| Conventional Hand Exercise Program First, Then Music Glove | Box and Blocks Test | 1Month Post 1st Intervention | 41.0 blocks | Standard Deviation 22.2 |
| Conventional Hand Exercise Program First, Then Music Glove | Box and Blocks Test | EOT 2nd Intervention | 43.2 blocks | Standard Deviation 20.9 |
Secondary
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
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.
Time frame: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Glove First, Then Conventional Hand Exercise Program | Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | 1-month post 1st Intervention | 19.6 points | Standard Deviation 4.2 |
| Music Glove First, Then Conventional Hand Exercise Program | Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | EOT 1st Intervention | 20.0 points | Standard Deviation 5.1 |
| Music Glove First, Then Conventional Hand Exercise Program | Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | EOT 2nd Intervention | 20.2 points | Standard Deviation 3.8 |
| Music Glove First, Then Conventional Hand Exercise Program | Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | 1-month post 2nd Intervention | 20.8 points | Standard Deviation 4.1 |
| Music Glove First, Then Conventional Hand Exercise Program | Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | Baseline | 18.6 points | Standard Deviation 3 |
| Conventional Hand Exercise Program First, Then Music Glove | Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | 1-month post 2nd Intervention | 20.2 points | Standard Deviation 5.7 |
| Conventional Hand Exercise Program First, Then Music Glove | Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | Baseline | 18.6 points | Standard Deviation 6.1 |
| Conventional Hand Exercise Program First, Then Music Glove | Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | EOT 1st Intervention | 19.0 points | Standard Deviation 6.4 |
| Conventional Hand Exercise Program First, Then Music Glove | Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | 1-month post 1st Intervention | 20.6 points | Standard Deviation 4.4 |
| Conventional Hand Exercise Program First, Then Music Glove | Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | EOT 2nd Intervention | 21.1 points | Standard Deviation 4.8 |