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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44HD074331-02 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Glove | Experimental | 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. |
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| Conventional Hand Exercise Program | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Glove | Device | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli Sharp, DPT | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36347833 | Derived | Sanders Q, Chan V, Augsburger R, Cramer SC, Reinkensmeyer DJ, Sharp K. Feasibility of home hand rehabilitation using musicglove after chronic spinal cord injury. Spinal Cord Ser Cases. 2022 Nov 9;8(1):86. doi: 10.1038/s41394-022-00552-4. |
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11 of the 34 participants were randomized.
34 subjects were screened for eligibility
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Weeks) |
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| Wash Out Period (3 Weeks) |
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| Second Intervention (3 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | blocks | Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention. |
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Through study completion an average of 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Music Glove | Participants participated in Music Glove therapy intervention 3 times a week for 3 weeks with a minimum of 3 hours per week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelli Sharp | University of California at Irvine | 9495107968 | ksharp@uci.edu |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Conventional Hand Exercise Program | Other | 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. |
|
| Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention. |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
|
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| 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. | Posted | Mean | Standard Deviation | points | Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention. |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Conventional Hand Exercise Program | Participants participated in conventional hand therapy 3 times a week for 3 weeks with a minimum of 3 hours per week. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D014947 | Wounds and Injuries |
| 1-month post 1st Intervention |
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| EOT 2nd Intervention |
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| 1-month post 2nd Intervention |
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