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Efficacy Study of the Music Glove Patients With Spinal Cord Injuries

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Glove
Conventional Hand Exercise Program
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 12, 2015
Last Updated
June 4, 2021
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT02473614
Brief Title
Efficacy Study of the Music Glove Patients With Spinal Cord Injuries
Official Title
To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11 (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 minimum 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 minimum of 3 hours per week.
Primary Outcome Measure Information:
Title
Box and Blocks Test
Description
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.
Secondary Outcome Measure Information:
Title
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Description
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.

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelli Sharp, DPT
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

Citations:
PubMed Identifier
36347833
Citation
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.
Results Reference
derived

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Efficacy Study of the Music Glove Patients With Spinal Cord Injuries

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