Efficacy Study of the Music Glove Patients With Spinal Cord Injuries

Spinal Cord Injuries Clinical Trial

Official title:

To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473614
• Other study ID #: 2R44HD074331-02 [2008-6432]
• Secondary ID: 2R44HD074331-02
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• Music 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.

Other:
• Conventional Hand Exercise Program
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.

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.
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.	Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.