Efficacy Study of the Music Glove Patients With Spinal Cord Injuries

NCT02473614 | Completed Results

• 2 other identifiers: 2R44HD074331-02 [2008-6432]2R44HD074331-02
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

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.

Device: Music Glove

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.

Other: Conventional Hand Exercise Program

Interventions

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.

Music Glove

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.

Conventional Hand Exercise Program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (1)

• 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.

  PMID: 36347833 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Kelli Sharp
• Organization: University of California at Irvine

ksharp@uci.edu

9495107968

Study Officials

• Kelli Sharp, DPT

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor at the Department of Dance

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 7, 2021
• Results First Posted: June 7, 2021

Record last verified: 2021-06

Locations

US (1)