Efficacy Study of the Music Glove Patients With Spinal Cord Injuries

NCT ID: NCT02473614

Last Updated: 2021-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Music Glove

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.

Group Type: EXPERIMENTAL

Music Glove

Intervention Type: 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.

Conventional Hand Exercise Program

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.

Group Type: ACTIVE_COMPARATOR

Conventional Hand Exercise Program

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Kelli Sharp

Assistant Professor at the Department of Dance

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelli Sharp, DPT

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36347833 (View on PubMed)

Other Identifiers

2R44HD074331-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2R44HD074331-02 [2008-6432]

Identifier Type: -

Identifier Source: org_study_id