Skip to main content
OpenTrials
Completed

NCT Number: NCT02473614

Efficacy Study of the Music Glove Patients With Spinal Cord Injuries

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine

Irvine, California, 92697, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Box and Blocks Test

    Time frame: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.

    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 outcomes

  1. Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

    Time frame: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.

    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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2015
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.