To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients

NCT ID: NCT02410629

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-07-31

Brief Summary

The investigators are trying to determine the therapeutic effect of the music glove and conventional hand exercise program to the subacute stroke patients. 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 a minimal 3 hours exercise time per week. Participants will receive the other intervention at 3-month post stroke date. Clinical evaluations will be performed at baseline, post therapy after first intervention, 3-week post intervention follow up, 3-month post stroke, post therapy after second intervention, 3-week post second intervention follow up, and 6-month post stroke follow up visits.

Conditions

Cerebrovascular Accident

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 minimal 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 minimal 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 minimal 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 minimal of 3 hours per week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• History of a single stroke at least 1 week prior to enrollment
• Upper Extremity weakness measured on a standard clinical scale
• No active major psychiatric problems, or neurological/orthopedic problems affecting the stroke affected upper extremity
• No active major neurological disease other than the stroke
• 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 aphasia as measured on a standard clinical scale
• Severe reduced level of consciousness
• Severe sensory/proprioception deficit at the affected upper extremity as measured on a standard clinical scale
• Currently pregnant
• 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 affected upper extremity

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

Sponsors

David Reinkensmeyer

OTHER

Sponsor Role: lead

Responsible Party

David Reinkensmeyer

Assistant Professor, Department of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

An Do, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

Other Identifiers

IRB# 2008-6432

Identifier Type: -

Identifier Source: org_study_id