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

NCT02410629 | Completed Results

• 1 other identifier: IRB# 2008-6432
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

• Box and Block Test

  We compared the change of Box and Block Test scores from baseline evaluation to the end of 3-week of therapy (Intervention 1), and from 12-week post-stroke to end of 3-week therapy (Intervention 2). 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 indicates a better outcome.

  From baseline to end of therapy (3 weeks)

Secondary Outcomes (3)

• Fugl-Meyer Motor Assessment of the Upper Extremity

  From baseline to end of therapy (3 weeks)

• Action Research Arm Test

  From baseline to end of therapy (3 weeks)

• 9-Hole Peg Test

  From baseline to end of therapy (3 week)

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 minimal 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 minimal 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Reinkensmeyer: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr An Do
• Organization: University of California Irvine

and@uci.edu

(714) 456-2332

Study Officials

• An Do, MD

  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: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Neurology

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 7, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 13, 2022
• Results First Posted: April 7, 2020

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)