Influence of Timing on Motor Learning

June 5, 2017 updated by: Steven C. Cramer, MD, University of California, Irvine
The purpose of this research study is to compare different methods for training hand movement at home after stroke. This study involves research because it will test two experimental devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to conventional hand and arm exercises. The MusicGlove is a glove that measures finger movements and allows its user to play a musical computer game using those movements. The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to compare different methods for training hand movement at home after stroke. This study involves research because it will test two experimental devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to conventional hand and arm exercises. The MusicGlove is a glove that measures finger movements and allows its user to play a musical computer game using those movements. The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 80 years of age
  • Sustained a single stroke affecting the arm, at least three months prior to enrollment
  • Minimal to moderate lost motor control of the arm after stroke
  • 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 stroke-affected upper extremity

Exclusion Criteria:

  • Severe tone at the affected upper extremity
  • Severe aphasia
  • Severe reduced level of consciousness
  • Severe sensory/proprioception deficit at the affected upper extremity
  • Currently pregnant
  • Difficulty in understanding or complying with instructions
  • Inability to perform the experimental task that will be studied
  • Increased pain with movement of the stroke-affected upper extremity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MusicGlove Group
Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program
Device: MusicGlove
The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
Active Comparator: Control Group for Music Glove
Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Other: Conventional hand exercise
Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
Experimental: Resonating Arm Exerciser (RAE)
Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program
Device: Resonating Arm Exerciser
The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.
Other Names:
  • RAE
Active Comparator: Control Group for RAE
Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.
Other: Conventional Arm Exercise
Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor and Strength Outcome Measure Using Box and Block Test
Time Frame: From baseline to 1 month post therapy
The primary end point was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 secons, from baseline to 1 month posttherapy. The higher the scores, the better arm and hand function indicated.
From baseline to 1 month post therapy
Motor and Strength Outcome Measure Using Fugl-Meyer Score
Time Frame: From baseline to 1 month post therapy
The primary outcome measure was the change in Upper Extremity FM score on a scale of 0 to 66 at one month post therapy. The higher the scores, the better arm and hand function indicated.
From baseline to 1 month post therapy

Other Outcome Measures

Outcome Measure
Time Frame
Range of Motion of Shoulder Joint
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Steven Cramer, MD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

January 14, 2013

First Posted (Estimate)

January 16, 2013

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS# 2008-6432
  • R43HD074331-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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