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Influence of Timing on Motor Learning

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventional hand exercise
MusicGlove
Conventional Arm Exercise
Resonating Arm Exerciser
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Irvine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

MusicGlove Group

Control Group for Music Glove

Resonating Arm Exerciser (RAE)

Control Group for RAE

Arm Description

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

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.

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

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.

Outcomes

Primary Outcome Measures

Motor and Strength Outcome Measure Using Box and Block Test
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.
Motor and Strength Outcome Measure Using Fugl-Meyer Score
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.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2012
Last Updated
June 5, 2017
Sponsor
University of California, Irvine
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01769326
Brief Title
Influence of Timing on Motor Learning
Official Title
Influence of Timing on Motor Learning
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MusicGlove Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group for Music Glove
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Resonating Arm Exerciser (RAE)
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group for RAE
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional hand exercise
Intervention Description
Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
Intervention Type
Device
Intervention Name(s)
MusicGlove
Intervention Description
The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
Intervention Type
Other
Intervention Name(s)
Conventional Arm Exercise
Intervention Description
Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
Intervention Type
Device
Intervention Name(s)
Resonating Arm Exerciser
Other Intervention Name(s)
RAE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motor and Strength Outcome Measure Using Box and Block Test
Description
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.
Time Frame
From baseline to 1 month post therapy
Title
Motor and Strength Outcome Measure Using Fugl-Meyer Score
Description
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.
Time Frame
From baseline to 1 month post therapy
Other Pre-specified Outcome Measures:
Title
Range of Motion of Shoulder Joint
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Cramer, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27532880
Citation
Zondervan DK, Friedman N, Chang E, Zhao X, Augsburger R, Reinkensmeyer DJ, Cramer SC. Home-based hand rehabilitation after chronic stroke: Randomized, controlled single-blind trial comparing the MusicGlove with a conventional exercise program. J Rehabil Res Dev. 2016;53(4):457-72. doi: 10.1682/JRRD.2015.04.0057.
Results Reference
derived
PubMed Identifier
25273359
Citation
Zondervan DK, Augsburger R, Bodenhoefer B, Friedman N, Reinkensmeyer DJ, Cramer SC. Machine-Based, Self-guided Home Therapy for Individuals With Severe Arm Impairment After Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Jun;29(5):395-406. doi: 10.1177/1545968314550368. Epub 2014 Oct 1.
Results Reference
derived

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Influence of Timing on Motor Learning

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