Influence of Timing on Motor Learning

NCT ID: NCT01769326

Last Updated: 2017-07-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Cerebrovascular Accident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

MusicGlove

Intervention Type DEVICE

The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.

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.

Group Type ACTIVE_COMPARATOR

Conventional hand exercise

Intervention Type OTHER

Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers

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

Group Type EXPERIMENTAL

Resonating Arm Exerciser

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Conventional Arm Exercise

Intervention Type OTHER

Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises

Interventions

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Conventional hand exercise

Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers

Intervention Type OTHER

MusicGlove

The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.

Intervention Type DEVICE

Conventional Arm Exercise

Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises

Intervention Type OTHER

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.

Intervention Type DEVICE

Other Intervention Names

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RAE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Steven C. Cramer, MD

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven Cramer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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University of California, Irvine

Irvine, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27532880 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25273359 (View on PubMed)

Other Identifiers

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R43HD074331-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HS# 2008-6432

Identifier Type: -

Identifier Source: org_study_id

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