Influence of Timing on Motor Learning

NCT01769326 | Completed Results

• 2 other identifiers: HS# 2008-6432R43HD074331-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Keywords

Stroke

Outcome Measures

Primary Outcomes (2)

• 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.

  From baseline to 1 month post therapy

• 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.

  From baseline to 1 month post therapy

Other Outcomes (1)

• Range of Motion of Shoulder Joint

  1 month

Study Arms (4)

MusicGlove Group

EXPERIMENTAL

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

Control Group for Music Glove

ACTIVE COMPARATOR

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

Resonating Arm Exerciser (RAE)

EXPERIMENTAL

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

Control Group for RAE

ACTIVE COMPARATOR

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

Interventions

Conventional hand exercise OTHER

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

Control Group for Music Glove

MusicGlove DEVICE

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

MusicGlove Group

Conventional Arm Exercise OTHER

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

Control Group for RAE

Resonating Arm Exerciser 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.

Also known as: RAE

Resonating Arm Exerciser (RAE)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (2)

• 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.

  PMID: 27532880 DERIVED

• 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.

  PMID: 25273359 DERIVED

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: Steven Cramer, M.D.
• Organization: University of California Irvine

scramer@uci.edu

(949) 824-8748

Study Officials

• Steven Cramer, 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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: January 16, 2013
• Study Start: September 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 2, 2017
• Results First Posted: June 5, 2017

Record last verified: 2017-06

Locations

US (1)