Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Influence of Timing on Motor Learning

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of California, Irvine
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01769326
First received: November 16, 2012
Last updated: October 24, 2016
Last verified: October 2016

November 16, 2012
October 24, 2016
September 2012
December 2016   (final data collection date for primary outcome measure)
Motor and Strength outcome measure using Box and Block Test [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01769326 on ClinicalTrials.gov Archive Site
Motor and Strength outcome measure using Fugl-Meyer Score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Not Provided
Range of Motion of Shoulder Joint [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Not Provided
 
Influence of Timing on Motor Learning
Influence of Timing on Motor Learning
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cerebrovascular Accident
  • Other: Conventional hand exercise
    Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
  • Device: MusicGlove
    The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
  • Other: Conventional Arm Exercise
    Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
  • 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 Name: RAE
  • 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
    Intervention: Device: MusicGlove
  • 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.
    Intervention: Other: Conventional hand exercise
  • 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
    Intervention: Device: Resonating Arm Exerciser
  • 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.
    Intervention: Other: Conventional Arm Exercise
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2016
December 2016   (final data collection date for primary outcome measure)

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
All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Vicky Chan, MS (949) 824-8423 vchan2@uci.edu
Contact: Renee Augsburger (949) 824- 8423 raugsbur@uci.edu
United States
 
NCT01769326
HS# 2008-6432, R43HD074331-01
No
Not Provided
Not Provided
Steven C. Cramer, MD, University of California, Irvine
University of California, Irvine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Steven Cramer, MD University of California, Irvine
University of California, Irvine
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP