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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
  Purpose
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.

Condition Intervention
Cerebrovascular Accident
Other: Conventional hand exercise
Device: MusicGlove
Other: Conventional Arm Exercise
Device: Resonating Arm Exerciser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Timing on Motor Learning

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Motor and Strength outcome measure using Box and Block Test [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor and Strength outcome measure using Fugl-Meyer Score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Range of Motion of Shoulder Joint [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769326

Contacts
Contact: Vicky Chan, MS (949) 824-8423 vchan2@uci.edu
Contact: Renee Augsburger (949) 824- 8423 raugsbur@uci.edu

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Vicky Chan, MS    949-824-8423    vchan2@uci.edu   
Contact: Renee Augsburger    (949) 824- 8423    raugsbur@uci.edu   
Sponsors and Collaborators
University of California, Irvine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Steven Cramer, MD University of California, Irvine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven C. Cramer, MD, Professor of Neurology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01769326     History of Changes
Other Study ID Numbers: HS# 2008-6432  R43HD074331-01 
Study First Received: November 16, 2012
Last Updated: October 24, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 02, 2016