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

Influence of Timing on Motor Learning

This study is ongoing, but not recruiting participants.
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: February 2, 2016
Last verified: February 2016

November 16, 2012
February 2, 2016
September 2012
June 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.

In humans, the acquisition of a new task seems to be based on an error-feedback paradigm, where motor command error generated in the first phase of learning is gradually corrected using peripheral feedback. Learning a new skill involves various brain structures and typically brain activation increases with the difficulty of the movement to be learned. To find ways to promote greater neuromotor adaptation during learning, some studies have tried to determine if subjecting individuals to a robot-generated force field that enhances movement error in the course of skill acquisition would improve learning. This premise could thus be used as a training paradigm during rehabilitation following a neurological insult such as a stroke. Results have shown that during training in an enhanced error situation, healthy individuals adapt to the presented perturbation and when this perturbation is removed, a greater improvement in performance is observed. It has been demonstrated that following a stroke, this adaptation still occurs, although to a lower extent than normal. Thus, stroke individuals present greater improvement in their motor performance after experiencing error-enhanced training with a robotic device than when receiving assistance in moving in the intended way. It seems that the impact of such robotic training on brain function is still unclear.

During the acquisition of a new task, not only the motor sequence of the action is crucial, but also the timing of the action. Most of the studies evaluating learning and the related brain structures mediating the acquisition of a new task have focused mainly on the motor sequence of the action and a paucity of them have assessed the timing of the action. Timing of an action plays a crucial role in the proper accomplishment of daily activities such as driving or playing tennis. Studies have found that, with practice, subjects are able to learn and anticipate the correct timing of a task and become more accurate in performing it. However, little is known about the effect of learning a new timing task on motor learning and brain related changes when individuals are subjected to a robotic error-enhanced timing of action.

The aim of the current project is to evaluate, in healthy and stroke individuals, the effect of introducing a change in movement timing or a feedback of movement timing that will either help or hinder individuals in accomplishing a new timing-based task, in order to determine which form of error modification will best induce motor learning as well as favorable brain plasticity. We hypothesize that the introduction of error amplification and error feedback during the practice of a timing-based task will provide the greatest benefit for motor learning and brain plasticity by providing the individuals with a constant error signal that will drive adaptation. Using a range of different devices, we will test the hypothesis that providing auditory and other types of feedback related to timing errors helps in learning timing tasks.

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. Epub 2014 Oct 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
June 2016
June 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
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
February 2016

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