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
  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

Resource links provided by NLM:


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: June 2016
Estimated Primary Completion Date: June 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:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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

Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92697
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

No publications provided by University of California, Irvine

Additional 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: February 2, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Stroke

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

ClinicalTrials.gov processed this record on February 11, 2016