Overview

This trial is active, not recruiting.

Condition cerebrovascular accident
Treatments conventional hand exercise, musicglove, conventional arm exercise, resonating arm exerciser
Sponsor University of California, Irvine
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date September 2012
End date June 2016
Trial size 40 participants
Trial identifier NCT01769326, HS# 2008-6432, R43HD074331-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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
musicglove
The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
(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.
conventional hand exercise
Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
(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
resonating arm exerciser RAE
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.
(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.
conventional arm exercise
Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises

Primary Outcomes

Measure
Motor and Strength outcome measure using Box and Block Test
time frame: 10 weeks

Secondary Outcomes

Measure
Motor and Strength outcome measure using Fugl-Meyer Score
time frame: 10 weeks

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Influence of Timing on Motor Learning
Principal investigator Steven Cramer, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of California, Irvine.