Brain and Coordination Changes Induced By Robotics and FES Treatment Following Stroke

Study Overview
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Brief Summary
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The long-range goal of this work is to identify how to target treatment so that the brain is functionally re-organized to produce movement. This study will compare treatment response to robotics versus functional neuromuscular stimulation.

Detailed Description
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Methods. Up to ninety-six chronic stroke subjects (> 12 months post stroke) will be randomized to one of the treatment groups: Wrist/hand Functional Electrical Stimulation (FES)+whole arm motor learning group; shoulder/elbow robotics + whole arm motor learning group; and whole arm motor learning group. For all groups, treatment will offered 5 hrs/day, 5 days/week, for 12 weeks. All three treatment groups will receive motor learning therapy. For the Wrist/hand FES+whole arm motor learning group, there will be the addition of FES during treatment. For the Shoulder/elbow robotics + whole arm motor learning group there will be the addition of robotics training. Outcome measures will be collected at weeks 1, 6, 12, and three months after the end of treatment. Measures will include muscle strength (Manual Muscle Testing); coordination of joint movement (Fugl-Meyer Coordination Scale); motor control of target acquisition, pathway maintenance; and smoothness of movement (robotics measures); performance of 13 functional tasks (Arm Motor Ability Test); and quality of life (Stroke Impact Scale). Measures of brain function will be non-invasive and will include cognitive planning time, cognitive effort level, and location of brain activity during simple shoulder and arm movements. Changes in brain function measures will reflect plasticity or adaptability in response to treatment.

Official Title
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CNS Plasticity Induced By Motor Learning Technologies Following Stroke

Conditions
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Cerebral Stroke, Cerebrovascular Accident, Stroke

Intervention / Treatment
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* Device: Robotics training for shoulder elbow.
* Device: Surface Functional Neuromuscular Stimulation
* Other: whole arm motor learning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically stable and at least 12 months post stroke. Difficulty using upper limb for functional tasks. Age >21 years Exclusion Criteria: uncontrolled, chronic medical condition

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wrist/Hand FES + Whole Arm Motor Learning<br>Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning training and FES of the wrist/hand. | Device: Surface Functional Neuromuscular Stimulation<br>* training utilizing FNS to assist with movement practice<br>Other: whole arm motor learning<br>* intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.<br>|
| Experimental: Shoulder/Elbow Robotics + Whole Arm Motor Learning<br>Subjects>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics. | Device: Robotics training for shoulder elbow.<br>* training utilizing a robot to assist with movement practice<br>Other: whole arm motor learning<br>* intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.<br>|
| Experimental: Whole Arm Motor Learning<br>Subjects>6 months following first stroke with diminished upper limb strength, coordination and function who received whole arm motor learning training without addition of FES or Robotics | Other: whole arm motor learning<br>* intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMAT | The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test. | prior to treatment and following 3 months of treatment | 
| M1 Activation Absolute Change Score | A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659. | at baseline and following 3 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor Learning, Rehabilitation, Robotics, Therapeutic Electric Stimulation