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

Not Applicable

Completed

• Conditions: Cerebral Stroke; Cerebrovascular Accident; Stroke
• Interventions: Device: Robotics training for shoulder elbow.; Device: Surface Functional Neuromuscular Stimulation; Other: whole arm motor learning

• Registration Number: NCT00237744
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2013-11-08
• Results First Submitted QC: 2014-07-24
• Results First Posted: 2014-08-15
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-03
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Medically stable and at least 12 months post stroke.
• Difficulty using upper limb for functional tasks.
• Age >21 years

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Exclusion Criteria

uncontrolled, chronic medical condition

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shoulder/Elbow Robotics + Whole Arm Motor Learning	Robotics training for shoulder elbow.	Subjects\>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
Wrist/Hand FES + Whole Arm Motor Learning	whole arm motor learning	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.
Wrist/Hand FES + Whole Arm Motor Learning	Surface Functional Neuromuscular Stimulation	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.
Whole Arm Motor Learning	whole arm motor learning	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
Shoulder/Elbow Robotics + Whole Arm Motor Learning	whole arm motor learning	Subjects\>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.

Primary Outcome Measures

Name	Time	Method
AMAT	prior to treatment and following 3 months of treatment	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.
M1 Activation Absolute Change Score	at baseline and following 3 months of treatment	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.

Trial Locations

Locations (1)

VA Medical Center, Cleveland; 🇺🇸 Cleveland, Ohio, United States