NCT00237744

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

CNS Plasticity Induced By Motor Learning Technologies Following Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cerebral Stroke
• Cerebrovascular Accident
• Stroke

Interventions

Type	Name	Description
DEVICE	Robotics training for shoulder elbow.	training utilizing a robot to assist with movement practice
DEVICE	Surface Functional Neuromuscular Stimulation	training utilizing FNS to assist with movement practice
OTHER	whole arm motor learning	intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.

Timeline

• Start date: 2005-04-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2005-10-12
• Last updated: 2014-10-13
• Results posted: 2014-08-15

Locations

1 site across 1 country: United States