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

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Cerebrovascular Accident; Stroke; Cerebral Stroke

Treatments: Device: Robotics training for shoulder elbow.; Device: Surface Functional Neuromuscular Stimulation; Other: whole arm motor learning

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00237744

B3709-I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 3 patient groups

Wrist/Hand FES + Whole Arm Motor Learning

Experimental group

Description:

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.

Treatment:

Other: whole arm motor learning

Device: Surface Functional Neuromuscular Stimulation

Shoulder/Elbow Robotics + Whole Arm Motor Learning

Experimental group

Description:

Subjects\>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.

Treatment:

Other: whole arm motor learning

Device: Robotics training for shoulder elbow.

Whole Arm Motor Learning

Experimental group

Description:

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

Treatment:

Other: whole arm motor learning