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

Completed

Phase N/A Results

Trial Description

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

Interventions

  • Robotic Aids Behavioral
    Intervention Desc: This category includes any mechanical and/or computerized device designed to improve extremity function.
  • Functional electrical stimulation (FES) Device
    Intervention Desc: a technique that electrically stimulates a muscle in a comfortable manner in order to contract the muscle. It uses an electrode placed on the surface of the skin.
  • Robotics training for shoulder elbow. Device
    Intervention Desc: training utilizing a robot to assist with movement practice
    ARM 1: Kind: Experimental
    Label: 1
    ARM 2: Kind: Experimental
    Label: Arm 1
    ARM 3: Kind: Experimental
    Label: Shoulder/Elbow Robotics + Whole Arm Motor Learning
    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.
  • Surface Functional Neuromuscular Stimulation Device
    Intervention Desc: training utilizing FNS to assist with movement practice
    ARM 1: Kind: Experimental
    Label: 1
    ARM 2: Kind: Experimental
    Label: Arm 1
    ARM 3: Kind: Experimental
    Label: Wrist/Hand FES + Whole Arm Motor Learning
    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.
  • Whole arm motor learning Other
    Intervention Desc: intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.
    ARM 1: Kind: Experimental
    Label: Wrist/Hand FES + Whole Arm Motor Learning
    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.
    ARM 2: Kind: Experimental
    Label: Shoulder/Elbow Robotics + Whole Arm Motor Learning
    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.
    ARM 3: Kind: Experimental
    Label: Whole Arm Motor Learning
    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

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of the treatment groups. For all groups, treatment will offered 5 hrs/day, 5 days/week, for 12 weeks. Outcome measures will be collected at weeks 1, 6, 12, and three months after the end of treatment. 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Following measures to be obtained before and after treatment: volume of activation in the motor cortex measured using fMRI; EEG-derived cognitive motor planning time; Arm Motor Ability Test (AMAT).
Secondary The following measures will be obtained before and after treatment: 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); quality of life (Stroke Impact Scale).
Primary fMRI post intervention No
Primary AMAT prior to treatment and following 3 months of treatment No
Primary M1 Activation Absolute Change Score following 3 months of treatment No

Sponsors