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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00237744
First received: October 7, 2005
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Cerebral Stroke
Cerebrovascular Accident
Stroke
Device: Robotics training for shoulder elbow.
Device: Surface Functional Neuromuscular Stimulation
Other: whole arm motor learning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CNS Plasticity Induced By Motor Learning Technologies Following Stroke

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • AMAT [ Time Frame: prior to treatment and following 3 months of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: following 3 months of treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: April 2005
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wrist/Hand FES + 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.
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.
Experimental: Shoulder/Elbow Robotics + 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.
Device: Robotics training for shoulder elbow.
training utilizing a robot 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.
Experimental: 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
Other: whole arm motor learning
intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237744

Locations
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Investigators
Principal Investigator: Janis Daly, PhD MS VA Medical Center, Cleveland
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00237744     History of Changes
Other Study ID Numbers: B3709-I
Study First Received: October 7, 2005
Results First Received: November 8, 2013
Last Updated: September 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Motor Learning
Rehabilitation
Robotics
Therapeutic Electric Stimulation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 22, 2014