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 16, 2013
Last verified: September 2013
  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

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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • fMRI [ Time Frame: post intervention ] [ Designated as safety issue: No ]

Enrollment: 72
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
Arm 1 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

Detailed Description:

Methods. Ninety-six chronic stroke subjects (> 12 months post stroke) 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 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
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

No publications provided

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
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 21, 2014