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Robot Assisted Upper Limb Neuro-Rehabilitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00011583
First Posted: February 26, 2001
Last Update Posted: March 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  Purpose

Our long term objectives are to understand the mechanisms of motor impairment following neurologic injury and to develop interventions to improve motor recovery. A series of complementary, overlapping clinical trials and development activities will validate and optimize the use of robot-assisted upper limb therapy for neuro rehabilitation.

We have developed a robotic system that assists or resists elbow and shoulder movements in three dimensional space. In addition to unilateral exercise modes, a novel bimanual mode enables hemiparetic subjects to practice mirror image upper limb exercises.


Condition Intervention Phase
Acute Stroke Device: Robot-assisted therapy Device: Traditional therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robot Assisted Upper Limb Neuro-Rehabilitation

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Fugl-Meyer score [ Time Frame: end of training, 6-month follow-up ]

Estimated Enrollment: 60
Study Start Date: January 2000
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1 hour/day of mechanically-assisted upper limb therapy
Device: Robot-assisted therapy
1 hour/day of mechanically-assisted upper limb therapy
Active Comparator: 2
1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot
Device: Traditional therapy
1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot

Detailed Description:
Randomized controlled clinical trial of the Mirror Image Movement Enabler (MIME) robotic device for shoulder and elbow neurorehabilitation in subacute stroke patients. MIME incorporates a PUMA 560 robot that applies forces to the paretic limb during unilateral and bilateral movements in three dimensions. Robot-assisted treatment (bilateral, unilateral, and combined bilateral and unilateral) was compared with conventional therapy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Stroke patients

Exclusion Criteria:

Unable to follow instructions; medically unstable.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00011583


Locations
United States, Texas
Central Texas Veterans Health Care System
Temple, Texas, United States, 76504
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Charles Burgar, MD Central Texas Veterans Health Care System
  More Information

Responsible Party: Burgar, Charles - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00011583     History of Changes
Other Study ID Numbers: B2156
First Submitted: February 22, 2001
First Posted: February 26, 2001
Last Update Posted: March 11, 2008
Last Verified: March 2008

Keywords provided by VA Office of Research and Development:
Cerebrovascular
Hemiplegia
Robotics

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