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Robot Assisted Upper Limb Neuro-Rehabilitation

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00011583
First received: February 22, 2001
Last updated: March 10, 2008
Last verified: March 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Robot Assisted Upper Limb Neuro-Rehabilitation

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Fugl-Meyer score [ Time Frame: end of training, 6-month follow-up ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Stroke patients

Exclusion Criteria:

Unable to follow instructions; medically unstable.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011583

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

No publications provided

Responsible Party: Burgar, Charles - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00011583     History of Changes
Other Study ID Numbers: B2156
Study First Received: February 22, 2001
Last Updated: March 10, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cerebrovascular
Hemiplegia
Robotics

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

ClinicalTrials.gov processed this record on May 16, 2013