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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
February 22, 2001
February 26, 2001
March 11, 2008
January 2000
December 2003   (Final data collection date for primary outcome measure)
Fugl-Meyer score [ Time Frame: end of training, 6-month follow-up ]
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Complete list of historical versions of study NCT00011583 on ClinicalTrials.gov Archive Site
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Robot Assisted Upper Limb Neuro-Rehabilitation
Robot Assisted Upper Limb Neuro-Rehabilitation

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.

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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Stroke
  • Device: Robot-assisted therapy
    1 hour/day of mechanically-assisted upper limb therapy
  • Device: Traditional therapy
    1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot
  • Experimental: 1
    1 hour/day of mechanically-assisted upper limb therapy
    Intervention: Device: Robot-assisted therapy
  • Active Comparator: 2
    1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot
    Intervention: Device: Traditional therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2003
December 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Stroke patients

Exclusion Criteria:

Unable to follow instructions; medically unstable.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00011583
B2156
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Burgar, Charles - Principal Investigator, Department of Veterans Affairs
VA Office of Research and Development
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Principal Investigator: Charles Burgar, MD Central Texas Veterans Health Care System
VA Office of Research and Development
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP