Robot Assisted Upper Limb Neuro-Rehabilitation - Full Text View

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 II

MedlinePlus related topics:

Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title:	Robot Assisted Upper Limb Neuro-Rehabilitation

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
1: Experimental 1 hour/day of mechanically-assisted upper limb therapy	Device: Robot-assisted therapy 1 hour/day of mechanically-assisted upper limb therapy
2: Active Comparator 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

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