Robot Assisted Upper Limb Neuro-Rehabilitation

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00011583

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Acute Stroke	Device: Robot-assisted therapy Device: Traditional therapy	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Robot Assisted Upper Limb Neuro-Rehabilitation

Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Dec 1, 2003

Actual Study Completion Date :

Dec 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Fugl-Meyer score [end of training, 6-month follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Stroke patients

Exclusion Criteria:

Unable to follow instructions; medically unstable.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Texas Veterans Health Care System	Temple	Texas	United States	76504

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

Principal Investigator: Charles Burgar, MD, Central Texas Veterans Health Care System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00011583

Other Study ID Numbers:

B2156

First Posted:

Feb 26, 2001

Last Update Posted:

Mar 11, 2008

Last Verified:

Mar 1, 2008

Keywords provided by , ,

Cerebrovascular

Hemiplegia

Robotics

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Mar 11, 2008