Robot Assisted Upper Limb Neuro-Rehabilitation

NCT ID: NCT00011583

Last Updated: 2008-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2003-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

1 hour/day of mechanically-assisted upper limb therapy

Group Type EXPERIMENTAL

Robot-assisted therapy

Intervention Type DEVICE

1 hour/day of mechanically-assisted upper limb therapy

2

1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot

Group Type ACTIVE_COMPARATOR

Traditional therapy

Intervention Type DEVICE

1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot

Interventions

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Robot-assisted therapy

1 hour/day of mechanically-assisted upper limb therapy

Intervention Type DEVICE

Traditional therapy

1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Stroke patients

Exclusion Criteria

Unable to follow instructions; medically unstable.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Department of Veterans Affairs

Principal Investigators

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Charles Burgar, MD

Role: PRINCIPAL_INVESTIGATOR

Central Texas Veterans Health Care System

Locations

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Central Texas Veterans Health Care System

Temple, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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B2156

Identifier Type: -

Identifier Source: org_study_id

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