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Completed

NCT Number: NCT00011583

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Central Texas Veterans Health Care System

Temple, Texas, 76504, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Stroke patients

Exclusion criteria

Unable to follow instructions; medically unstable.

Treatment and study plan

Robot-assisted therapy

Device

1 hour/day of mechanically-assisted upper limb therapy

Traditional therapy

Device

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

Primary outcomes

  1. Fugl-Meyer score

    Time frame: end of training, 6-month follow-up

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Feb 26, 2001
Registry last updated
Mar 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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