Robot Assisted Upper Limb Neuro-Rehabilitation

Acute Stroke Clinical Trial

Official title:

Robot Assisted Upper Limb Neuro-Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00011583
• Other study ID #: B2156
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2001
• Last updated: March 10, 2008
• Start date: January 2000
• Est. completion date: December 2003

Study information

• Verified date: March 2008
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Stroke patients

Exclusion Criteria:

Unable to follow instructions; medically unstable.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke

Intervention

Device:
• Robot-assisted therapy
1 hour/day of mechanically-assisted upper limb therapy
• Traditional therapy
1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot

Locations

Country	Name	City	State
United States	Central Texas Veterans Health Care System	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer score		end of training, 6-month follow-up	No