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Clinical Trials/NCT00037934
NCT00037934
Completed
Phase 2

Evaluation of Robotic Upper Extremity Neuro-Rehabilitation

US Department of Veterans Affairs1 site in 1 country30 target enrollmentApril 2002
ConditionsStroke

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stroke
Sponsor
US Department of Veterans Affairs
Enrollment
30
Locations
1
Primary Endpoint
Upper limb Motor Status Score, Wolf Motor Function Test, Motor Power Assessment, and Fugl-Meyer Upper Extremity Motor Performance Test
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke patients using a robot for neurological rehabilitation designed and built by MIT. Results of a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated by patients and produces a significant, measurable benefit. We propose to test that the robotic upper extremity trainer is an acceptable cost effective adjunct to standard occupational therapy for patients with dysfunction of the shoulder and elbow due to hemiparetic stroke in a VA rehabilitation program.

Registry
clinicaltrials.gov
Start Date
April 2002
End Date
December 2004
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Chronic Stroke
  • Manual Muscle Score of Grade 3 or lower in at least one muscle of the affected arm

Exclusion Criteria

  • Acute Stroke
  • Contracture or orthopedic problems limiting the movement of the affected arm
  • Visual deficit such that the participant cannot see the test pattern on the robot trainer
  • Serious complicating medical illness
  • Botox treatment to the involved arm within three months of enrollment

Outcomes

Primary Outcomes

Upper limb Motor Status Score, Wolf Motor Function Test, Motor Power Assessment, and Fugl-Meyer Upper Extremity Motor Performance Test

Time Frame: The Primary Outcome measures were performed at baseline, after completion of 18 sessions of intervention and at 3 months follow-up.

Study Sites (1)

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