Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

Phase 2

Completed

• Conditions: Stroke
• Interventions: Device: Upper extremity robot; Other: Traditional Supervised Upper Extremity Exercises

• Registration Number: NCT00037934
• Lead Sponsor: US Department of Veterans Affairs

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2002-05-24
• Study First Submitted QC: 2002-05-24
• Study First Posted: 2002-05-27
• Primary Completion: 2004-09
• Study Completion: 2004-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-06
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Upper extremity robot	Traditional exercise group
1	Upper extremity robot	Robot exercise group
2	Traditional Supervised Upper Extremity Exercises	Traditional exercise group

Primary Outcome Measures

Name	Time	Method
Upper limb Motor Status Score, Wolf Motor Function Test, Motor Power Assessment, and Fugl-Meyer Upper Extremity Motor Performance Test	The Primary Outcome measures were performed at baseline, after completion of 18 sessions of intervention and at 3 months follow-up.

Trial Locations

Locations (1)

VA Maryland Health Care System, Baltimore; 🇺🇸 Baltimore, Maryland, United States