Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

Stroke Clinical Trial

Official title:

Evaluation of Robotic Upper Extremity Neuro-Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037934
• Other study ID #: B2436
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2002
• Last updated: October 6, 2011
• Start date: April 2002
• Est. completion date: December 2004

Study information

• Verified date: October 2011
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Upper extremity robot
Robotic upper extremity neuro-rehabilitation

Other:
• Traditional Supervised Upper Extremity Exercises
Arm ergometer, reaching, and stretching exercises

Locations

Country	Name	City	State
United States	VA Maryland Health Care System, Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No