Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00037934
• Collaborator: Massachusetts Institute of Technology (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Upper extremity robot; Other: Traditional Supervised Upper Extremity Exercises	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Robotic Upper Extremity Neuro-Rehabilitation
• Study Start Date: Apr 1, 2002
• Actual Primary Completion Date: Sep 1, 2004
• Actual Study Completion Date: Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Robot exercise group	Device: Upper extremity robot; Robotic upper extremity neuro-rehabilitation
Active Comparator: 2 Traditional exercise group	Device: Upper extremity robot; Robotic upper extremity neuro-rehabilitation; Other: Traditional Supervised Upper Extremity Exercises; Arm ergometer, reaching, and stretching exercises

Outcome Measures

Primary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Maryland Health Care System, Baltimore	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• US Department of Veterans Affairs
• Massachusetts Institute of Technology

Investigators

• Principal Investigator: Christopher Bever, MD, VA Maryland Health Care System, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00037934
• Other Study ID Numbers: B2436
• First Posted: May 27, 2002
• Last Update Posted: Oct 7, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by US Department of Veterans Affairs: Robot; Stroke; Upper Extremity
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Oct 7, 2011