Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient - Tabular View

Tracking Information

First Received Date ^ICMJE

May 24, 2002

Last Updated Date

February 2, 2009

Start Date ^ICMJE

April 2002

Primary Completion Date

November 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Fugl-Meyer Upper Extremity Motor Performance Test [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00037934 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

Official Title ^ICMJE

Evaluation of Robotic Upper Extremity Neuro-Rehabilitation

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Stroke

Intervention ^ICMJE

Device: Upper extremity robot
Other: Traditional Supervised Upper Extremity Exercises

Study Arms / Comparison Groups

Experimental: Robot exercise group
Active Comparator: Traditional exercise group

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2005

Primary Completion Date

November 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00037934

Responsible Party

Bever, Christopher - Principal Investigator, Department of Veterans Affairs

Study ID Numbers ^ICMJE

B2436

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Christopher Bever, MD

VA Maryland Health Care System, Baltimore

Information Provided By

Department of Veterans Affairs

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP