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Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Upper extremity robot
Traditional Supervised Upper Extremity Exercises
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Robot, Stroke, Upper Extremity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Maryland Health Care System, Baltimore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Robot exercise group

Traditional exercise group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 24, 2002
Last Updated
October 6, 2011
Sponsor
US Department of Veterans Affairs
Collaborators
Massachusetts Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00037934
Brief Title
Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient
Official Title
Evaluation of Robotic Upper Extremity Neuro-Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Massachusetts Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Robot, Stroke, Upper Extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Robot exercise group
Arm Title
2
Arm Type
Active Comparator
Arm Description
Traditional exercise group
Intervention Type
Device
Intervention Name(s)
Upper extremity robot
Intervention Description
Robotic upper extremity neuro-rehabilitation
Intervention Type
Other
Intervention Name(s)
Traditional Supervised Upper Extremity Exercises
Intervention Description
Arm ergometer, reaching, and stretching exercises
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Bever, MD
Organizational Affiliation
VA Maryland Health Care System, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Maryland Health Care System, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

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