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Robotic Upper-Limb Neurorehabilitation in Chronic Stroke Patient

NCT ID: NCT00037934

Last Updated: 2011-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-12-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Robot exercise group

Group Type EXPERIMENTAL

Upper extremity robot

Intervention Type DEVICE

Robotic upper extremity neuro-rehabilitation

2

Traditional exercise group

Group Type ACTIVE_COMPARATOR

Upper extremity robot

Intervention Type DEVICE

Robotic upper extremity neuro-rehabilitation

Traditional Supervised Upper Extremity Exercises

Intervention Type OTHER

Arm ergometer, reaching, and stretching exercises

Interventions

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Upper extremity robot

Robotic upper extremity neuro-rehabilitation

Intervention Type DEVICE

Traditional Supervised Upper Extremity Exercises

Arm ergometer, reaching, and stretching exercises

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts Institute of Technology

OTHER

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Bever, MD

Role: PRINCIPAL_INVESTIGATOR

VA Maryland Health Care System, Baltimore

Locations

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VA Maryland Health Care System, Baltimore

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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B2436

Identifier Type: -

Identifier Source: org_study_id