Evaluation of Robotic Arm Rehabilitation in Stroke Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.

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Detailed Description

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A robotic exercise device has been developed(MIT-MANUS)capable of providing therapy to the arm for patients with weakness due to stroke. The randomized trial will compare conventional care, planar robot intervention and an intervention of planar and vertical robot training among patients with chronic, stable deficits. We will evaluate motor outcomes, effectiveness, cost, patient satisfaction and quality of life. The study will determine the efficacy of upper extremity robot therapy compared to supervised self-administered exercise therapy in patients with deficits due to stroke.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Robot Exercise Group

Group Type EXPERIMENTAL

Robotic Upper Extremity Neurorehabilitation

Intervention Type DEVICE

Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot

Arm 2

Traditional Upper Extremity Exercise Group

Group Type ACTIVE_COMPARATOR

Traditional Upper Extremity Exercise Group

Intervention Type OTHER

Upper extremity stretching, skateboard reaching activities, and arm ergometer

Interventions

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Robotic Upper Extremity Neurorehabilitation

Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot

Intervention Type DEVICE

Traditional Upper Extremity Exercise Group

Upper extremity stretching, skateboard reaching activities, and arm ergometer

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects must have a clinically, defined, unilateral, hemiparetic stroke with radiologic exclusion of other diagnoses
* Stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients
* A grade 3 or lower in Manual Muscle Test in the hemiparetic elbow flexion and shoulder abduction

Exclusion Criteria

* Subjects unable to give informed consent
* Serious complicating medical illness
* Contracture or orthopedic problems limiting the range of joint movement in the study arm
* Visual loss
* Stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients
* Botox treatment within 3 months of enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No