Evaluation of Robotic Arm Rehabilitation in Stroke Patients

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Robotic Upper Extremity Neurorehabilitation; Other: Traditional Upper Extremity Exercise Group

• Registration Number: NCT00333983
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-06
• Primary Completion: 2010-04
• Study Completion: 2011-02
• Results First Submitted: 2013-08-30
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-03
• Last Update Submitted: 2014-02-03
• Results First Posted: 2014-03-20
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Robotic Upper Extremity Neurorehabilitation	Robot Exercise Group
Arm 2	Traditional Upper Extremity Exercise Group	Traditional Upper Extremity Exercise Group

Primary Outcome Measures

Name	Time	Method
Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment	Baseline to Final Training (6 weeks)	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, \& Steglind, 1975; Gladstone, Danells, \& Black, 2002).; Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully.; The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome.

Trial Locations

Locations (1)

VA Maryland Health Care System, Baltimore; 🇺🇸 Baltimore, Maryland, United States