Evaluation of Robotic Arm Rehabilitation in Stroke Patients

Study Overview
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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.

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.

Official Title
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Evaluation of Robotic Arm Rehabilitation in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: Robotic Upper Extremity Neurorehabilitation
* Other: Traditional Upper Extremity Exercise Group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Robot Exercise Group | Device: Robotic Upper Extremity Neurorehabilitation<br>* Upper extremity exercise using a planar robot Upper extremity exercise using a planar and vertical robot<br>|
| Active Comparator: Arm 2<br>Traditional Upper Extremity Exercise Group | Other: Traditional Upper Extremity Exercise Group<br>* Upper extremity stretching, skateboard reaching activities, and arm ergometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment | 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. | Baseline to Final Training (6 weeks) |