Evaluation of Robotic Arm Rehabilitatio… | Clinical Trial

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic Upper Extremity Neurorehabilitation

Device

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

Traditional Upper Extremity Exercise Group

Other

Upper extremity stretching, skateboard reaching activities, and arm ergometer

Primary outcomes

Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment

Time frame: 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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2011
First posted: Jun 6, 2006
Registry last updated: Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed