Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Summary
The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.
Description
This study continues our investigation of the optimal timing, intensity, and duration of robot-assisted training to improve motor performance in patients with hemiplegia following stroke. These hypotheses will be tested: 1) subjects receiving robot-assisted upper limb therapy with MIME in the initial phase of recovery from stroke experience greater functional gains than a control group receiving additional conventional therapy of equal intensity and duration, 2) robot-assisted therapy results in a dose-dependent response, and 3) robot-assisted therapy promotes greater control of movement, greater recovery of strength, and greater reduction of co-contraction than the control intervention.Research Plan - A multi-site clinical trial is in progress at the Houston VA Medical Center (VAMC), the VA Greater Los Angeles Health Care System (GLAHCS), the VA Palo Alto Rehabilitation Research and Development Center (RR&DC), and the Central Texas Veterans Health Care System (CTVHCS). CTVHCS serves as the coordinating site. The RR&DC provides training and technical assistance for the other sites. Methods - Subjects with hemiparesis due to a stroke are randomly assigned to 3 groups. Group 1 receives 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Group 2 receives a total of 2 hours/day of robot-assisted therapy. Group 3 receives 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Outcome measures include assessment of strength, motor control, functional status, and patient satisfaction at intake, discharge, 6 and 12 months.
Study Design
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Cerebrovascular Disorders
Intervention
Mechanically-assisted upper limb exercise using MIME, Mechanically-assisted upper limb exercise using MIME (high-dose), Additional usual therapy
Location
VA Palo Alto Health Care System
Palo Alto
California
United States
94304-1290
Status
Completed
Source
Department of Veterans Affairs
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00223808
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Potexvirus
A genus of plant viruses in the family FLEXIVIRIDAE, that cause mosaic and ringspot symptoms. Transmission occurs mechanically. Potato virus X is the type species.
Leporipoxvirus
A genus of the family POXVIRIDAE, subfamily CHORDOPOXVIRINAE, consisting of ether-sensitive viruses of leporids and squirrels. They commonly cause tumors and are usually transmitted mechanically by arthropods. MYXOMA VIRUS is the type species.
Plasticizers
Materials incorporated mechanically in plastics (usually PVC) to increase flexibility, workability or distensibility; due to the non-chemical inclusion, plasticizers leach out from the plastic and are found in body fluids and the general environment.
Picornaviridae
A family of small RNA viruses comprising some important pathogens of humans and animals. Transmission usually occurs mechanically. There are nine genera: APHTHOVIRUS; CARDIOVIRUS; ENTEROVIRUS; ERBOVIRUS; HEPATOVIRUS; KOBUVIRUS; PARECHOVIRUS; RHINOVIRUS; and TESCHOVIRUS.
Tombusvirus
A genus of plant viruses that infects ANGIOSPERMS. Transmission occurs mechanically and through soil, with one species transmitted via a fungal vector. The type species is Tomato bushy stunt virus.
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