Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): Rationale, Design, and Protocol of a Pilot Randomized Clinical Trial Assessing the Wii Gaming System

Authors

  • G. Saposnik,

    Corresponding author
    1. Division of Neurology, Departments of Medicine and Health Policy Management and Evaluation, and Institute of Clinical Evaluative Sciences, St. Michael's Hospital, University of Toronto, Toronto, Ontario
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  • M. Mamdani,

    1. Division of Neurology, Departments of Medicine and Health Policy Management and Evaluation, and Institute of Clinical Evaluative Sciences, St. Michael's Hospital, University of Toronto, Toronto, Ontario
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  • M. Bayley,

    1. Neuro Rehabilitation Program, Toronto Rehabilitation Institute, University of Toronto, Canada
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  • K.E. Thorpe,

    1. Neuro Rehabilitation Program, Toronto Rehabilitation Institute, University of Toronto, Canada
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  • J. Hall,

    1. Neuro Rehabilitation Program, Toronto Rehabilitation Institute, University of Toronto, Canada
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  • L.G. Cohen,

    1. Human Cortical Physiology and Stroke Neurorehabilitation Section, National Institute of Neurological Disorders (NINDS), National Institute of Health (NIH), Bethesda, Washington, USA
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  • R. Teasell,

    1. Stroke Rehabilitation Program, Parkwood Hospital, SJHC Health Care London, University of Western Ontario, London, Canada
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  • on behalf of the Steering Committee and EVREST Study Group* for the Stroke Outcome Research Canada (SORCan) Working Group

    1. Division of Neurology, Departments of Medicine and Health Policy Management and Evaluation, and Institute of Clinical Evaluative Sciences, St. Michael's Hospital, University of Toronto, Toronto, Ontario
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  • Conflict of Interest: Authors declare no financial conflicts of interest.

  • Dr Robert Teasell and Dr. Leonardo G. Cohen both equally contributed to the manuscript and project to qualify as the senior investigators.

Dr. Gustavo Saposnik. Assistant Professor. Director, Stroke Research Unit. Stroke Outcome Research Canada (SORCan) Working Group. Department of Medicine, St. Michael's Hospital, University of Toronto. 55 Queen St E, Toronto, Ontario, M5C 1R6. E-mail: saposnikg@smh.toronto.on.ca

Abstract

Background Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients.

Methods Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of ≥3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18–85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period).

Outcome measures The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41–83) years. Mean time from stroke onset 25 (range 10–56) days.

Conclusions EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration#NTC692523

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