Open AccessE ffectiveness of V irtual R eality E xercises in ST roke Rehabilitation (EVREST): Rationale, Design, and Protocol of a Pilot Randomized Clinical Trial Assessing the Wii Gaming System
Author(s) -
Saposnik G.,
Mamdani M.,
Bayley M.,
Thorpe K.E.,
Hall J.,
Cohen L.G.,
Teasell R.
Publication year - 2010
Publication title -
international journal of stroke
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.375
H-Index - 74
eISSN - 1747-4949
pISSN - 1747-4930
DOI - 10.1111/j.1747-4949.2009.00404.x
Subject(s) - medicine , physical medicine and rehabilitation , protocol (science) , rehabilitation , virtual reality , stroke (engine) , physical therapy , randomized controlled trial , clinical neurology , pilot trial , telerehabilitation , protocol design , telemedicine , human–computer interaction , alternative medicine , neuroscience , surgery , health care , communications protocol , economic growth , economics , biology , operating system , mechanical engineering , pathology , computer science , engineering
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