Efficacy of Virtual Reality Exercises in STroke Rehabilitation: A Multicentre Study (EVREST Multicentre)
A multicentre, randomized, two parallel group study comparing virtual reality using Wii gaming technology versus Recreational activities in patients receiving conventional rehabilitation after an ischemic stroke.
Primary Hypothesis: Virtual reality using the Wii gaming system is more efficacious in improving motor function than recreational therapy among patients receiving conventional rehabilitation following a recent ischemic stroke.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
|Official Title:||Efficacy of Virtual Reality Exercises Using Wii Gaming Technology in STroke Rehabilitation: A Multicentre Randomized Clinical Trial (EVREST Multicentre)|
- Difference in motor performance between groups measured using the Wolf Motor function Test. [ Time Frame: 1 (±3) days after the end of the intervention ] [ Designated as safety issue: No ]Efficacy in motor function improvement at the end of the intervention will be measured by the abbreviated Wolf Motor Function Test. The Wolf MFT is a time-based method to evaluate upper extremity performance while providing insight into total limb movements. It consists of 15 timed measures and 2 force-based measures which progress in complexity. Difference in Wolf MFT is one of the most commonly used outcome measures in stroke rehabilitation trials.
- Improvement in motor function, performing activities of daily living, and quality of life, as well as sustainability of motor improvement [ Time Frame: End of intervention and 4 weeks post-intervention ] [ Designated as safety issue: No ]Secondary efficacy outcome measures include Box & Block Test, quality of life as measured by the Stroke Impact Scale, and Barthel Index at the end of the interventions. In addition, sustainability of motor improvement will be assessed through the Wolf Motor Function Test and Box & Block Test conducted at 4 weeks post-intervention, which is approximately 3 months from stroke onset.
- Proportion of patients experiencing intervention-related adverse events or any serious adverse events during the study period [ Time Frame: Subjects will be followed for the duration of their participation in the study, an expected time frame of 6 weeks ] [ Designated as safety issue: Yes ]Secondary safety outcome will be measured as the proportion of patients experiencing intervention-related adverse events (e.g. pain, dizziness), or any serious adverse event (death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity) during the study period. We will also measure patients' perceived exertion after treatment by using the Borg Perceived Exertion scale (excessive fatigue defined as any score > 13 points)
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Recreational Activity Arm
recreational activity includes playing cards, ominoes, jenga or a ball game.
Other: Recreational Activity
Recreational activities (playing cards, arts and crafts, dominoes, jenga or a ball game) and conventional rehabilitation.
Experimental: Wii Gaming System Arm
Use of Wii gaming technology (e.g. commercially available games)
Other: Wii Gaming System Arm
Virtual reality Wii games (tennis and bowling from Wii® Sports, and bean bag, bocce ball, ping cup, darts or shuffleboard from Wii® Game Party 3) and conventional rehabilitation.
Other Name: Virtual Reality Wii games
Virtual reality (VR) gaming systems are novel and potentially useful technologies that allow users to interact in three dimensions with a computer-generated scenario (a virtual world). In particular, the Nintendo Wii gaming system applies relevant concepts in rehabilitation (i.e. repetition, intensity, and task-oriented training of the paretic extremity) showing benefits in motor function improvement after stroke. While standard rehabilitation (i.e. physiotherapy and occupational therapy) helps improve motor function after stroke, the magnitude of its benefit is suboptimal. The implementation of conventional rehabilitation is resource-intensive and costly, usually requiring transportation of patients and affecting adherence. Moreover, as improvement of motor function may be achieved after multiple sessions over a period of rehabilitation. The duration and intensity of the rehabilitation strategy are important factors in its effectiveness. Some studies compared an intervention plus conventional physical therapy versus conventional physical therapy alone, which by necessity allowed for more rehabilitation time in the experimental group. This creates a bias in favour of the new intervention as the intensity and frequency of rehabilitation per se is known to directly and beneficially affect functional outcomes. Therefore, the investigators are proposing comparing VR Wii versus an active control [(recreational activities (RA)].
|Contact: Gustavo Saposnik, MD||416-864-6060 ext email@example.com|
|Contact: Mark Bayley, MD||416-597-3422||Bayley.Mark@TorontoRehab.on.ca|
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|Buenos Aires, Argentina|
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|Sub-Investigator: German Malaga, MD|
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|Principal Investigator:||Gustavo Saposnik, MD||St. Michael's Hospital, Toronto|
|Principal Investigator:||Mark Bayley, MD||Toronto Rehabilitation Institute|