Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST)
This study is a pilot, randomized trial that will examine whether the Nintendo Wii virtual gaming system is safe and feasible for use in patients who have had a recent stroke.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Randomised, Two Parallel Group Study Comparing Wii Gaming Versus Recreational Activity in Patients Receiving Standard Rehabilitation After Stroke|
- The primary feasibility outcome is the total time receiving the intervention. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- The primary safety outcome is the proportion of patients experiencing intervention-related adverse events, or any serious adverse event during the study period. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
The control group will receive 8 recreational therapy sessions over a 2-week (14 day) period, to be scheduled in a flexible manner as long as all 8 sessions are completed within the 2 week period, and no more than 2 sessions are completed on any one day.
Other: Recreational therapy activities
Recreational therapy sessions will include leisure activities such as playing cards and/or doing arts and crafts.
Patients randomized to Wii technology will receive an intensive program consisting of 8 Wii gaming sessions, 60 minutes each, over a 2-week (14 day) period. These 8 sessions can be scheduled in a flexible manner as long as all 8 sessions are completed within the 2 week period, and no more than 2 sessions are completed on any one day.
Other: Nintendo Wii
The Nintendo Wii gaming system, released in 2005, introduced a new style of virtual reality by using a wireless controller that interacts with the player through a motion detection system. Nintendo Wii involves the incorporation of 3-dimensional accelerometer technology that can respond to changes in direction, speed, and acceleration, down to the most delicate movements. Specifically, the controllers use embedded acceleration sensors to enable players' wrist, arm, and hand movements to interact with the games. Tilt measurements allow users to move characters, while the accurate three-axis acceleration sensing easily transforms the controller into a virtual sword, gearshift, or musical instrument
A pilot, randomized (1:1) controlled trial to compare the safety and feasibility of Nintendo Wii gaming versus other recreational therapy activities (playing cards) in post-stroke patients. All patients will continue to receive all other standard medical and physiotherapy treatments while in the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692523
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1X2|
|Principal Investigator:||Gustavo Saposnik, MD||St. Michael's Hospital, Toronto|