Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST) (EVREST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00692523|
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : October 2, 2009
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Recreational therapy activities Other: Nintendo Wii||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Randomised, Two Parallel Group Study Comparing Wii Gaming Versus Recreational Activity in Patients Receiving Standard Rehabilitation After Stroke|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
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
- The primary feasibility outcome is the total time receiving the intervention. [ Time Frame: 2 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692523
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1X2|
|Principal Investigator:||Gustavo Saposnik, MD||St. Michael's Hospital, Toronto|