Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST) (EVREST)
October 1, 2009 updated by: Unity Health Toronto
A Pilot Randomised, Two Parallel Group Study Comparing Wii Gaming Versus Recreational Activity in Patients Receiving Standard Rehabilitation After Stroke
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 1X2
- St. Michael's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient has provided written informed consent prior to entry into the study
- In-patient at one of the two study institutions at the time of randomization
- Males or females, aged over 18 and younger than 85
- Evidence of stroke confirmed by CT head (ischemic or hemorrhagic)
- Time: Onset of symptoms within 6 months prior to randomization
- Measurable Chedoke-McMaster scale stage of =>4 on the "arm" item (10)
- Functional independence prior to present stroke (baseline mRS = 0-1)
- Patient is alert, medically stable according to the treating physician and able to follow simple verbal commands
Exclusion Criteria:
- Acute stroke onset more than 6 months ago
- Patient is unable to follow verbal commands or has global aphasia
- Severe illness with life expectancy less than 3 months (cancer, endocarditis, metastasis with an occult primary malignancy, coagulopathy).
- Uncontrolled hypertension according to the treating physician
- Unstable angina or recent myocardial infarction (within the last 3 months), current NY Heart Association Class III (marked limitation of physical activity; although patients are comfortable at rest, less-than-ordinary activity leads to fatigue, dyspnea, palpitations, or angina3) or IV (symptomatic at rest; symptoms of CHF are present at rest; discomfort increases with any physical activity) or symptomatic ventricular tachyarrhythmias, as per medical history (a baseline ECG will not be required.)
- Any history of seizure, except for febrile seizures of childhood
- Participation in another clinical trial involving rehabilitation (recreational therapy, occupational therapy, physiotherapy) or involving an investigational drug.
- Patient is unwilling or unable to comply with the protocol or can not/will not cooperate fully with the investigator or study personnel.
- Any condition(s) that, in the Investigator's opinion, would a) warrant exclusion from the study (i.e., participation in the study is not in the best interest of the patient) or b) prevent the patient from completing the study.
- Any medical condition that might confound the interpretation of results or put the patient at risk (amputation of one extremity).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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Recreational therapy sessions will include leisure activities such as playing cards and/or doing arts and crafts.
|
|
Experimental: 2
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.
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The primary feasibility outcome is the total time receiving the intervention.
Time Frame: 2 weeks
|
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
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gustavo Saposnik, MD, Unity Health Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
June 4, 2008
First Submitted That Met QC Criteria
June 5, 2008
First Posted (Estimate)
June 6, 2008
Study Record Updates
Last Update Posted (Estimate)
October 2, 2009
Last Update Submitted That Met QC Criteria
October 1, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMH - GS - 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.