Clinical trial NCT00692523: Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST)
Official title: A Pilot Randomised, Two Parallel Group Study Comparing Wii Gaming Versus Recreational Activity in Patients Receiving Standard Rehabilitation After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
rehabilitation
Nintendo Wii
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The primary feasibility outcome is the total time receiving the intervention.
timeFrame: 2 weeks
measure: The primary safety outcome is the proportion of patients experiencing intervention-related adverse events, or any serious adverse event during the study period.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Gustavo Saposnik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saposnik G, Mamdani M, Bayley M, Thorpe KE, Hall J, Cohen LG, Teasell R; EVREST Steering Committee; EVREST Study Group for the Stroke Outcome Research Canada Working Group. Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system. Int J Stroke. 2010 Feb;5(1):47-51. doi: 10.1111/j.1747-4949.2009.00404.x.