Clinical trial NCT01406912: Efficacy of Virtual Reality Exercises in STroke Rehabilitation: A Multicentre Study (EVREST Multicentre)
Official title: Efficacy of Virtual Reality Exercises Using Wii Gaming Technology in STroke Rehabilitation: A Multicentre Randomized Clinical Trial (EVREST Multicentre)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: Stroke Rehabilitation
Ischemic Stroke
Virtual Reality
Nintendo Wii
Recreational Activity
Motor Function
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
name: Ontario Stroke Network
name: Ontario Ministry of Health and Long Term Care
First posted: 2011-08-01
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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 \[(recreational activities (RA)\].

Eligibility criteria: Inclusion Criteria:

* Patient has provided written informed consent prior to entry into the study
* Males or females, aged 18 to 85 years
* In-patient at the time of randomization
* Evidence of ischemic stroke confirmed by CT or MRI head scan
* Patients with onset of symptoms less than 3 months at time of randomization
* Measurable deficit of the upper extremity (arm) equal to or greater than 3 according to the Chedoke McMaster scale (e.g.: participants should be able to touch their chin and contralateral knee to be eligible)
* 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 3 months ago
* Patient is unable to follow verbal commands or has global aphasia
* Severe illness and 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 angina) 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
* Pain or joint problems limiting movement of the arm (e.g. shoulder pain)
* 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 cannot / 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).

Enrollment Criteria

* Upon meeting all eligibility criteria and providing written informed consent, the patient will be enrolled into the study contingent on successfully completing a one hour training session with Virtual Reality Wii.

Primary outcomes:
measure: Difference in motor performance between groups measured using the Wolf Motor function Test.
timeFrame: 1 (±3) days after the end of the intervention
Secondary outcomes:
measure: Improvement in motor function, performing activities of daily living, and quality of life, as well as sustainability of motor improvement
timeFrame: End of intervention and 4 weeks post-intervention
measure: Proportion of patients experiencing intervention-related adverse events or any serious adverse events during the study period
timeFrame: Subjects will be followed for the duration of their participation in the study, an expected time frame of 6 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: FLENI
city: Sao Paulo
country: Brazil
facility: Lucy Montoro Network
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Winnipeg
country: Canada
facility: Riverview Health Centre
state: Manitoba
city: St John's
country: Canada
facility: LA Miller Centre
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: Parkwood Hospital, St. Joseph's Health Care London
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners
state: Ontario
city: Scarborough
country: Canada
facility: Providence Healthcare
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
city: Montreal
country: Canada
facility: CSSS Cavendish Richardson Hospital
state: Quebec
city: Lima
country: Peru
facility: Clinica San Felipe
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Unity Health Toronto
name: Gustavo Saposnik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Rehabilitation Institute
name: Mark Bayley, MD
role: PRINCIPAL_INVESTIGATOR
References: