Status:
COMPLETED
Efficacy of Virtual Reality Exercises in STroke Rehabilitation: A Multicentre Study (EVREST Multicentre)
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Heart and Stroke Foundation of Ontario
Ontario Stroke Network
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
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 isch...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT01406912
Start Date
July 1 2011
End Date
October 1 2015
Last Update
November 13 2015
Active Locations (13)
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1
FLENI
Buenos Aires, Buenos Aires, Argentina
2
Lucy Montoro Network
São Paulo, Brazil
3
University of Calgary
Calgary, Alberta, Canada, T2N 0P8
4
Riverview Health Centre
Winnipeg, Manitoba, Canada, R3L 2P4