Efficacy of Virtual Reality Exercises in STroke Rehabilitation: A Multicentre Study (EVREST Multicentre)

Unity Health Toronto

Status

Completed

Conditions

Ischemic Stroke

Treatments

Other: Recreational Activity

Other: Wii Gaming System Arm

Study type

Interventional

Funder types

Other

Identifiers

NCT01406912

11-188C

Details and patient eligibility

About

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.

Full 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)].

Enrollment

141 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.