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

NCT ID: NCT01406912

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-10-31

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)].

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Recreational Activity Arm

recreational activity includes playing cards, ominoes, jenga or a ball game.

Group Type: ACTIVE_COMPARATOR

Recreational Activity

Intervention Type: OTHER

Recreational activities (playing cards, arts and crafts, dominoes, jenga or a ball game) and conventional rehabilitation.

Wii Gaming System Arm

Use of Wii gaming technology (e.g. commercially available games)

Group Type: EXPERIMENTAL

Wii Gaming System Arm

Intervention Type: OTHER

Virtual reality Wii games (tennis and bowling from Wii® Sports, and bean bag, bocce ball, ping cup, darts or shuffleboard from Wii® Game Party 3) and conventional rehabilitation.

Interventions

Recreational Activity

Recreational activities (playing cards, arts and crafts, dominoes, jenga or a ball game) and conventional rehabilitation.

Intervention Type: OTHER

Wii Gaming System Arm

Virtual reality Wii games (tennis and bowling from Wii® Sports, and bean bag, bocce ball, ping cup, darts or shuffleboard from Wii® Game Party 3) and conventional rehabilitation.

Intervention Type: OTHER

Other Intervention Names

Virtual Reality Wii games

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role: collaborator

Ontario Stroke Network

OTHER

Sponsor Role: collaborator

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gustavo Saposnik, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Mark Bayley, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto Rehabilitation Institute

Locations

FLENI

Buenos Aires, Buenos Aires, Argentina

Lucy Montoro Network

São Paulo, , Brazil

University of Calgary

Calgary, Alberta, Canada

Riverview Health Centre

Winnipeg, Manitoba, Canada

LA Miller Centre

St. John's, Newfoundland and Labrador, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

Parkwood Hospital, St. Joseph's Health Care London

London, Ontario, Canada

Trillium Health Partners

Mississauga, Ontario, Canada

Providence Healthcare

Scarborough Village, Ontario, Canada

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

CSSS Cavendish Richardson Hospital

Montreal, Quebec, Canada

Clinica San Felipe

Lima, , Peru

Siriraj Hospital

Bangkok, , Thailand

Countries

Argentina; Brazil; Canada; Peru; Thailand

Other Identifiers

11-188C

Identifier Type: -

Identifier Source: org_study_id