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

NCT01406912 | Completed DMC

• 1 other identifier: 11-188C
• Study Type: interventional
• Target: 141
• Locations: 5 countries
• Sites: 13

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.

Conditions

Ischemic Stroke

Keywords

Stroke Rehabilitation; Ischemic Stroke; Virtual Reality; Nintendo Wii; Recreational Activity; Motor Function

Outcome Measures

Primary Outcomes (1)

• Difference in motor performance between groups measured using the Wolf Motor function Test.

  Efficacy in motor function improvement at the end of the intervention will be measured by the abbreviated Wolf Motor Function Test. The Wolf MFT is a time-based method to evaluate upper extremity performance while providing insight into total limb movements. It consists of 15 timed measures and 2 force-based measures which progress in complexity. Difference in Wolf MFT is one of the most commonly used outcome measures in stroke rehabilitation trials.

  1 (±3) days after the end of the intervention

Secondary Outcomes (2)

• Improvement in motor function, performing activities of daily living, and quality of life, as well as sustainability of motor improvement

  End of intervention and 4 weeks post-intervention

• Proportion of patients experiencing intervention-related adverse events or any serious adverse events during the study period

  Subjects will be followed for the duration of their participation in the study, an expected time frame of 6 weeks

Study Arms (2)

Recreational Activity Arm

ACTIVE COMPARATOR

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

Other: Recreational Activity

Wii Gaming System Arm

EXPERIMENTAL

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

Other: Wii Gaming System Arm

Interventions

Recreational Activity OTHER

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

Recreational Activity Arm

Wii Gaming System Arm 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.

Also known as: Virtual Reality Wii games

Wii Gaming System Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Unity Health Toronto: lead
• Heart and Stroke Foundation of Ontario: collaborator
• Ontario Stroke Network: collaborator
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (13)

FLENI

Buenos Aires, Buenos Aires, Argentina

Location

Lucy Montoro Network

São Paulo, Brazil

Location

University of Calgary

Calgary, Alberta, T2N 0P8, Canada

Location

Riverview Health Centre

Winnipeg, Manitoba, R3L 2P4, Canada

Location

LA Miller Centre

St. John's, Newfoundland and Labrador, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Parkwood Hospital, St. Joseph's Health Care London

London, Ontario, N6C 5J1, Canada

Location

Trillium Health Partners

Mississauga, Ontario, L5B 1B8, Canada

Location

Providence Healthcare

Scarborough Village, Ontario, M1L 1W1, Canada

Location

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

Location

CSSS Cavendish Richardson Hospital

Montreal, Quebec, Canada

Location

Clinica San Felipe

Lima, Peru

Location

Siriraj Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gustavo Saposnik, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Mark Bayley, MD

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: August 1, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

TH (1); BR (1); PE (1); AR (1); CA (9)