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

This study is currently recruiting participants.
Verified August 2013 by St. Michael's Hospital, Toronto
Sponsor:
Collaborators:
Heart and Stroke Foundation of Ontario
Ontario Stroke Network
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Gustavo Saposnik, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01406912
First received: July 25, 2011
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Ischemic Stroke
Other: Recreational Activity
Other: Wii Gaming System Arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Efficacy of Virtual Reality Exercises Using Wii Gaming Technology in STroke Rehabilitation: A Multicentre Randomized Clinical Trial (EVREST Multicentre)

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Difference in motor performance between groups measured using the Wolf Motor function Test. [ Time Frame: 1 (±3) days after the end of the intervention ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Improvement in motor function, performing activities of daily living, and quality of life, as well as sustainability of motor improvement [ Time Frame: End of intervention and 4 weeks post-intervention ] [ Designated as safety issue: No ]
    Secondary efficacy outcome measures include Box & Block Test, quality of life as measured by the Stroke Impact Scale, and Barthel Index at the end of the interventions. In addition, sustainability of motor improvement will be assessed through the Wolf Motor Function Test and Box & Block Test conducted at 4 weeks post-intervention, which is approximately 3 months from stroke onset.

  • Proportion of patients experiencing intervention-related adverse events or any serious adverse events during the study period [ Time Frame: Subjects will be followed for the duration of their participation in the study, an expected time frame of 6 weeks ] [ Designated as safety issue: Yes ]
    Secondary safety outcome will be measured as the proportion of patients experiencing intervention-related adverse events (e.g. pain, dizziness), or any serious adverse event (death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity) during the study period. We will also measure patients' perceived exertion after treatment by using the Borg Perceived Exertion scale (excessive fatigue defined as any score > 13 points)


Estimated Enrollment: 140
Study Start Date: July 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Recreational Activity Arm
recreational activity includes playing cards, ominoes, jenga or a ball game.
Other: Recreational Activity
Recreational activities (playing cards, arts and crafts, dominoes, jenga or a ball game) and conventional rehabilitation.
Experimental: Wii Gaming System Arm
Use of Wii gaming technology (e.g. commercially available games)
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.
Other Name: Virtual Reality Wii games

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406912

Contacts
Contact: Gustavo Saposnik, MD 416-864-6060 ext 5155 saposnikg@smh.ca
Contact: Mark Bayley, MD 416-597-3422 Bayley.Mark@TorontoRehab.on.ca

Locations
Argentina
FLENI Not yet recruiting
Buenos Aires, Argentina
Principal Investigator: Lisandro Olmos, MD         
Brazil
Lucy Montoro Network Not yet recruiting
Sao Paulo, Brazil
Principal Investigator: Marta Imamura, MD         
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 0P8
Principal Investigator: Sean Dukelow, MD         
Canada, Manitoba
Riverview Health Centre Recruiting
Winnipeg, Manitoba, Canada, R3L 2P4
Principal Investigator: Sepideh Pooyania, MD         
Canada, Newfoundland and Labrador
LA Miller Centre Not yet recruiting
St John's, Newfoundland and Labrador, Canada
Principal Investigator: Michelle Ploughman, MD         
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Principal Investigator: Demetrios Sahlas, MD         
Parkwood Hospital, St. Joseph's Health Care London Terminated
London, Ontario, Canada, N6C 5J1
Trillium Health Partners Recruiting
Mississauga, Ontario, Canada, L5B 1B8
Principal Investigator: Lisa Brice-Leddy, MSc(RS), BScPT         
Providence Healthcare Recruiting
Scarborough, Ontario, Canada, M1L 1W1
Principal Investigator: Peter Nord, MD         
Toronto Rehabilitation Institute Recruiting
Toronto, Ontario, Canada, M5G 2A2
Principal Investigator: Mark Bayley, MD         
Canada, Quebec
CSSS Cavendish Richardson Hospital Not yet recruiting
Montreal, Quebec, Canada
Principal Investigator: Theodore Wein, MD         
Peru
Clinica San Felipe Not yet recruiting
Lima, Peru
Principal Investigator: Felipe De los Rios La Rosa, MD         
Sub-Investigator: German Malaga, MD         
Thailand
Siriraj Hospital Not yet recruiting
Bangkok, Thailand
Principal Investigator: Yongchai Nilanont, MD         
Sub-Investigator: Vimonwan Hiengkaew, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Heart and Stroke Foundation of Ontario
Ontario Stroke Network
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Gustavo Saposnik, MD St. Michael's Hospital, Toronto
Principal Investigator: Mark Bayley, MD Toronto Rehabilitation Institute
  More Information

No publications provided

Responsible Party: Gustavo Saposnik, Principal Investigator, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01406912     History of Changes
Other Study ID Numbers: 11-188C
Study First Received: July 25, 2011
Last Updated: August 26, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
Stroke Rehabilitation
Ischemic Stroke
Virtual Reality
Nintendo Wii
Recreational Activity
Motor Function

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014