Ischemic StrokeNCT01406912
Efficacy of Virtual Reality Exercises in STroke Rehabilitation: A Multicentre Study (EVREST Multicentre)
A study testing Recreational Activity and Wii Gaming System Arm in people with Ischemic Stroke, run by Unity Health Toronto at 13 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Recreational Activity and Wii Gaming System Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Jul 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Canada9 sites
University of Calgary
Calgary, Alberta, T2N 0P8
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Parkwood Hospital, St. Joseph's Health Care London
London, Ontario, N6C 5J1
Trillium Health Partners
Mississauga, Ontario, L5B 1B8
CSSS Cavendish Richardson Hospital
Montreal, Quebec
Providence Healthcare
Scarborough Village, Ontario, M1L 1W1
LA Miller Centre
St. John's, Newfoundland and Labrador
Toronto Rehabilitation Institute
Toronto, Ontario, M5G 2A2
Riverview Health Centre
Winnipeg, Manitoba, R3L 2P4
About this study
Official title: Efficacy of Virtual Reality Exercises Using Wii Gaming Technology in STroke Rehabilitation: A Multicentre Randomized Clinical Trial (EVREST Multicentre)
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.
Read the 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
- Being tested
- Recreational Activity, Wii Gaming System Arm
- Keywords
- Stroke Rehabilitation, Ischemic Stroke, Virtual Reality, Nintendo Wii, Recreational Activity, Motor Function
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recreational ActivityOther
Recreational activities (playing cards, arts and crafts, dominoes, jenga or a ball game) and conventional rehabilitation.
Wii Gaming System ArmOther
Also called Virtual Reality Wii games
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.
| Study group | Role | What they receive |
|---|---|---|
| Recreational Activity Arm | Active comparator | recreational activity includes playing cards, ominoes, jenga or a ball game. Receives: Other: Recreational Activity |
| Wii Gaming System Arm | Experimental | Use of Wii gaming technology (e.g. commercially available games) Receives: Other: Wii Gaming System Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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)
Measured: Subjects will be followed for the duration of their participation in the study, an expected time frame of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario, Ontario Stroke Network, Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- Gustavo Saposnik, MD, Principal investigator, Unity Health TorontoMark Bayley, MD, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406912
- Sponsor's protocol ID
- 11-188C
- Status last verified
- Nov 2015
- First submitted
- 25 Jul 2011
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality Exercises Using Wii Gaming Technology in STroke Rehabilitation: A Multicentre Randomized Clinical Trial (EVREST Multicentre)
- ClinicalTrials.gov ID
- NCT01406912
- Acronym / sponsor ID
- 11-188C
- Conditions
- Ischemic Stroke
- Keywords
- Stroke Rehabilitation, Ischemic Stroke, Virtual Reality, Nintendo Wii, Recreational Activity, Motor Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario, Ontario Stroke Network, Ontario Ministry of Health and Long Term Care
- Study start
- Jul 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)].
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recreational Activity Arm | Active comparator | Other: Recreational Activityrecreational activity includes playing cards, ominoes, jenga or a ball game. |
| Wii Gaming System Arm | Experimental | Other: Wii Gaming System ArmUse of Wii gaming technology (e.g. commercially available games) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recreational ActivityRecreational activities (playing cards, arts and crafts, dominoes, jenga or a ball game) and conventional rehabilitation. | Other | Recreational Activity Arm |
| Wii Gaming System ArmAlso: Virtual Reality Wii gamesVirtual 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 | Wii Gaming System Arm |
Primary outcome
Difference in motor performance between groups measured using the Wolf Motor function Test.
Time frame: 1 (±3) days after the end of the intervention
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Saposnik, MD principal investigator
Unity Health Toronto
Mark Bayley, MD principal investigator
Toronto Rehabilitation Institute
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recreational Activity and Wii Gaming System Arm in people with Ischemic Stroke, run by Unity Health Toronto at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, Argentina, Brazil, Peru, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in motor performance between groups measured using the Wolf Motor function Test. (time frame: 1 (±3) days after the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.