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

Ischemic Stroke Clinical Trial

Official title:

Efficacy of Virtual Reality Exercises Using Wii Gaming Technology in STroke Rehabilitation: A Multicentre Randomized Clinical Trial (EVREST Multicentre)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406912
• Other study ID #: 11-188C
• Status: Completed
• Phase: N/A
• First received: July 25, 2011
• Last updated: November 11, 2015
• Start date: July 2011
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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.

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.

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)].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
Argentina	FLENI	Buenos Aires
Brazil	Lucy Montoro Network	Sao Paulo
Canada	University of Calgary	Calgary	Alberta
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Parkwood Hospital, St. Joseph's Health Care London	London	Ontario
Canada	Trillium Health Partners	Mississauga	Ontario
Canada	CSSS Cavendish Richardson Hospital	Montreal	Quebec
Canada	Providence Healthcare	Scarborough	Ontario
Canada	LA Miller Centre	St John's	Newfoundland and Labrador
Canada	Toronto Rehabilitation Institute	Toronto	Ontario
Canada	Riverview Health Centre	Winnipeg	Manitoba
Peru	Clinica San Felipe	Lima
Thailand	Siriraj Hospital	Bangkok

Sponsors (4)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Heart and Stroke Foundation of Ontario, Ontario Ministry of Health and Long Term Care, Ontario Stroke Network

Countries where clinical trial is conducted

Argentina,  Brazil,  Canada,  Peru,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	End of intervention and 4 weeks post-intervention	No
Secondary	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)	Subjects will be followed for the duration of their participation in the study, an expected time frame of 6 weeks	Yes