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Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST) (EVREST)

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Recreational therapy activities

Nintendo Wii

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, rehabilitation, Nintendo Wii

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient has provided written informed consent prior to entry into the study
In-patient at one of the two study institutions at the time of randomization
Males or females, aged over 18 and younger than 85
Evidence of stroke confirmed by CT head (ischemic or hemorrhagic)
Time: Onset of symptoms within 6 months prior to randomization
Measurable Chedoke-McMaster scale stage of =>4 on the "arm" item (10)
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 6 months ago
Patient is unable to follow verbal commands or has global aphasia
Severe illness with 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 angina3) 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
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 can not/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).

Sites / Locations

St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

The control group will receive 8 recreational therapy sessions over a 2-week (14 day) period, to be scheduled in a flexible manner as long as all 8 sessions are completed within the 2 week period, and no more than 2 sessions are completed on any one day.

Patients randomized to Wii technology will receive an intensive program consisting of 8 Wii gaming sessions, 60 minutes each, over a 2-week (14 day) period. These 8 sessions can be scheduled in a flexible manner as long as all 8 sessions are completed within the 2 week period, and no more than 2 sessions are completed on any one day.

Outcomes

Primary Outcome Measures

The primary feasibility outcome is the total time receiving the intervention.

The primary safety outcome is the proportion of patients experiencing intervention-related adverse events, or any serious adverse event during the study period.

Secondary Outcome Measures

Full Information

NCT ID

NCT00692523

First Posted

June 4, 2008

Last Updated

October 1, 2009

Sponsor

Unity Health Toronto

1. Study Identification

Unique Protocol Identification Number

NCT00692523

Brief Title

Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST)

Acronym

EVREST

Official Title

A Pilot Randomised, Two Parallel Group Study Comparing Wii Gaming Versus Recreational Activity in Patients Receiving Standard Rehabilitation After Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Unity Health Toronto

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is a pilot, randomized trial that will examine whether the Nintendo Wii virtual gaming system is safe and feasible for use in patients who have had a recent stroke.

Detailed Description

A pilot, randomized (1:1) controlled trial to compare the safety and feasibility of Nintendo Wii gaming versus other recreational therapy activities (playing cards) in post-stroke patients. All patients will continue to receive all other standard medical and physiotherapy treatments while in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, rehabilitation, Nintendo Wii

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Recreational therapy activities

Intervention Description

Recreational therapy sessions will include leisure activities such as playing cards and/or doing arts and crafts.

Intervention Type

Other

Intervention Name(s)

Nintendo Wii

Intervention Description

The Nintendo Wii gaming system, released in 2005, introduced a new style of virtual reality by using a wireless controller that interacts with the player through a motion detection system. Nintendo Wii involves the incorporation of 3-dimensional accelerometer technology that can respond to changes in direction, speed, and acceleration, down to the most delicate movements. Specifically, the controllers use embedded acceleration sensors to enable players' wrist, arm, and hand movements to interact with the games. Tilt measurements allow users to move characters, while the accurate three-axis acceleration sensing easily transforms the controller into a virtual sword, gearshift, or musical instrument

Primary Outcome Measure Information:

Title

The primary feasibility outcome is the total time receiving the intervention.

Time Frame

2 weeks

Title

The primary safety outcome is the proportion of patients experiencing intervention-related adverse events, or any serious adverse event during the study period.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient has provided written informed consent prior to entry into the study In-patient at one of the two study institutions at the time of randomization Males or females, aged over 18 and younger than 85 Evidence of stroke confirmed by CT head (ischemic or hemorrhagic) Time: Onset of symptoms within 6 months prior to randomization Measurable Chedoke-McMaster scale stage of =>4 on the "arm" item (10) 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 6 months ago Patient is unable to follow verbal commands or has global aphasia Severe illness with 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 angina3) 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 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 can not/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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gustavo Saposnik, MD

Organizational Affiliation

Unity Health Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1X2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

20088994

Citation

Saposnik G, Mamdani M, Bayley M, Thorpe KE, Hall J, Cohen LG, Teasell R; EVREST Steering Committee; EVREST Study Group for the Stroke Outcome Research Canada Working Group. Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system. Int J Stroke. 2010 Feb;5(1):47-51. doi: 10.1111/j.1747-4949.2009.00404.x.

Results Reference

derived

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Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST)

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