Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST)

This study has been completed.
Sponsor:
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00692523
First received: June 4, 2008
Last updated: October 1, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Stroke
Other: Recreational therapy activities
Other: Nintendo Wii

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Randomised, Two Parallel Group Study Comparing Wii Gaming Versus Recreational Activity in Patients Receiving Standard Rehabilitation After Stroke

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary feasibility outcome is the total time receiving the intervention. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.
Other: Recreational therapy activities
Recreational therapy sessions will include leisure activities such as playing cards and/or doing arts and crafts.
Experimental: 2
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.
Other: Nintendo Wii
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

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.

  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
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692523

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1X2
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Gustavo Saposnik, MD St. Michael's Hospital, Toronto
  More Information

No publications provided by St. Michael's Hospital, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Gustavo Saposnik, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT00692523     History of Changes
Other Study ID Numbers: SMH - GS - 001
Study First Received: June 4, 2008
Last Updated: October 1, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
Stroke
rehabilitation
Nintendo Wii

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
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 July 28, 2014