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

Completed

Phase N/A Results

Trial Description

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.

Conditions

Interventions

  • Recreational Therapy Behavioral
    Intervention Desc: Recreational therapy sessions will include leisure activities such as playing cards and/or doing arts and crafts.
  • Wii technology (The Nintendo Wii gaming system)Behavioral
    Intervention Desc: It uses a wireless controller that interacts with the player through a motion detection system. It involves the incorporation of 3-dimensional accelerometer technology that can respond to changes in direction, speed, and acceleration, down to the most delicate movements.
  • Recreational therapy activities Other
    Intervention Desc: Recreational therapy sessions will include leisure activities such as playing cards and/or doing arts and crafts.
    ARM 1: Kind: Experimental
    Label: 1
    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.
  • Nintendo Wii Other
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: 2
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will have baseline CT to confirm stroke, Chedoke-McMaster scale score, and mRS. The patients will be randomized to one of two groups: 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 or 2) 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. All patients will continue to receive all other standard medical and physiotherapy treatments while in the study.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit.
Primary The primary feasibility outcome is the total time receiving the intervention. 2 weeks No
Primary The primary safety outcome is the proportion of patients experiencing intervention-related adverse events, or any serious adverse event during the study period. 6 weeks Yes

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