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

Completed

Phase N/A Results N/A

Trial Description

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)].

Conditions

Interventions

  • Recreational Activity + Conventional Rehabilitation Other
    Intervention Desc: Recreational activities (playing cards, arts and crafts, dominoes, jenga or a ball game) and conventional rehabilitation.
    ARM 1: Kind: Experimental
    Label: Recreational Activity Arm
  • Nintendo Wii Gaming Technology + Conventional Rehabilitation Other
    Other Names: Virtual Reality
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Wii Gaming System Arm
  • Recreational Activity Other
    Intervention Desc: Recreational activities (playing cards, arts and crafts, dominoes, jenga or a ball game) and conventional rehabilitation.
    ARM 1: Kind: Experimental
    Label: Recreational Activity Arm
    Description: recreational activity includes playing cards, ominoes, jenga or a ball game.
  • Wii Gaming System Arm Other
    Other Names: Virtual Reality Wii games
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Wii Gaming System Arm
    Description: Use of Wii gaming technology (e.g. commercially available games)

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Difference in motor performance between groups measured using the Wolf Motor function Test. 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 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 Subjects will be followed for the duration of their participation in the study, an expected time frame of 6 weeks Yes

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