Virtual Reality Intervention for Stroke Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      In Israel approximately 16,000 people have a stroke each year. Most of these people suffer
      from weakness or paralysis of half of their body which leads to difficulties performing basic
      activities of daily life (BADL) such as dressing and walking. Due to the stroke, these
      individuals need to undergo intensive rehabilitation. After rehabilitation, physical activity
      has been strongly recommended to maintain their functional level which was achieved during
      rehabilitation. In addition regular physical activity can prevent secondary condition
      However, recent findings suggest that people with stroke do not perform enough physical
      activity with their upper and lower extremities.

      The use of Virtual Reality (VR) for rehabilitation has been found to have potential for
      encouraging active purposeful movement. Many researchers have assessed the feasibility &
      usability of different VR systems and environments for individuals with stroke. Costly VR
      systems in addition to off-the-shelf video game consoles (e.g. Sony PlayStation EyeToy,
      Nintendo Wii) have been found to have great potential to encourage active purposeful
      movement. However, to date, only a limited number of studies have investigated the
      effectiveness of VR therapy post-stroke.

      Since physical activity is important after stroke and the fact that individuals with stroke
      are not participating sufficiently in physical activity, I suggest to carry out this study.

      The overall aim of this study is to assess the effectiveness of using novel technology of VR
      therapy to promote the participation in daily physical activity of individuals with stroke. A
      'Community based' VR program will be compared to a traditional therapy program in promoting
      daily physical activity of the lower and upper extremities.

      It is hypothesized that the VR intervention will be more efficient than the traditional
      therapy in promoting physical activity (walking and use of the weak upper extremity).
    

Detailed description: 
      In Israel there are approximately 16,000 new cases of stroke per year and recently stroke has
      been recognized by the Israeli health-care policy planners as a top priority disease.
      Individuals who have sustained a stroke constitute a large population with significant needs
      for rehabilitation. The most common symptom following stroke is paresis or paralysis to half
      of the body, contralateral to the side of brain lesion. These individuals experience
      difficulties performing basic activities of daily life (BADL) such as dressing and walking,
      in addition to instrumental activities of daily life (IADL) such as shopping and cooking.

      Physical activity has been strongly recommended for these individuals to maintain their
      functional level which was achieved during rehabilitation. In addition regular physical
      activity can prevent secondary conditions such as heart disease, diabetes, obesity and
      decreases the risk of a recurrent stroke. Reduced physical activity can also lead to disuse
      atrophy and cardiovascular de-conditioning, which can result in deterioration of the person's
      physical condition. However, recent findings suggest that people with stroke do not perform
      enough physical activity with their upper and lower extremities.

      The use of Virtual Reality (VR) for rehabilitation has been found to have potential for
      encouraging active purposeful movement. Many researchers have assessed the feasibility &
      usability of different VR systems and environments for individuals with stroke. Costly VR
      systems in addition to off-the-shelf video game consoles (e.g. Sony PlayStation EyeToy,
      Nintendo Wii) have been found to have great potential to encourage active purposeful
      movement. However, to date, only a limited number of studies have investigated the
      effectiveness of VR therapy post-stroke.

      Since physical activity has been recognized to be a main factor in facilitating recovery post
      stroke and an important factor in preventing a recurrent stroke and due to the fact that
      individuals with stroke are not participating sufficiently in physical activity. Their
      physical and functional ability may deteriorate leading to expensive hospitalization and
      devastating outcomes, therefore, I suggest to carry out this study.

      STUDY OBJECTIVES:

      The overall aim of this study is to assess the effectiveness of using novel technology of VR
      therapy to promote the participation in daily physical activity of individuals with stroke. A
      'Community based' VR program will be compared to a traditional therapy program in promoting
      daily physical activity of the lower and upper extremities.

      METHODS:

      A Randomized Controlled Trial (RCT) comparing VR therapy to traditional therapy will be
      applied. Eligible participants will be randomly allocated to the experimental or the control
      group. Blind assessors will assess their ability pre and post a 3-month intervention and at
      3-month follow-up. Novel instrumentation of VR systems and video-game consoles will be
      applied for the intervention of the experimental group and accelerometers (that measure the
      intensity and duration of movement) will be utilized for assessing 'free-living' daily
      physical activity of the upper and lower extremities of both groups. In addition clinical
      assessments will be administered to assess the motor and functional ability of these
      individuals.

      The main hypotheses are:

        1. Daily walking post intervention will increase significantly more in the VR therapy
           groups compared to the traditional therapy groups.

        2. Daily use of the weak upper extremity post intervention will increase significantly more
           in the VR therapy groups compared to the traditional therapy groups.

        3. Daily walking on follow-up will be significantly higher in the VR therapy groups
           compared to the traditional therapy groups.

        4. Daily use of the weak upper extremity on follow-up will increase significantly more in
           the VR therapy groups compared to the traditional therapy groups.

      Secondary hypotheses;

        1. Post intervention and on follow-up, the motor and functional ability of the weak upper
           extremity of the individuals in the VR therapy group will improve significantly more
           compared to the motor and functional ability of the weak upper extremity of individuals
           in the traditional therapy group.

        2. Post intervention and on follow-up, the motor and functional ability of the weak lower
           extremity and balance of the individuals in the VR therapy group will improve
           significantly more compared to the individuals in the traditional therapy group.

        3. Participation in ADL post intervention and on follow-up will be significantly higher in
           the VR therapy groups compared to the traditional therapy groups.

        4. The executive functions of the individuals post intervention and on follow-up will be
           significantly higher in the VR therapy group compared to the traditional therapy group.
    

Intervention name(s): Virtual Reality; Traditional Therapy
Intervention type(s): Other; Other
Intervention description(s): The VR-therapy will include the playing of various virtual reality or video-games which encourages the use of the extremities while sitting and standing; The traditional therapy will include exercise for balance and walking and for the upper extremity using traditional therapeutic tools such as balls, weights, chairs, bands, steps, etc.
Other intervention name(s): 'Community based' VR program; 'Community based' Traditional therapy program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; stroke; intervention; physical activity; participation