Immersive VR in Stroke Pilot Study
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Over 15,000 Veterans are treated by the VA for stroke each year. A stroke means that part of
      the brain dies. Many people who have a stroke have difficulty with moving their arm, using
      their hand, and they have pain. Virtual reality is a video-game based treatment that may help
      people with stroke improve in these areas. Virtual reality involves using a computer and
      goggles to make a person feel like they are in a different world with new sights and sounds,
      relaxing on a beach where there is no pain, or playing the piano. In virtual reality, stroke
      patients can practice movement in a safe and motivating environment. For example, a person
      with stroke who has weakness in his/her arm can safely reach for plates in a virtual
      cupboard. In a virtual environment, the plates can't break. This study will help
      investigators to determine if people with strokes who are treated with virtual reality like
      it, and if they have less pain and better movement.
    

Detailed description: 
      Background. Over the last decade, Virtual Reality (VR) has emerged as a cutting-edge
      technology in stroke rehabilitation. VR is defined as a type of user-computer interface that
      implements real-time simulation of an activity or environment allowing user interaction via
      multiple sensory modalities. VR interventions in a stroke population have been shown to be
      equivalent to usual care therapies and to enhance motor recovery when utilized as an adjunct.
      Significance/Impact/Innovation. This research will advance knowledge in rehabilitation
      research by testing state-of-the-art immersive 3-dimensional VR technology with the
      post-acute stroke Veteran population. The proposed project addresses: (1) the RR&D goal of
      maximizing functional recovery, (2) interest in non-pharmacological activity-based
      interventions for pain, and (3) supports modernization of the Veterans' Health Administration
      by incorporating technology-assisted rehabilitation.

      Specific Aims. (1) Determine the feasibility and tolerability of using a therapeutic VR
      platform in an inpatient comprehensive stroke rehabilitation program and (2) Estimate the
      initial clinical efficacy, or effect size, associated with the VR platform using APPS for
      distraction and upper extremity exercise for Veterans post-stroke.

      Methodology. Prospective within-subject pre-post pilot and survey study designs will be used.
      The target populations are (1) clinical staff who work on the Comprehensive Interdisciplinary
      Inpatient Rehabilitation Program (CIIRP) at the James A. Haley Veterans' Hospital (JAHVH) in
      Tampa (sample size N=10) and Veterans who are inpatients in the CIIRP (sample size N=10). The
      VR intervention consists of wearing a head mounted display that plays APPs ranging from music
      and nature views for pain distraction to more challenging strengthening and coordination
      activities such as playing the piano virtually. The intervention will last four weeks. The
      analytic approach will use descriptive statistics and qualitative methods. Aim 1 will
      administer a survey with open and closed ended questions to clinicians to examine the
      feasibility of successfully integrating a VR intervention into the flow of usual care.
      Feasibility constructs include adaptability (can VR intervention be adapted to an inpatient
      unit), patient need (do Veterans like and benefit from the intervention), and staff
      comments/impressions. Responses for each construct will be entered into an excel spreadsheet,
      one tab for each construct. Responses will then be grouped by similar content. Results will
      be reported as themes and subthemes. Aim 1 will also track patient VR tolerability by
      documenting and discussing patient complaints and adverse events. Tolerability data will be
      extracted from meeting minutes and grouped by similar occurrences. Results will be reported
      as themes and subthemes. Aim 2 will estimate effect sizes and degree of precision for upper
      extremity neurologic recovery, hand dexterity, and pain outcomes measured pre and post VR
      intervention. Neurologic recovery is measured with the Fugl-Meyer Assessment of Motor
      Recovery after Stroke-Upper Extremity, dexterity is measured with the Action Research Arm
      Test, and pain is measured with the Pain Outcomes Questionnaire-VA. Because standard scores
      do not necessarily translate to meaningful clinical differences (improvements), the
      investigators will identify the proportion of subjects who experience the minimal clinically
      important difference (MCID). Metrics will also be compared across outcomes.

      Next Steps/Implementation. Our next step is to work with our Program Partner in the Physical
      Medicine and Rehabilitation Office to conduct a large multi-site clinical trial that will
      incorporate the lessons learned from this feasibility pilot study to test the efficacy of a
      VR intervention in inpatient rehabilitation and transition to home evironments.
    

Intervention name(s): Virtual Reality
Intervention type(s): Device
Intervention description(s): Virtual Reality Headset with Virtual Reality Applications
Other intervention name(s): Oculus Quest
Intervention model: Single Group Assignment
Intervention model description: Once patients are enrolled, baseline data and pre-intervention outcome measures will be collected. APPs will be selected from the VR Toolkit that best address the individual patient's treatment goals.
Patients will be instructed in the use of the head mounted display with VR APPs. VR dosage will be two one-half hour sessions per therapy day. Patients can initiate use of a more challenging APPs that gradually includes hand/arm movement.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; virtual reality; rehabilitation