Virtual Reality Mirror Therapy for Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Mirror box therapy is a treatment option that has shown promise for people with difficulty
      moving their arm after a brain injury, such as stroke. During mirror box therapy, people
      place their affected arm inside a box, where they are unable to see it. They then focus their
      attention on the outside of the box, which has been fitted with a mirror. The mirror reflects
      the movements of their intact hand and makes it appear that both hands are moving normally.
      Research has shown that this type of therapy can help people recover some use of the arm.

      This study is designed to examine a new type of treatment, which uses a virtual reality
      headset (Oculus Rift) to recreate this effect in a virtual environment. Up to twenty people
      who have had a stroke and now have difficulty using an arm (Fugl-Meyer Upper Extremity range
      10-50) will be asked to come in for four weeks of treatment, during which they will perform a
      set of movements and games using the virtual reality platform, while focusing on the image of
      their affected arm. Treatment will include two fifteen minute sessions, three times/week for
      a period of four weeks. Participants will complete pre-testing, which will provide a baseline
      measure of performance, and post-testing, to see if the treatment has been well-tolerated and
      has had any impact on their motor performance.

      This research is important because it may demonstrate the usefulness of a new treatment
      method for people who have suffered a stroke, or generally demonstrate that virtual reality
      platforms may be useful treatment tools for stroke survivors. It may also provide a
      relatively low-cost and motivating rehabilitation tool for use in the hospital or home
      environment outside of therapy hours.
    

Detailed description: 
      Up to twenty stroke survivors with upper extremity impairment will be enrolled in this study.
      After subjects have been consented, they will undergo screening to ensure they meet
      inclusion/exclusion criteria. This will include the Motion Sickness Susceptibility
      Questionnaire (Short Form). Demographics will be recorded including: relevant medical history
      (including any contraindications to engage in virtual reality therapy), age, gender, hand
      dominance, and location and date of stroke. The Montreal Cognitive Assessment will be
      performed to assess feasibility of the intervention for subjects of varying cognitive levels.
      Subjects who meet study requirements and score between 10-50 points on the Fugl-Meyer
      Assessment of Motor Recovery after Stroke (Arm/hand section) will complete pre-testing using
      the Action Research Arm Test (ARAT).

      Virtual reality mirror therapy will be delivered via the commercially available Oculus Rift
      gaming system, using novel software (WiseMind), developed by Realiteer. Subjects will
      complete treatment in a designated space clear of distractions and physical objects. They
      will remain seated in a chair throughout treatment.

      A member of the research team will configure the system, entering in the subject's skin tone,
      height, and weight to enable the system to best approximate their physical form. The subject
      will then don the Oculus Rift headset, which will block external visual stimuli and provide
      an immersive visual environment for training. Researchers will position game controller using
      a wrist strap to ensure patient safety. Researchers will orient subjects to the training
      environment and ensure patient comfort with the system before initiating treatment. Patients
      will complete a System Usability Scale and the Simulator Sickness Questionnaire on the first
      and final treatment day to assess system tolerance. Adherence and adverse events will also be
      recorded throughout the trial.

      The WiseMind software will allow subjects to view an approximation of their upper limbs. As
      the subject moves their arms, the system will detect these movements and mimic them through
      the headset, so the patient envisions a virtual limb moving as their own. Training will
      incorporate range of motion exercises, virtual reality games that require reaching, and
      interacting with functional objects in the virtual environment.

      An occupational therapist, physical therapist or exercise physiologist from the research team
      will run all treatment sessions. Training will be immediately terminated if the subject feels
      excessively queasy or requests termination for any reason. Training will consist of two,
      fifteen minute sessions, 3x/week for four weeks.

      At the completion of treatment, subjects will repeat the Fugl-Meyer and ARAT assessments to
      determine if improvements have been made in motor performance.
    

Intervention name(s): Virtual Reality Mirror Therapy
Intervention type(s): Device
Intervention description(s): Virtual reality mirror therapy (WiseMind) developed by Realiteer and delivered via Oculus Rift virtual reality platform.
Intervention model: Single Group Assignment
Intervention model description: This is an interventional pilot study with a pre-test/post-test design. All eligible subjects will receive the intervention. We plan to enroll up to 20 subjects, with the goal of having 10-12 evaluable subjects.
Masking: None (Open Label)
Primary purpose: Device Feasibility