ImGTS for Patients With Cerebral Palsy and With Mobility Limitations
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy; Mobility Limitation
Study type: Interventional

Summary: 
      The proposed research project aims to answer the question "Are immersive technology systems
      effective in the rehabilitation management of pediatric patients with cerebral palsy and with
      mobility limitations?". The current study is the first of three phases, and it aims to create
      an immersive gamification technology system for the management of patients with cerebral
      palsy and with mobility disorders and to determine its acceptability, usability, and safety
      in healthy children.
    

Detailed description: 
      The participants will undergo an intervention using the assigned ImGTS for four sessions
      (twice a week for two weeks) for at most 1 hour per session. The experience will last for at
      most 20 minutes, interspersed with 5- to 20-minute breaks. The researchers will document the
      participants' reaction and interaction with the ImGTS. Participants will be staying at the
      designated laboratory for not more than one hour.

      Demographic characteristics of the participant (age, sex, educational level, primary
      caregiver, list of medications, hobbies and interests, previous experience with VR
      applications, existing illnesses and medications) will be collected through an interview with
      the child and the participant's parent, legal guardian, or caregiver.

      Safety will be determined by assessing a participant's experience of cybersickness using a
      cybersickness questionnaire that will be administered before and after each session. In this
      self-report questionnaire, nine symptoms will be rated as absent/none, slight, moderate, or
      severe. These symptoms are general discomfort, fatigue, eyestrain, difficulty focusing,
      headache, fullness of head, blurred vision, dizziness when the eyes are closed, and vertigo.
      The questionnaire will take around 10 minutes to complete. If a participant will experience
      severe cybersickness, the participant may opt to discontinue the experience. The participant
      will be instructed to remove the HMD or to step out of the Semi-CAVE room to rest and recover
      from the symptoms. A medical professional will be present to monitor the participant's
      symptoms and to attend to the participant for further management. The reason(s) for
      discontinuing the experience will be documented.

      The acceptability of the design will be measured using the Place Probe, a sense of place
      questionnaire. The questionnaire will be administered after each session, and it will collect
      information on a participant's experience in the VR application, particularly on (1) general
      impression of the environment, (2) the key features of the environment, and (3) feelings of
      presence. A positive general impression, a memorable environment, and a high level of
      presence will indicate that the VE developed is acceptable. This will take about 10 minutes
      to complete.

      Usability testing will be performed according to the PNS ISO/IEC Metrics. The goal is to
      provide continuous improvement in the design and user experience to maximize the three
      components of usability: effectiveness, efficiency, and satisfaction. Additional usability
      metrics will be identified during the first phase of the study. The metrics will be
      specifically adjusted to the target participants as well as the contents to be included in
      the ImGTS.
    

Intervention name(s): Virtual reality using Semi-CAVE; Virtual reality using the HMD
Intervention type(s): Procedure; Procedure
Intervention description(s): The Semi-CAVE will use two screens positioned at a corner of the room, each with a ceiling-mounted short throw projector in front. The participant will stand in the middle of the area, giving them a viewing angle of roughly 180 degrees. The participant will be wearing a safety harness secured to an overhead guide rail, if necessary. The participant may be standing freely, on a treadmill, or on a step stool depending on the type of activity to be performed. The participant will interact with the system through motion sensors positioned at the corners of the area. To one side of the area will be a sufficiently powerful computer running the software. The projectors will be connected to this computer via HDMI cables or similar.; The HMD will be a commercially available device that uses handheld controllers to control movement while in the VE. The researchers will use a room-scale set-up where a 3 m x 3 m square space is required. Oculus Quest 2 Controllers will be used to interact with the VE. The user will be positioned at the center of the square by default. A therapist will assist them through a separate program called the Observation Module. This program will let the therapist view what the patient can see in the HMD. This will also be used by the therapist to guide the patient navigate through the VE and give instructions for the activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other