Clinical trial NCT05299905: ImGTS for Patients With Cerebral Palsy and With Mobility Limitations
Official title: Developing Immersive Gamification Technology System (ImGTS) for Rehabilitation Management of Pediatric Patients With Cerebral Palsy and With Mobility Limitations (Phase 1 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Augmented eXperience E-health Laboratory
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Aged 6 to 12 years old
* Demonstrates fine and gross motor abilities within the norm for the child's age as measured by the Bruininks-Oseretsky Test of Motor Proficiency Test (BOTMP)

Exclusion Criteria:

* Previously diagnosed with any developmental disorder including CP
* Has had episodes of seizures or previously diagnosed as having epilepsy
* Has a history of motion sickness
* Unable to follow one-step instructions

Primary outcomes:
measure: Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 1
timeFrame: Immediately before Session 1, within an hour of before use of the virtual reality game
measure: Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 1
timeFrame: Immediately after Session 1, within an hour of completion of the virtual reality game
measure: Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 2
timeFrame: Immediately before Session 2, within an hour of before use of the virtual reality game
measure: Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 2
timeFrame: Immediately after Session 2, within an hour of completion of the virtual reality game
measure: Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 3
timeFrame: Immediately before Session 3, within an hour of before use of the virtual reality game
measure: Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 3
timeFrame: Immediately after Session 3, within an hour of completion of the virtual reality game
measure: Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 4
timeFrame: Immediately before Session 4, within an hour of before use of the virtual reality game
measure: Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 4
timeFrame: Immediately after Session 4, within an hour of completion of the virtual reality game
measure: The acceptability of the design for Session 1 will be measured using the Place Probe
timeFrame: Immediately after Session 1, within an hour of completion of the virtual reality game
measure: The acceptability of the design for Session 2 will be measured using the Place Probe
timeFrame: Immediately after Session 2, within an hour of completion of the virtual reality game
measure: The acceptability of the design for Session 3 will be measured using the Place Probe
timeFrame: Immediately after Session 3, within an hour of completion of the virtual reality game
measure: The acceptability of the design for Session 4 will be measured using the Place Probe
timeFrame: Immediately after Session 4, within an hour of completion of the virtual reality game
measure: Observation of completion of the game in the given time during Session 4 to measure effectiveness of the application
timeFrame: For one hour during Session 4
measure: Observation of ease of use of controls and user interaction during Session 4 to measure efficiency of the application during Session 4
timeFrame: For one hour during Session 4
measure: Observation of user reactions to measure satisfaction in using the application through during Session 4
timeFrame: For one hour during Session 4
Secondary outcomes:
Other outcomes:
Locations:
city: City Of Manila
country: Philippines
facility: College of Allied Medical Professions Clinic for Therapy Services
state: National Capital Region
Study officials:
affiliation: University of the Philippines Manila
name: Maria Eliza R Aguila, PhD
role: PRINCIPAL_INVESTIGATOR
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