Cerebral PalsyNCT05299905
ImGTS for Patients With Cerebral Palsy and With Mobility Limitations
A study testing Virtual reality using Semi-CAVE and Virtual reality using the HMD in people with Cerebral Palsy, run by Augmented eXperience E-health Laboratory at 1 site in Philippines.
Trial 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?". Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Virtual reality using Semi-CAVE and Virtual reality using the HMD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePhilippines
- Study dates
- 28 Apr 2022to 22 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Philippines1 site
College of Allied Medical Professions Clinic for Therapy Services
Manila, National Capital Region, 1000
About this study
Official title: Developing Immersive Gamification Technology System (ImGTS) for Rehabilitation Management of Pediatric Patients With Cerebral Palsy and With Mobility Limitations (Phase 1 Trial)
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Virtual reality using Semi-CAVE, Virtual reality using the HMD
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality using Semi-CAVEProcedure or surgery
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.
Virtual reality using the HMDProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Semi-CAVE | Experimental | Not described Receives: Procedure: Virtual reality using Semi-CAVE |
| Head-mounted display system | Experimental | Not described Receives: Procedure: Virtual reality using the HMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 1
Baseline assessment for the presence of cybersickness symptoms for Session 1 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Measured: Immediately before Session 1, within an hour of before use of the virtual reality game
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 1
Assessment for the occurrence of cybersickness symptoms for Session 1 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Measured: Immediately after Session 1, within an hour of completion of the virtual reality game
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 2
Baseline assessment for the presence of cybersickness symptoms for Session 2 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Measured: Immediately before Session 2, within an hour of before use of the virtual reality game
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 2
Assessment for the occurrence of cybersickness symptoms for Session 2 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Measured: Immediately after Session 2, within an hour of completion of the virtual reality game
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 3
Baseline assessment for the presence of cybersickness symptoms for Session 3 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Measured: Immediately before Session 3, within an hour of before use of the virtual reality game
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 3
Assessment for the occurrence of cybersickness symptoms for Session 3 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Measured: Immediately after Session 3, within an hour of completion of the virtual reality game
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 4
Baseline assessment for the presence of cybersickness symptoms for Session 4 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Measured: Immediately before Session 4, within an hour of before use of the virtual reality game
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 4
Assessment for the occurrence of cybersickness symptoms for Session 4 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Measured: Immediately after Session 4, within an hour of completion of the virtual reality game
The acceptability of the design for Session 1 will be measured using the Place Probe
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
Measured: Immediately after Session 1, within an hour of completion of the virtual reality game
The acceptability of the design for Session 2 will be measured using the Place Probe
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
Measured: Immediately after Session 2, within an hour of completion of the virtual reality game
The acceptability of the design for Session 3 will be measured using the Place Probe
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
Measured: Immediately after Session 3, within an hour of completion of the virtual reality game
The acceptability of the design for Session 4 will be measured using the Place Probe
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
Measured: Immediately after Session 4, within an hour of completion of the virtual reality game
Observation of completion of the game in the given time during Session 4 to measure effectiveness of the application
Effectiveness is a component of usability, and will be assessed through observing completion of the game within the allotted time. If at least 85% of the participants complete the game within the allotted time, the game is said to be effective.
Measured: For one hour during Session 4
Observation of ease of use of controls and user interaction during Session 4 to measure efficiency of the application during Session 4
Efficiency is a component of usability that will assess a participant's ease of use of the controls and user interface during the experience. If at least 85% of the participants do not encounter or express difficulties in using the application during the experience, the game is said to be efficient.
Measured: For one hour during Session 4
Observation of user reactions to measure satisfaction in using the application through during Session 4
Satisfaction is a component of usability that will assess a participant's enjoyment in using the game. It will be assessed through observing the reaction of the participant during Session 4. If 90% of the participants visibly show or verbally express enjoyment during the experience, the game is said to be satisfactory.
Measured: For one hour during Session 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start28 Apr 2022
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augmented eXperience E-health Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Eliza R Aguila, PhD, Principal investigator, University of the Philippines Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299905
- Sponsor's protocol ID
- AXEL0002
- Status last verified
- Mar 2022
- First submitted
- 6 Feb 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
PubMed 23961782Birckhead B, Khalil C, Liu X, Conovitz S, Rizzo A, Danovitch I, Bullock K, Spiegel B. Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study. JMIR Ment Health. 2019 Jan 31;6(1):e11973. doi: 10.2196/11973.
PubMed 30702436Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.
PubMed 29088476Demers M, Fung K, Subramanian SK, Lemay M, Robert MT. Integration of Motor Learning Principles Into Virtual Reality Interventions for Individuals With Cerebral Palsy: Systematic Review. JMIR Serious Games. 2021 Apr 7;9(2):e23822. doi: 10.2196/23822.
PubMed 33825690Kim HK, Park J, Choi Y, Choe M. Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment. Appl Ergon. 2018 May;69:66-73. doi: 10.1016/j.apergo.2017.12.016. Epub 2018 Jan 16.
PubMed 29477332Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
PubMed 23962350Paulson A, Vargus-Adams J. Overview of Four Functional Classification Systems Commonly Used in Cerebral Palsy. Children (Basel). 2017 Apr 24;4(4):30. doi: 10.3390/children4040030.
PubMed 28441773Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477Sandlund M, McDonough S, Hager-Ross C. Interactive computer play in rehabilitation of children with sensorimotor disorders: a systematic review. Dev Med Child Neurol. 2009 Mar;51(3):173-9. doi: 10.1111/j.1469-8749.2008.03184.x. Epub 2009 Jan 26.
PubMed 19191834Smits-Engelsman BC, Blank R, van der Kaay AC, Mosterd-van der Meijs R, Vlugt-van den Brand E, Polatajko HJ, Wilson PH. Efficacy of interventions to improve motor performance in children with developmental coordination disorder: a combined systematic review and meta-analysis. Dev Med Child Neurol. 2013 Mar;55(3):229-37. doi: 10.1111/dmcn.12008. Epub 2012 Oct 29.
PubMed 23106530Weber H, Barr C, Gough C, van den Berg M. How Commercially Available Virtual Reality-Based Interventions Are Delivered and Reported in Gait, Posture, and Balance Rehabilitation: A Systematic Review. Phys Ther. 2020 Sep 28;100(10):1805-1815. doi: 10.1093/ptj/pzaa123.
PubMed 32691059Weiss PL, Rand D, Katz N, Kizony R. Video capture virtual reality as a flexible and effective rehabilitation tool. J Neuroeng Rehabil. 2004 Dec 20;1(1):12. doi: 10.1186/1743-0003-1-12.
PubMed 15679949
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Immersive Gamification Technology System (ImGTS) for Rehabilitation Management of Pediatric Patients With Cerebral Palsy and With Mobility Limitations (Phase 1 Trial)
- ClinicalTrials.gov ID
- NCT05299905
- Acronym / sponsor ID
- AXEL0002
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Augmented eXperience E-health LaboratoryUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semi-CAVE | Experimental | Procedure: Virtual reality using Semi-CAVE |
| Head-mounted display system | Experimental | Procedure: Virtual reality using the HMD |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality using Semi-CAVEThe 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. | Procedure or surgery | Semi-CAVE |
| Virtual reality using the HMDThe 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. | Procedure or surgery | Head-mounted display system |
Primary outcome
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 1
Time frame: Immediately before Session 1, within an hour of before use of the virtual reality game
Baseline assessment for the presence of cybersickness symptoms for Session 1 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 1
Time frame: Immediately after Session 1, within an hour of completion of the virtual reality game
Assessment for the occurrence of cybersickness symptoms for Session 1 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 2
Time frame: Immediately before Session 2, within an hour of before use of the virtual reality game
Baseline assessment for the presence of cybersickness symptoms for Session 2 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 2
Time frame: Immediately after Session 2, within an hour of completion of the virtual reality game
Assessment for the occurrence of cybersickness symptoms for Session 2 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 3
Time frame: Immediately before Session 3, within an hour of before use of the virtual reality game
Baseline assessment for the presence of cybersickness symptoms for Session 3 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 3
Time frame: Immediately after Session 3, within an hour of completion of the virtual reality game
Assessment for the occurrence of cybersickness symptoms for Session 3 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 4
Time frame: Immediately before Session 4, within an hour of before use of the virtual reality game
Baseline assessment for the presence of cybersickness symptoms for Session 4 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 4
Time frame: Immediately after Session 4, within an hour of completion of the virtual reality game
Assessment for the occurrence of cybersickness symptoms for Session 4 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
The acceptability of the design for Session 1 will be measured using the Place Probe
Time frame: Immediately after Session 1, within an hour of completion of the virtual reality game
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
The acceptability of the design for Session 2 will be measured using the Place Probe
Time frame: Immediately after Session 2, within an hour of completion of the virtual reality game
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
The acceptability of the design for Session 3 will be measured using the Place Probe
Time frame: Immediately after Session 3, within an hour of completion of the virtual reality game
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
The acceptability of the design for Session 4 will be measured using the Place Probe
Time frame: Immediately after Session 4, within an hour of completion of the virtual reality game
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
Observation of completion of the game in the given time during Session 4 to measure effectiveness of the application
Time frame: For one hour during Session 4
Effectiveness is a component of usability, and will be assessed through observing completion of the game within the allotted time. If at least 85% of the participants complete the game within the allotted time, the game is said to be effective.
Observation of ease of use of controls and user interaction during Session 4 to measure efficiency of the application during Session 4
Time frame: For one hour during Session 4
Efficiency is a component of usability that will assess a participant's ease of use of the controls and user interface during the experience. If at least 85% of the participants do not encounter or express difficulties in using the application during the experience, the game is said to be efficient.
Observation of user reactions to measure satisfaction in using the application through during Session 4
Time frame: For one hour during Session 4
Satisfaction is a component of usability that will assess a participant's enjoyment in using the game. It will be assessed through observing the reaction of the participant during Session 4. If 90% of the participants visibly show or verbally express enjoyment during the experience, the game is said to be satisfactory.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 23961782Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
- Background: PubMed 30702436Birckhead B, Khalil C, Liu X, Conovitz S, Rizzo A, Danovitch I, Bullock K, Spiegel B. Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study. JMIR Ment Health. 2019 Jan 31;6(1):e11973. doi: 10.2196/11973.
- Background: PubMed 29088476Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.
- Background: PubMed 33825690Demers M, Fung K, Subramanian SK, Lemay M, Robert MT. Integration of Motor Learning Principles Into Virtual Reality Interventions for Individuals With Cerebral Palsy: Systematic Review. JMIR Serious Games. 2021 Apr 7;9(2):e23822. doi: 10.2196/23822.
- Background: PubMed 29477332Kim HK, Park J, Choi Y, Choe M. Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment. Appl Ergon. 2018 May;69:66-73. doi: 10.1016/j.apergo.2017.12.016. Epub 2018 Jan 16.
- Background: PubMed 23962350Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
- Background: PubMed 28441773Paulson A, Vargus-Adams J. Overview of Four Functional Classification Systems Commonly Used in Cerebral Palsy. Children (Basel). 2017 Apr 24;4(4):30. doi: 10.3390/children4040030.
- Background: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Background: PubMed 19191834Sandlund M, McDonough S, Hager-Ross C. Interactive computer play in rehabilitation of children with sensorimotor disorders: a systematic review. Dev Med Child Neurol. 2009 Mar;51(3):173-9. doi: 10.1111/j.1469-8749.2008.03184.x. Epub 2009 Jan 26.
- Background: PubMed 23106530Smits-Engelsman BC, Blank R, van der Kaay AC, Mosterd-van der Meijs R, Vlugt-van den Brand E, Polatajko HJ, Wilson PH. Efficacy of interventions to improve motor performance in children with developmental coordination disorder: a combined systematic review and meta-analysis. Dev Med Child Neurol. 2013 Mar;55(3):229-37. doi: 10.1111/dmcn.12008. Epub 2012 Oct 29.
- Background: PubMed 32691059Weber H, Barr C, Gough C, van den Berg M. How Commercially Available Virtual Reality-Based Interventions Are Delivered and Reported in Gait, Posture, and Balance Rehabilitation: A Systematic Review. Phys Ther. 2020 Sep 28;100(10):1805-1815. doi: 10.1093/ptj/pzaa123.
- Background: PubMed 15679949Weiss PL, Rand D, Katz N, Kizony R. Video capture virtual reality as a flexible and effective rehabilitation tool. J Neuroeng Rehabil. 2004 Dec 20;1(1):12. doi: 10.1186/1743-0003-1-12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Eliza R Aguila, PhD principal investigator
University of the Philippines Manila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality using Semi-CAVE and Virtual reality using the HMD in people with Cerebral Palsy, run by Augmented eXperience E-health Laboratory at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 1 (time frame: Immediately before Session 1, within an hour of before use of the virtual reality game). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05299905, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.