Parkinson DiseaseNCT07382401
Developing Immersive Gamification Technology Systems For The Rehabilitation Management Of Adults With Parkinson's Disease (Phase 1 Trial)
A study testing VR-HMD, AR-HMD and semi-CAVE in people with Parkinson Disease and Parkinson's Disease (PD), run by Augmented eXperience E-health Laboratory at 1 site in Philippines.
Trial summary
This clinical trial aims to develop and test a prototype immersive gamification technology system (ImGTS) among healthy volunteers and to determine its acceptability, safety, and usability in a healthy population. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Parkinson's Disease (PD)
- What is being tested?
- VR-HMD, AR-HMD and semi-CAVE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Feb 2026to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50 to 70 years old
- Able to understand Filipino and English
- Montreal Cognitive Assessment - Philippines (MOCA-P) score >27
- Timed Up and Go <10 seconds
Who cannot join
- Previously diagnosed with any neurologic condition
- With any form of aphasia
- Previously diagnosed with a psychiatric disorder
- Previously diagnosed with seizures or epilepsy
- Significant visual or hearing impairment (including individuals who have difficulties seeing or hearing even with the use of assistive devices like eyeglasses or hearing aids) or use of mobility aids
- Has a history of motion sickness
Show all 9Show fewer
- Has quadriplegia or paralysis of dominant hand
- Has a life expectancy of less than a year
- Has previously used an ImGTS (e.g., a head-mounted display (HMD) or a cave automatic virtual environment (CAVE))
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Philippines1 site
Augmented Experience eHealth Laboratory
Manila, National Capital Region, 1000
Maria Eliza R. Aguila, PhD, +63 917 821 2563, mraguila1@up.edu.ph
Roland Dominic G. Jamora, MD, PhD
About this study
This clinical trial aims to develop and test a prototype immersive gamification technology system (ImGTS) among healthy volunteers and to determine its acceptability, safety, and usability in a healthy population. The main question it aims to answer is:
Does ImGTS provide an acceptable, safe, and usable therapeutic modality for patients with Parkinson's Disease? Researchers will compare a head-mounted display (HMD) system and a semi cave automatic virtual environment (semi-CAVE) system to see if they are acceptable, safe, and usable as therapy for PD.
Participants will be will undergoing their assigned ImGTS intervention for four sessions (twice a week for two weeks) supervised by a trained therapist. Afterwards, they will be interviewed based on specific questionnaires used to check for acceptability, safety, and usability.
Read the detailed description
Parkinson's disease (PD) is one of the fastest growing neurological conditions worldwide. Oral medications and surgery are currently the standard of care, but these interventions are expensive and not widely available in the Philippines. Immersive technologies such as virtual reality and augmented reality applications have shown promise in improving clinical outcomes for persons with PD such as their gait and balance. However, there are currently no local immersive technology applications tailor-made for persons with PD in the Philippines. Hence, the current objective of this study is to develop and test prototype immersive gamification technology systems (ImGTS) among healthy volunteers and to determine its acceptability, safety, and usability in a healthy population. The pilot study will be divided into two stages: the development stage and the clinical trial stage. The development stage will utilize an iterative process and will involve the participation of various stakeholder groups such as caregivers of patients with PD, therapists, doctors, members of patient advocacy groups, and game development experts in order to design and develop the proposed immersive technology interventions. The clinical trial stage will utilize these prototypes and will test them among healthy volunteers for four sessions (two sessions a week for two weeks). Acceptability will be determined through the participants' responses to open ended questions on their preferences, perceptions, and experience with the ImGTS. Safety will be assessed using cybersickness questionnaires for virtual reality and augmented reality, to be supplemented with participant reports/observations of adverse events during their participation in the study. Finally, usability will be determined using the System Usability Scale, as well as through the ImGTS' performance during the sessions.
- Conditions
- Parkinson Disease, Parkinson's Disease (PD)
- Being tested
- VR-HMD, AR-HMD, semi-CAVE
- Keywords
- Parkinson Disease, Rehabilitation, Immersive Technology
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-HMDDevice
The immersive experience features in-game elements that can be controlled or altered upon the discretion of a therapist trained to operate the modality through a connected laptop. This modality will be used in therapy sessions administered for four sessions (twice a week for two weeks), with a maximum of 45 minutes per session. Each session would be in 10- to 20-minute periods with introduction, orientation, and provisions for rest periods for patient comfort.
AR-HMDDevice
This is similarly administered as the VR-HMD through a wearable headset. However, this modality incorporates real-world elements that support the rehabilitative exercises such as treadmills. This modality will be used in therapy sessions administered for four sessions (twice a week for two weeks), with a maximum of 45 minutes per session. Each session would be in 10- to 20-minute periods with introduction, orientation, and provisions for rest periods for patient comfort.
semi-CAVEDevice
This is administered through three short-throw projectors operated by external sensors using an outside-in tracking technology. Similar with other modalities, in-game elements can be controlled or altered upon the discretion of a therapist trained to operate the modality through a connected laptop. This modality will be used in therapy sessions administered for four sessions (twice a week for two weeks), with a maximum of 45 minutes per session. Each session would be in 10- to 20-minute periods with introduction, orientation, and provisions for rest periods for patient comfort.
| Study group | Role | What they receive |
|---|---|---|
| VR-HMD | Experimental | This arm is the "VR-HMD" or virtual reality using a head-mounted display. Receives: Device: VR-HMD |
| AR-HMD | Experimental | This arm is the "AR-HMD" or augmented reality using a head-mounted display. Receives: Device: AR-HMD |
| Semi-CAVE | Experimental | This arm is the "semi-CAVE" or semi-cave automated virtual environment. Receives: Device: semi-CAVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the intervention - Virtual Reality Sickness Questionnaire
Safety is defined as the low or decreased incidence of adverse events with the use of the ImGTS and will be measured using the Virtual Reality Sickness Questionnaire by Kim et al., 2018 (https://doi.org/10.1016/j.apergo.2017.12.016). The questionnaire are based on the Simulator Sickness Questionnaire by Kennedy et al., 1993 (https://doi.org/10.1207/s153), and each highlight nine symptoms of cybersickness specific to VR and to AR. Symptoms are rated on a 4-point Likert scale from "None" (0) to "Severe" (3). Other adverse events observed during and after the ImGTS experience that are not covered by the questionnaires will be recorded by the researchers. Documentation of the patient's reaction and interaction with the ImGTS (including the duration of the experience, frequency of rest periods, and technical difficulties) will also be recorded by the researchers.
Measured: Two weeks
Safety of the intervention - Augmented Reality Sickness Questionnaire
Safety is defined as the low or decreased incidence of adverse events with the use of the ImGTS and will be measured using the Augmented Reality Sickness Questionnaire by Hussain et al., 2023 (https://doi.org/10.1016/j.ergon.2023.103495). The questionnaire are based on the Simulator Sickness Questionnaire by Kennedy et al., 1993 (https://doi.org/10.1207/s153), and each highlight nine symptoms of cybersickness specific to VR and to AR. Symptoms are rated on a 4-point Likert scale from "None" (0) to "Severe" (3). Other adverse events observed during and after the ImGTS experience that are not covered by the questionnaires will be recorded by the researchers. Documentation of the patient's reaction and interaction with the ImGTS (including the duration of the experience, frequency of rest periods, and technical difficulties) will also be recorded by the researchers.
Measured: Two weeks
Usability of the intervention
Usability is defined as the system's ability to be easy to use as determined through user perception and game performance. User perceptions will be determined using the system usability scale (SUS by Brooke, 1995). Each question has 5 response options ranging from 'Strongly agree' to 'Strongly disagree', which has a corresponding number value. Each response is added and multiplied by 2.5 to obtain the final score that ranges from 0 to 100. A SUS score above 68 is considered above average. The SUS will be used after each session and will require about 10 minutes to complete. More specific metrics on the system's performance, including an assessment of the environmental factors of usability, will also be developed once the game itself has been made. These metrics will be based on input from the researchers and the stakeholders during the FGD(s) of the pilot studies.
Measured: Two weeks
Acceptability of the intervention
Acceptability is defined as the positive perceptions toward the ImGTS as a game and as a therapeutic tool, which will be assessed using open-ended questions. Participants during the ImGTS development stage will be asked these questions during an FGD, while the healthy volunteers (non-stakeholders) during the clinical trial will be interviewed (semi-structured) after completing each session. Questions on specific game components will be added for the clinical trial once the prototype development has been completed.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augmented eXperience E-health Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Science and Technology (DOST) - Philippine Council for Health Research and Development (PCHRD)
- Responsible party
- Sponsor
- Investigators
- Roland Dominic G Jamora, MD, PhD, Principal investigator, University of the Philippines Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382401
- Sponsor's protocol ID
- AXEL0005
- Status last verified
- Jan 2026
- First submitted
- 23 Jun 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Immersive Gamification Technology Systems For The Rehabilitation Management Of Adults With Parkinson's Disease (Phase 1 Trial)
- ClinicalTrials.gov ID
- NCT07382401
- Acronym / sponsor ID
- AXEL0005
- Conditions
- Parkinson Disease, Parkinson's Disease (PD)
- Keywords
- Parkinson Disease, Rehabilitation, Immersive Technology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Augmented eXperience E-health LaboratoryUniversity, hospital or other
- Collaborators
- Department of Science and Technology (DOST) - Philippine Council for Health Research and Development (PCHRD)
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 2 Feb 2026 (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.
This clinical trial aims to develop and test a prototype immersive gamification technology system (ImGTS) among healthy volunteers and to determine its acceptability, safety, and usability in a healthy population. The main question it aims to answer is:
Does ImGTS provide an acceptable, safe, and usable therapeutic modality for patients with Parkinson's Disease? Researchers will compare a head-mounted display (HMD) system and a semi cave automatic virtual environment (semi-CAVE) system to see if they are acceptable, safe, and usable as therapy for PD.
Participants will be will undergoing their assigned ImGTS intervention for four sessions (twice a week for two weeks) supervised by a trained therapist. Afterwards, they will be interviewed based on specific questionnaires used to check for acceptability, safety, and usability.
Detailed description
Parkinson's disease (PD) is one of the fastest growing neurological conditions worldwide. Oral medications and surgery are currently the standard of care, but these interventions are expensive and not widely available in the Philippines. Immersive technologies such as virtual reality and augmented reality applications have shown promise in improving clinical outcomes for persons with PD such as their gait and balance. However, there are currently no local immersive technology applications tailor-made for persons with PD in the Philippines. Hence, the current objective of this study is to develop and test prototype immersive gamification technology systems (ImGTS) among healthy volunteers and to determine its acceptability, safety, and usability in a healthy population. The pilot study will be divided into two stages: the development stage and the clinical trial stage. The development stage will utilize an iterative process and will involve the participation of various stakeholder groups such as caregivers of patients with PD, therapists, doctors, members of patient advocacy groups, and game development experts in order to design and develop the proposed immersive technology interventions. The clinical trial stage will utilize these prototypes and will test them among healthy volunteers for four sessions (two sessions a week for two weeks). Acceptability will be determined through the participants' responses to open ended questions on their preferences, perceptions, and experience with the ImGTS. Safety will be assessed using cybersickness questionnaires for virtual reality and augmented reality, to be supplemented with participant reports/observations of adverse events during their participation in the study. Finally, usability will be determined using the System Usability Scale, as well as through the ImGTS' performance during the sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR-HMD | Experimental | Device: VR-HMDThis arm is the "VR-HMD" or virtual reality using a head-mounted display. |
| AR-HMD | Experimental | Device: AR-HMDThis arm is the "AR-HMD" or augmented reality using a head-mounted display. |
| Semi-CAVE | Experimental | Device: semi-CAVEThis arm is the "semi-CAVE" or semi-cave automated virtual environment. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 50 to 70 years old
- Able to understand Filipino and English
- Montreal Cognitive Assessment - Philippines (MOCA-P) score >27
- Timed Up and Go <10 seconds
Key exclusion criteria (9 listed)
- Previously diagnosed with any neurologic condition
- With any form of aphasia
- Previously diagnosed with a psychiatric disorder
- Previously diagnosed with seizures or epilepsy
- Significant visual or hearing impairment (including individuals who have difficulties seeing or hearing even with the use of assistive devices like eyeglasses or hearing aids) or use of mobility aids
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 |
|---|---|---|
| VR-HMDThe immersive experience features in-game elements that can be controlled or altered upon the discretion of a therapist trained to operate the modality through a connected laptop. This modality will be used in therapy sessions administered for four sessions (twice a week for two weeks), with a maximum of 45 minutes per session. Each session would be in 10- to 20-minute periods with introduction, orientation, and provisions for rest periods for patient comfort. | Device | VR-HMD |
| AR-HMDThis is similarly administered as the VR-HMD through a wearable headset. However, this modality incorporates real-world elements that support the rehabilitative exercises such as treadmills. This modality will be used in therapy sessions administered for four sessions (twice a week for two weeks), with a maximum of 45 minutes per session. Each session would be in 10- to 20-minute periods with introduction, orientation, and provisions for rest periods for patient comfort. | Device | AR-HMD |
| semi-CAVEThis is administered through three short-throw projectors operated by external sensors using an outside-in tracking technology. Similar with other modalities, in-game elements can be controlled or altered upon the discretion of a therapist trained to operate the modality through a connected laptop. This modality will be used in therapy sessions administered for four sessions (twice a week for two weeks), with a maximum of 45 minutes per session. Each session would be in 10- to 20-minute periods with introduction, orientation, and provisions for rest periods for patient comfort. | Device | Semi-CAVE |
Primary outcome
Safety of the intervention - Virtual Reality Sickness Questionnaire
Time frame: Two weeks
Safety is defined as the low or decreased incidence of adverse events with the use of the ImGTS and will be measured using the Virtual Reality Sickness Questionnaire by Kim et al., 2018 (https://doi.org/10.1016/j.apergo.2017.12.016). The questionnaire are based on the Simulator Sickness Questionnaire by Kennedy et al., 1993 (https://doi.org/10.1207/s153), and each highlight nine symptoms of cybersickness specific to VR and to AR. Symptoms are rated on a 4-point Likert scale from "None" (0) to "Severe" (3). Other adverse events observed during and after the ImGTS experience that are not covered by the questionnaires will be recorded by the researchers. Documentation of the patient's reaction and interaction with the ImGTS (including the duration of the experience, frequency of rest periods, and technical difficulties) will also be recorded by the researchers.
Safety of the intervention - Augmented Reality Sickness Questionnaire
Time frame: Two weeks
Safety is defined as the low or decreased incidence of adverse events with the use of the ImGTS and will be measured using the Augmented Reality Sickness Questionnaire by Hussain et al., 2023 (https://doi.org/10.1016/j.ergon.2023.103495). The questionnaire are based on the Simulator Sickness Questionnaire by Kennedy et al., 1993 (https://doi.org/10.1207/s153), and each highlight nine symptoms of cybersickness specific to VR and to AR. Symptoms are rated on a 4-point Likert scale from "None" (0) to "Severe" (3). Other adverse events observed during and after the ImGTS experience that are not covered by the questionnaires will be recorded by the researchers. Documentation of the patient's reaction and interaction with the ImGTS (including the duration of the experience, frequency of rest periods, and technical difficulties) will also be recorded by the researchers.
Usability of the intervention
Time frame: Two weeks
Usability is defined as the system's ability to be easy to use as determined through user perception and game performance. User perceptions will be determined using the system usability scale (SUS by Brooke, 1995). Each question has 5 response options ranging from 'Strongly agree' to 'Strongly disagree', which has a corresponding number value. Each response is added and multiplied by 2.5 to obtain the final score that ranges from 0 to 100. A SUS score above 68 is considered above average. The SUS will be used after each session and will require about 10 minutes to complete. More specific metrics on the system's performance, including an assessment of the environmental factors of usability, will also be developed once the game itself has been made. These metrics will be based on input from the researchers and the stakeholders during the FGD(s) of the pilot studies.
Acceptability of the intervention
Time frame: Two weeks
Acceptability is defined as the positive perceptions toward the ImGTS as a game and as a therapeutic tool, which will be assessed using open-ended questions. Participants during the ImGTS development stage will be asked these questions during an FGD, while the healthy volunteers (non-stakeholders) during the clinical trial will be interviewed (semi-structured) after completing each session. Questions on specific game components will be added for the clinical trial once the prototype development has been completed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- The website is the official website of the laboratoryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Roland Dominic G Jamora, MD, 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 VR-HMD, AR-HMD and semi-CAVE in people with Parkinson Disease and Parkinson's Disease (PD), 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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 2 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland Dominic G. Jamora, MD, PhD (+63 998 543 8062, rgjamora@up.edu.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the intervention - Virtual Reality Sickness Questionnaire (time frame: Two weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.