Developing Immersive Gamification Technology Systems For The Rehabilitation Management Of Adults With Parkinson's Disease (Phase 1 Trial)

NCT07382401 | Not Yet Recruiting DMC

• 1 other identifier: AXEL0005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease; Parkinson's Disease (PD)

Keywords

Parkinson Disease; Rehabilitation; Immersive Technology

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Two weeks

Study Arms (3)

VR-HMD

EXPERIMENTAL

This arm is the "VR-HMD" or virtual reality using a head-mounted display.

Device: VR-HMD

AR-HMD

EXPERIMENTAL

This arm is the "AR-HMD" or augmented reality using a head-mounted display.

Device: AR-HMD

Semi-CAVE

EXPERIMENTAL

This arm is the "semi-CAVE" or semi-cave automated virtual environment.

Device: semi-CAVE

Interventions

VR-HMD DEVICE

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.

VR-HMD

AR-HMD DEVICE

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.

AR-HMD

semi-CAVE DEVICE

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.

Semi-CAVE

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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))

Sponsors & Collaborators

• Augmented eXperience E-health Laboratory: lead
• Department of Science and Technology (DOST) - Philippine Council for Health Research and Development (PCHRD): collaborator

Study Sites (1)

Augmented Experience eHealth Laboratory

Manila, National Capital Region, 1000, Philippines

Location

Related Links

• The website is the official website of the laboratory

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Roland Dominic G Jamora, MD, PhD

  University of the Philippines Manila

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Dominic G. Jamora, MD, PhD

CONTACT

+63 998 543 8062; rgjamora@up.edu.ph

Maria Eliza R. Aguila, PhD

CONTACT

+63 917 821 2563; mraguila1@up.edu.ph

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: February 2, 2026
• Study Start: February 1, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

PH (1)