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.
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
Previously diagnosed with any neurologic condition
With any form of aphasia
Previously diagnosed with a psychiatric disorder
Previously diagnosed with seizures or epilepsy
Parallel
VR-HMD
DeviceThe 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-HMD
DeviceThis 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-CAVE
DeviceThis 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.
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.
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.
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.
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.
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Augmented eXperience E-health Laboratory
Lead sponsor
Department of Science and Technology (DOST) - Philippine Council for Health Research and Development (PCHRD)
Collaborator
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