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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство VR-HMD
  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.
• Устройство AR-HMD
  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.
• Устройство semi-CAVE
  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

Первичные конечные точки

• Safety of the intervention - Virtual Reality Sickness Questionnaire [Срок оценки: Two weeks]
• Safety of the intervention - Augmented Reality Sickness Questionnaire [Срок оценки: Two weeks]
• Usability of the intervention [Срок оценки: Two weeks]
• Acceptability of the intervention [Срок оценки: Two weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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))

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Филиппины · 1 центр

• Augmented Experience eHealth Laboratory — Manila

Идентификаторы

NCT: NCT07382401 · AXEL0005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗