Immersive Virtual Reality Program in Down Syndrome

Официальное название

Integration and Equal Opportunities for People With Down Syndrome: An Innovative Proposal Through Immersive Virtual Reality

Обзор

The presented project aims to bring immersive technology to individuals with Down syndrome (DS) through the development of innovative proposals for acquiring skills and abilities, and enhancing their capabilities by combining the motor and cognitive components so important for this group. Various strategies have been used to improve the functionality (physical and cognitive) and quality of life of people with DS; however, one of the problems observed in practice is the low motivation and commitment to the interventions being implemented. In response to this problem, the use of technology and gamified environments has been proposed in recent years to make therapies more engaging. Therefore, this project arises with the objective of developing and evaluating the effects of an immersive intervention program on the physical and cognitive abilities of individuals with Down syndrome.

Подробное описание

Down syndrome is the leading cause of intellectual disability and one of the most common genetic disorders, with an estimated prevalence of approximately 34,000 individuals in Spain and around 3,000 in Galicia. This population presents physical, motor, cognitive, and communication characteristics that affect functional ability and independence throughout life, including muscle hypotonia, difficulties in information processing, memory and attention impairments, and delayed language development.

Although various intervention strategies have been developed to improve functionality and quality of life in individuals with Down syndrome, a key limitation in practice is low motivation and adherence to traditional programs. In this context, technology-based and gamified interventions have shown potential to enhance engagement and improve motor outcomes, particularly balance and physical performance.

However, previous evidence has mainly focused on non-immersive exergaming, with limited research on immersive virtual reality approaches. Therefore, this study aims to develop and evaluate an immersive intervention program designed to improve physical and cognitive capacities in individuals with Down syndrome.

Вмешательства

• Поведенческое RVI_Experimental_Immersive Virtual Reality Exergame
  Participants assigned to the experimental group wil complete a 12-week immersive virtual reality (IVR) intervention based on high-intensity gamified physical exercise, with two (2) supervised sessions per week. The program will be conducted in a controlled environment within the participants' center gym and will be supervised by exercise and health professionals. The exergames used will be: Beat Saber (Beat Games) (6 sessions): Participants perform upper-limb and whole-body movements by hittin
• Поведенческое RVI_ControGroup_Immersive Virtual Reality Exergame
  Participants assigned to the experimental group wil complete a 12-week immersive virtual reality (IVR) intervention based on high-intensity gamified physical exercise, with one (1) supervised sessions per week. The program will be conducted in a controlled environment within the participants' center gym and will be supervised by exercise and health professionals. The exergames used will be: Beat Saber (Beat Games) (3 sessions): Participants perform upper-limb and whole-body movements by hitting

Первичные конечные точки

• 1. Assessment body composition [Срок оценки: 12 weeks]
• Assessment usability [Срок оценки: 12 weeks]
• Cognitive parameters: Executive function [Срок оценки: 12 weeks]
• Assessment Aerobic endurance [Срок оценки: 12 weeks]
• Health-related quality of life [Срок оценки: 12 weeks]
• Assessment Safety and cybersickness symptoms [Срок оценки: 12 weeks]
• Assessment user experience and engagement [Срок оценки: 12 weeks]
• Cognitive parameters: processing speed [Срок оценки: 12 weeks]
• Assessment Dynamic balance [Срок оценки: 12 weeks]
• Assessment Upper body muscular strength [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Mild to moderate intellectual disability as reported by parents
• Ability to follow simple verbal instructions in Spanish or Galician
• Adequate physical condition to engage in a high-intensity exercise program. .

Критерии исключения

• Individuals who had participated in a high-intensity exercise program within the previous three months
• Those with concurrent medical conditions such as chronic arthritis, autism, unrepaired congenital heart defect; or a history of violent episodes, elopement, aggressive behavior, or antisocial conduct; presenting severe visual or auditory disturbances, vertigo, psychosis or uncontrolled epilepsy that would prevent the sessions being carried out.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Xuntos Down Pontevedra — Pontevedra

Идентификаторы

NCT: NCT07668908 · CEIHG 2023-00125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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