Immersive Virtual Reality Program in Down Syndrome (IN DOWN)
Integration and Equal Opportunities for People With Down Syndrome: An Innovative Proposal Through Immersive Virtual Reality
Обзор исследования
Статус
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Pontevedra
-
Pontevedra, Pontevedra, Испания, 36003
- Xuntos Down Pontevedra
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- 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. .
Exclusion Criteria:
- 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.
-
-
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: RVI_E_Immersive Virtual Reality Exergame
Participants will complete a 12-week immersive virtual reality (VR) intervention based on high-intensity, gamified physical exercise, with two (2) supervised sessions per week.
The program will take place in a controlled environment within the participants' center's gym and will be supervised by fitness and health professionals.
|
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 hitting virtual targets in time with music, promoting coordination, reaction time, and cardiovascular fitness. FitXR (14 sessions): A virtual reality training program based on high-intensity interval training (HIIT), boxing, and functional movement exercises. It enhances cardiovascular endurance, motor coordinat and cognitive engagement through structured tasks with progressively increasing difficulty levels. Alcove VR (1 session): Used as an initial familiarization and adaptat |
|
Плацебо Компаратор: RVI_ControGroup_Immersive Virtual Reality Exergame
Participants will complete a 12-week immersive virtual reality (VR) intervention based on high-intensity, gamified physical exercise, with one (1) supervised sessions per week.
The program will take place in a controlled environment within the participants' center's gym and will be supervised by fitness and health professionals.
|
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 virtual targets in time with music, promoting coordination, reaction time, and cardiovascular fitness.
FitXR (FitXR Ltd., London, UK) (7 sessions): A virtual reality training program based on high-intensity interval training (HIIT), boxing, and functional movement exercises.
It enhances cardiovascular endurance, motor coordinat and cognitive engagement through structured tasks with progressively increasing difficulty levels.
Alcove VR (1 session): Used as an initial familiarization and adaptat
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
1. Assessment body composition
Временное ограничение: 12 weeks
|
Description: Body composition was assessed using the Tanita MC-780 bioelectrical impedance analyzer. Measured variables included fat mass (FM), fat-free mass (FFM), muscle mass (MM), total body water (TBW), and segmental body composition of the trunk and limbs. Unit of Measurement: Fat Mass (FM): kg Fat-Free Mass (FFM): kg Muscle Mass (MM): kg Total Body Water (TBW): kg Segmental Body Composition: kg Interpretation: Higher FFM, MM, and TBW indicate better physical fitness. Lower FM indicates better body composition. |
12 weeks
|
|
Assessment usability
Временное ограничение: 12 weeks
|
1. System usability will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire. Scores range from 0 to 100, with higher scores indicating better usability. Unit of Measure: SUS score (0-100) Interpretation: Scores ≥68 indicate acceptable usability; scores >80 indicate excellent usability. |
12 weeks
|
|
Cognitive parameters: Executive function
Временное ограничение: 12 weeks
|
Description: Clock Drawing Test (CDT) Participants are asked to draw an analog clock and set the hands to a specified time. Performance is scored using methods such as TRO and TCR, which evaluate the accuracy and organization of the drawing. Unit of measurement Total CDT score (scoring scale) ( 0-20 points) Interpretation Higher scores: better cognitive performance, particularly in executive and visuospatial functions Lower scores: possible impairment in planning, spatial organization, and other cognitive functions |
12 weeks
|
|
Assessment Aerobic endurance
Временное ограничение: 12 weeks
|
2-Minute Step Test Participants march in place for 2 minutes, raising their knees to a specified height. The total number of correctly completed steps is recorded. Unit of measurement Number of steps completed in 2 minutes Interpretation Higher scores: better aerobic capacity and physical fitness Lower scores: reduced endurance and lower cardiorespiratory fitness |
12 weeks
|
|
Health-related quality of life
Временное ограничение: 12 weeks
|
Description: Health-related quality of life will be assessed using the KidsLife-Down Questionnaire, a validated instrument for individuals with Down syndrome that evaluates eight domains of quality of life and provides standardized scores and percentiles. Unit of Measure: KidsLife-Down total standardized score (scale) Interpretation: Higher scores indicate better quality of life and well-being. Lower scores indicate greater limitations in quality of life and daily functioning. |
12 weeks
|
|
Assessment Safety and cybersickness symptoms
Временное ограничение: 12 weeks
|
Safety and cybersickness symptoms will be assessed using the Simulator Sickness Questionnaire (SSQ). Higher scores indicate greater severity of cybersickness symptoms. Unit of Measure: SSQ total score Interpretation: Lower scores indicate better tolerability and safety; a score of 0 indicates no symptoms. |
12 weeks
|
|
Assessment user experience and engagement
Временное ограничение: 12 weeks
|
User experience and engagement will be assessed using the Game Experience Questionnaire (GEQ - Post-Game Module). Items are rated from 0 to Unit of Measure: GEQ subscale scores (0-4) Interpretation: Higher scores indicate better experience for positive dimensions and poorer experience for negative dimensions. |
12 weeks
|
|
Cognitive parameters: processing speed
Временное ограничение: 12 weeks
|
Description: Symbol Digit Modalities Test (SDMT) Participants match symbols to corresponding numbers using a reference key and complete as many correct pairings as possible within a time limit. Unit of measurement Number of correct responses (raw score) Interpretation Higher scores: better attention, faster processing speed, and higher cognitive efficiency Lower scores: reduced attention, slower processing speed, and poorer cognitive performance |
12 weeks
|
|
Assessment Dynamic balance
Временное ограничение: 12 weeks
|
Timed Up and Go (TUG) Test The participant stands up from a chair, walks a set distance (usually 3 meters), turns, walks back, and sits down. The total time is recorded. Unit of measurement Seconds (time to complete the test) Interpretation Lower times: better mobility, balance, and functional performance Higher times: impaired mobility, poorer balance, and increased risk of falls |
12 weeks
|
|
Assessment Upper body muscular strength
Временное ограничение: 12 weeks
|
Handgrip Strength (Jamar Dynamometer) Participants squeeze a Jamar hand dynamometer with maximum voluntary force, usually with the dominant hand or both hands depending on protocol. Unit of measurement
|
12 weeks
|
|
Assessment Lower limb strength
Временное ограничение: 12 weeks
|
Five Sit to stand Test (5STS) Participants perform five full squats as quickly and safely as possible. The total time to complete the five repetitions is recorded. Unit of measurement Seconds (time to complete 5 squats) Interpretation Lower times: greater lower limb strength and better functional capacity Higher times: reduced strength and poorer functional performance |
12 weeks
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CEIHG 2023-00125
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .