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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pontevedra
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Pontevedra, Pontevedra, 스페인, 36003
- Xuntos Down Pontevedra
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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 |
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위약 비교기: 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.
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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1. Assessment body composition
기간: 12 weeks
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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
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Assessment usability
기간: 12 weeks
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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
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Cognitive parameters: Executive function
기간: 12 weeks
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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
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Assessment Aerobic endurance
기간: 12 weeks
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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
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Health-related quality of life
기간: 12 weeks
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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
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Assessment Safety and cybersickness symptoms
기간: 12 weeks
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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
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Assessment user experience and engagement
기간: 12 weeks
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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
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Cognitive parameters: processing speed
기간: 12 weeks
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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
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Assessment Dynamic balance
기간: 12 weeks
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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
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Assessment Upper body muscular strength
기간: 12 weeks
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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
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12 weeks
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Assessment Lower limb strength
기간: 12 weeks
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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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
RVI_Experimental_Immersive Virtual Reality Exergame에 대한 임상 시험
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Region Skane초대로 등록
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Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)모병
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Emrah AyAtaturk University; Prof. Dr. Mağfiret Kaşıkçı완전한