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Immersive Virtual Reality Program in Down Syndrome (IN DOWN)

19 giugno 2026 aggiornato da: José M. Cancela, University of Vigo

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

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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
    • Pontevedra
      • Pontevedra, Pontevedra, Spagna, 36003
        • Xuntos Down Pontevedra

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

  1. Individuals who had participated in a high-intensity exercise program within the previous three months

  2. 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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Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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 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
Comparatore placebo: 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.
Comportamentale: 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 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
1. Assessment body composition
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

  • Kilograms (kg) Interpretation
  • Higher values: greater muscular strength and better physical condition
  • Lower values: reduced strength and poorer physical fitness
12 weeks
Assessment Lower limb strength
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Vigo

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 gennaio 2026

Completamento primario (Stimato)

30 giugno 2026

Completamento dello studio (Stimato)

1 luglio 2026

Date di iscrizione allo studio

Primo inviato

9 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 giugno 2026

Primo Inserito (Effettivo)

25 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CEIHG 2023-00125

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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