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Enrolling by Invitation

NCT Number: NCT07668908

Immersive Virtual Reality Program in Down Syndrome

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.

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Key information

Conditions

Down Syndrome Immersive Physical Activity Behavior Motor Activity

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuntos Down Pontevedra

Pontevedra, 36003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

RVI_Experimental_Immersive Virtual Reality Exergame

Behavioral

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

RVI_ControGroup_Immersive Virtual Reality Exergame

Behavioral

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

Primary outcomes

  1. 1. Assessment body composition

    Time frame: 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.

  2. Assessment usability

    Time frame: 12 weeks

    • 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.

  3. Cognitive parameters: Executive function

    Time frame: 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

  4. Assessment Aerobic endurance

    Time frame: 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

  5. Health-related quality of life

    Time frame: 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.

  6. Assessment Safety and cybersickness symptoms

    Time frame: 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.

  7. Assessment user experience and engagement

    Time frame: 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.

  8. Cognitive parameters: processing speed

    Time frame: 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

  9. Assessment Dynamic balance

    Time frame: 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

  10. Assessment Upper body muscular strength

    Time frame: 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

  11. Assessment Lower limb strength

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Vigo

Other

Registry information

Official study title

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

Acronym: IN DOWN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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