By InvitationNot Applicable

Immersive Virtual Reality Program in Down Syndrome

Spain20 participantsStarted 2026-01-22

Plain-language summary

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.

Who can participate

Age range

16 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

1. Assessment body composition

Timeframe: 12 weeks

Assessment usability

Timeframe: 12 weeks

Cognitive parameters: Executive function

Timeframe: 12 weeks

Assessment Aerobic endurance

Timeframe: 12 weeks

Health-related quality of life

Timeframe: 12 weeks

Assessment Safety and cybersickness symptoms

Timeframe: 12 weeks

Assessment user experience and engagement

Timeframe: 12 weeks

Cognitive parameters: processing speed

Timeframe: 12 weeks

Trial details

NCT IDNCT07668908

SponsorUniversity of Vigo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Down Syndrome Immersive Physical Activity trials

Plain-language summary

Who can participate

Age range

16 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

1. Assessment body composition

Timeframe: 12 weeks

Assessment usability

Timeframe: 12 weeks

Cognitive parameters: Executive function

Timeframe: 12 weeks

Assessment Aerobic endurance

Timeframe: 12 weeks

Health-related quality of life

Timeframe: 12 weeks

Assessment Safety and cybersickness symptoms

Timeframe: 12 weeks

Assessment user experience and engagement

Timeframe: 12 weeks

Cognitive parameters: processing speed

Timeframe: 12 weeks