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VR therapy shows promise for autism social skills

NCT ID NCT06453629

Symptom relief Sponsor: Floreo, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a virtual reality (VR) product called Floreo can help autistic children improve their social skills. 117 children aged 5 to 18 used the VR program twice a week for 12 weeks. Researchers compared the Floreo VR group to a control VR group to see if there were meaningful improvements in autism symptoms and daily living skills.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

117 people

The number who actually took part.

Started

May 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Five to eighteen years old (inclusive) at the time of consent * Legal guardian is able and willing to properly sign and date informed consent indicating that they have been informed about the study and able to complete all visits \[If age appropriate, an assent will also be administered to the participant to inform them of the study and give them an opportunity to proceed or decline\] * Verified diagnosis of ASD documented by a qualified clinician according to DSM-V criteria * Receiving therapies at least two times per week in a clinic setting * Participant is able to complete and pass the VR orientation screening Exclusion Criteria: * Significant medical condition(s) \[examples listed below\] or other circumstances which, in the opinion of the treating clinician, would preclude compliance with the protocol, adequate cooperation in the study, or may prevent the participant from safely participating in the study: * Uncontrolled neurological conditions such as epilepsy, migraine * Current disorders affecting balance, such as vertigo * Primary sensory impairment such as blindness or deafness * Eye movement impairment, such as strabismus * Participants are enrolled in another clinical study * Participants known to be pregnant * Participation in this study is not in the best interest of the child, at the discretion of the treating clinician and the primary investigator.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder Communication

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder Social communication

Contacts and locations

Locations

  • Cortica- Burlington

    Burlington, Massachusetts, 01830, United States

  • Cortica- Carlsbad

    Carlsbad, California, 92008, United States

  • Cortica- Dedham

    Dedham, Massachusetts, 20815, United States

  • Cortica- Glendale

    Glendale, California, 91203, United States

  • Cortica- Irvine

    Irvine, California, 92705, United States

  • Cortica- Laguna Niguel

    Laguna Niguel, California, 92677, United States

  • Cortica- Marin

    San Rafael, California, 94903, United States

  • Cortica- Naperville

    Naperville, Illinois, 60564, United States

  • Cortica- Plano

    Plano, Texas, 75093, United States

  • Cortica- Ridgefield

    Ridgefield, Connecticut, 06877, United States

  • Cortica- San Diego

    San Diego, California, 92121, United States

  • Cortica- Shrewsbury

    Shrewsbury, Massachusetts, 01545, United States

  • Cortica- The Woodlands

    The Woodlands, Texas, 77381, United States

  • Cortica- Torrance

    Torrance, California, 90503, United States

  • Cortica- Trumbull

    Trumbull, Connecticut, 06611, United States

  • Cortica- Westchester

    Westchester, Illinois, 60154, United States

  • Cortica- Westlake Village

    Westlake Village, California, 91361, United States

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