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NCT Number: NCT04791748

Virtual Reality in Children With and Without Vestibular Deficits

Vestibular information is important in establishing a child's static and dynamic postural control. Any vestibular deficit can have major consequences on development, spatial cognition and quality of life.

In order to interact with the world around us, we must simultaneously integrate different sources of sensory informations (vision, hearing, perception of the body...). The brain integrates these different sensory components to form a unified and coherent perception: this is multisensory integration.

Multisensory integration has been studied using virtual reality in adults, in the "spatial orientation" team of the Center for Integrative Neurosciences and Cognition. These experiments were carried out on healthy subjects and in weightless situations (international space station or parabolic flight). However, no protocol has been developed in children or in subjects with vestibular deficit. Virtual reality is interesting for developing such a protocol because it creates multisensory stimulation capable of promoting visual and proprioceptive compensation of the vestibular deficit.

It induces an immersion of the patient in a virtual spatial and temporal environment difficult to carry out with traditional vestibular rehabilitation techniques. Its main advantage is that it is a fun and safe interactive diagnostic and therapeutic tool, which is particularly suitable for children. Being able to modulate certain sensory information using virtual reality, in children without vestibular function deficit and in children with vestibular function deficit, will make it possible to better understand the role of the vestibule in the construction of the self in relation to space and environment. In addition to the scientific aspect, the diagnostic and therapeutic benefits are potentially numerous.

The objective of the study is to determine a reliable, well-tolerated and age-appropriate virtual reality protocol in children without vestibular deficit and in children with chronic vestibular deficit, making it possible to study the hand-eye coordination.

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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location status: Recruiting

Location contact

Françoise Denoyelle, MD, PhD

CONTACT

[email protected]

1 71 39 67 85 ext. +33

Natalie Loundon, MD, PhD

SUB_INVESTIGATOR

Salma Jbyeh, MD

PRINCIPAL_INVESTIGATOR

About this study

Vestibular information is important in establishing a child's static and dynamic postural control. Any vestibular deficit can have major consequences on development, spatial cognition and quality of life.

In order to interact with the world around us, we must simultaneously integrate different sources of sensory informations (vision, hearing, perception of the body ...). The brain integrates these different sensory components to form a unified and coherent perception: this is multisensory integration.

It is particularly important in children for the acquisition of sitting, standing and then walking. When a congenital vestibular deficit exists, adaptive behaviors using visual and proprioceptive inputs are set up.

Multisensory integration has been studied using virtual reality in adults, in the "spatial orientation" team of the Center for Integrative Neurosciences and Cognition. These experiments were carried out on healthy subjects and in weightless situations (international space station or parabolic flight). However, no protocol has been developed in children or in subjects with vestibular deficit. Virtual reality is interesting for developing such a protocol because it creates multisensory stimulation capable of promoting visual and proprioceptive compensation of the vestibular deficit.

It induces an immersion of the patient in a virtual spatial and temporal environment difficult to carry out with traditional vestibular rehabilitation techniques. Its main advantage is that it is a fun and safe interactive diagnostic and therapeutic tool, which is particularly suitable for children. Being able to modulate certain sensory information using virtual reality, in children without vestibular function deficit and in children with vestibular function deficit, will make it possible to better understand the role of the vestibule in the construction of the self in relation to space and environment. In addition to the scientific aspect, the diagnostic and therapeutic benefits are potentially numerous.

The objective of the study is to determine a reliable, well-tolerated and age-appropriate virtual reality protocol in children without vestibular deficit and in children with chronic vestibular deficit, making it possible to study the hand-eye coordination.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Minors aged 7 to 17 years (inclusive)
  • Volunteers adult
  • Information and consent of holders of parental authority of minors, minors and of adult subjects

Patients :

  • Presence of unilateral or bilateral chronic vestibular pathology
  • Minor patients followed in consultation at Necker Hospital in the Pediatric ENT department
  • Adult patients followed at adult vestibulometry services (Lariboisière and Pitié Salpêtrière Hospitals)

Controls:

  • No history of otological surgery and absence of vestibular pathology
  • Patients followed in consultation at Necker Hospital, siblings or adult parents

Exclusion criteria

  • Presence of an ophthalmological pathology (including refractive errors)
  • Presence of neurological pathology including epilepsy or any pathology that can alter mobility and interfere with the performance of tasks

Treatment and study plan

Vestibular tests

Diagnostic Test

Screening vestibular test for patients without chronic vestibular deficits Complete vestibular test if not done yet in care of patients with chronic vestibular deficits

Virtual Reality

Other

Virtual reality protocol : doing tasks involving hand-eye coordination, in virtual reality, and in different sensory situations

Primary outcomes

  1. Degree of reproducibility

    Time frame: Day 0

    Doing a task involving hand-eye coordination, in virtual reality, and in different sensory situations. Success rate for each task is measured

  2. Degree of precision

    Time frame: Day 0

    Doing a task involving hand-eye coordination, in virtual reality, and in different sensory situations. Rate of errors during the test

Secondary outcomes

  1. Compare the success rate in eye-hand coordination

    Time frame: Day 0

    Compare eye-hand coordination in :

    • children without vestibular pathology and in children with vestibular déficits.
    • children with vestibular deficits and in adults with vestibular déficits.
    • children without vestibular pathology and in adults without vestibular déficits.
    • adults without vestibular pathology and in adults with vestibular déficits. Success rate for each task will be measured and compared between groups.
  2. Correlate virtual reality results with vestibular test results

    Time frame: Day 0

    Correlation between success rate during virtual reality and vestibular function (normal vestibular function or not in both ears).

  3. Stratify responses to virtual reality by age

    Time frame: Day 0

    Patients without chronic vestibular déficits. Comparison of success rate according to age.

  4. Occurrence of side effects of virtual reality

    Time frame: Day 0

    Possible side effects of virtual reality.

  5. Children's satisfaction concerning the virtual reality protocol

    Time frame: Day 0

    Open satisfaction questionnaire analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Françoise Denoyelle, MD, PhD

CONTACT

[email protected]

1 71 39 67 85 ext. +33

Hélène Morel

CONTACT

[email protected]

1 71 19 63 46 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Validation and Comparison of a Virtual Reality Protocol in Children Without Vestibular Pathology and Children With Chronic Vestibular déficits : Prospective Study ReViCHILD

Acronym: ReViCHILD

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2021
Registry last updated
Apr 3, 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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