Virtual Reality in Children With and Without Vestibular Deficits

NCT ID: NCT04791748

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vestibular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Children and adolescents patients with chronic vestibular deficits

Patients aged 7 to 17 years with chronic vestibular deficits

Group Type EXPERIMENTAL

Vestibular tests

Intervention Type 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

Intervention Type OTHER

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

children and adolescents controls

Patients aged 7 to 17 years without chronic vestibular deficits

Group Type ACTIVE_COMPARATOR

Vestibular tests

Intervention Type 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

Intervention Type OTHER

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

Adults without chronic vestibular deficits

Group Type ACTIVE_COMPARATOR

Vestibular tests

Intervention Type 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

Intervention Type OTHER

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

Adults with chronic vestibular deficits

Group Type ACTIVE_COMPARATOR

Vestibular tests

Intervention Type 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

Intervention Type OTHER

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

Interventions

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Vestibular tests

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

Intervention Type DIAGNOSTIC_TEST

Virtual reality

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Françoise Denoyelle, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

François SIMON, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Necker-Enfants Malades

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Françoise Denoyelle, MD, PhD

Role: CONTACT

1 71 39 67 85 ext. +33

Hélène Morel

Role: CONTACT

1 71 19 63 46 ext. +33

Facility Contacts

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Françoise Denoyelle, MD, PhD

Role: primary

1 71 39 67 85 ext. +33

Other Identifiers

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2020-A02283-36

Identifier Type: OTHER

Identifier Source: secondary_id

APHP201074

Identifier Type: -

Identifier Source: org_study_id

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