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Virtual Reality in Children With and Without Vestibular Deficits (ReViCHILD)

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Vestibular Diseases

Treatments

Other: Virtual reality
Diagnostic Test: Vestibular tests

Study type

Interventional

Funder types

Other

Identifiers

NCT04791748
APHP201074
2020-A02283-36 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

140 estimated patients

Sex

All

Ages

7 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 4 patient groups

Children and adolescents patients with chronic vestibular deficits
Experimental group
Description:
Patients aged 7 to 17 years with chronic vestibular deficits
Treatment:
Diagnostic Test: Vestibular tests
Other: Virtual reality
children and adolescents controls
Active Comparator group
Description:
Patients aged 7 to 17 years without chronic vestibular deficits
Treatment:
Diagnostic Test: Vestibular tests
Other: Virtual reality
Adults without chronic vestibular deficits
Active Comparator group
Treatment:
Diagnostic Test: Vestibular tests
Other: Virtual reality
Adults with chronic vestibular deficits
Active Comparator group
Treatment:
Diagnostic Test: Vestibular tests
Other: Virtual reality

Trial contacts and locations

1

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Central trial contact

Hélène Morel; Françoise Denoyelle, MD, PhD

Data sourced from clinicaltrials.gov

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