Clinical trial NCT04791748: Virtual Reality in Children with and Without Vestibular Deficits
Official title: Validation and Comparison of a Virtual Reality Protocol in Children Without Vestibular Pathology and Children with Chronic Vestibular Déficits : Prospective Study ReViCHILD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Diseases
Keywords: Chronic vestibular deficit in children
Virtual reality protocol
Multisensory integration
Hand-eye coordination
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 140
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of reproducibility
timeFrame: Day 0
measure: Degree of precision
timeFrame: Day 0
Secondary outcomes:
measure: Compare the success rate in eye-hand coordination
timeFrame: Day 0
measure: Correlate virtual reality results with vestibular test results
timeFrame: Day 0
measure: Stratify responses to virtual reality by age
timeFrame: Day 0
measure: Occurrence of side effects of virtual reality
timeFrame: Day 0
measure: Children's satisfaction concerning the virtual reality protocol
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Françoise Denoyelle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: François SIMON, MD, PhD
role: STUDY_DIRECTOR
References: