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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vestibular Diseases
• Intervention / Treatment: Diagnostic test: Vestibular tests; Other: Virtual reality

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Françoise Denoyelle, MD, PhD; Phone Number: +33 1 71 39 67 85; Email: f.denoyelle@aphp.fr
• Study Contact Backup: Name: Hélène Morel; Phone Number: +33 1 71 19 63 46; Email: helene.morel@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hôpital Necker-Enfants Malades
    • Contact: Françoise Denoyelle, MD, PhD; Phone Number: +33 1 71 39 67 85; Email: f.denoyelle@aphp.fr
    • Sub-Investigator: Natalie Loundon, MD, PhD
    • Principal Investigator: Salma Jbyeh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Minors aged 7 to 17 years (inclusive)
• holders of parental authority not opposed to participation in the study

Patients :

• Presence of unilateral or bilateral chronic vestibular pathology
• Patients followed in consultation at Necker Hospital in the Pediatric ENT department

Controls:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with chronic vestibular deficits; Patients aged 7 to 17 years with chronic vestibular deficits	Diagnostic test: 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; Other: Virtual reality; Virtual reality protocol : doing tasks involving hand-eye coordination, in virtual reality, and in different sensory situations
Active Comparator: Controls; Patients aged 7 to 17 years without chronic vestibular deficits	Diagnostic test: 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; Other: Virtual reality; Virtual reality protocol : doing tasks involving hand-eye coordination, in virtual reality, and in different sensory situations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of reproducibility	Doing a task involving hand-eye coordination, in virtual reality, and in different sensory situations. Success rate for each task is measured	Day 0
Degree of precision	Doing a task involving hand-eye coordination, in virtual reality, and in different sensory situations. Rate of errors during the test	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the success rate in eye-hand coordination	Compare eye-hand coordination in children without vestibular pathology and in children with vestibular déficits. Success rate for each task will be measured and compared between both groups	Day 0
Correlate virtual reality results with vestibular test results	Correlation between success rate during virtual reality and vestibular function (normal vestibular function or not in both ears)	Day 0
Stratify responses to virtual reality by age	Patients without chronic vestibular déficits. Comparison of success rate according to age	Day 0
Occurrence of side effects of virtual reality	Possible side effects of virtual reality	Day 0
Children's satisfaction concerning the virtual reality protocol	Open satisfaction questionnaire analysis	Day 0

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Françoise Denoyelle, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Director: François SIMON, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Chronic vestibular deficit in children; Virtual reality protocol; Multisensory integration; Hand-eye coordination
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases
• Other Study ID Numbers: APHP201074; 2020-A02283-36 (Other Identifier: ID RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No