Virtual Reality in Children With and Without Vestibular Deficits

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 12, 2022

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Patients with chronic vestibular deficits
    • Patients aged 7 to 17 years with chronic vestibular deficits
  • Active Comparator: Controls
    • Patients aged 7 to 17 years without chronic vestibular deficits

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

  • 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. Success rate for each task will be measured and compared between both groups
  • 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)
  • Stratify responses to virtual reality by age
    • Time Frame: Day 0
    • Patients without chronic vestibular déficits. Comparison of success rate according to age
  • Occurrence of side effects of virtual reality
    • Time Frame: Day 0
    • Possible side effects of virtual reality
  • Children’s satisfaction concerning the virtual reality protocol
    • Time Frame: Day 0
    • Open satisfaction questionnaire analysis

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Françoise Denoyelle, MD, PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris
    • François SIMON, MD, Study Director, Assistance Publique – Hôpitaux de Paris
  • Overall Contact(s)
    • Françoise Denoyelle, MD, PhD, 1 71 39 67 85, f.denoyelle@aphp.fr

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