Virtual Reality in Children With and Without Vestibular Deficits

Vestibular Diseases Clinical Trial

— ReViCHILD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791748
• Other study ID #: APHP201074
• Secondary ID: 2020-A02283-36
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Françoise Denoyelle, MD, PhD
• Phone: 1 71 39 67 85
• Email: f.denoyelle[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Vestibular Diseases

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Stratify responses to virtual reality by age	Patients without chronic vestibular déficits. Comparison of success rate according to age	Day 0
Secondary	Occurrence of side effects of virtual reality	Possible side effects of virtual reality	Day 0
Secondary	Children's satisfaction concerning the virtual reality protocol	Open satisfaction questionnaire analysis	Day 0