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

Primary Purpose

Vestibular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vestibular tests
Virtual reality
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vestibular Diseases focused on measuring Chronic vestibular deficit in children, Virtual reality protocol, Multisensory integration, Hand-eye coordination

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Necker-Enfants MaladesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with chronic vestibular deficits

Controls

Arm Description

Patients aged 7 to 17 years with chronic vestibular deficits

Patients aged 7 to 17 years without chronic vestibular deficits

Outcomes

Primary Outcome Measures

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
Degree of precision
Doing a task involving hand-eye coordination, in virtual reality, and in different sensory situations. Rate of errors during the test

Secondary Outcome Measures

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
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)
Stratify responses to virtual reality by age
Patients without chronic vestibular déficits. Comparison of success rate according to age
Occurrence of side effects of virtual reality
Possible side effects of virtual reality
Children's satisfaction concerning the virtual reality protocol
Open satisfaction questionnaire analysis

Full Information

First Posted
March 2, 2021
Last Updated
December 7, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04791748
Brief Title
Virtual Reality in Children With and Without Vestibular Deficits
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Diseases
Keywords
Chronic vestibular deficit in children, Virtual reality protocol, Multisensory integration, Hand-eye coordination

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with chronic vestibular deficits
Arm Type
Experimental
Arm Description
Patients aged 7 to 17 years with chronic vestibular deficits
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
Patients aged 7 to 17 years without chronic vestibular deficits
Intervention Type
Diagnostic Test
Intervention Name(s)
Vestibular tests
Intervention Description
Screening vestibular test for patients without chronic vestibular deficits Complete vestibular test if not done yet in care of patients with chronic vestibular deficits
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
Virtual reality protocol : doing tasks involving hand-eye coordination, in virtual reality, and in different sensory situations
Primary Outcome Measure Information:
Title
Degree of reproducibility
Description
Doing a task involving hand-eye coordination, in virtual reality, and in different sensory situations. Success rate for each task is measured
Time Frame
Day 0
Title
Degree of precision
Description
Doing a task involving hand-eye coordination, in virtual reality, and in different sensory situations. Rate of errors during the test
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Compare the success rate in eye-hand coordination
Description
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
Time Frame
Day 0
Title
Correlate virtual reality results with vestibular test results
Description
Correlation between success rate during virtual reality and vestibular function (normal vestibular function or not in both ears)
Time Frame
Day 0
Title
Stratify responses to virtual reality by age
Description
Patients without chronic vestibular déficits. Comparison of success rate according to age
Time Frame
Day 0
Title
Occurrence of side effects of virtual reality
Description
Possible side effects of virtual reality
Time Frame
Day 0
Title
Children's satisfaction concerning the virtual reality protocol
Description
Open satisfaction questionnaire analysis
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Françoise Denoyelle, MD, PhD
Phone
1 71 39 67 85
Ext
+33
Email
f.denoyelle@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène Morel
Phone
1 71 19 63 46
Ext
+33
Email
helene.morel@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françoise Denoyelle, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François SIMON, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Françoise Denoyelle, MD, PhD
Phone
1 71 39 67 85
Ext
+33
Email
f.denoyelle@aphp.fr
First Name & Middle Initial & Last Name & Degree
Natalie Loundon, MD, PhD
First Name & Middle Initial & Last Name & Degree
Salma Jbyeh, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality in Children With and Without Vestibular Deficits

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