Vestibular DiseasesReViCHILDNCT04791748
Virtual Reality in Children With and Without Vestibular Deficits
A study testing Vestibular tests and Virtual reality in people with Vestibular Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Vestibular Diseases
- What is being tested?
- Vestibular tests and Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2021to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Françoise Denoyelle, MD, PhD, 1 71 39 67 85 ext. +33, f.denoyelle@aphp.fr
Natalie Loundon, MD, PhD
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Vestibular Diseases
- Being tested
- Vestibular tests, Virtual reality
- Keywords
- Chronic vestibular deficit in children, Virtual reality protocol, Multisensory integration, Hand-eye coordination
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular testsDiagnostic test
Screening vestibular test for patients without chronic vestibular deficits Complete vestibular test if not done yet in care of patients with chronic vestibular deficits
Virtual realityOther
Virtual reality protocol : doing tasks involving hand-eye coordination, in virtual reality, and in different sensory situations
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents patients with chronic vestibular deficits | Experimental | Patients aged 7 to 17 years with chronic vestibular deficits Receives: Diagnostic Test: Vestibular tests; Other: Virtual reality |
| children and adolescents controls | Active comparator | Patients aged 7 to 17 years without chronic vestibular deficits Receives: Diagnostic Test: Vestibular tests; Other: Virtual reality |
| Adults without chronic vestibular deficits | Active comparator | Not described Receives: Diagnostic Test: Vestibular tests; Other: Virtual reality |
| Adults with chronic vestibular deficits | Active comparator | Not described Receives: Diagnostic Test: Vestibular tests; Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: Day 0
Secondary outcomes (5)
Compare the success rate in eye-hand coordination
Compare eye-hand coordination in :
- children without vestibular pathology and in children with vestibular déficits.
- children with vestibular deficits and in adults with vestibular déficits.
- children without vestibular pathology and in adults without vestibular déficits.
- adults without vestibular pathology and in adults with vestibular déficits. Success rate for each task will be measured and compared between groups.
Measured: 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).
Measured: Day 0
Stratify responses to virtual reality by age
Patients without chronic vestibular déficits. Comparison of success rate according to age.
Measured: Day 0
Occurrence of side effects of virtual reality
Possible side effects of virtual reality.
Measured: Day 0
Children's satisfaction concerning the virtual reality protocol
Open satisfaction questionnaire analysis
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start12 Apr 2021
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Françoise Denoyelle, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisFrançois SIMON, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791748
- Sponsor's protocol ID
- APHP201074
- Other IDs
- 2020-A02283-36
- Acronym
- ReViCHILD
- Status last verified
- Sep 2025
- First submitted
- 2 Mar 2021
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Comparison of a Virtual Reality Protocol in Children Without Vestibular Pathology and Children With Chronic Vestibular déficits : Prospective Study ReViCHILD
- ClinicalTrials.gov ID
- NCT04791748
- Acronym / sponsor ID
- ReViCHILD / APHP201074
- Conditions
- Vestibular Diseases
- Keywords
- Chronic vestibular deficit in children, Virtual reality protocol, Multisensory integration, Hand-eye coordination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents patients with chronic vestibular deficits | Experimental | Diagnostic Test: Vestibular tests, Other: Virtual realityPatients aged 7 to 17 years with chronic vestibular deficits |
| children and adolescents controls | Active comparator | Diagnostic Test: Vestibular tests, Other: Virtual realityPatients aged 7 to 17 years without chronic vestibular deficits |
| Adults without chronic vestibular deficits | Active comparator | Diagnostic Test: Vestibular tests, Other: Virtual reality |
| Adults with chronic vestibular deficits | Active comparator | Diagnostic Test: Vestibular tests, Other: Virtual reality |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Minors aged 7 to 17 years (inclusive)
- Volunteers adult
- Information and consent of holders of parental authority of minors, minors and of adult subjects
- Presence of unilateral or bilateral chronic vestibular pathology
- Minor patients followed in consultation at Necker Hospital in the Pediatric ENT department
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular testsScreening vestibular test for patients without chronic vestibular deficits Complete vestibular test if not done yet in care of patients with chronic vestibular deficits | Diagnostic test | Adults with chronic vestibular deficits, Adults without chronic vestibular deficits, Children and adolescents patients with chronic vestibular deficits, children and adolescents controls |
| Virtual realityVirtual reality protocol : doing tasks involving hand-eye coordination, in virtual reality, and in different sensory situations | Other | Adults with chronic vestibular deficits, Adults without chronic vestibular deficits, Children and adolescents patients with chronic vestibular deficits, children and adolescents controls |
Primary outcome
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
5 secondary outcomes
Compare the success rate in eye-hand coordination
Time frame: Day 0
Correlate virtual reality results with vestibular test results
Time frame: Day 0
Stratify responses to virtual reality by age
Time frame: Day 0
Occurrence of side effects of virtual reality
Time frame: Day 0
Children's satisfaction concerning the virtual reality protocol
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Françoise Denoyelle, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
François SIMON, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular tests and Virtual reality in people with Vestibular Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Françoise Denoyelle, MD, PhD (1 71 39 67 85 ext. +33, f.denoyelle@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of reproducibility (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.