NCT04791748

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Apr 2021Feb 2027

First Submitted

Initial submission to the registry

March 2, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

5.8 years

First QC Date

March 2, 2021

Last Update Submit

September 8, 2025

Conditions

Vestibular Diseases

Keywords

Chronic vestibular deficit in childrenVirtual reality protocolMultisensory integrationHand-eye coordination

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Compare the success rate in eye-hand coordination

    Day 0

  • Correlate virtual reality results with vestibular test results

    Day 0

  • Stratify responses to virtual reality by age

    Day 0

  • Occurrence of side effects of virtual reality

    Day 0

  • Children's satisfaction concerning the virtual reality protocol

    Day 0

Study Arms (4)

Children and adolescents patients with chronic vestibular deficits

EXPERIMENTAL

Patients aged 7 to 17 years with chronic vestibular deficits

Diagnostic Test: Vestibular testsOther: Virtual reality

children and adolescents controls

ACTIVE COMPARATOR

Patients aged 7 to 17 years without chronic vestibular deficits

Diagnostic Test: Vestibular testsOther: Virtual reality

Adults without chronic vestibular deficits

ACTIVE COMPARATOR
Diagnostic Test: Vestibular testsOther: Virtual reality

Adults with chronic vestibular deficits

ACTIVE COMPARATOR
Diagnostic Test: Vestibular testsOther: Virtual reality

Interventions

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

Adults with chronic vestibular deficitsAdults without chronic vestibular deficitsChildren and adolescents patients with chronic vestibular deficitschildren and adolescents controls
Virtual realityOTHER

Virtual reality protocol : doing tasks involving hand-eye coordination, in virtual reality, and in different sensory situations

Adults with chronic vestibular deficitsAdults without chronic vestibular deficitsChildren and adolescents patients with chronic vestibular deficitschildren and adolescents controls

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Vestibular Diseases

Interventions

Vestibular Function Tests

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Françoise Denoyelle, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • François SIMON, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Françoise Denoyelle, MD, PhD

CONTACT

1 71 39 67 85f.denoyelle@aphp.fr

Hélène Morel

CONTACT

1 71 19 63 46helene.morel@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 10, 2021

Study Start

April 12, 2021

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)