Health TrialsbyHealthPanel

Virtual Reality in Children With and Without Vestibular Deficits

ConditionVestibular Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Vestibular tests

    Diagnostic 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 reality

    Other intervention

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

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Children and adolescents patients with chronic vestibular deficitsExperimental treatment 2 interventions
Group B: children and adolescents controlsActive comparator 2 interventions
Group C: Adults without chronic vestibular deficitsActive comparator 2 interventions
Group D: Adults with chronic vestibular deficitsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Day 0
2

Degree of precision

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 outcomes

1

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.

Time frame
Day 0
2

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).

Time frame
Day 0
3

Stratify responses to virtual reality by age

Patients without chronic vestibular déficits. Comparison of success rate according to age.

Time frame
Day 0
4

Occurrence of side effects of virtual reality

Possible side effects of virtual reality.

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
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