跳至主要内容
临床试验/NCT04791748
NCT04791748招募中不适用

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

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年4月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
2
主要终点
Degree of precision

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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
  • •Adult patients followed at adult vestibulometry services (Lariboisière and Pitié Salpêtrière Hospitals)
  • •No history of otological surgery and absence of vestibular pathology
  • •Patients followed in consultation at Necker Hospital, siblings or adult parents

排除标准

  • •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

研究组 & 干预措施

Children and adolescents patients with chronic vestibular deficits

Experimental

Patients aged 7 to 17 years with chronic vestibular deficits

干预措施: Vestibular tests (Diagnostic Test)

Children and adolescents patients with chronic vestibular deficits

Experimental

Patients aged 7 to 17 years with chronic vestibular deficits

干预措施: Virtual reality (Other)

children and adolescents controls

Active Comparator

Patients aged 7 to 17 years without chronic vestibular deficits

干预措施: Vestibular tests (Diagnostic Test)

children and adolescents controls

Active Comparator

Patients aged 7 to 17 years without chronic vestibular deficits

干预措施: Virtual reality (Other)

Adults without chronic vestibular deficits

Active Comparator

干预措施: Vestibular tests (Diagnostic Test)

Adults without chronic vestibular deficits

Active Comparator

干预措施: Virtual reality (Other)

Adults with chronic vestibular deficits

Active Comparator

干预措施: Vestibular tests (Diagnostic Test)

Adults with chronic vestibular deficits

Active Comparator

干预措施: Virtual reality (Other)

结局指标

主要结局

Degree of precision

时间窗: Day 0

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

Degree of reproducibility

时间窗: Day 0

Doing a task involving hand-eye coordination, in virtual reality, and in different sensory situations. Success rate for each task is measured

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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