跳至主要内容
临床试验/NCT02851524
NCT02851524
已完成
不适用

Proof of Concept Study Concerning Vestibular Stimulation Using a New Method of Dynamic Posturography.

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 30 人2016年6月23日

概览

阶段
不适用
干预措施
posturography
疾病 / 适应症
Vestibular Stimulation
发起方
Centre Hospitalier Universitaire Dijon
入组人数
30
试验地点
1
主要终点
Cinematics of eye movements (amplitude and direction) evaluated by videonystagmography (VNG).
状态
已完成
最后更新
2个月前

概览

简要总结

Falls in the elderly population are a major public health problem because of their frequency and their consequences, notably in terms of dependence their cost to society. In most cases, balance disorders related to an impaired vestibular system are blamed, even though there is no formal evidence that this is the case.

Vestibular tests in routine otoneurological practice are based on the exploration of vestibulo-ocular or even vestibulo-cortical reflexes. They are not particularly suitable to screen for vestibular disorders in falls.

A prototype rocking chair has been developed to test psycho-vestibular pathways, defined as the pathways via which vestibular afferents are transported to the subject's conscience. Thanks to this apparatus, a stimulus of body movement will be generated, but with limited tactile, visual and proprioceptive afferents, in such a way that the vestibular system alone is able to indicate to subjects their position in space. The subject will be required to detect oscillatory movement, and then to distinguish between a vestibular stimulus and a pulsed auditory stimulus.

The study hypothesis is that the movement stimulation generated by our prototype will be sufficient to stimulate the vestibular system, which will manifest itself as a conscious sensation of movement and by a vestibulo-ocular reflex causing oculomotor manifestations.

注册库
clinicaltrials.gov
开始日期
2016年6月23日
结束日期
2017年4月21日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

入排标准

入选标准

  • Older than 18 years
  • National health insurance cover
  • Written consent
  • Subjects able to understand simple instructions and packaging information and to provide informed consent

排除标准

  • Vertigo, consciousness disorders, nausea or pain before the tests
  • Bilateral deafness
  • History of neurological, rheumatic or orthopaedic disease likely by itself to trigger a fall
  • Psychiatric disorder likely to compromise participation.
  • Personal history of falls of undetermined cause.
  • Présence de saccades et/ou nystagmus en position statique
  • Femme enceinte

研究组 & 干预措施

posturography

干预措施: posturography

结局指标

主要结局

Cinematics of eye movements (amplitude and direction) evaluated by videonystagmography (VNG).

时间窗: At Day 0

研究点 (1)

Loading locations...

相似试验