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临床试验/NCT02733055
NCT02733055已完成不适用

Posturography as Biomarker of Oculomotor and Postural Control Integration

Carrick Institute for Graduate Studies3 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
3
主要终点
Stability Score

研究概览

简要总结

Determine the effects looking in certain direction or moving the eyes in a certain way have on the ability of a subject to maintain equilibrium in different circumstances (eyes open/closed, and standing on hard or compliant surface, with the head straight or rotated right or left, flexed or extended).

详细描述

Subjects will undergo computerized dynamic posturography (CDP) testing using the extended modified Clinical Testing of Sensory Integration in Balance (ext_mCTSIB) protocol: the subjects will be required to stand on a hard or the compliant surface in a comfortable posture, feet shoulder width, with eyes open or closed, arms to the side and free to move, gazing forward, and breathing normally, with head straight, turned right or left, flexed or extended. This testing will be used to determine the health status of the subjects.

Then a sequence of tests will be performed (they could be done in different days to avoid fatiguing the subject): each sequence will comprise of a baseline test in one of the ext_mCTSIB testing conditions and a subsequent test in the same conditions but with an oculomotor additional task, such as gazing in a specific direction other than straight, performing saccades in different directions, at different speed and using different paradigms (prosaccades, antisaccades, to a remembered target, gap saccades, ...), following a target moving on the screen at different speed and in different directions, receiving an optokinetic stimulation in different directions and at different speeds. Video recordings of the eyes movement may be done to make sure that the subject is actually moving the eyes, to verify that the observers are well trained to detect and count the saccadic movements, as well as to obtain quantitative information regarding the eye movements per se.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Self assessed healthy subjects

排除标准

  • subjects suffering from pathology known to affect balance

结局指标

主要结局

Stability Score

时间窗: immediately after data collection

The Stability Score (calculated as percentage ratio of the actual sway and the theoretical limit of stability) will be used to investigate if there is any difference between the test without and with oculomotor task. Statistical tools such t-tests and correlation coefficients will be used to assess if there is a difference between the two tests

次要结局

  • sway path length [mm](immediately after data collection)
  • frequency content [Hz](immediately after data collection)
  • average velocity moment [mm^2/s](immediately after data collection)

研究者

发起方
Carrick Institute for Graduate Studies
申办方类型
Other
责任方
Sponsor

研究点 (3)

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