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临床试验/NCT03271775
NCT03271775Unknown不适用

Vestibulopathy With Vestibulo Ocular Reflex (VOR) Gain Deficit - Characteristics of Overt and Covert Saccadic Eye Movements Measured by the Video Head Impulse Test (vHIT)

University of Haifa2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Change from baseline saccadic eye movements after 3 and 6 months measured by The video head impulse test (vhit)

研究概览

简要总结

The study is examine the eye movements characteristics of patients with VOR gain deficits (overt and covert saccades) before and after physical therapy intervention program and examine the most effective physical therapy treatment program for patients with vestibulopathy.

详细描述

The vestibular system receives and conveys information about head motion in space, and is the main human sensory system dedicated to detecting self-motion.The vestibular system plays a crucial role in static and dynamic balance control, stabilizing the head and trunk, especially on unstable surfaces . In terms of postural control and falls, the literature describes a direct association between VOR deficits, gait instability, and falls.The "gain" of the VOR is defined as the change in the eye angle divided by the change in the head angle during the head turn. Under ideal conditions, the gain of the rotational VOR is 1.0, meaning there is a compensatory eye velocity equal to the head velocity and in the opposite direction. In case of a positive vHIT, the VOR gain is decreased and refixating saccades are observed. The video Head Impulse Test measures eye velocity during head rotation. Instant feedback about every single head impulse allows the examiner to apply a set of standardized graded impulses. The system is easy to use in a clinical setting, provides an objective measure of the VOR, and detects both overt and covert catch-up saccades in patients with vestibular loss. Measurements are quick and noninvasive, and the automated analysis software provides instant results.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Diagnosed with unilateral or bilateral vestibulopathy living independently in the community

排除标准

  • cognitive state decline neurological disorder disease or disorders that can affect balance

研究组 & 干预措施

control group

No Intervention

Patients in the control group will follow the doctor's instructions (medications and etc.) and will not participate in any physical therapy program.

PT treatment group for balance disorder

Experimental

Patients in this research group will join to a 3 months' physical therapy treatment group designed to improve balance. The service for the group is provided by laboratory.

干预措施: physical therapy program (group) (Other)

independant home computerized exercises

Experimental

Patients in this group will be treated by 3 months' independent home computerized exercise program. Each patient will receive a personal access code for the exercise program. The duration of each practice is 5-10 minutes per day.

干预措施: physical therapy program (computerized exercises) (Other)

结局指标

主要结局

Change from baseline saccadic eye movements after 3 and 6 months measured by The video head impulse test (vhit)

时间窗: up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy

The Vhit incorporates a new technology that uses a high speed light weight video goggle to measure high velocity and record "catch up" saccades in patients with impaired VOR function. we will examine the changes from baseline in the latency, frequency and duration of the overt and covert saccadic eye movements. In addition, we would like to examine changes over time in the ratio between the head and the eye movement (Gain).

次要结局

  • Change from baseline velocity sway at 3 and 6 months measured by force platform(up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy)
  • Changes from baseline in balance confidence at 3 and 6 months after vestibulopathy measured by the ABC questionnire(up to 7 days after acute vestibulopathy, after 3 and 6 months after acute vestibulopathy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmeli Eli

Prof.

University of Haifa

研究点 (2)

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