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临床试验/NCT06332326
NCT06332326已完成不适用

Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients

Medipol University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2021年10月15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
40
试验地点
2
主要终点
Unterberger test

研究概览

简要总结

The purpose of this study: To investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with Unilateral Vestibular Hypofunction (UVH).

详细描述

It was planned to include 40 patients diagnosed with UHV in the study. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation).

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • He learned about unilateral peripheral vestibular hypofunction with videonystagmography
  • Being able to communicate well

排除标准

  • Having cognitive impairment
  • Presence of central neurological disease
  • Lack of cooperation
  • Previous ear surgery
  • Accompanied by Benign Proxysmal Positional Vertigo
  • Having acute Meniere's disease
  • Finding pathology in temporal bone MRI
  • Having a lower extremity disorder that prevents walking
  • Evidence of central pathology in videonystagmography results

结局指标

主要结局

Unterberger test

时间窗: 5 minutes

Unterberger test: The patient first takes 10 steps quickly with his eyes open, then With his eyes closed, he takes 50 steps quickly in place. If there is a lesion, apply it to the side of the lesion. correct deviation occurs.

Semitandem test

时间窗: 10 minutes

semitandem stance positions; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.

tandem test

时间窗: 10 minutes

tandem semitandem stance positions; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.

one-leg standing test

时间窗: 10 minutes

one-leg standing test; The conditions (sec) of remaining in balance with eyes open and closed on hard and soft surfaces will be measured.

Dynamic visual acuity test

时间窗: 5 minutes

Dynamic visual acuity test; It measures the ability to see an object during rapid head movements.

Modified-CTSIB

时间窗: 30 minutes

Modified-CTSIB; It is generally used as a semi-quantitative test measurement and clinical practice in which points are scored based on the ability to perform various standing static positions It is a test. It covers different situations where the patient must stand under different conditions: foam surface versus hard floor, tested with eyes open and closed in six different test groups.

VAS Visual Analogue Scale (dizziness severity)

时间窗: 5 minutes

Visual Analogue Scale will be applied to evaluate dizziness severity and patient satisfaction. With this scale, scoring from 0 to 10 is requested. While 0 indicates the lowest dizziness severity and lowest patient satisfaction, 10 indicates the highest dizziness severity and highest patient satisfaction.

次要结局

  • Tampa Kinesiophobia Scale(5 minutes)
  • Hospital Anxiety and Depression Scale (HAD)(5 minutes)
  • Dizziness Handicap Inventory Scale(5 minutes)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tugba Turk Kalkan

principal investigator

Medipol University

研究点 (2)

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