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临床试验/NCT05127694
NCT05127694已完成不适用

Comparison of the Efficacy of Medical Treatment and Vestibular Rehabilitation In Patients With Acute Benign Paroxysmal Positional Vertigo

Istanbul Medipol University Hospital2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2019年7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
30
试验地点
2
主要终点
Dynamic Visual Acuity

研究概览

简要总结

Benign paroxysmal positional vertigo (BPPV) is a vestibular disorder that manifests itself as a result of dizziness caused by the otoconia in the inner ear coming out of their places and circulating freely in the semicircular canals or by attaching to the cupula and sensitizing the cupula to head movements against gravity. The aim of the study is to compare the effectiveness of pharmacological treatment initiated by the physician and vestibular rehabilitation initiated by physiotherapist in patients with acute benign paroxysmal positional vertigo (BPPV). Thirty patients, aged 18-50 years, who applied to the Bağcılar Safa Hospital, were included in the study. The patients were divided into two groups, 15 pharmacological control group and 15 vestibular rehabilitation group. 8 patients in the pharmacological control group were given the drug containing betahistine by the physician, and 7 patients received the drug containing additional dimenhydrinate to the betahistine. In the rehabilitation group, exercises including head and eye movements and maneuvering were performed according to the direction of the canal after the exercise, and the patients were given a home exercise program. Treatment continued for 4 weeks. Visual Analogue Scale (VAS), dynamic visual acuity test, romberg, semitandem, tandem posture tests with a stopwatch, standing test on one leg with eyes open and closed, and unterberger tests were applied to patients before and after treatment.

研究设计

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

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

  • 18-50 years of age,
  • Positive Dix-Hallpike test result, and
  • No spontaneous nystagmus.

排除标准

  • Patients with Meniere's disease, vestibular neuritis, labyrinthitis, sudden sensory hearing loss, chronic otitis media, non-ambulatory patients, patients with vertigo due to central causes, and patients with cardiac complaints were excluded from the study.
  • In addition, patients with conditions contraindicated for canalith repositioning procedures (such as cervical spine stenosis, severe kyphoscoliosis, cervical radiculopathy, ankylosing spondylitis, severe lumbar dysfunction, and spinal injuries) were excluded from the vestibular rehabilitation group.

结局指标

主要结局

Dynamic Visual Acuity

时间窗: Four weeks

Dynamic visual acuity was evaluated using the Snellen chart. A person taking the test is seated in a chair 2 meters away from the Snellen chart and while the therapist shakes the patient's head from right to left, the patient is asked if he can see the letters of each line, starting from the top. The test is terminated on the line where the letter sequence cannot be seen clearly.

Perceptual Dizziness

时间窗: Four weeks

Perceived dizziness was assessed using the Visual Analog Scale (VAS). The patients stated the severity of their dizziness between 0-10 (0 being the mildest, 10 being unbearable).

Balance

时间窗: Four weeks

The balance of the patients was evaluated using the tandem, romberg, and one-leg standing test with eyes open and closed using a stopwatch. Individuals were expected to maintain their balance for 30 seconds.

Vestibular Dysfunction

时间窗: Four weeks

Vestibular Dysfunction was assessed with the Unterberger Test performed with the eyes closed. During the Unterberger test, the patient should marching where they are. If more than 45 degrees of deflection is detected, the test is positive.

次要结局

未报告次要终点

研究者

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

gorkem ata

Physiotherapist MSc, Lecturer

Medipol University

研究点 (2)

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