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临床试验/NCT01231009
NCT01231009Unknown早期 1 期

The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis: a Prospective Randomized Controlled Clinical Trial

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
40
试验地点
1
主要终点
clinical recovery of vestibular function

研究概览

简要总结

Aim of present study is to determine whether corticosteroids and vestibular exercises are equal effective in the recovery of balance in patients with acute vestibular neuritis.

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 (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with history of acute or sub-acute rotatory vertigo with postural imbalance, nausea and imbalance.
  • Horizontal-rotatory spontaneous nystagmus.

排除标准

  • History of vestibular disfunction before the acute onset of symptoms
  • Simultaneous Hearing loss
  • Neurologic disorder
  • Pregnancy or lactation
  • History of psychiatric disorders
  • History of glaucoma
  • Hypertension
  • Contraindication in receiving corticosteroids

研究组 & 干预措施

Corticosteroids

Active Comparator

Patients receive for 7 days intravenous corticosteroids, dexamethasone, and they continue receiving for 7 days corticosteroids per os

干预措施: Corticosteroids (Drug)

Corticosteroids

Active Comparator

Patients receive for 7 days intravenous corticosteroids, dexamethasone, and they continue receiving for 7 days corticosteroids per os

干预措施: Vestibular exercises (Other)

Vestibular exercises

Placebo Comparator

Patients perform for 15 days certain vestibular exercises under suspicion of an expert physiotherapist

干预措施: Corticosteroids (Drug)

Vestibular exercises

Placebo Comparator

Patients perform for 15 days certain vestibular exercises under suspicion of an expert physiotherapist

干预措施: Vestibular exercises (Other)

结局指标

主要结局

clinical recovery of vestibular function

时间窗: 1 year

clinical examination (nystagmus, Romberg test, head-thrust test, head-shaking test) and questionnaires (Greek edition of Dizziness Handicap Inventory and European Evaluation of Vertigo Scale)

Laboratory recovery of vestibular

时间窗: 1 year

caloric test and vestibular evoked myogenic potentials

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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