跳至主要内容
临床试验/NCT04280302
NCT04280302Unknown不适用

Realitat Virtual Com a Tractament Coadjuvant en rehabilitació Vestibular

Universitat Pompeu Fabra2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Change pre-post treatment in the Dizziness handicap inventory (DHI) (0-100)

研究概览

简要总结

Vertigo / dizziness, imbalance and other symptoms related to vestibular pathology have a life prevalence of 7.4%. Peripheral and unilateral vestibulopathy are among the most common types, and in some patients the symptoms become chronic and disabling, which makes it difficult for them to lead a normal life and has a significant socio-economic impact. In recent years, the effect of vestibular rehabilitation with virtual reality has been studied and positive results have been obtained when compared with traditional rehabilitation, but despite rehabilitation there is patients who are still chronic, and the reasons for this prognostic variability are still unknown and require further treatment. Virtual reality-based stimulation can play a significant role as an adjunct to conventional vestibular rehabilitation, improving its effectiveness.

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
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

  • Unilateral vestibular deficit
  • Vestibular neuritis
  • Sudden hearing loss with vestibular involvement
  • Labyrinthitis
  • Ménière's disease
  • Vestibular Shwannoma
  • Benign paroxysmal positional vertigo
  • Vestibular symptoms (vertigo, dizziness, imbalance, gait instability, kinosis and / or oscillopsy) chronic (more than 6 weeks of evolution)
  • Over 18 years old

排除标准

  • Failure to meet some of the inclusion criteria
  • Neurological, traumatological, rheumatological, ophthalmological or systemic pathology that may interfere with the balance
  • Inability to understand participation in the study
  • Non-acceptance to participate in the study

结局指标

主要结局

Change pre-post treatment in the Dizziness handicap inventory (DHI) (0-100)

时间窗: 4 weeks

Change within subjects from baseline to the end of week 4

次要结局

  • Change pre-post treatment in Tinneti Test (1-28)(4 weeks)
  • Change pre-post treatment in Berg Scale (0-56)(4 weeks)
  • Change pre-post treatment in the SF 12 Test (0-100)(4 weeks)
  • Change pre-post treatment in Posturography (Wii+software RombergLab)(4 weeks)
  • Change pre-post treatment in Test up and go (TUG)(4 weeks)
  • Change pre-post treatment in the Barthel Index (0-100)(4 weeks)
  • Change pre-post treatment in Simulator Sickness Questionnaire (SSQ) (0-14)(4 weeks)
  • Change pre-post treatment in the Video-head impulse test (vHIT)(4 weeks)

研究者

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

Paul Verschure

PhD

Universitat Pompeu Fabra

研究点 (2)

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