跳至主要内容
临床试验/NCT05002374
NCT05002374招募中不适用

Application of Vestibular Rehabilitation Incorporated With Optokinetic Stimulation in Virtual Reality Environment in Patients With Peripheral Vestibular Dysfunction

National Cheng Kung University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Postural stability

研究概览

简要总结

Background Patients with peripheral vestibular dysfunction often complain of dizziness, blurred vision, imbalance and etc. Vestibular rehabilitation although has been proved to be an efficient method to improve the symptoms, the optimal treatment type, intensity and frequency is still unclear. Base on the mechanisms of vestibular rehabilitation, vestibular adaptation, substitution, and habituation, repeated practice and exposure to symptom-provoked movement could improve the symptoms. However, the symptom-provoked movement generated by only head and eye movement might not create sufficient threshold to induce vestibulo-ocular reflex adaptation. Practicing vestibular exercises in the same environment might be difficult for the patients to transfer learned ability to the real world environment. Therefore, optokinetic stimulation could potentially provide stronger visual-vestibular mismatch, and when combining with a virtual reality system could also simulate real world environment. Furthermore, an intensive training protocol on a daily basis might possibly promote the mechanisms of vestibular rehabilitation to enhance recovery from peripheral vestibular lesions. The purpose of this study is to investigate the efficacy of an intense vestibular rehabilitation programme incorporated with optokinetic stimulation in virtual reality environment on both subjective and objective symptoms in patients with peripheral vestibular dysfunction in the short and long term.

Methods This study will be an assessor-blind randomised controlled trial. Patients diagnosed as peripheral vestibular dysfunction aged between 20-80 years will be recruited and randomly allocated into two groups: vestibular rehabilitation incorporated with optokinetic stimulation in virtual reality (Group OKN) and vestibular rehabilitation only (Group C). Group C will receive customised vestibular rehabilitation, while Group OKN will receive the same exercise programme as Group C plus optokinetic stimulation provided in virtual environment. Both groups will receive vestibular rehabilitation intensively for five consecutive days with a trained physiotherapist, following with daily home exercise for two months. Self-perceived symptoms, spatial orientation, postural control and gait performance will be assessed prior to treatment (baseline), at the end of the five-day treatment, at four and eight weeks following the five-day training.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed as peripheral vestibular dysfunction with bithermal caloric irrigation
  • having one or more of the following subjective complains for longer than four weeks: vertigo/dizziness, disequilibrium, gait instability or motion sensitivity

排除标准

  • central nervous system involvement
  • active or poorly controlled migraine (more than one severe migraine a month)
  • fluctuating symptoms e.g. Meniere's disease
  • active benign paroxysmal positional vertigo (BPPV)
  • have previous vestibular rehabilitation
  • inability to attend sessions
  • other medical conditions in the acute phase e.g. orthopaedic injury

结局指标

主要结局

Postural stability

时间窗: At eight weeks after the treatment

Standing postural stability under various conditions measured by a force platform

Subjective visual vertical test

时间窗: At eight weeks after the treatment

This test is to assess a person's perception of verticality. In this test, the subject is instructed to align a tilted illuminated line to self-perceived verticality in a completely darkened room. Differences between the subject's adjusted orientation and true spatial vertical are calculated as the subjective visual vertical.

次要结局

  • The vestibular disorders activities of daily living scale(Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment)
  • The hospital anxiety and depression scale(Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment)
  • Gait performance(Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment)
  • The dizziness handicap inventory(Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment)

研究者

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

Pei-Yun Lee

Assistant professor

National Cheng Kung University

研究点 (2)

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