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临床试验/NCT07606196
NCT07606196已完成不适用

The Effect and Rehabilitation of Otolith Dysfunction in Vestibular Diseases: A Randomized Comparison of Cawthorne-Cooksey Exercises, 2D Visual Habituation, and 3D/Virtual Reality Visual Habituation

Medipol University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1

研究概览

简要总结

This randomized controlled study compared the clinical and electrophysiological effectiveness of three vestibular rehabilitation approaches in patients with unilateral peripheral vestibular disease accompanied by otolith dysfunction: (1) traditional Cawthorne-Cooksey exercises (CCE), (2) two-dimensional (2D) otolith-targeted visual habituation, and (3) three-dimensional/virtual reality (3D/VR) otolith-targeted visual habituation. Forty-five patients aged 18-60 years were randomized into three groups and followed for 6 weeks. The Dizziness Handicap Inventory (DHI) was used as the primary clinical outcome, and cervical and ocular Vestibular Evoked Myogenic Potentials (cVEMP and oVEMP) were used as objective electrophysiological measures. Patients were monitored remotely using the Moodle learning management system.

详细描述

Vestibular rehabilitation is a cornerstone of management in peripheral vestibular hypofunction. While conventional protocols such as the Cawthorne-Cooksey exercises focus largely on vestibulo-ocular reflex adaptation, otolith organs (utricle and saccule) are often underaddressed despite their critical role in spatial orientation and postural stability. Visual habituation protocols delivering wide-field optokinetic stimuli in the horizontal and vertical planes may target otolith-related symptoms more directly.

In this trial, 45 patients with chronic unilateral peripheral vestibular hypofunction (>3 months post-attack) and VEMP asymmetry >40% were randomized into three groups: CCE (n=16), 2D visual habituation (n=13), and 3D/VR visual habituation (n=16). Each group performed assigned exercises three times daily for 6 weeks, supported by the Moodle e-learning platform. Outcomes were assessed pre- and post-intervention using DHI and cVEMP/oVEMP latency, amplitude, and interaural asymmetry ratio (IAR).

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed unilateral peripheral vestibular disease No identified hearing loss (symmetric hearing) VEMP interaural asymmetry >40% At least 3 months post-acute attack (chronic phase) No ocular disorders No cervical/physical problems No history of psychological or neurological disorders No regular use of alcohol or vestibular suppressant medications Non-fluctuating vestibular symptoms

排除标准

  • Additional balance disorder pathology beyond unilateral peripheral vestibular disease BPPV repositioning maneuver within the last 30 days Asymmetric or moderate-to-severe hearing loss Motion sickness Active BPPV symptoms in history

研究者

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

Şeyma Tuğba Öztürk

PhD Candidate / Principal Investigator

Medipol University

研究点 (1)

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