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临床试验/NCT07318142
NCT07318142已完成不适用

Evaluation of the Effectiveness of Vestibular Rehabilitation With Virtual Reality Systems in Individuals With Visually Induced Motion Sickness

Istanbul Aydın University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年6月21日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Simulator Sickness Questionnaire (SSQ) Total Score Unit of Measure: points (0-42; higher scores indicate worse symptoms) Time Frame: Baseline and 4 weeks

研究概览

简要总结

In recent years, rapidly advancing virtual reality (VR) technology has been widely used in many fields, from education to health and from entertainment to therapeutic applications, by creating interactive and highly immersive digital environments. However, the increasing use of VR systems has also been associated with physiological side effects. One of these is Visually Induced Motion Sickness (VIMS), a syndrome characterized by symptoms such as eye strain, fatigue, dizziness, headache, and nausea, especially when individuals experience a sense of motion in virtual environments despite physical immobility. VIMS is thought to occur due to sensory conflicts among the visual, vestibular, and motor systems, and its severity may vary depending on individual factors and the intensity of the visual motion cues.

The aim of this study is to evaluate the effect of a VR-based vestibular rehabilitation program on symptoms associated with VIMS. The VR stimuli consist of real travel videos available on the YouTube VR platform. To enhance familiarity and the sense of presence, 360° videos depicting scenes from Istanbul, Turkey were selected and categorized based on difficulty level.

The study includes two groups: a control group of healthy individuals and an experimental group of individuals diagnosed with VIMS. All participants undergo baseline assessments. The experimental group receives a VR-based vestibular rehabilitation program for 4 weeks, delivered twice per week, with each session lasting 30 minutes. The intervention uses a VR headset and consists of progressively challenging visual motion stimuli.

The effectiveness of the intervention will be evaluated using both subjective and objective outcome measures, including the Simulator Sickness Questionnaire (SSQ), visual analog scale (VAS) symptom ratings, and static posturography assessments (Balance Screening and Limits of Stability - Reaction Time). Pre- and post-intervention assessments will be compared within and between groups to determine the impact of the rehabilitation program.

This study is designed to contribute to the understanding of VR-based vestibular rehabilitation approaches and to support the development of safer and more effective VR applications.

详细描述

This prospective single-arm interventional study was designed to evaluate the effects of a virtual reality (VR)-based rehabilitation program in individuals with visually induced motion sickness (VIMS). Following baseline assessment, participants underwent a structured VR rehabilitation protocol over a four-week period.

The intervention consisted of eight supervised sessions, conducted twice weekly, with each session lasting approximately 30 minutes. VR exposure was delivered using a head-mounted display and included visually complex motion stimuli aimed at gradually increasing visual-vestibular tolerance. The difficulty and visual motion intensity were progressed based on participant tolerance throughout the program.

Outcome assessments were performed at baseline and after completion of the intervention period. Postural control was objectively evaluated using static posturography, and symptom severity was monitored using validated subjective assessment tools.

This design allowed for within-subject comparison of pre- and post-intervention outcomes to examine the potential effectiveness of VR-based rehabilitation in reducing VIMS-related symptoms and improving postural stability.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • General Inclusion Criteria (n = 46)
  • Aged between 18 and 30 years
  • No history of otologic surgery
  • No history of orthopedic surgery related to the lower extremities
  • No claustrophobia
  • Female participants not in menstrual or premenstrual periods
  • No diagnosed neurological disorders/diseases (e.g., MS, epilepsy, cerebrovascular accident, etc.)
  • No diagnosed peripheral vestibular pathologies such as Meniere's disease, BPPV, or vestibular neuritis (participants' lack of peripheral vestibular pathology confirmed by audiovestibular vHIT testing)
  • No spontaneous nystagmus
  • Study Group (21.8 ± 2.9 years, n = 23) Inclusion Criteria
  • VIMSSQ Questionnaire:
  • Participants answered "occasionally" or "frequently" to Question 2
  • Control Group (23.7 ± 3.3 years, n = 23) Inclusion Criteria
  • GUHHYSA Questionnaire:
  • Participants answered "never" to Question 2

排除标准

  • History of otologic surgery
  • History of orthopedic surgery in the lower extremities
  • Presence of claustrophobia
  • Female participants in menstrual or premenstrual periods
  • Diagnosed neurological disorders/diseases (e.g., MS, epilepsy, cerebrovascular accident, etc.)
  • Diagnosed peripheral vestibular pathologies such as Meniere's disease, BPPV, or vestibular neuritis (as confirmed by audiovestibular vHIT testing)
  • Presence of spontaneous nystagmus
  • Participants who did not sign the informed consent form

研究组 & 干预措施

Virtual Reality-Based Vestibular Rehabilitation

Experimental

The study group consisted of individuals with visually induced motion sickness (VIMS). Participants underwent a four-week virtual reality-based rehabilitation program consisting of eight sessions (30 minutes per session). The effects of VR exposure were assessed using posturography.

干预措施: The effects of virtual reality exposure were assessed using posturography. (Other)

结局指标

主要结局

Simulator Sickness Questionnaire (SSQ) Total Score Unit of Measure: points (0-42; higher scores indicate worse symptoms) Time Frame: Baseline and 4 weeks

时间窗: Time Frame: Baseline and 4 weeks

Assessment of VIMS-related symptoms using the Simulator Sickness Questionnaire.

次要结局

  • Visual Analog Scale (VAS) Symptom Score(Time Frame: Baseline and 4 weeks)

研究者

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

Rukiye Tanisir Disci

Research Assistant

Istanbul Aydın University

研究点 (1)

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