Smartphone-based Utility of the Vestibulo-ocular Reflex: a Pilot Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Accuracy of mVOR mHealth application system in assessing gaze stability
研究概览
简要总结
The goal of this observational study is to evaluate whether a novel smartphone-based (mHealth) application can accurately assess gaze stability and vestibulo-ocular reflex (VOR) function in adults with vestibular dysfunction. This pilot clinical ststudy includes adult participants with and without unilateral peripheral vestibular dysfunction to determine the feasibility of a mobile-based assessment of gaze stabilization.
The main questions it aims to answer are:
- Can a prototype mHealth application accurately measure outcomes associated with standard dynamic gaze stabilization tests (e.g., static visual acuity, perception time, and maximal head velocity measurements)?
- How well does a prototype mHealth application identify patients with unilateral peripheral vestibular dysfunction when compared to healthy volunteers?
- Does a prototype mHealth application differ in identifying patients with unilateral peripheral vestibular dysfunction when compared to a commercially-available computer system that uses a gold-standard head-mounted sensor for gaze stabilization testing (GST)?
Participants will:
Perform the well-established GST protocol using a commercially-available computer system that uses a gold-standard head-mounted sensor Perform the well-established GST protocol a novel mHealth application
The following outcomes will be measured:
- Standard visual acuity (SVA): The smallest readable target based on the user's best-aided vision
- A perception time test (PTT): The shortest time a target can be accurately identified
- A dynamic gaze stability test (GST): The maximal head velocity at which a patient can accurately identify the orientation of a presented visual target
This pilot clinical study will provide evidence to further support the use of mobile technology as a low-cost, accessible alternative for vestibular function assessment, particularly for patients in resource-limited settings.
详细描述
Background & Rationale Vestibular dysfunction is a common condition affecting over a third of U.S. adults over the age of 40. It significantly increases the risk of falls, especially in those experiencing dizziness, where the odds of falling are increased 12-fold. Current best practices recommend vestibular rehabilitation, which includes gaze stability exercises designed to improve balance and reduce fall risk. However, many individuals, particularly those relying on home-based therapy or telehealth, face challenges in accessing objective assessments of their vestibulo-ocular reflex (VOR) contribution to gaze stabilization.
As telehealth has expanded rapidly in response to the COVID-19 pandemic, there is an increasing need for remote, real-time VOR teleassessments that can provide clinicians and patients with quantifiable, velocity-specific gaze stability data. While some computer-based remote VOR assessment tools exist, they often suffer from limitations in user satisfaction and accuracy. The Gaze Stabilization Test (GST), developed by Goebel et al., provides clinicians with velocity-specific data associated with the VOR's contribution to gaze stabilization. However, this test is typically performed in a clinical setting with specialized equipment, limiting access for many patients.
This pilot clinical study aims to validate a mHealth application (mVOR) prototype as a low-cost, accessible alternative to traditional VOR assessments. By leveraging the head- and eye-tracking capabilities of modern smartphones, this proof-of-concept prototype seeks to provide a novel, mobile-based framework for measuring visual acuity, head velocity, and gaze estimation in patients undergoing vestibular rehabilitation.
Study Objectives & Hypothesis
Primary Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years or older
- •Able to provide informed consent
- •Normal or corrected-to-normal vision (e.g., with glasses or contact lenses)
- •Able to sit upright and follow instructions for the duration of the test (~2-3 hours)
- •No known contraindications to head movement (e.g., musculoskeletal or neurological conditions that prevent safe head rotation)
- •For vestibular dysfunction group: Participants must have a diagnosed vestibular disorder (e.g., vestibular hypofunction, vestibular neuritis, Meniere's disease, labyrinthitis, vestibular migraine, or post-concussive dizziness)
- •For control group: Participants must be free from diagnosed vestibular disorders and report no history of balance issues, dizziness, or vertigo
排除标准
- •Severe visual impairment that cannot be corrected with glasses or contact lenses
- •Cognitive impairment or neurological conditions that could interfere with following instructions (e.g., moderate to severe dementia, uncontrolled seizures, severe traumatic brain injury)
- •Severe musculoskeletal or orthopedic conditions affecting the neck or cervical spine that prevent safe head movement (e.g., cervical fusion, severe arthritis, neck instability)
- •Acute illness or infection at the time of testing (e.g., flu, COVID-19, severe sinus infection that may impact vestibular function)
- •Recent vestibular or neurological surgery (<6 months prior to study participation)
- •Severe hearing loss that prevents understanding spoken instructions
- •History of stroke or progressive neurological disorders affecting balance or gaze stability (e.g., Parkinson's disease, multiple sclerosis, ALS)
- •Use of vestibular suppressants (e.g., meclizine, diazepam, scopolamine) within 24 hours of testing
结局指标
主要结局
Accuracy of mVOR mHealth application system in assessing gaze stability
时间窗: Immediately after testing (single session, approximately 2-3 hour per participant)
The mVOR application is expected to be able to distinguish the direction and peak velocity of head rotation as well as the consistency of gaze fixation. The primary outcome measure for this system is the "GST score", which is recorded as the maximum head velocity (in degrees/s) while maintaining visual acuity, a measure of gaze stabilization or dynamic visual. This clinical measure of vestibular function will be compared to a commercially available, in-office system (Bertex, Inc) that utilizes the GST protocol and a head-mounted sensory and is often used in Dizziness and Balance Centers around the world for vestibular rehabilitation. Primary variable analysis will include standard descriptive statistics and within-group and between in-group (UVD vs healthy volunteer) pairwise comparisons. ROC and AUC curves will be generated to evaluate the sensitivity and specificity of the mVOR application in distinguishing vestibular dysfunction from healthy controls.
次要结局
- Assessment of static visual acuity(Immediately during (2-3 hours) and following testing)
- Assessment of visual perception time(Immediately during (2-3 hours) and following testing)
研究者
Bradley Kesser, MD
Department Vice-Chair
University of Virginia