Effect of Peripheral Vestibular Pathology Location on the Ability of Home-based Virtual Reality to Improve Symptoms of Peripheral Vestibular Disorders
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
- Dizziness Handicap Inventory (DHI) score
研究概览
简要总结
This parallel-group randomized controlled trial aims to determine if the location of the lesion(s) in the vestibular system (unilateral versus bilateral, lateral semi-circular canal versus otolith) impacts the effectiveness of adjunct take-home head-mounted display (HMD) virtual reality (VR) therapy in improving patient symptomatology. Fifty patients meeting inclusion criteria will be recruited from the principal investigator's neurotology clinic. Baseline symptomatology questionnaires will be completed, followed by random allocation to virtual reality and control groups. Vestibular rehabilitation and virtual reality protocols will be adhered to for 4 to 8 weeks, followed by symptomatology questionnaires. Data analysis will be conducted to answer the study's objectives.
详细描述
Purpose:
To determine if the location of the peripheral vestibular lesion(s) impacts the efficacy of adjunct at-home head-mounted display virtual reality therapy to improve patient symptomatology 0-3 months after the intervention. Also to determine the adverse effects caused by at-home head-mounted display virtual reality therapy.
Justification:
Home-based head-mounted display virtual reality video game exercises utilize a virtual environment to encourage wearers to complete head movements that mimic vestibular rehabilitation exercises. This virtual reality intervention could act as a valuable adjunct to standard virtual reality therapy. However, current literature lacks information on how the location of peripheral vestibular pathology impacts the efficacy of HBVR vestibular rehabilitation. Adding this information to the field could further personalize vestibular rehabilitation to the patient. Our research study personnel, specialist clinic, and access to vestibular investigations positions us well to undertake this work.
Research Design:
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 (Care Provider)
盲法说明
The care provider(s) being masked to interventions assigned to participants in this clinical trial are the physiotherapists providing standard vestibular rehabilitation sessions to study participants. No other parties will be masked in this clinical trial.
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
- •Participants diagnosed with chronic (≥3 months) unilateral or bilateral peripheral vestibular disorders such as vestibular neuritis, labyrinthitis, Ramsay Hunt syndrome, ischemic lesion and trauma.
- •Diagnosis made using caloric testing (≥25% reduced vestibular response) and either ocular vestibular evoked myogenic potential (oVEMP) or cervical vestibular evoked myogenic potential (cVEMP) testing.
- •Participants prescribed vestibular rehabilitation
- •Participants ≥18 years of age
- •Access to an android or iOS smart phone
排除标准
- •Pregnant participants
- •Participant diagnosed with a central vestibular disorder
结局指标
主要结局
Dizziness Handicap Inventory (DHI) score
时间窗: Change from baseline DHI score at 2 weeks post-intervention will be recorded for each patient.
The Dizziness Handicap Inventory (DHI) score is a validated symptom index score created in 1990 that measures the functional, emotional and physical impacts of dizziness on the patient. This involves 25 questions which are answered as yes, sometimes or no. Yes response is 4 points, sometimes is 2 points and no is 0 points. The sum of these points are used to determine the severity of functional impairment. This severity is classified by the following ranges: mild 0-30, moderate 31-60 and severe 61-100.
次要结局
- Activities-specific Balance Confidence (ABC) score(This ABC score will be calculated 2 weeks before intervention and 2 weeks after intervention.)
研究者
Desmond A Nunez
Head, Division of Otolaryngology - Head and Neck Surgery, The University of British Columbia; Staff Otolaryngologist, Vancouver Hospital & Health Sciences Centre
University of British Columbia