Evaluation of Virtual Reality Assisted Therapy as an Adjunct to Conventional Vestibular Rehabilitation Therapy for Chronic Vestibular Hypofunction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient reported outcome measures: Dizziness Handicap Inventory (DHI), Activities-specific Balance Confidence Scale (ABC), Vestibular Rehabilitation Benefit Questionnaire (VRBQ), Visual Vertigo Analogue Scale (VVAS)
研究概览
简要总结
The primary purpose of this study is to evaluate the effectiveness of Virtual Reality Assisted Therapy (VRAT) as an adjunct to Conventional Vestibular Rehabilitation Therapy (VRT) in patients with chronic vestibular hypofunction. The study aims to assess whether the addition of VRAT can enhance treatment outcomes, improve patient compliance, and ultimately lead to a significant improvement in symptoms and quality of life compared to VRT alone. The hypothesis of this study is that the combination of VRAT and VRT will be more effective in reducing symptoms of chronic vestibular hypofunction and improving patient-reported outcomes than VRT alone. Specifically, it is expected that patients receiving both VRAT and VRT will show greater improvements in objective vestibular assessments and patient-reported outcome measures (PROMs) compared to those undergoing conventional VRT alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Chronic vestibular hypofunction: Duration of vestibular symptoms of 3 months or more 2.Definitive diagnosis of chronic vestibular hypofunction based reduced VOR function documented on one / more of following: a.
- •VOR gain less than 0.6 on video head impulse test b.
- •reduced angular VOR gain (less than 0.1) on sinusoidal acceleration on rotary chair testing (0.16Hz), Vmax 50 degrees/second and phase lead more than 68 degrees, time constant less than 5 seconds c.
- •reduced caloric response, sum of bithermal maximum peak SPV on each side less than 6 degrees/ second, % canal paresis as per Jonkees formula 20% or more.
排除标准
- •Use of vestibular suppressants in last 72 hours.
- •Diseases with fluctuating vestibulopathy e.g. Meniere’s Disease
- •Already diagnosed clinical psychiatric conditions/ neurodegenerative/ neuromuscular/ musculoskeletal/ motor disorders/ peripheral neuropathy/ arthropathy in lower extremities/ uncorrected ocular disorders that will interfere with performance of rehabilitation exercises
- •Significant medical disorders e.g. severe anaemia, uncontrolled hypertension, cardiorespiratory disorders, epilepsy, vertebro-basilar insufficiency, cervical spondylosis, etc.
- •that may be aggravated by exercises.
- •Pregnant females
- •Inability to follow-up.
结局指标
主要结局
Patient reported outcome measures: Dizziness Handicap Inventory (DHI), Activities-specific Balance Confidence Scale (ABC), Vestibular Rehabilitation Benefit Questionnaire (VRBQ), Visual Vertigo Analogue Scale (VVAS)
时间窗: 1. Baseline assessment (at presentation) | 2. At 6 weeks (at completion of intervention) | 3. At 12 weeks (6 weeks post completion of intervention) | 4. At 18 weeks (12 weeks post completion of intervention)
Clinical assessment tools: Berg Balance Scale, Dynamic Gait Index, Timed up and Go (TUG) test
时间窗: 1. Baseline assessment (at presentation) | 2. At 6 weeks (at completion of intervention) | 3. At 12 weeks (6 weeks post completion of intervention) | 4. At 18 weeks (12 weeks post completion of intervention)
Objective vestibular testing: Video Head Impulse Test, Rotary chair testing, Bithermal Caloric test, Computerized Dynamic Posturography, Craniocorporography
时间窗: 1. Baseline assessment (at presentation) | 2. At 6 weeks (at completion of intervention) | 3. At 12 weeks (6 weeks post completion of intervention) | 4. At 18 weeks (12 weeks post completion of intervention)
次要结局
未报告次要终点
研究者
Dr Garima Upreti
All India Institute of Medical Sciences-Rajkot