The Efficacy of Vestibular Rehabilitation Exercises and General Fitness Training pn Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Vertigo Symptom Scale (VSS) Scores from Baseline to 8 Weeks
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of Vestibular Rehabilitation Exercises (VRE) and General Fitness Training (GFT) in adults diagnosed with vestibular disorders. The main questions it aims to answer are:
Does VRE lead to better improvements in gaze stabilization, balance, and gait than GFT? Does GFT lead to more improvements in overall fitness than VRE? Participants will be randomly assigned to either the VRE or GFT group and will participate in 60-minute exercise sessions twice weekly for 8 weeks. Researchers will compare the improvements in the two groups to see which intervention is more effective.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 18 - 60 years.
- •Diagnosis of a vestibular disorder confirmed by a healthcare professional.
- •Able to walk unassisted for at least 10 meters.
- •Able to understand and comply with the procedures of this study.
- •Willing to provide informed consent.
排除标准
- •Severe cardiovascular, respiratory, or metabolic disease that contraindicates physical exercise.
- •Neuromuscular disorders that may affect balance and mobility other than the diagnosed vestibular disorder.
- •History of orthopedic surgery within the past 6 months.
- •Currently participating in another interventional clinical trial.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Change in Vertigo Symptom Scale (VSS) Scores from Baseline to 8 Weeks
时间窗: Changes between Baseline and 8 weeks
This outcome is the difference in scores on the Vertigo Symptom Scale (VSS), a validated vestibular symptom questionnaire, from baseline to 8 weeks. The VSS has two components: a vertigo/balance scale, with a score range of 0-36, and an autonomic/anxiety scale, with a score range of 0-28. Higher scores on both scales indicate more severe symptoms.
Change in Biodex Balance System Scores from Baseline to 8 Weeks
时间窗: Baseline and 8 weeks
This outcome is the difference in scores on the Biodex Balance System, a validated tool for balance assessment, from baseline to 8 weeks. The Biodex Balance System assesses participants' ability to maintain postural control through a variety of tests, including the Stability Index, Fall Risk Test, and Postural Stability Test. Lower scores on the Stability Index indicate better balance, while lower scores on the Fall Risk and Postural Stability tests indicate lower risk of falling and better postural stability, respectively.
次要结局
- Change in Flexibility Test Scores from Baseline to 8 Weeks(Baseline and 8 weeks)
- Change in Six-Minute Walk Test (6MWT) Distance from Baseline to 8 Weeks(Baseline and 8 weeks)
研究者
Mohamed Magdy ElMeligie
Lecturer of Physical Therapy and Director of Electromyography Lab
Ahram Canadian University