The Effect of Vestibular Rehabilitation Treatment (VRT) on Patients With Unsteadiness After Intratympanic Gentamicin in Meniere's Disease: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Functional Gait Assessment (FGA)
研究概览
简要总结
To investigate the efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease.
详细描述
Previous studies have generally focused on the efficacy of VRT for Meniere's disease, with little attention paid to the effect of VRT on MD patients who still have vestibular dysfunction even after intratympanic gentamicin treatment.
The aim of this study is to compare the efficacy of VRT with usual care in MD patients who experience persistence of unsteadiness 1 month after intratympanic gentamicin treatment, in order to understand whether VR has a positive impact on balance maintenance and vertigo control in MD patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 75 years old;
- •Complained of persistent unsteadiness 1 month after intratympanic gentamicin treatment;
- •Be willing to sign the informed consent of the study.
排除标准
- •Conformed to neuromuscular disease;
- •Conformed to severe cervical spine disease;
- •Conformed to congenital inner ear disease (except vestibular migraine(VM))
- •Concurrent manifestation of psychiatric or psychological disorders.
研究组 & 干预措施
Group A: usual care (UC)
Group A (UC) will receive conventional medications.
干预措施: Health Education (Other)
Group B: vestibular rehabilitation treatment (VRT)
Group B (VRT) will receive outpatient VRT in combination with home practice based on conventional treatment.
干预措施: vestibular rehabilitation (Behavioral)
Group A: usual care (UC)
Group A (UC) will receive conventional medications.
干预措施: Usual care (Drug)
结局指标
主要结局
Functional Gait Assessment (FGA)
时间窗: Change from baseline, at 8 weeks and 6 months post-randomization
FGA is a semi-quantitative measure of walking balance ability.
次要结局
- Vestibular Activities and Participation Measure (VAP)(Change from baseline, at 8 weeks and 6 months post-randomization)
- Sensory Organization Test (SOT)(Change from baseline, at 8 weeks and 6 months post-randomization)
- Visual Vertigo Analogue Scale (VVAS)(Change from baseline, at 8 weeks and 6 months post-randomization)
- Meniere's Disease Outcomes Questionnaire (MDOQ)(Change from baseline, at 8 weeks and 6 months post-randomization)