Comparison of Treatment Efficacy of Automated Robotic Maneuvering System (RMS) Reposition Chair Versus Traditional Manual Repositioning Maneuvers in Benign Paroxysmal Positional Vertigo (BPPV)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Treatment success
研究概览
简要总结
Comparison of treatment efficacy of an automated robotic maneuvering system (RMS) repositioning chair versus manual positioning maneuvers in Benign Paroxysmal Positional Vertigo.
详细描述
The standard treatments for Benign Paroxysmal Positional Vertigo (BPPV) are manual positioning maneuvers. This method, beyond being costly and requiring extensive training, is a significant burden on healthcare resources. We developed an automated robotic maneuvering system, hereby known as RMS, to tackle this problem. Our Clinical Investigation is two-fold; (1) test the safety of RMS and, (2) understand the viability of RMS for treating BPPV when compared to manual positioning maneuvers.
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
- Double (Participant, Care Provider)
盲法说明
Every enrolled patients records were randomized, and based on the outcome, subjects were either assigned to control or experimental arm groups. A report detailing the outcome, but omitting the method of treatment, was given to patients and their care provider.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Characteristic positional nystagmus (for BPPV)
- •Positive Dix-Hallpike
- •Positive supine roll test
- •Positive Deep Head Hanging
- •Vertigo-Dizziness Imbalance symptom scores compatible with BPPV
排除标准
- •Pregnant patients
- •Patients who have taken vertigo suppressing agents (Dimenhydrinate) in the last 48 hours
- •Patients taller than 200 cm (2.0 m)
- •Patients who have had a cardiovascular or neurosurgical operation in the last month
- •Patients with retinal detachment and/or glaucoma
- •Lack of treatment cooperation
研究组 & 干预措施
Robotic Maneuvering System (RMS)
BPPV subtype diagnosis and corresponding treatment will be performed using automated RMS chair and recorded with video frenzel goggle.
In cases of posterior canal involvement, Epley's maneuver will be used for canalithiasis and cupulolithiasis. Semont maneuver will be used as a second-line treatment for cupulolithiasis, in cases of initial failure.
In cases of horizontal canal involvement, Barbecue (Lempert) maneuver will be used. If canalithiasis or cupulolithiasis is diagnosed, Gufoni's maneuver will be performed.
In cases of anterior canal involvement, Yacovino's maneuver will be used.
干预措施: Automated vertigo repositioning chair (Device)
Canalith Reposition Maneuver
BPPV subtype diagnosis and corresponding treatment will be performed with manual repositioning maneuvers and recorded with video frenzel goggle.
In cases of posterior canal involvement, Epley's maneuver will be used. In cases of horizontal canal involvement, Log roll maneuver will be used. In cases of anterior canal involvement, Yacovino's maneuver will be used.
干预措施: Canalith Reposition Maneuver (Other)
结局指标
主要结局
Treatment success
时间窗: After treatment: 1 week - 1 month (30 days)
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Number of Treatments
时间窗: 1 month (30 days)
Number of treatment necessary to achieve resolution of vertigo and nystagmus
次要结局
- Vertigo-Dizziness Imbalance (VDI) questionnaire(1 month (30 days))
- Adverse events(1 month (30 days))
研究者
Murat Haluk Ozkul
Chief Medical Officer (CMO)
Stratejik Yenilikci Girisimler Ltd.