Evaluation of the Effect of Bariatric Surgery on the Vestibular System in Obese Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Balance Performance Using Static Posturography
研究概览
简要总结
Previous studies have demonstrated that obesity negatively affects the human vestibular system. However, whether improvement in vestibular function occurs following the resolution of obesity remains an area requiring further investigation. Therefore, the investigators aimed to assess and analyze vestibular system functions in patients scheduled for bariatric surgery, both before the surgery, after the surgery, and following significant weight loss.
Participants aged between 18 and 60 years who meet the inclusion criteria will be enrolled in the study. Initially, participants will undergo medical history assessment and Body Mass Index (BMI) measurement. The enrolled participants will be evaluated using the following tests at three different time points-preoperatively, at the 1st month postoperatively, and at the 6th month postoperatively: Video Head Impulse Test (vHIT), static posturography test, Berg Balance Scale, SF-12 Quality of Life Scale, and the Activity-specific Balance Confidence (ABC) Scale.
Although obesity has been shown to be associated with impaired postural balance, studies evaluating the direct effect of BMI on postural sway are limited. The aim of our study is to assess the vestibular system in obese patients before and after bariatric surgery. Through this, the investigators hope to contribute to the literature by providing balance assessments in individuals with obesity
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •The native language must be Turkish
- •The participant must be between the ages of 18-60
- •The participant must be suitable for bariatric surgery (BMI ≥40 kg/m2)
- •Not have any previous vestibular diagnosis
- •Not have any problems such as joints, muscles, or walking
排除标准
- •Individuals with additional disabilities, neurological problems, vestibulopathy, joint, muscle or walking disorders will not be included in the study.
结局指标
主要结局
Change in Balance Performance Using Static Posturography
时间窗: 12 months
Objective measurement of postural sway and stability using a force platform system under various sensory conditions.
Change in Vestibular Function as Measured by Video Head Impulse Test (vHIT)
时间窗: 12 months
The vHIT assesses semicircular canal function by recording eye movements in response to brief, passive head rotations.
次要结局
- Change in Functional Balance Measured by Berg Balance Scale (BBS)(12 months)
- Change in Quality of Life as Measured by the SF-12 Health Survey(12 months)
- Change in Balance Confidence Measured by the Activity-specific Balance Confidence (ABC) Scale(12 months)
研究者
Yusuf Emre ALTUNDAL
Assistant Professor
Istanbul Aydın University