Assessment of Perceptual and Postural Performances Following a Cochlear Implantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline in postural perception of the gravitational vertical
研究概览
简要总结
The cochlear implant is an electrical hearing aid that restores the perception of surrounding sounds and speech intelligibility in profoundly deaf patients. During surgery, the labyrinthine break necessary for insertion into the cochlea of the implantable part may cause a malfunction of the vestibular system which can induce dizziness, balance and perception (of the gravitational vertical) disorders. Vestibular compensation and new sonic interactions could alter the balance control and the visual and postural spatial orientation perceptions.
The usual treatment includes the monitoring of the patient's quality of life, of the vestibular function and of hearing. This study adds an assessment of spatial orientation and of posture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Profound deaf patients who are scheduled for a cochlear implantation
- •Patients gave their written informed consent
- •Patients are affiliated to the french social welfare
排除标准
- •Disorders from the motor and/or somesthetic systems (especially the lower limbs)
- •Contraindications to the scheduled functional assessments
结局指标
主要结局
Change from baseline in postural perception of the gravitational vertical
时间窗: One year
The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery). The measure is the average difference between the gravitational vertical and the tilt of the platform (in degree) over 20 trials.
次要结局
- Change from baseline in dynamic balance control(One year)
- Change from baseline in vestibular function(One year)
- Change from baseline in dizziness(One year)
- Change from baseline in quiet standing within a specific sound environment(One year)
- Change from baseline in speech recognition(One year)
- Change from baseline in quality of life(One year)
- Change from baseline in visual perception of the gravitational vertical(One year)
研究者
Cecile PARIETTI-WINKLER
University Professor - Hospital Practitioner
Central Hospital, Nancy, France