Dysphagia and Cervical Spine Disorders in Patients With Neurologic Deficits Due to Brain Lesions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- change of swallowing ability by Okuma's questionnaire
研究概览
简要总结
The research is about a prospective study conducted in patients suffering from dysphagia and cervical spine disorders and how they are interrelated. Three questionnaires have been given to patients with neurologic deficits, the first of these investigates the occurence of dysphagia in the three stages of swallowing, the second looks into the quality of life following a stroke or other neurologic damage and the third analyses how cervical spine disorders can affect every day life. After the bedside examination, VFSS or FEES, the patients are submitted to swallowing and cervical resistance exercises in fixed time periods after their hospitalisation. The results will be collected and evaluated using the statistical programme SPSS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •brain lesions and cervical spine disorders
排除标准
- •peripheral damages
研究组 & 干预措施
Videofluroscopic swallow study (VFSS)
To investigate the swallowing ability of patients with neurologic problems
干预措施: Videofluroscopic swallow study (VFSS) (Procedure)
cervical spine isometric excercises
isometric exercises in patients with cervical spine scoliosis
干预措施: cervical spine isometric exercises (Procedure)
Fiberoptic endoscopic esophageal study (FEES)
To investigate the anatomic structures during swallowing of patients with neurologic problems
干预措施: Fiberoptic endoscopic esophageal study (FEES) (Procedure)
结局指标
主要结局
change of swallowing ability by Okuma's questionnaire
时间窗: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
change of cervical scoliosis measured by Cobb method in x-rays
时间窗: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
change in swallowing ability and quality of life by swal-quol questionnaire
时间窗: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
次要结局
- change of cervical oswestry disability index(at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year)
研究者
Avraam Ploumis
Assistant Professor of PMR, Orthopaedic Spine Surgeon
University of Ioannina