Description and Modeling of Swallowing Disorders After a Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change of Clinical severity score
研究概览
简要总结
The oropharyngeal junction participates in 3 interpenetrating functions: Swallowing, Breathing and Speech. In the context of ischemic or hemorrhagic stroke, these are altered, isolated or associated manner, causing major disorders and representing a source of handicap for patients.
Understanding the swallowing mechanisms is therefore a major challenge to guide the rehabilitation and improve the initial and long-term prognosis of patients with stroke.
The main objective of this study is to describe and modeling, thanks to a clinical, physiological and radiological knowledge base, swallowing, speech and breathing, in patients with stroke and in healthy subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First stroke confirmed by MRI < 15 days
- •No severe leukoaraiosis
- •Swallowing disorders identified (GUSS scale < 20)
- •Neurological deficit identified (NIHSS scale <15)
- •Patient able to cooperate for investigations
- •Informed consent signed
排除标准
- •Cerebral hemorrhage
- •History of neurological disease that can lead to swallowing disorders
- •History of laryngological disease such as previous surgery or radiation neck
- •Tracheotomy
- •Vigilance disorders
- •Pregnant, parturient or nursing woman
- •Protected adult
- •Simultaneous participation in another study
- •Non registered to the French social security system
- •For healthy subjects
- •Inclusion Criteria :
- •Age between 18 and 40 years old
- •French native speaker
- •Normal hearing with or without corrective
- •No oral or written language disorders
- •No neurological or psychiatric disorders
- •Informed consent signed
- •Exclusion Criteria
- •MRI contraindication
- •Pregnant, parturient or nursing woman
- •Simultaneous participation in another study
- •Non registered to the French social security system
结局指标
主要结局
Change of Clinical severity score
时间窗: At inclusion and 6 months after diagnosis
NIHSS scale
Change of swallowing disorder
时间窗: Within 15 days after diagnosis and 6 months after diagnosis
Test : GUgging Swallowing Screen
次要结局
- Change of aphasia disorder(Within 15 days after diagnosis and 6 months after diagnosis)
- Change of behavioural attention(Within 15 days after diagnosis and 6 months after diagnosis)
- Change of state of depression and anxiety(Within 15 days after diagnosis and 6 months after diagnosis)