A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- survival free of an abnormal diet at 6 months
研究概览
简要总结
Swallowing dysfunction after stroke is common, but there is no reliable evidence for how it should be managed other than perhaps by nasogastric tube. This study compared the effectiveness of standardised, low and high intensity behavioral intervention for dysphagia with that of "usual care".
详细描述
Stroke compromises swallowing function, causing dysphagia, in one quarter to one half of all patients. Dysphagia is associated with an increased risk of aspiration pneumonia, dehydration and malnutrition. Despite the development and implementation of several strategies of managing dysphagia after stroke, Few have been evaluated by means of randomised controlled trials.
Comparisons: This study aims to compare stroke patients with dysphagia assigned to receive usual swallowing care, prescribed by the attending physician; standardised low intensity intervention comprising swallowing compensation strategies and diet prescription; or standardised high intensity intervention and dietary prescription .
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
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of stroke within the previous 7 days
- •clinical diagnosis of swallowing difficulty
排除标准
- •no previous history of swallowing treatment
- •no previous history of surgery of the head or neck
结局指标
主要结局
survival free of an abnormal diet at 6 months
次要结局
- time to return to normal diet over the study
- recovery of swallowing ability at 6 months after stroke
- the occurrence of dysphagia - related medical complications at 6 months.