The Impact of Chewing Food on Stroke Patients With Dysphagia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Modified Barium Swallow Impairment Profile
研究概览
简要总结
The goal of this clinical trial is to explore the effect of Chewing Food on quality of life and nutritional status in ischemic stroke patients. Patients will be randomly divided into an interventional group and a control group, all receiving routine rehabilitation treatment and enteral nutrition feeding. On this basis, the interventional group will receive Chewing Food training before each feeding for 10 min. Researchers will compare changes in quality of life, and nutritional status of two groups of patients before and after the study to see if Chewing Food can improve the quality of life and nutritional status in ischemic stroke patients.
详细描述
The study will last 15 days for each participant. The goal of this clinical trial is to explore the effect of Chewing Food on quality of life and nutritional status in ischemic stroke patients. Patients will be randomly divided into an interventional group and a control group, all receiving routine rehabilitation treatment and enteral nutrition feeding. On this basis, the interventional group will receive Chewing Food training before each feeding for 10 min. Researchers will compare changes in quality of life, and nutritional status of two groups of patients before and after the study to see if Chewing Food can improve the quality of life and nutritional status in ischemic stroke patients.
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 (Outcomes Assessor)
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
- •Age>18 years.
- •Meeting the diagnostic criteria for ischemic stroke .
- •Dysphagia confirmed by Videofluoroscopic Swallowing Study.
- •Clear consciousness.
- •No history of prior stroke.
- •Stable vital signs.
排除标准
- •Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
- •Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- •Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
- •Pregnant or nursing females.
研究组 & 干预措施
Chewing Food Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with real food for 15 days.
干预措施: routine rehabilitation therapy (Behavioral)
Chewing Food Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with real food for 15 days.
干预措施: Oral tube feeding (Behavioral)
Control Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with lotus root powder for 15 days.
干预措施: routine rehabilitation therapy (Behavioral)
Chewing Food Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with real food for 15 days.
干预措施: Chewing Real Food (Behavioral)
Control Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with lotus root powder for 15 days.
干预措施: Oral tube feeding (Behavioral)
Control Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with lotus root powder for 15 days.
干预措施: Chewing Lotus Root Powder Food (Behavioral)
结局指标
主要结局
Modified Barium Swallow Impairment Profile
时间窗: Day 1 and day 15
The Modified Barium Swallow Impairment Profile is used to assess the clinical severity of oropharyngeal dysphagia. It includes 16 items and incorporates a standard Modified Barium Swallow test and is based on the gold standard of swallowing function assessment, Videofluoroscopic Swallowing Studies. The total score could range from 0 to 51, with higher scores indicating more severe oropharyngeal dysphagia.
次要结局
- Rehabilitation adherence(Day 1 and day 15)
- Dysphagia Handicap Index(Day 1 and day 15)
- Penetration-Aspiration Scale(Day 1 and day 15)
- 7-item Generalized Anxiety Disorder(Day 1 and day 15)
- Stroke Self-Efficacy Questionnaire(Day 1 and day 15)
研究者
Zeng Xi
The Research Director
Buraidah Central Hospital