Complementary Acupuncture Treatment of Dysphagia in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- the functional oral intake scale (FOIS)
研究概览
简要总结
A Taiwanese study pointed out that stroke patients who have language barriers, dysphagia, and aspiration pneumonia are more likely to suffer from prolonged hospitalization. Improvements in dysphagia and subsequent complications in patients should be effective in reducing hospital stays and improving the quality of long-term care. In view of clinical medical needs and policy trends, this study aims to explore the efficacy of using traditional Chinese medicine to treat cerebral apoplexy sequelae in Taiwan. It is expected that through (1) exploration of real-world data analysis, combined with the advantages of Taiwan's biomedical database, data exploration will be carried out to provide big data (2) Multi-center prospective randomized clinical trials, providing clinical evidence of the highest level of evidence in empirical medicine.
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
- Double (Participant, Outcomes Assessor)
盲法说明
In this study, the participants, assessor, and statistician are all blinded to the treatment assignments except for the acupuncturist and study coordinator.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.Patients aged more than 20 years
- •The diagnosis of first stroke was established within the six months
- •Patients had a score ≥ 25 of Mini-Mental State Examination (MMSE)
- •Patients met one or both indications as follows
- •Dysphagia confirmed under the standardized swallowing assessment
- •Nasogastric tube feeding already
排除标准
- •Previous history of swallowing disability
- •Currently known coagulopathy leading to bleeding disorder.
- •Previous surgery of head or neck
- •Local infection at or near the acupuncture site is not suitable for acupuncture after physician examination.
- •Psychological or behavior disorder
- •Currently pregnant or breastfeeding women.
- •Previous acupuncture treatment for any indication within 30 days of enrollment.
- •Severe chronic or uncontrollable complications interference the processing of the trial
结局指标
主要结局
the functional oral intake scale (FOIS)
时间窗: baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period
the functional oral intake scale(FOIS) is used to assessing the functional level of oral intake of food and liquid in stroke patients. It is a 7-point scale, with level 1 indicating complete impairment of oral intake, and level 7 indicating complete oral intake regardless of food consistency or type. Changes from baseline to the 2nd week of the intervention, the 1st and 4th week of follow-up period.
dysphagia severity rating scale (DSRS)
时间窗: baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period
dysphagia severity rating scale(DSRS) indicates the feeding status of the dysphagia patient in three subdomains: fluids, diet, and level of supervision required for feeding. The total score from 0 to 12. The higher scores means the better outcome. Changes from baseline to the 2nd week of the intervention, the 1st and 4th week of follow-up period.
次要结局
未报告次要终点