A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Standardized Swallowing Assessment
研究概览
简要总结
The traditional Chinese medicine rehabilitation for post-stroke dysphagia impairment will be intervened, which can promote the recovery of dysphagia function of stroke patients, reduce the disability rate and improve the quality of life.
详细描述
This study will collect inpatients from April 2020 to December 2022 who from the third affiliated hospital of Zhejiang university of traditional Chinese medicine, Jiaxing hospital of traditional Chinese medicine, Hangzhou hospital of traditional Chinese medicine.this study sets strict time window (stroke recovery, 30-180 days), use multi-center, large sample, randomized controlled study method and the objective recognition rehabilitation evaluation criteria and efficacy evaluation system to evaluate the clinical effect and analysis of health economics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dysphagia
- •Meet the diagnostic criteria of stroke in traditional Chinese medicine;
- •Meet the diagnostic criteria of ischemic stroke in western medicine;
- •meet the diagnostic criteria of pseudobulbar palsy;
- •Age is 18-85, gender not limited;
- •The course of disease is 30 to 180 days;
- •Water test level 3 and level 3 above;
- •Meet the requirements for indications of acupuncture and moxibustion techniques; Volunteer to participate in this project, the patient has no serious complications, can accept acupuncture treatment and good compliance;
- •Sign informed consent
- •MOCA（Montreal Cognitive Assessment） score above 15.
排除标准
- •Dysphagia
- •Patients with true bulbar palsy caused by brainstem encephalitis, motor neurone disease, pontine tumor, multiple sclerosis, myasthenia gravis, medulla bulbar cavity;
- •Cerebral hemorrhage caused by cerebrovascular malformation, trauma, aneurysm and other causes;
- •Pregnant or lactating women;
- •Patients with severe primary chronic diseases, severe dementia and cognitive impairment, serious language understanding disorders, and mental illness, including heart, liver, kidney and other viscera, as well as the endocrine system and hematopoietic system;
- •Suffered from a variety of bleeding tendency diseases;
- •The patient to swallow contrast drug allergy;
- •Patients who do not meet the inclusion criteria, do not have poor treatment compliance as prescribed, cannot judge the efficacy or incomplete data affect the judgment of efficacy and are not suitable for clinical observation;
结局指标
主要结局
Standardized Swallowing Assessment
时间窗: Change from Baseline Standardized Swallowing Assessment at 4 weeks
use Standardized Swallowing Assessment to evaluate the patient's conscious, lip closure control ability, the head and trunk control ability, the respiratory mode.
次要结局
- video fluoroscopic swallowing study score，VFSS score(0 week；4 weeks)
- The effective rate of swallowing function treatment(at baseline, 0 week, 4 weeks, 8 weeks and 16 weeks)
- Time required for swallowing to improve(at 0 week, 4 weeks, 8 weeks, 16 weeks)
研究者
Ruijie Ma
Clinical Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University