A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke

Conditions
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Stroke

Intervention / Treatment
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* Combination Product: acupuncture
* Combination Product: Liu-Zi-Jue Gongfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>basic treatment+Swallowing rehabilitation training | |
| Experimental: Combination treatment<br>basic treatment+Swallowing rehabilitation training+Chinese traditional rehabilitation | Combination Product: acupuncture<br>* acupuncture<br>Combination Product: Liu-Zi-Jue Gongfa<br>* Liu-Zi-Jue Gongfa<br>|
| Experimental: Liu-Zi-Jue treatment<br>basic treatment+Swallowing rehabilitation training+Liu-Zi-Jue | Combination Product: Liu-Zi-Jue Gongfa<br>* Liu-Zi-Jue Gongfa<br>|
| Experimental: acupuncture treatment<br>basic treatment+Swallowing rehabilitation training+acupuncture | Combination Product: acupuncture<br>* acupuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized Swallowing Assessment | use Standardized Swallowing Assessment to evaluate the patient's conscious, lip closure control ability, the head and trunk control ability, the respiratory mode. | Change from Baseline Standardized Swallowing Assessment at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| video fluoroscopic swallowing study score，VFSS score | Mainly includes oral stage, pharynx stage, the degree of pharynx three parts, oral stage for 0-2 points; The pharyngeal period was 0-3 points; The degree of pharynx error is 0-4 points, with a total score of 9 points for the sum of the three points. The higher the score, the better the swallowing function is. | 0 week；4 weeks | 
| The effective rate of swallowing function treatment | The effective rate was calculated according to the score of the standard swallowing function evaluation,scale, and the effective criterion was as follows: the patient's score increased by more than 30% > compared with that before treatment. | at baseline, 0 week, 4 weeks, 8 weeks and 16 weeks | 
| Time required for swallowing to improve | it will be assessed by Water Swallow Test (WST),this test divided into 1   5 levels. The higher level means less dysphagia | at 0 week, 4 weeks, 8 weeks, 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, dysphagia, rehabilitation, traditional Chinese medicine