Clinical trial NCT04398355: A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke
Official title: A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
dysphagia
rehabilitation
traditional Chinese medicine
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Standardized Swallowing Assessment
timeFrame: Change from Baseline Standardized Swallowing Assessment at 4 weeks
Secondary outcomes:
measure: video fluoroscopic swallowing study score，VFSS score
timeFrame: 0 week；4 weeks
measure: The effective rate of swallowing function treatment
timeFrame: at baseline, 0 week, 4 weeks, 8 weeks and 16 weeks
measure: Time required for swallowing to improve
timeFrame: at 0 week, 4 weeks, 8 weeks, 16 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou hospital of traditional Chinese medicine
state: Zhejiang
city: Jiaxing
country: China
facility: Jiaxing hospital of Chinese traditional medicine
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: RUIJIE MA, Doctor
role: STUDY_DIRECTOR
affiliation: Zhejiang Chinese Medical University
name: XINYUN LI, Master
role: PRINCIPAL_INVESTIGATOR
References: