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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04398355
• Other study ID #: 2020ZJZS001
• Status: Recruiting
• Phase: N/A
• Start date: December 25, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: XINYUN LI, Doctor
• Phone: +8618069783240
• Email: lxyjasmine2010[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Deglutition Disorders
• Stroke

Intervention

Combination Product:
• acupuncture
acupuncture
• Liu-Zi-Jue Gongfa
Liu-Zi-Jue Gongfa

Locations

Country	Name	City	State
China	Hangzhou hospital of traditional Chinese medicine	Hangzhou	Zhejiang
China	The Third Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang
China	Jiaxing hospital of Chinese traditional medicine	Jiaxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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