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

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Unknown

Conditions: Stroke

Treatments: Combination Product: acupuncture; Combination Product: Liu-Zi-Jue Gongfa

Study type: Interventional

Funder types: Other

Identifiers

NCT04398355

2020ZJZS001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 4 patient groups

control

No Intervention group

Description:

basic treatment+Swallowing rehabilitation training

Combination treatment

Experimental group

Description:

basic treatment+Swallowing rehabilitation training+Chinese traditional rehabilitation

Treatment:

Combination Product: acupuncture

Combination Product: Liu-Zi-Jue Gongfa

Liu-Zi-Jue treatment

Experimental group

Description:

basic treatment+Swallowing rehabilitation training+Liu-Zi-Jue

Treatment:

Combination Product: Liu-Zi-Jue Gongfa

acupuncture treatment

Experimental group

Description:

basic treatment+Swallowing rehabilitation training+acupuncture

Treatment:

Combination Product: acupuncture