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

Not Applicable

• Conditions: Stroke
• Interventions: Combination Product: acupuncture; Combination Product: Liu-Zi-Jue Gongfa

• Registration Number: NCT04398355
• Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

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.

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-21
• Study Start: 2021-12-25
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-04-04
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture treatment	acupuncture	basic treatment+Swallowing rehabilitation training+acupuncture
Liu-Zi-Jue treatment	Liu-Zi-Jue Gongfa	basic treatment+Swallowing rehabilitation training+Liu-Zi-Jue
Combination treatment	Liu-Zi-Jue Gongfa	basic treatment+Swallowing rehabilitation training+Chinese traditional rehabilitation
Combination treatment	acupuncture	basic treatment+Swallowing rehabilitation training+Chinese traditional rehabilitation

Primary Outcome Measures

Name	Time	Method
Standardized Swallowing Assessment	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.

Secondary Outcome Measures

Name	Time	Method
video fluoroscopic swallowing study score，VFSS score	0 week；4 weeks	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.
The effective rate of swallowing function treatment	at baseline, 0 week, 4 weeks, 8 weeks and 16 weeks	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.
Time required for swallowing to improve	at 0 week, 4 weeks, 8 weeks, 16 weeks	it will be assessed by Water Swallow Test (WST),this test divided into 1 \~ 5 levels. The higher level means less dysphagia

Trial Locations

Locations (3)

The Third Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China

Hangzhou hospital of traditional Chinese medicine; 🇨🇳 Hangzhou, Zhejiang, China

Jiaxing hospital of Chinese traditional medicine; 🇨🇳 Jiaxing, Zhejiang, China