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

March 23, 2022 updated by: Ruijie Ma, The Third Affiliated hospital of Zhejiang Chinese Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Third Affiliated hospital of Zhejiang Chinese Medical University
        • Contact:
          • Xinyun Li, Master
          • Phone Number: +86 18069783240
        • Sub-Investigator:
          • Siwen Li, Master
      • Hangzhou, Zhejiang, China, 310002
        • Recruiting
        • Hangzhou Hospital of Traditional Chinese Medicine
      • Jiaxing, Zhejiang, China, 314000
        • Recruiting
        • Jiaxing hospital of Chinese traditional medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control
basic treatment+Swallowing rehabilitation training
EXPERIMENTAL: Combination treatment
basic treatment+Swallowing rehabilitation training+Chinese traditional rehabilitation
Combination product: acupuncture
acupuncture
Combination product: Liu-Zi-Jue Gongfa
Liu-Zi-Jue Gongfa
EXPERIMENTAL: Liu-Zi-Jue treatment
basic treatment+Swallowing rehabilitation training+Liu-Zi-Jue
Combination product: Liu-Zi-Jue Gongfa
Liu-Zi-Jue Gongfa
EXPERIMENTAL: acupuncture treatment
basic treatment+Swallowing rehabilitation training+acupuncture
Combination product: acupuncture
acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Swallowing Assessment
Time Frame: 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.
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
Time Frame: 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.
0 week；4 weeks
The effective rate of swallowing function treatment
Time Frame: 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.
at baseline, 0 week, 4 weeks, 8 weeks and 16 weeks
Time required for swallowing to improve
Time Frame: 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
at 0 week, 4 weeks, 8 weeks, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 25, 2021

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (ACTUAL)

May 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020ZJZS001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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