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

NCT ID: NCT04398355

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-25

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control

basic treatment+Swallowing rehabilitation training

Group Type NO_INTERVENTION

No interventions assigned to this group

Combination treatment

basic treatment+Swallowing rehabilitation training+Chinese traditional rehabilitation

Group Type EXPERIMENTAL

acupuncture

Intervention Type COMBINATION_PRODUCT

acupuncture

Liu-Zi-Jue Gongfa

Intervention Type COMBINATION_PRODUCT

Liu-Zi-Jue Gongfa

Liu-Zi-Jue treatment

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

Group Type EXPERIMENTAL

Liu-Zi-Jue Gongfa

Intervention Type COMBINATION_PRODUCT

Liu-Zi-Jue Gongfa

acupuncture treatment

basic treatment+Swallowing rehabilitation training+acupuncture

Group Type EXPERIMENTAL

acupuncture

Intervention Type COMBINATION_PRODUCT

acupuncture

Interventions

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acupuncture

acupuncture

Intervention Type COMBINATION_PRODUCT

Liu-Zi-Jue Gongfa

Liu-Zi-Jue Gongfa

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ruijie Ma

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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RUIJIE MA, Doctor

Role: STUDY_DIRECTOR

The Third Affiliated hospital of Zhejiang Chinese Medical University

XINYUN LI, Master

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Chinese Medical University

Locations

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The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Hangzhou hospital of traditional Chinese medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Jiaxing hospital of Chinese traditional medicine

Jiaxing, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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XINYUN LI, Doctor

Role: CONTACT

+8618069783240

Facility Contacts

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Ruijie Ma, Doctor

Role: primary

+86 18057102851

Xinyun Li, Master

Role: backup

+86 18069783240

Liping LI, Doctor

Role: primary

+86 13857161334

Kaitao LUO, Master

Role: primary

+86 13758395805

Other Identifiers

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2020ZJZS001

Identifier Type: -

Identifier Source: org_study_id

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