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

NCT04398355 | Unknown

• 1 other identifier: 2020ZJZS001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

stroke; dysphagia; rehabilitation; traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• video fluoroscopic swallowing study score，VFSS score

  0 week；4 weeks

• The effective rate of swallowing function treatment

  at baseline, 0 week, 4 weeks, 8 weeks and 16 weeks

• Time required for swallowing to improve

  at 0 week, 4 weeks, 8 weeks, 16 weeks

Study Arms (4)

control

NO INTERVENTION

basic treatment+Swallowing rehabilitation training

Combination treatment

EXPERIMENTAL

basic treatment+Swallowing rehabilitation training+Chinese traditional rehabilitation

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

Liu-Zi-Jue treatment

EXPERIMENTAL

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

Combination Product: Liu-Zi-Jue Gongfa

acupuncture treatment

EXPERIMENTAL

basic treatment+Swallowing rehabilitation training+acupuncture

Combination Product: acupuncture

Interventions

acupuncture COMBINATION_PRODUCT

acupuncture

Combination treatment; acupuncture treatment

Liu-Zi-Jue Gongfa COMBINATION_PRODUCT

Liu-Zi-Jue Gongfa

Combination treatment; Liu-Zi-Jue treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (3)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Hangzhou hospital of traditional Chinese medicine

Hangzhou, Zhejiang, 310002, China

RECRUITING

Jiaxing hospital of Chinese traditional medicine

Jiaxing, Zhejiang, 314000, China

RECRUITING

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• RUIJIE MA, Doctor

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  STUDY DIRECTOR

• XINYUN LI, Master

  Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XINYUN LI, Doctor

CONTACT

+8618069783240; lxyjasmine2010@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 21, 2020
• Study Start: December 25, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

CN (3)