Clinical trial NCT05602922: Liu-Zi-Jue Exercise Combined With Conventional Rehabilitation Treat Dysphagia in Post-stroke
Official title: A Randomised Controlled Study of Liu-Zi-Jue Exercise Combined With Conventional Rehabilitation for Dysphagia in Post-stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Dysphagia
Keywords: stroke
dysphagia
rehabilitation
Liu-Zi-Jue Exercise
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, a prospective, randomized controlled method was adopted, with patients with post-stroke dysphagia as the main research objects, applying "Liu-Zi-Jue" to the patients for rehabilitation intervention, and to explore the effect of "Liu-Zi-Jue" on the swallowing function of patients with post-stroke dysphagia. In order to provide a safe and effective TCM treatment plan for patients with dysphagia after stroke, reduce the disability rate after stroke and improve the quality of life of patients.

Detailed description: This study is a single-center, prospective, randomized, controlled, clinical trial. A total of 60 inpatients with post-stroke dysphagia in the Third Affiliated Hospital of Zhejiang Chinese Medical University from April 2022 to December 2023 will be selected, and the patients will be assigned to the experimental group and the control group with 30 cases in each group according to the random number table. The control group will be given basic treatment and swallowing rehabilitation therapy, while the experimental group will be given Liu-Zi-Jue Exercise on the basis of the control group. Both groups are going to treat for 4 weeks and follow up for 60 days. Standardized Swallowing Assessment, Video Fluoroscopic Swallowing Study, Volume Viscosity Swallow Test, Penetration-aspiration scale, Water Swallow Test, Modified Barthel Index will be used to evaluate the swallowing function and living ability of patients, and to evaluate the clinical effect of Liu-Zi-Jue Exercise training on patients with dysphagia after stroke. Efficacy, clear its treatment advantages, in order to optimize the cost-effective and standardized rehabilitation program for dysphagia during stroke recovery, improve patients' swallowing function, improve their activities of daily living, and minimize the waste of health resources.

Eligibility criteria: Inclusion Criteria:

1.Meeting the diagnostic criteria of stroke in traditional Chinese medicine. 2.Meeting the diagnostic criteria of ischemic stroke in Western medicine. 3.Meeting the diagnostic criteria for swallowing disorders. 4.30 ≤ age ≤ 85 years; gender not restricted. 5.Duration of illness ≤ 180 days. 6.Water test at level 3 and above. 7.Voluntary participation in the subject, no serious complications, acceptable and good compliance with Liu-Zi-Jue Exercise treatment.

8.Sign the informed consent form.

Exclusion Criteria:

1. Patients with true bulbar palsy caused by brainstem encephalitis, motor neuron disease, pontine extension tumor, multiple sclerosis, myasthenia gravis, syringomyelia, etc.
2. Cerebrovascular malformation, trauma, aneurysm, etc.
3. Pregnant or lactating women.
4. Patients with severe primary chronic diseases such as heart, liver, kidney and other organs, as well as endocrine system and hematopoietic system, severe dementia and cognitive impairment (Simple Mental State Scale Examination (MMSE): score \&lt;15 points), severe language comprehension disorder, mentally ill patients.
5. Patients with various bleeding tendency diseases.
6. Patients who are allergic to swallowing contrast drugs.
7. Patients who do not meet the inclusion criteria, do not have poor treatment compliance as prescribed, cannot judge the efficacy or have incomplete data, which affect the judgment of efficacy and are not suitable for clinical observation.

Primary outcomes:
measure: Rate of Change in Standardized Swallowing Assessment
timeFrame: Baseline, 4 weeks and 60 days
Secondary outcomes:
measure: Video fluoroscopic swallowing study
timeFrame: Baseline and 4 weeks
measure: The volume viscosity swallow test
timeFrame: Baseline and 4 weeks
measure: Penetration-aspiration scale
timeFrame: Baseline and 4 weeks
measure: Water swallow test
timeFrame: Before treatment, after 4 weeks of treatment and after 60 days of treatment.
measure: Modified Barthel Index
timeFrame: Baseline, 4 weeks and 60 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated hospital of Zhejiang Chinese Medical University
state: 浙江
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: RUJIE MA, Doctor
role: STUDY_DIRECTOR
References: