Liu-Zi-Jue Exercise Combined With Conventional Rehabilitation Treat Dysphagia in Post-stroke

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Enrolling

Conditions: Dysphagia; Stroke

Treatments: Other: Basic treatment +Swallowing rehabilitation training; Combination Product: Liu-Zi-Jue Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05602922

20220605105846789

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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 <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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

basic treatment+ swallowing rehabilitation treatment

Active Comparator group

Description:

Swallowing function training mainly includes indirect training, direct training, and compensatory techniques, once a day for 20 minutes each time. In addition, a low-frequency electric VitalStim swallowing therapy device (produced by Chattanooga, USA) was also used for electrical stimulation therapy. The treatment parameters were 700ms in width, two-way square wave, 0～25mA in amplitude, and 30～80Hz in fixed frequency. The A electrode of channel 1 is placed above the hyoid bone, and the B electrode is placed above the notch on the thyroid cartilage. The channel 2 electrode C and electrode D of the therapeutic apparatus are arranged vertically and equidistantly according to the electrode A and electrode B. After the electrodes are placed, turn on the power. The stimulation intensity is based on the maximum stimulation that the patient can tolerate. 1 time a day, 30min each time, a total of 4 weeks.

Treatment:

Other: Basic treatment +Swallowing rehabilitation training

basic treatment+ swallowing rehabilitation treatment+ Liu-Zi-Jue

Experimental group

Description:

On the basis of the control group, the Liu-Zi-Jue exercises were performed, including "Xu, He, Hu, Si, Chui, Xi", 6 times each time, 5 times a week, each exercise for 30 minutes, and continuous treatment for 4 weeks.

Treatment:

Combination Product: Liu-Zi-Jue Exercise