Liu-Zi-Jue Exercise Combined With Conventional Rehabilitation Treat Dysphagia in Post-stroke
A Randomised Controlled Study of Liu-Zi-Jue Exercise Combined With Conventional Rehabilitation for Dysphagia in Post-stroke
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 25, 2022
CompletedFirst Posted
Study publicly available on registry
November 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedNovember 2, 2022
November 1, 2022
1.7 years
September 25, 2022
November 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Change in Standardized Swallowing Assessment
The scale consists of 3 parts, the first part includes the overall evaluation of the patient\'s consciousness, lip closure control, head and trunk control, breathing pattern, soft palate movement, posterior function, gag reflex, spontaneous cough, etc., with a total of 8-23 points; Part 2: Let the patient drink 5ml of water, repeat 3 times, observe the water flow at the corners of the mouth when drinking water, laryngeal movement during swallowing, repeated swallowing, wheezing and laryngeal function, a total of 5 to 11 points; in the second part, if 2 or more times swallowing is normal Then carry out the third part of the assessment: the patient drinks 60 ml of water, and observes the drinking and swallowing, with a total of 5 to 12 points. The total score of this scale is 18-46 points, and the higher the score, the worse the swallowing function.
Baseline, 4 weeks and 60 days
Secondary Outcomes (5)
Video fluoroscopic swallowing study
Baseline and 4 weeks
The volume viscosity swallow test
Baseline and 4 weeks
Penetration-aspiration scale
Baseline and 4 weeks
Water swallow test
Before treatment, after 4 weeks of treatment and after 60 days of treatment.
Modified Barthel Index
Baseline, 4 weeks and 60 days
Study Arms (2)
basic treatment+ swallowing rehabilitation treatment
ACTIVE COMPARATORSwallowing 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.
basic treatment+ swallowing rehabilitation treatment+ Liu-Zi-Jue
EXPERIMENTALOn 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.
Interventions
Combined with the actual situation of stroke patients, this Liu-Zi-Jue Exercise adopts the sitting position.
Basic treatment +Swallowing rehabilitation training
Eligibility Criteria
You may qualify if:
- 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.
- Sign the informed consent form.
You may not qualify if:
- Patients with true bulbar palsy caused by brainstem encephalitis, motor neuron disease, pontine extension tumor, multiple sclerosis, myasthenia gravis, syringomyelia, etc.
- Cerebrovascular malformation, trauma, aneurysm, etc.
- Pregnant or lactating women.
- 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.
- Patients with various bleeding tendency diseases.
- Patients who are allergic to swallowing contrast drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Third Affiliated hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
RUJIE MA, Doctor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Central Study Contacts
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
September 25, 2022
First Posted
November 2, 2022
Study Start
April 1, 2022
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
November 2, 2022
Record last verified: 2022-11