Stroke
Conditions
Keywords
stroke, dysphagia, rehabilitation, traditional Chinese medicine
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTacupuncture
acupuncture
COMBINATION_PRODUCTLiu-Zi-Jue Gongfa
Liu-Zi-Jue Gongfa
Sponsors
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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; * Patients who do not meet the inclusion criteria, do not have poor treatment compliance as prescribed, cannot judge the efficacy or incomplete data affect the judgment of efficacy and are not suitable for clinical observation;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Swallowing Assessment | Change from Baseline Standardized Swallowing Assessment at 4 weeks | use Standardized Swallowing Assessment to evaluate the patient's conscious, lip closure control ability, the head and trunk control ability, the respiratory mode. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| video fluoroscopic swallowing study score，VFSS score | 0 week；4 weeks | Mainly includes oral stage, pharynx stage, the degree of pharynx three parts, oral stage for 0-2 points; The pharyngeal period was 0-3 points; The degree of pharynx error is 0-4 points, with a total score of 9 points for the sum of the three points. The higher the score, the better the swallowing function is. |
| The effective rate of swallowing function treatment | at baseline, 0 week, 4 weeks, 8 weeks and 16 weeks | The effective rate was calculated according to the score of the standard swallowing function evaluation,scale, and the effective criterion was as follows: the patient's score increased by more than 30% \> compared with that before treatment. |
| Time required for swallowing to improve | at 0 week, 4 weeks, 8 weeks, 16 weeks | it will be assessed by Water Swallow Test (WST),this test divided into 1 \ 5 levels. The higher level means less dysphagia |
Countries
China
Contacts
Primary ContactXINYUN LI, Doctor
Outcome results
None listed