Back to resultsLiu-Zi-Jue Exercise Combined With Conventional Rehabilitation Treat Dysphagia in Post-stroke
Primary Purpose
Stroke, Dysphagia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Liu-Zi-Jue Exercise
Basic treatment +Swallowing rehabilitation training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, dysphagia, rehabilitation, Liu-Zi-Jue Exercise
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: 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. 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.
Sites / Locations
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
basic treatment+ swallowing rehabilitation treatment
basic treatment+ swallowing rehabilitation treatment+ Liu-Zi-Jue
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Video fluoroscopic swallowing study
The scale mainly includes three parts: oral stage, pharyngeal stage, and the degree of aspiration. The oral stage is 0-2 points; the pharyngeal stage is 0-3, and the degree of aspiration is 0-4. The total score is 9 points. The higher the value, the better the swallowing function.
The volume viscosity swallow test
The volume selected during the test is a small amount (5ml), a medium amount (10ml), a large amount (20ml), and the consistency is low consistency (water sample), medium consistency (thick paste), high consistency (pudding), according to different Combination, the complete test requires a total of 9 mouthfuls to eat, observe whether the patient coughs, whether the sound quality changes, and whether the blood oxygen saturation decreases to determine the patient's swallowing safety, observe the patient's lip closure, oral cavity residue, pharyngeal residue, and divided swallowing to determine the patient's swallowing status Effectiveness to analyze the risk of swallowing and eating in patients.
Penetration-aspiration scale
The scale is divided into 3 categories and 8 grades according to whether the contrast agent enters the airway, the depth of entering the airway, and whether it can be discharged.
Water swallow test
The patient sits, drinks 30 ml of warm water, and is divided into 5 grades according to the time required and the condition of choking.
Modified Barthel Index
The scale is scored by the patient's ability to complete specific tasks in daily life, including grooming, eating, bathing, dressing, stool control, urination control, toilet use, bed and chair transfer, walking on level ground, and going up and down stairs with 10 items.
Full Information
NCT ID
NCT05602922
First Posted
September 25, 2022
Last Updated
November 1, 2022
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05602922
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dysphagia
Keywords
stroke, dysphagia, rehabilitation, Liu-Zi-Jue Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
basic treatment+ swallowing rehabilitation treatment
Arm Type
Active Comparator
Arm 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.
Arm Title
basic treatment+ swallowing rehabilitation treatment+ Liu-Zi-Jue
Arm Type
Experimental
Arm 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.
Intervention Type
Combination Product
Intervention Name(s)
Liu-Zi-Jue Exercise
Intervention Description
Combined with the actual situation of stroke patients, this Liu-Zi-Jue Exercise adopts the sitting position.
Intervention Type
Other
Intervention Name(s)
Basic treatment +Swallowing rehabilitation training
Intervention Description
Basic treatment +Swallowing rehabilitation training
Primary Outcome Measure Information:
Title
Rate of Change in Standardized Swallowing Assessment
Description
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.
Time Frame
Baseline, 4 weeks and 60 days
Secondary Outcome Measure Information:
Title
Video fluoroscopic swallowing study
Description
The scale mainly includes three parts: oral stage, pharyngeal stage, and the degree of aspiration. The oral stage is 0-2 points; the pharyngeal stage is 0-3, and the degree of aspiration is 0-4. The total score is 9 points. The higher the value, the better the swallowing function.
Time Frame
Baseline and 4 weeks
Title
The volume viscosity swallow test
Description
The volume selected during the test is a small amount (5ml), a medium amount (10ml), a large amount (20ml), and the consistency is low consistency (water sample), medium consistency (thick paste), high consistency (pudding), according to different Combination, the complete test requires a total of 9 mouthfuls to eat, observe whether the patient coughs, whether the sound quality changes, and whether the blood oxygen saturation decreases to determine the patient's swallowing safety, observe the patient's lip closure, oral cavity residue, pharyngeal residue, and divided swallowing to determine the patient's swallowing status Effectiveness to analyze the risk of swallowing and eating in patients.
Time Frame
Baseline and 4 weeks
Title
Penetration-aspiration scale
Description
The scale is divided into 3 categories and 8 grades according to whether the contrast agent enters the airway, the depth of entering the airway, and whether it can be discharged.
Time Frame
Baseline and 4 weeks
Title
Water swallow test
Description
The patient sits, drinks 30 ml of warm water, and is divided into 5 grades according to the time required and the condition of choking.
Time Frame
Before treatment, after 4 weeks of treatment and after 60 days of treatment.
Title
Modified Barthel Index
Description
The scale is scored by the patient's ability to complete specific tasks in daily life, including grooming, eating, bathing, dressing, stool control, urination control, toilet use, bed and chair transfer, walking on level ground, and going up and down stairs with 10 items.
Time Frame
Baseline, 4 weeks and 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BEI QIU
Phone
15270855600
Email
1109476936@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
RUIJIE MA, Doctor
Phone
18057102851
Email
maria7878@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RUJIE MA, Doctor
Organizational Affiliation
The Third Affiliated hospital of Zhejiang Chinese Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The Third Affiliated hospital of Zhejiang Chinese Medical University
City
Hangzhou
State/Province
浙江
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BEI QIU
Phone
15270855600
Email
1109476936@qq.com
12. IPD Sharing Statement
Learn more about this trial
Liu-Zi-Jue Exercise Combined With Conventional Rehabilitation Treat Dysphagia in Post-stroke
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