StrokeNCT05602922
Liu-Zi-Jue Exercise Combined With Conventional Rehabilitation Treat Dysphagia in Post-stroke
A study testing Liu-Zi-Jue Exercise and Basic treatment +Swallowing rehabilitation training in people with Stroke and Dysphagia, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- What is being tested?
- Liu-Zi-Jue Exercise and Basic treatment +Swallowing rehabilitation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
BEI QIU, 15270855600, 1109476936@qq.com
About this study
Official title: A Randomised Controlled Study of Liu-Zi-Jue Exercise Combined With Conventional Rehabilitation for Dysphagia in Post-stroke
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.
Read the 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.
- Being tested
- Liu-Zi-Jue Exercise, Basic treatment +Swallowing rehabilitation training
- Keywords
- stroke, dysphagia, rehabilitation, Liu-Zi-Jue Exercise
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liu-Zi-Jue ExerciseCombination product
Combined with the actual situation of stroke patients, this Liu-Zi-Jue Exercise adopts the sitting position.
Basic treatment +Swallowing rehabilitation trainingOther
Basic treatment +Swallowing rehabilitation training
| Study group | Role | What they receive |
|---|---|---|
| basic treatment+ swallowing rehabilitation treatment | Active comparator | 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. Receives: Other: Basic treatment +Swallowing rehabilitation training |
| basic treatment+ swallowing rehabilitation treatment+ Liu-Zi-Jue | Experimental | 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. Receives: Combination Product: Liu-Zi-Jue Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks and 60 days
Secondary outcomes (5)
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.
Measured: Baseline and 4 weeks
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.
Measured: Baseline and 4 weeks
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.
Measured: Baseline and 4 weeks
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.
Measured: Before treatment, after 4 weeks of treatment and after 60 days of treatment.
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.
Measured: Baseline, 4 weeks and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Apr 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruijie Ma, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- RUJIE MA, Doctor, Study director, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602922
- Sponsor's protocol ID
- 20220605105846789
- Status last verified
- Nov 2022
- First submitted
- 25 Sep 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Study of Liu-Zi-Jue Exercise Combined With Conventional Rehabilitation for Dysphagia in Post-stroke
- ClinicalTrials.gov ID
- NCT05602922
- Acronym / sponsor ID
- 20220605105846789
- Keywords
- stroke, dysphagia, rehabilitation, Liu-Zi-Jue Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| basic treatment+ swallowing rehabilitation treatment | Active comparator | Other: Basic treatment +Swallowing rehabilitation trainingSwallowing 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 | Experimental | Combination Product: Liu-Zi-Jue ExerciseOn 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. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liu-Zi-Jue ExerciseCombined with the actual situation of stroke patients, this Liu-Zi-Jue Exercise adopts the sitting position. | Combination product | basic treatment+ swallowing rehabilitation treatment+ Liu-Zi-Jue |
| Basic treatment +Swallowing rehabilitation trainingBasic treatment +Swallowing rehabilitation training | Other | basic treatment+ swallowing rehabilitation treatment |
Primary outcome
Rate of Change in Standardized Swallowing Assessment
Time frame: Baseline, 4 weeks and 60 days
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.
5 secondary outcomes
Video fluoroscopic swallowing study
Time frame: Baseline and 4 weeks
The volume viscosity swallow test
Time frame: Baseline and 4 weeks
Penetration-aspiration scale
Time frame: Baseline and 4 weeks
Water swallow test
Time frame: Before treatment, after 4 weeks of treatment and after 60 days of treatment.
Modified Barthel Index
Time frame: Baseline, 4 weeks and 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RUJIE MA, Doctor study director
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liu-Zi-Jue Exercise and Basic treatment +Swallowing rehabilitation training in people with Stroke and Dysphagia, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BEI QIU (15270855600, 1109476936@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Change in Standardized Swallowing Assessment (time frame: Baseline, 4 weeks and 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.