StrokeNCT04398355
A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke
A study testing acupuncture and Liu-Zi-Jue Gongfa in people with Stroke, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- acupuncture and Liu-Zi-Jue Gongfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- 25 Dec 2021to 31 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Ruijie Ma, Doctor, +86 18057102851, maria7878@sina.com
Xinyun Li, Master, +86 18069783240
- Recruiting
Hangzhou hospital of traditional Chinese medicine
Hangzhou, Zhejiang, 310002
Liping LI, Doctor, +86 13857161334
Liping LI, Doctor
- Recruiting
Jiaxing hospital of Chinese traditional medicine
Jiaxing, Zhejiang, 314000
Kaitao LUO, Master, +86 13758395805
Kaitao LUO, Master
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- acupuncture, Liu-Zi-Jue Gongfa
- Keywords
- stroke, dysphagia, rehabilitation, traditional Chinese medicine
- 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.
acupunctureCombination product
acupuncture
Liu-Zi-Jue GongfaCombination product
Liu-Zi-Jue Gongfa
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | basic treatment+Swallowing rehabilitation training |
| Combination treatment | Experimental | basic treatment+Swallowing rehabilitation training+Chinese traditional rehabilitation Receives: Combination Product: acupuncture; Combination Product: Liu-Zi-Jue Gongfa |
| Liu-Zi-Jue treatment | Experimental | basic treatment+Swallowing rehabilitation training+Liu-Zi-Jue Receives: Combination Product: Liu-Zi-Jue Gongfa |
| acupuncture treatment | Experimental | basic treatment+Swallowing rehabilitation training+acupuncture Receives: Combination Product: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Swallowing Assessment
use Standardized Swallowing Assessment to evaluate the patient's conscious, lip closure control ability, the head and trunk control ability, the respiratory mode.
Measured: Change from Baseline Standardized Swallowing Assessment at 4 weeks
Secondary outcomes (3)
video fluoroscopic swallowing study score，VFSS score
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.
Measured: 0 week；4 weeks
The effective rate of swallowing function treatment
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.
Measured: at baseline, 0 week, 4 weeks, 8 weeks and 16 weeks
Time required for swallowing to improve
it will be assessed by Water Swallow Test (WST),this test divided into 1 ~ 5 levels. The higher level means less dysphagia
Measured: at 0 week, 4 weeks, 8 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start25 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 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
- 240 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
- RUIJIE MA, Doctor, Study director, The Third Affiliated hospital of Zhejiang Chinese Medical UniversityXINYUN LI, Master, Principal investigator, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398355
- Sponsor's protocol ID
- 2020ZJZS001
- Status last verified
- Mar 2022
- First submitted
- 24 Apr 2020
- Last updated
- 4 Apr 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 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trail of Acupuncture and Liu-Zi-Jue Exercise for Dysphagia in Post-stroke
- ClinicalTrials.gov ID
- NCT04398355
- Acronym / sponsor ID
- 2020ZJZS001
- Conditions
- Stroke
- Keywords
- stroke, dysphagia, rehabilitation, traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 May 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –basic treatment+Swallowing rehabilitation training |
| Combination treatment | Experimental | Combination Product: acupuncture, Combination Product: Liu-Zi-Jue Gongfabasic treatment+Swallowing rehabilitation training+Chinese traditional rehabilitation |
| Liu-Zi-Jue treatment | Experimental | Combination Product: Liu-Zi-Jue Gongfabasic treatment+Swallowing rehabilitation training+Liu-Zi-Jue |
| acupuncture treatment | Experimental | Combination Product: acupuncturebasic treatment+Swallowing rehabilitation training+acupuncture |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Dysphagia
Key exclusion criteria (8 listed)
- Dysphagia
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 |
|---|---|---|
| acupunctureacupuncture | Combination product | Combination treatment, acupuncture treatment |
| Liu-Zi-Jue GongfaLiu-Zi-Jue Gongfa | Combination product | Combination treatment, Liu-Zi-Jue treatment |
Primary outcome
Standardized Swallowing Assessment
Time frame: 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.
3 secondary outcomes
video fluoroscopic swallowing study score，VFSS score
Time frame: 0 week；4 weeks
The effective rate of swallowing function treatment
Time frame: at baseline, 0 week, 4 weeks, 8 weeks and 16 weeks
Time required for swallowing to improve
Time frame: at 0 week, 4 weeks, 8 weeks, 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
RUIJIE MA, Doctor study director
The Third Affiliated hospital of Zhejiang Chinese Medical University
XINYUN LI, Master principal investigator
Zhejiang Chinese Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and Liu-Zi-Jue Gongfa in people with Stroke, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 3 sites 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 10 inclusion and 8 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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 XINYUN LI, Doctor (+8618069783240, lxyjasmine2010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Swallowing Assessment (time frame: Change from Baseline Standardized Swallowing Assessment at 4 weeks). 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 4 Apr 2022.