DysphagiaNCT05982977
Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke
A study testing Acupuncture and Conventional rehabilitation in people with Dysphagia and Stroke, run by Qingqing Zhang.
Trial summary
Up to 84% of patients after stroke are accompanied by dysphagia, of which 53% are oral dysphagia. The oral phase is the initial phase of swallowing activity and the only stage of swallowing that is completely discretionary. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Dysphagia, Stroke, Oral Phase
- What is being tested?
- Acupuncture and Conventional rehabilitation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2023to 1 Aug 2025
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting the diagnostic criteria for acute ischemic stroke established by the Neurology Society of the Chinese Medical Association and confirmed by craniocerebral CT or MRI;
- Oral dysphagia caused by stroke;
- Currently diet is restricted, FOIS score is 5 or less; WST score 3 or above;
- MoCA score of 21 or above, able to understand and follow simple instructions from the treatment staff, able to cooperate and willing to undergo examination and treatment;
- 40 to 75 years old;
- Conscious and stable vital signs;
- Convalescent patients with stroke course and dysphagia duration between 1-6 months;
- Voluntary participation and informed consent.
Who cannot join
- Patients with dysphagia not caused by stroke or non-stroke oral dysphagia;
- Previous history of stroke or dysphagia;
- Patients with serious primary diseases or mental disorders of other systems;
- Suffering from various bleeding prone diseases;
- Severe needle fainting;
- People with metal implants.
- Patients with poor compliance are not treated as prescribed
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training to Regulate the Cortical Swallowing Network in Oral Dysphagia of Stroke
Up to 84% of patients after stroke are accompanied by dysphagia, of which 53% are oral dysphagia. The oral phase is the initial phase of swallowing activity and the only stage of swallowing that is completely discretionary. Swallowing activity in the oral stage is not only related to the formation and push of food pellets, but also affects the continuity between the transition from spontaneous swallowing to the swallowing reflex.
Read the detailed description
After stroke, patients are prone to oral dysphagia, poor control of food masses and liquids in the mouth, resulting in food spillover, residual and premature overflow, resulting in dehydration, malnutrition, aspiration, pneumonia and other serious consequences, which greatly reduce the eating safety and quality of life of patients after stroke. Therefore, the rehabilitation of oral swallowing function is a way for patients with swallowing disorder after stroke to return to society and improve their quality of life. Previous studies have found that acupuncture is an effective intervention to improve swallowing disorder in oral stage after stroke. Whether acupuncture promotes the improvement of swallowing function in oral stage by regulating the synergic activity of cortical swallowing network and muscle group has not been fully clarified.
- Conditions
- Dysphagia, Stroke, Oral Phase
- Being tested
- Acupuncture, Conventional rehabilitation
- Keywords
- Dysphagia, stroke, cortical swallowing network, Oral Phase
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
The patient was placed in a supine position, selected Lianquan, Fengchi, and acupoints.
Conventional rehabilitationBehavioural
swallowing training included breathing training, masticatory muscle training, oral movement training and feeding training.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture rehabilitation group | Experimental | Acupuncture rehabilitation intervention was given on the basis of conventional rehabilitation therapy.Disinfected with 75% alcohol and applied the needles at a depth of 25-35mm. Acupuncture stimulation of Lianquan (CV23) and Fengchi (GB20). The needles were retained for 30 minutes/time, once a day, and 5 days/week for a total of 4 weeks. Receives: Other: Acupuncture |
| Conventional rehabilitation group | Active comparator | This group participants would take swallowing training 30 minutes/time, once a day, 5 days/week, a total of 4 weeks of intervention. At the same time, stroke basic treatment, nutritional support and other symptomatic treatment Receives: Behavioral: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral functional score
To assess participants' oral swallowing function
Measured: 4 weeks (Before and after intervation)
Secondary outcomes (6)
Surface electromyography
To assess the swallowing muscle activity
Measured: 4 weeks (Before and after intervation)
Water swallowing test (WST)
The severity of dysphagia was assessed by the WST. Level 1: Can drink 30ml water successfully within 5 seconds; Level 2: Drink water more than 2 times, can swallow without choking. Level 3: Can be drunk once, but cough. Level 4: swallowed more than twice, but with choking. Level 5: Frequent choking, unable to swallow all. Normal: Level 1, Suspicious: Level 1, more than 5 seconds or level 2; Abnormal: Level 3 to 5
Measured: 4 weeks (Before and after intervation)
Standardized Swallowing Assessment (SSA)
To assess the severity of swallowing. The lowest score on this scale is 18 points, the highest score is 46 points, the higher the score, the worse the swallowing function.
Measured: 4 weeks (Before and after intervation)
Functional Oral Intake Scale (FOIS)
To assess the condition of swallowing. The grade of FOIS was categorized as level 1 to 3 (poor FOIS: tube feeding), levels 4 and 5 (moderate FOIS: total oral diet requiring special preparation) or levels 6 and 7 (good FOIS: total oral diet without special preparation).
Measured: 4 weeks (Before and after intervation)
Teacher salivation rating (TDS)
Assess salivation. Level 1: No salivation; Level 2: Small amount, occasional flow. Level 3: Stream from time to time; Level 4: Flow frequently, but not linearly; Level 5: Flow in line, chest often wet
Measured: 4 weeks (Before and after intervation)
Swallowing Related Daily Quality of Life Scale (SWAL-QOL)
Assessed patients' quality of life. The SWAL-QOL scale consists of 11 dimensions, covering 44 items, of which 10 dimensions measure patients' quality of life and one dimension measures patients' swallowing symptoms. The 10 quality of life dimensions included 30 items, of which 8 (25 items in total) were related to swallowing, including psychological burden, eating time, appetite, food choice, verbal communication, fear of eating, mental health, and social interaction: the common dimension had 2 (5 items in total), including fatigue and sleep. The dimension of swallowing symptoms included 14 items. The SWAL-OOL scale was scored by Likert scoring method. The higher the score of five levels (1-5 respectively), the better the quality of life.
Measured: 4 weeks (Before and after intervation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start30 Sep 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Model description
- This study was a parallel, randomized controlled trial. Qualified subjects were numbered according to the inclusion order and randomly assigned to the swallowing training treatment group and the acupuncture combined swallowing training treatment group in a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingqing Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian University of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Qingqing Zhang, Fujian University of Traditional Chinese Medicine
- Investigators
- Qingqing Zhang, Principal investigator, Fujian University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982977
- Sponsor's protocol ID
- 2022J01880
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training to Regulate the Cortical Swallowing Network in Oral Dysphagia of Stroke
- ClinicalTrials.gov ID
- NCT05982977
- Acronym / sponsor ID
- 2022J01880
- Conditions
- Dysphagia, Stroke, Oral Phase
- Keywords
- Dysphagia, stroke, cortical swallowing network, Oral Phase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Qingqing ZhangUniversity, hospital or other
- Collaborators
- Fujian University of Traditional Chinese Medicine
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 9 Aug 2023 (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.
Up to 84% of patients after stroke are accompanied by dysphagia, of which 53% are oral dysphagia. The oral phase is the initial phase of swallowing activity and the only stage of swallowing that is completely discretionary. Swallowing activity in the oral stage is not only related to the formation and push of food pellets, but also affects the continuity between the transition from spontaneous swallowing to the swallowing reflex.
Detailed description
After stroke, patients are prone to oral dysphagia, poor control of food masses and liquids in the mouth, resulting in food spillover, residual and premature overflow, resulting in dehydration, malnutrition, aspiration, pneumonia and other serious consequences, which greatly reduce the eating safety and quality of life of patients after stroke. Therefore, the rehabilitation of oral swallowing function is a way for patients with swallowing disorder after stroke to return to society and improve their quality of life. Previous studies have found that acupuncture is an effective intervention to improve swallowing disorder in oral stage after stroke. Whether acupuncture promotes the improvement of swallowing function in oral stage by regulating the synergic activity of cortical swallowing network and muscle group has not been fully clarified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was a parallel, randomized controlled trial. Qualified subjects were numbered according to the inclusion order and randomly assigned to the swallowing training treatment group and the acupuncture combined swallowing training treatment group in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture rehabilitation group | Experimental | Other: AcupunctureAcupuncture rehabilitation intervention was given on the basis of conventional rehabilitation therapy.Disinfected with 75% alcohol and applied the needles at a depth of 25-35mm. Acupuncture stimulation of Lianquan (CV23) and Fengchi (GB20). The needles were retained for 30 minutes/time, once a day, and 5 days/week for a total of 4 weeks. |
| Conventional rehabilitation group | Active comparator | Behavioral: Conventional rehabilitationThis group participants would take swallowing training 30 minutes/time, once a day, 5 days/week, a total of 4 weeks of intervention. At the same time, stroke basic treatment, nutritional support and other symptomatic treatment |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients meeting the diagnostic criteria for acute ischemic stroke established by the Neurology Society of the Chinese Medical Association and confirmed by craniocerebral CT or MRI;
- Oral dysphagia caused by stroke;
- Currently diet is restricted, FOIS score is 5 or less; WST score 3 or above;
- MoCA score of 21 or above, able to understand and follow simple instructions from the treatment staff, able to cooperate and willing to undergo examination and treatment;
- 40 to 75 years old;
Key exclusion criteria (7 listed)
- Patients with dysphagia not caused by stroke or non-stroke oral dysphagia;
- Previous history of stroke or dysphagia;
- Patients with serious primary diseases or mental disorders of other systems;
- Suffering from various bleeding prone diseases;
- Severe needle fainting;
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 |
|---|---|---|
| AcupunctureThe patient was placed in a supine position, selected Lianquan, Fengchi, and acupoints. | Other | Acupuncture rehabilitation group |
| Conventional rehabilitationswallowing training included breathing training, masticatory muscle training, oral movement training and feeding training. | Behavioural | Conventional rehabilitation group |
Primary outcome
Oral functional score
Time frame: 4 weeks (Before and after intervation)
To assess participants' oral swallowing function
6 secondary outcomes
Surface electromyography
Time frame: 4 weeks (Before and after intervation)
Water swallowing test (WST)
Time frame: 4 weeks (Before and after intervation)
Standardized Swallowing Assessment (SSA)
Time frame: 4 weeks (Before and after intervation)
Functional Oral Intake Scale (FOIS)
Time frame: 4 weeks (Before and after intervation)
Teacher salivation rating (TDS)
Time frame: 4 weeks (Before and after intervation)
Swallowing Related Daily Quality of Life Scale (SWAL-QOL)
Time frame: 4 weeks (Before and after intervation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Qingqing Zhang principal investigator
Fujian University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Conventional rehabilitation in people with Dysphagia and Stroke, run by Qingqing Zhang.
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 8 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 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Qingqing Zhang (18150019719, 2017013@fjtcm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral functional score (time frame: 4 weeks (Before and after intervation)). 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 22 Aug 2023.