Clinical trial NCT05982977: Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke
Official title: Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training to Regulate the Cortical Swallowing Network in Oral Dysphagia of Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Stroke
Oral Phase
Keywords: Dysphagia
stroke
cortical swallowing network
Oral Phase
Lead sponsor: Fujian University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Fujian University of Traditional Chinese Medicine
First posted: 2023-08-09
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Oral dysphagia caused by stroke;
3. Currently diet is restricted, FOIS score is 5 or less; WST score 3 or above;
4. 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;
5. 40 to 75 years old;
6. Conscious and stable vital signs;
7. Convalescent patients with stroke course and dysphagia duration between 1-6 months;
8. Voluntary participation and informed consent.

Exclusion Criteria:

1. Patients with dysphagia not caused by stroke or non-stroke oral dysphagia;
2. Previous history of stroke or dysphagia;
3. Patients with serious primary diseases or mental disorders of other systems;
4. Suffering from various bleeding prone diseases;
5. Severe needle fainting;
6. People with metal implants.
7. Patients with poor compliance are not treated as prescribed

Primary outcomes:
measure: Oral functional score
timeFrame: 4 weeks (Before and after intervation)
Secondary outcomes:
measure: Surface electromyography
timeFrame: 4 weeks (Before and after intervation)
measure: Water swallowing test (WST)
timeFrame: 4 weeks (Before and after intervation)
measure: Standardized Swallowing Assessment (SSA)
timeFrame: 4 weeks (Before and after intervation)
measure: Functional Oral Intake Scale (FOIS)
timeFrame: 4 weeks (Before and after intervation)
measure: Teacher salivation rating (TDS)
timeFrame: 4 weeks (Before and after intervation)
measure: Swallowing Related Daily Quality of Life Scale (SWAL-QOL)
timeFrame: 4 weeks (Before and after intervation)
Other outcomes:
Locations:
Study officials:
affiliation: Fujian University of Traditional Chinese Medicine
name: Qingqing Zhang
role: PRINCIPAL_INVESTIGATOR
References: