Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training to Regulate the Cortical Swallowing Network in Oral Dysphagia of Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 主要终点
- Oral functional score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Since acupuncture intervention could not blind subjects and investigators, evaluators and statisticians were secretly grouped to avoid measurement bias as much as possible
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Oral functional score
时间窗: 4 weeks (Before and after intervation)
To assess participants' oral swallowing function
次要结局
- Standardized Swallowing Assessment (SSA)(4 weeks (Before and after intervation))
- Swallowing Related Daily Quality of Life Scale (SWAL-QOL)(4 weeks (Before and after intervation))
- Surface electromyography(4 weeks (Before and after intervation))
- Water swallowing test (WST)(4 weeks (Before and after intervation))
- Functional Oral Intake Scale (FOIS)(4 weeks (Before and after intervation))
- Teacher salivation rating (TDS)(4 weeks (Before and after intervation))
研究者
Qingqing Zhang
Lecturer
Fujian University of Traditional Chinese Medicine