Strategic Oral Care and Intervention for Enhanced Outcomes in Acute Ischemic Stroke Patients with Dysphagia: a Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Changes in stroke severity and swallowing function (GUSS) at three-time points-baseline (T0), the fourth-day post-stroke (T1), and the eighth-day post-stroke (T2)
研究概览
简要总结
This study aims to evaluate whether combining neuromuscular electrical stimulation (NMES) with oral care can improve swallowing function in patients who have experienced an acute stroke and are dealing with dysphagia (difficulty swallowing). The researchers are exploring two main questions: Is this combined approach practical and manageable for patients and caregivers to use during the early stages of stroke recovery? And does this combination lead to better swallowing function and fewer stroke-related complications compared to using only oral care or traditional routine care? The goal is to identify effective strategies to support safer and faster recovery in stroke patients with swallowing difficulties.
详细描述
This randomized controlled trial (RCT) investigates the potential benefits of combining neuromuscular electrical stimulation (NMES) with standard oral care to improve swallowing function and reduce the incidence of stroke-associated pneumonia (SAP) in acute ischemic stroke (AIS) patients. Our study uses a rigorous, evidence-based approach to determine the clinical efficacy and feasibility of this therapeutic regimen during the critical early phase following a stroke.
Study Design
Conducted at a medical center from November 2021 to May 2023, this study enrolled AIS patients meeting specific criteria, such as being 20 years or older, diagnosed with acute ischemic stroke within 48 hours, and presenting with difficulty swallowing. Patients were randomly assigned to one of three groups:
Group A (Oral Care Group): Received comprehensive oral care twice daily for at least five days.
Group B (O-NMES Group): Received oral care paired with NMES therapy administered after each session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years.
- •First diagnosis of acute ischemic stroke (AIS) and hospitalization.
- •Stroke onset within 48 hours.
- •NIHSS score ≥ 5 upon admission, with at least one of the following NIHSS items: facial palsy, language, or dysarthria.
- •Difficulty swallowing upon admission, indicated by a Gugging Swallowing Screen-Indirect Test score <
- •Ability to communicate verbally or in writing and provide informed consent.
排除标准
- •Diagnosed with pneumonia or exhibiting clinical symptoms of infection upon admission.
- •Requiring mechanical ventilation.
- •Use of antibiotics or immunosuppressants within the past month.
- •Eligible for intravenous recombinant tissue plasminogen activator (r-tPA) or mechanical thrombectomy.
- •History of seizure or epilepsy.
- •Severe communication impairment due to cognitive deficits or psychological disorders.
- •Presence of oral-pharyngeal tumors or a history of extensive surgery or radiotherapy in the head and neck region.
- •Use of electrically sensitive biomedical devices (e.g., defibrillators or pacemakers).
结局指标
主要结局
Changes in stroke severity and swallowing function (GUSS) at three-time points-baseline (T0), the fourth-day post-stroke (T1), and the eighth-day post-stroke (T2)
时间窗: From enrollment to the end of treatment at day 8 post-stroke. Outcome measures were assessed at baseline (day 0), day 4, and day 8 post-stroke.
The Revised Oral Assessment Guide (ROAG) is a standardized tool for comprehensive oral health status and function assessment. It comprises eight categories: voice, lips, mucous membranes, tongue, gums, teeth or dentures, saliva production, and swallowing function. Assessors describe each category and rate them on a scoring scale, where one indicates healthy, 2 indicates minor problems, and 3 indicates severe problems. The ROAG total score ranges from 3 to 24 points, with higher scores suggesting the need for more care and attention to the participant's oral health.
Changes in stroke severity and swallowing function (ROAG) at three-time points-baseline (T0), the fourth-day post-stroke (T1), and the eighth-day post-stroke (T2)
时间窗: From enrollment to the end of treatment at day 8 post-stroke. Outcome measures were assessed at baseline (day 0), day 4, and day 8 post-stroke.
The Bedside Gugging Swallow Screen (GUSS) is a screening tool used to assess swallowing function, aiming to comprehensively evaluate a patient's ability to swallow at different viscosities. It utilizes a scoring system ranging from 0-20 points, with higher scores indicating better swallowing function. GUSS consists of a preliminary assessment, the Indirect Swallow Test (5 points), and the Direct Swallow Test (15 points). The first part includes a simple saliva swallow test, observing the patient's alertness, voluntary cough, throat clearing, and saliva swallowing. The second part comprises three subtests challenging the patient's ability to swallow semi-solids, liquids, and solids. This graded assessment design allows for a detailed evaluation of different viscosities, aiding in the timely detection of swallowing impairments and facilitating personalized dietary recommendations.
Changes in stroke severity and swallowing function (NIHSS) at three-time points-baseline (T0), the fourth-day post-stroke (T1), and the eighth-day post-stroke (T2)
时间窗: From enrollment to the end of treatment at day 8 post-stroke. Outcome measures were assessed at baseline (day 0), day 4, and day 8 post-stroke.
The National Institutes of Health Stroke Scale (NIHSS) comprises 15 neurological examination items and is commonly used to assess stroke severity. Due to its simplicity, repeatability, reliability, and validity, NIHSS scores have become a widely utilized indicator in stroke models for evaluating Acute Ischemic Stroke (AIS) outcomes. Although the NIHSS scale does not directly assess swallowing function, language impairments or speech difficulties may affect oral control in patients, potentially correlating with swallowing function to some extent. Similarly, facial palsy is associated with control of facial and oral muscles, thereby impacting swallowing function. In this study, we included patients with at least one of the NIHSS subitems involving facial palsy, language impairment, or speech difficulty to thoroughly evaluate the treatment effects and the risk of post-stroke pneumonia in AIS patients exhibiting these symptoms.
Reducing stroke-associated pneumonia (SAP) incidence in acute stroke patients
时间窗: Comparison of SAP occurrence within seven days after stroke.
In 2014, a consensus meeting was held in Manchester, UK, and after literature search, evidence review and consensus negotiation, SAP was defined as respiratory infection within seven days after stroke. SAP diagnosis is mainly based on the diagnostic criteria for pneumonia proposed by the Centers for Disease Control and Prevention (CDC): typical pulmonary symptoms (tachypnea, inspiratory crackles, bronchial breathing) or chest X-ray Abnormalities (infiltrates, parenchymal lesions) and other evidence such as fever (temperature \>38°C), cough with purulent sputum, or isolation of pathogens by blood/sputum culture (Garner et al., 1988).
次要结局
未报告次要终点