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Strategic Oral Care and Intervention for Enhanced Outcomes in Acute Ischemic Stroke Patients with Dysphagia: a Pilot Randomized Controlled Study
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.
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. Group C (Control Group): Received standard care, including routine oral hygiene practices. Participant Screening and Baseline Assessment Upon admission, all participants underwent brain imaging (CT or MRI) to confirm stroke and exclude other conditions. Demographic data (age, gender, and cerebrovascular risk factors) and baseline assessments, such as the National Institutes of Health Stroke Scale (NIHSS) for stroke severity, were collected. Laboratory tests were performed to evaluate blood cell counts, creatinine, albumin, and glycated hemoglobin (HbA1c) levels. Participants' swallowing function and the need for nasogastric tube (NGT) insertion were also recorded. Intervention Protocols Oral Care Procedures (Group A \& B): Included the use of a toothbrush, dental floss, and fluoridated toothpaste, with the Bass method for brushing. Tongue cleaning and saliva aspiration were also performed to maintain oral hygiene. NMES Therapy (Group B Only): NMES was delivered using the VitalStim® system. Four electrode pads were placed on the neck, and stimulation parameters were adjusted based on patient tolerance. Each NMES session lasted 30 minutes, following strict preparation and placement protocols. Data Collection and Outcome Measures Data were collected at baseline, on day 4 (T1), and on day 8 (T2) post-stroke. Key outcomes included changes in swallowing function, assessed using tools like the Gugging Swallowing Screen (GUSS) and the incidence of SAP. The study's primary hypothesis is that combining NMES with oral care will yield better outcomes in swallowing function and reduce pneumonia risk compared to oral care alone or standard care. Assessment Tools NIHSS: Used to evaluate stroke severity, focusing on items like facial palsy, language, and speech that may influence oral and swallowing control. ROAG: Assesses oral health status across multiple categories, with higher scores indicating more severe oral health issues. GUSS: A comprehensive tool to screen and monitor swallowing function, facilitating the identification of impairments and personalized care. Study Implications This research is designed to contribute valuable insights into stroke rehabilitation and offer evidence-based guidelines for enhancing clinical care. By exploring different treatment strategies, we aim to inform future practices in managing dysphagia and preventing SAP in stroke patients, ultimately improving recovery outcomes and quality of life.
Age
0 - No limit years
Sex
ALL
Healthy Volunteers
No
Department of Neurology, Shuang Ho Hospital, Taipei Medical University
New Taipei City, Taiwan
Start Date
December 9, 2021
Primary Completion Date
May 3, 2023
Completion Date
May 9, 2023
Last Updated
November 18, 2024
35
ACTUAL participants
oral care
OTHER
Neuromuscular Electrical Stimulation (NMES)
DEVICE
Lead Sponsor
Taipei Medical University Shuang Ho Hospital
NCT06827301
NCT06195501
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