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.
