Clinical trial NCT06692101: Oral Care Strategies for Stroke Patients with Dysphagia
Official title: Strategic Oral Care and Intervention for Enhanced Outcomes in Acute Ischemic Stroke Patients with Dysphagia: a Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke (AIS)
Stroke-Associated Pneumonia (SAP)
Dysphagia Following Cerebrovascular Accident
Keywords: oral care.
transcutaneous neuromuscular electrical stimulation
stroke-associated pneumonia
acute cerebral infarction
dysphagia
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Model Description: This study is a parallel-group randomized controlled trial (RCT) employing a superiority trial design to evaluate the efficacy of combining neuromuscular electrical stimulation (NMES) with oral care compared to oral care alone and standard care in improving swallowing function and reducing the incidence of stroke-associated pneumonia (SAP) in patients with acute ischemic stroke (AIS).

Randomization and Blinding: Participants were randomly assigned to one of the three intervention groups (Group A, Group B, or Group C) using a computer-generated randomization sequence to ensure unbiased group allocation.

Intervention Overview:

Group A (Oral Care Group): Focused on comprehensive oral hygiene practices administered twice daily for at least five days.

Group B (Oral Care + NMES Group, O-NMES): Received the same oral care regimen as Group A, followed
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 20 years.
2. First diagnosis of acute ischemic stroke (AIS) and hospitalization.
3. Stroke onset within 48 hours.
4. NIHSS score ≥ 5 upon admission, with at least one of the following NIHSS items: facial palsy, language, or dysarthria.
5. Difficulty swallowing upon admission, indicated by a Gugging Swallowing Screen-Indirect Test score \< 5.
6. Ability to communicate verbally or in writing and provide informed consent.

Exclusion Criteria:

1. Diagnosed with pneumonia or exhibiting clinical symptoms of infection upon admission.
2. Requiring mechanical ventilation.
3. Use of antibiotics or immunosuppressants within the past month.
4. Eligible for intravenous recombinant tissue plasminogen activator (r-tPA) or mechanical thrombectomy.
5. History of seizure or epilepsy.
6. Severe communication impairment due to cognitive deficits or psychological disorders.
7. Presence of oral-pharyngeal tumors or a history of extensive surgery or radiotherapy in the head and neck region.
8. Use of electrically sensitive biomedical devices (e.g., defibrillators or pacemakers).
9. Pregnancy.

Primary outcomes:
measure: 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)
timeFrame: 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.
measure: 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)
timeFrame: 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.
measure: 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)
timeFrame: 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.
measure: Reducing stroke-associated pneumonia (SAP) incidence in acute stroke patients
timeFrame: Comparison of SAP occurrence within seven days after stroke.
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Neurology, Shuang Ho Hospital, Taipei Medical University
Study officials:
References: