Oral Care Strategies for Stroke Patients with Dysphagia

NCT ID: NCT06692101

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-09
• Study Completion Date: 2023-05-09

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.

Conditions

Acute Ischemic Stroke (AIS); Stroke-Associated Pneumonia (SAP); Dysphagia Following Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A (Oral Care)

Participants received oral care twice daily for at least five days. Oral care procedures included:

• Preparation: Necessary tools and suction devices were prepared, and patients were assisted in upright sitting before oral care.
• Oral Assessment: A flashlight and toothbrush were used to perform an oral assessment and remove food debris. Saliva was aspirated if necessary.
• Oral Cleaning: Oral cleaning tools, including a toothbrush, dental floss, and interdental brush, were utilized with fluoridated toothpaste (fluoride >1,000 ppm, <0.5 cm³). The Bass method of brushing was employed for toothbrushing.
• Tongue Cleaning: The anterior two-thirds of the tongue was cleaned with a moistened toothbrush following brushing.

Group Type: ACTIVE_COMPARATOR

oral care

Intervention Type: OTHER

We prepared the necessary tools and suction devices, then helped patients sit upright before starting oral care. Using a flashlight and toothbrush, we assessed the mouth and removed any food debris, aspirating saliva if needed. We cleaned the teeth using a toothbrush, dental floss, and an interdental brush with a small amount of fluoridated toothpaste. The Bass method was used for brushing. Finally, we cleaned the front two-thirds of the tongue with a damp toothbrush.

Group B (O-NMES)

Participants received the same oral care as Group A, and NMES therapy was administered after each oral care session. NMES therapy involved:

• Equipment: NMES was administered using VitalStim® (Chattanooga, TN, USA).
• Preparation: Participants were instructed to shave facial hair and cleanse the neck skin with alcohol wipes before electrode placement.
• Electrode Placement: Four electrode pads were placed horizontally above and below the hyoid bone. (Figure 1.)
• Stimulation Parameters: The NMES unit provided dual-pole stimulation across four channels at a fixed pulse rate of 80 Hz and a fixed biphasic pulse duration of 300 μs.
• Session Duration and Intensity: Each session lasted 30 minutes, with the stimulation intensity gradually increased in intervals of 0.5 mA, adjusted based on patient feedback, and set to the maximum tolerance level defined by the patient.

Group Type: ACTIVE_COMPARATOR

oral care

Intervention Type: OTHER

We prepared the necessary tools and suction devices, then helped patients sit upright before starting oral care. Using a flashlight and toothbrush, we assessed the mouth and removed any food debris, aspirating saliva if needed. We cleaned the teeth using a toothbrush, dental floss, and an interdental brush with a small amount of fluoridated toothpaste. The Bass method was used for brushing. Finally, we cleaned the front two-thirds of the tongue with a damp toothbrush.

Neuromuscular Electrical Stimulation (NMES)

Intervention Type: DEVICE

We used the VitalStim® device to deliver neuromuscular electrical stimulation (NMES). Before placing the electrodes, participants were asked to shave any facial hair and clean their neck skin with alcohol wipes. We positioned four electrode pads horizontally, above and below the hyoid bone. The device provided stimulation at a pulse rate of 80 Hz with a biphasic pulse duration of 300 microseconds. Each session lasted 30 minutes, with the intensity gradually increased in 0.5 mA intervals, based on the patient's comfort level, and adjusted to their maximum tolerance.

Group C (Control)

Participants received standard care per the unit's existing protocol, which included oral care administered by nurses and verbal education provided to patients and their caregivers to encourage oral hygiene practices at least once daily.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

oral care

We prepared the necessary tools and suction devices, then helped patients sit upright before starting oral care. Using a flashlight and toothbrush, we assessed the mouth and removed any food debris, aspirating saliva if needed. We cleaned the teeth using a toothbrush, dental floss, and an interdental brush with a small amount of fluoridated toothpaste. The Bass method was used for brushing. Finally, we cleaned the front two-thirds of the tongue with a damp toothbrush.

Intervention Type: OTHER

Neuromuscular Electrical Stimulation (NMES)

We used the VitalStim® device to deliver neuromuscular electrical stimulation (NMES). Before placing the electrodes, participants were asked to shave any facial hair and clean their neck skin with alcohol wipes. We positioned four electrode pads horizontally, above and below the hyoid bone. The device provided stimulation at a pulse rate of 80 Hz with a biphasic pulse duration of 300 microseconds. Each session lasted 30 minutes, with the intensity gradually increased in 0.5 mA intervals, based on the patient's comfort level, and adjusted to their maximum tolerance.

Intervention Type: DEVICE

Other Intervention Names

oral care

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.

• Minimum Eligible Age: 20 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Neurology, Shuang Ho Hospital, Taipei Medical University

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

111HHC-02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N202108021

Identifier Type: -

Identifier Source: org_study_id