Acute Ischemic Stroke (AIS)NCT06692101
Oral Care Strategies for Stroke Patients with Dysphagia
A study testing oral care and Neuromuscular Electrical Stimulation (NMES) in people with Acute Ischemic Stroke (AIS) and Stroke-Associated Pneumonia (SAP), run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 days and older
- Conditions the study is for
- Acute Ischemic Stroke (AIS), Stroke-Associated Pneumonia (SAP), Dysphagia Following Cerebrovascular Accident
- What is being tested?
- oral care and Neuromuscular Electrical Stimulation (NMES)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Dec 2021to 9 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 < 5.
- Ability to communicate verbally or in writing and provide informed consent.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Neurology, Shuang Ho Hospital, Taipei Medical University
New Taipei City, 235603
About this study
Official title: 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.
Read the 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
- Being tested
- oral care, Neuromuscular Electrical Stimulation (NMES)
- Keywords
- oral care., transcutaneous neuromuscular electrical stimulation, stroke-associated pneumonia, acute cerebral infarction, dysphagia
- Medical subject headings
- Ischemic Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral careOther
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)Device
Also called oral care
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Oral Care) | Active comparator | 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. Receives: Other: oral care |
| Group B (O-NMES) | Active comparator | 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. Receives: Other: oral care; Device: Neuromuscular Electrical Stimulation (NMES) |
| Group C (Control) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: 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.
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)
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.
Measured: 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.
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)
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.
Measured: 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.
Reducing stroke-associated pneumonia (SAP) incidence in acute stroke patients
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).
Measured: Comparison of SAP occurrence within seven days after stroke.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start9 Dec 2021
- Primary completion3 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke (AIS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692101
- Sponsor's protocol ID
- N202108021
- Other IDs
- 111HHC-02
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The content is not yet complete.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Oral Care and Intervention for Enhanced Outcomes in Acute Ischemic Stroke Patients with Dysphagia: a Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06692101
- Acronym / sponsor ID
- N202108021
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A (Oral Care) | Active comparator | Other: oral careParticipants 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 B (O-NMES) | Active comparator | Other: oral care, Device: Neuromuscular Electrical Stimulation (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 C (Control) | No intervention | –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. |
Who may qualify
- Ages
- 20 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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 < 5.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral careWe 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. | Other | Group A (Oral Care), Group B (O-NMES) |
| Neuromuscular Electrical Stimulation (NMES)Also: oral careWe 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. | Device | Group B (O-NMES) |
Primary outcome
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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Undecided. The content is not yet complete.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral care and Neuromuscular Electrical Stimulation (NMES) in people with Acute Ischemic Stroke (AIS) and Stroke-Associated Pneumonia (SAP), run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.