Dsyphagia After StrokeNCT07059351
Oral Status as Predictors of Stroke-Associated Pneumonia and Swallowing Recovery in Patients With Post-Stroke Dysphagia
An observational study of Dsyphagia After Stroke, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Post-stroke dysphagia (PSD) is a common condition that significantly impacts recovery and increases the risk of complications such as pneumonia, malnutrition, and prolonged hospital stays. Early identification and management are essential, as emphasized in several international clinical guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dsyphagia After Stroke
- How many people
- 260 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jul 2025to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute stroke patients with dysphagia
Who may be able to join
- Patients admitted to the stroke unit at Ghent University Hospital with ischemic or hemorrhagic stroke who are diagnosed with oropharyngeal dysphagia.
- Patients over 18 years of age with sufficient cognitive abilities and language skills to understand the swallowing exercises.
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Sungkrit Pojmonpiti, +32456398999, sungkrit.pojmonpiti@ugent.be
Barbara Janssens, +32473615130, barbarae.janssens@ugent.be
About this study
Official title: Oral Status as Predictors of Stroke-Associated Pneumonia and Swallowing Recovery in Patients With Post-Stroke Dysphagia: A Prospective Cohort Study
Post-stroke dysphagia (PSD) is a common condition that significantly impacts recovery and increases the risk of complications such as pneumonia, malnutrition, and prolonged hospital stays. Early identification and management are essential, as emphasized in several international clinical guidelines. However, predicting which patients will develop stroke-associated pneumonia (SAP) or experience delayed swallowing recovery remains a challenge. Recent evidence suggests that oral health status-including hygiene, tongue strength, and dental support-may play a key role in these outcomes. Assessing oral health could therefore aid in identifying high-risk patients and improving rehabilitation strategies.
Study Design and Setting A cohort study was designed with prospective data collection, conducted in parallel with a randomized controlled trial (RCT) at the stroke unit of Ghent University Hospital, Ghent, Belgium (ONZ-2024-0245). Data collection is expected to occur over two years, from 2025 to 2027.
Read more
The RCT is a one-day experimental study investigating the immediate effects of oral hygiene care on swallowing and masticatory functions. The interventions performed in this clinical study involve routine oral care procedures and are not expected to influence the outcomes of the cohort study.
Participants Participants will be recruited from all consecutive patients admitted to the stroke unit at Ghent University Hospital with ischemic or hemorrhagic stroke and a diagnosis of oropharyngeal dysphagia. For the diagnosis of oropharyngeal dysphagia, all patients will be restricted from oral intake upon arrival until a stroke nurse completes a step-by-step standardized protocol to screen for swallowing disorders.
Read the detailed description
Data Collection A team of trained dental professionals and speech therapists will collect demographic and clinical data within the first three days after admission and will monitor cohort outcomes at day seven post-admission and weekly thereafter until discharge.
During the initial visit, baseline characteristics-including socio-demographic, medical, and clinical information-will be documented, with a specific focus on oral health status. Socio-demographic data will include age, gender, education level, living situation, and eligibility for increased healthcare cost reimbursement. Medical history will include smoking status, body mass index (BMI), medication use, stroke type, stroke location, and prior stroke events. Standardized assessment scores-namely the National Institutes of Health Stroke Scale (NIHSS), the Modified Rankin Scale (mRS), and the Functional Oral Intake Scale (FOIS)-will also be recorded. These data will be obtained from medical records and patient interviews conducted by the research team.
Oral status assessment includes two main components: dental information, and oral and masticatory function. Dental data will be gathered by a dentist using a standard dental probe, mirror, and headlamp at the bedside. Documented parameters will include oral care capacity, oral hygiene indices (dental plaque using a modified Turesky-Quigley-Hein index, tongue plaque via Winkel's index, and denture plaque assessed with the Augsburger and Elahi index). Additionally, oral disease status will be evaluated by measuring periodontal condition (Dutch Periodontal Screening Index - DPSI), tooth mobility (Miller's classification), clinical caries (International Caries Detection and Assessment System - ICDAS), and denture stomatitis (Newton's classification). Further oral status indicators will include the number of functional teeth, the number of posterior occluding pairs, denture status, and clinical signs of oral dryness.
Oral and masticatory function will be assessed using the Test of Masticating and Swallowing Solids (TOMASS), which evaluates the number of masticatory cycles, swallows, total time, and discrete bites while consuming a standardized cracker. Tongue strength will be measured using the Iowa Oral Performance Instrument during both resting and swallowing phases. Residual oral content will be scored using the Oral Residue Score-a 4-point scale (0-3) across eight oral regions: left teeth, right teeth, left sulcus and cheek, right sulcus and cheek, hard palate, soft palate, tongue dorsum, and floor of the mouth-yielding a maximum score of 24.
- Conditions
- Dsyphagia After Stroke
- Keywords
- Stroke, Deglutition, Dysphagia, Oral care, Swallowing disorder
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute stroke with dysphagia | Acute stroke patients with dysphagia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pneumonia
Diagnosed based on the modified Centers for Disease Control and Prevention criteria (Smith CJ, Kishore AK, Vail A, Chamorro A, Garau J, Hopkins SJ, et al. Diagnosis of stroke-associated pneumonia. Stroke. 2015)
Measured: At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.
Secondary outcomes (3)
Oral intake status
Oral intake status is interpreted for swallowing recovery and recorded as dichotomous data, with recovered swallowing defined as FOIS (Functional Oral Intake Scale) greater than five and unrecovered swallowing as FOIS equal to or less than five.
Measured: At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.
Length of hospital stays
Length of Stay refers to the total duration of time a patient spends in a hospital
Measured: At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.
In-hospital mortality
Death occurring during the hospital stay
Measured: At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start2 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dsyphagia After StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059351
- Sponsor's protocol ID
- ONZ-2025-0250
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD must be shared as anonymized or pseudonymized information, which may be included in a meta-analysis upon request. Data transfer must be conducted under Ghent University Hospital conditions, with legal experts drafting and reviewing the agreement (https://hiruz.be/cu/). Additionally, any data containing personal information requires approval from the Ethics Committee before transfer.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Status as Predictors of Stroke-Associated Pneumonia and Swallowing Recovery in Patients With Post-Stroke Dysphagia: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07059351
- Acronym / sponsor ID
- ONZ-2025-0250
- Conditions
- Dsyphagia After Stroke
- Keywords
- Stroke, Deglutition, Dysphagia, Oral care, Swallowing disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 10 Jul 2025 (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.
Post-stroke dysphagia (PSD) is a common condition that significantly impacts recovery and increases the risk of complications such as pneumonia, malnutrition, and prolonged hospital stays. Early identification and management are essential, as emphasized in several international clinical guidelines. However, predicting which patients will develop stroke-associated pneumonia (SAP) or experience delayed swallowing recovery remains a challenge. Recent evidence suggests that oral health status-including hygiene, tongue strength, and dental support-may play a key role in these outcomes. Assessing oral health could therefore aid in identifying high-risk patients and improving rehabilitation strategies.
Study Design and Setting A cohort study was designed with prospective data collection, conducted in parallel with a randomized controlled trial (RCT) at the stroke unit of Ghent University Hospital, Ghent, Belgium (ONZ-2024-0245). Data collection is expected to occur over two years, from 2025 to 2027.
The RCT is a one-day experimental study investigating the immediate effects of oral hygiene care on swallowing and masticatory functions. The interventions performed in this clinical study involve routine oral care procedures and are not expected to influence the outcomes of the cohort study.
Participants Participants will be recruited from all consecutive patients admitted to the stroke unit at Ghent University Hospital with ischemic or hemorrhagic stroke and a diagnosis of oropharyngeal dysphagia. For the diagnosis of oropharyngeal dysphagia, all patients will be restricted from oral intake upon arrival until a stroke nurse completes a step-by-step standardized protocol to screen for swallowing disorders.
Detailed description
Data Collection A team of trained dental professionals and speech therapists will collect demographic and clinical data within the first three days after admission and will monitor cohort outcomes at day seven post-admission and weekly thereafter until discharge.
During the initial visit, baseline characteristics-including socio-demographic, medical, and clinical information-will be documented, with a specific focus on oral health status. Socio-demographic data will include age, gender, education level, living situation, and eligibility for increased healthcare cost reimbursement. Medical history will include smoking status, body mass index (BMI), medication use, stroke type, stroke location, and prior stroke events. Standardized assessment scores-namely the National Institutes of Health Stroke Scale (NIHSS), the Modified Rankin Scale (mRS), and the Functional Oral Intake Scale (FOIS)-will also be recorded. These data will be obtained from medical records and patient interviews conducted by the research team.
Oral status assessment includes two main components: dental information, and oral and masticatory function. Dental data will be gathered by a dentist using a standard dental probe, mirror, and headlamp at the bedside. Documented parameters will include oral care capacity, oral hygiene indices (dental plaque using a modified Turesky-Quigley-Hein index, tongue plaque via Winkel's index, and denture plaque assessed with the Augsburger and Elahi index). Additionally, oral disease status will be evaluated by measuring periodontal condition (Dutch Periodontal Screening Index - DPSI), tooth mobility (Miller's classification), clinical caries (International Caries Detection and Assessment System - ICDAS), and denture stomatitis (Newton's classification). Further oral status indicators will include the number of functional teeth, the number of posterior occluding pairs, denture status, and clinical signs of oral dryness.
Oral and masticatory function will be assessed using the Test of Masticating and Swallowing Solids (TOMASS), which evaluates the number of masticatory cycles, swallows, total time, and discrete bites while consuming a standardized cracker. Tongue strength will be measured using the Iowa Oral Performance Instrument during both resting and swallowing phases. Residual oral content will be scored using the Oral Residue Score-a 4-point scale (0-3) across eight oral regions: left teeth, right teeth, left sulcus and cheek, right sulcus and cheek, hard palate, soft palate, tongue dorsum, and floor of the mouth-yielding a maximum score of 24.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute stroke with dysphagia | – | –Acute stroke patients with dysphagia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute stroke patients with dysphagia
Key inclusion criteria (2 listed)
- Patients admitted to the stroke unit at Ghent University Hospital with ischemic or hemorrhagic stroke who are diagnosed with oropharyngeal dysphagia.
- Patients over 18 years of age with sufficient cognitive abilities and language skills to understand the swallowing exercises.
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of pneumonia
Time frame: At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.
Diagnosed based on the modified Centers for Disease Control and Prevention criteria (Smith CJ, Kishore AK, Vail A, Chamorro A, Garau J, Hopkins SJ, et al. Diagnosis of stroke-associated pneumonia. Stroke. 2015)
3 secondary outcomes
Oral intake status
Time frame: At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.
Length of hospital stays
Time frame: At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.
In-hospital mortality
Time frame: At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No. The IPD must be shared as anonymized or pseudonymized information, which may be included in a meta-analysis upon request. Data transfer must be conducted under Ghent University Hospital conditions, with legal experts drafting and reviewing the agreement (https://hiruz.be/cu/). Additionally, any data containing personal information requires approval from the Ethics Committee before transfer.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dsyphagia After Stroke, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Jul 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sungkrit Pojmonpiti (+32456398999, sungkrit.pojmonpiti@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pneumonia (time frame: At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.). 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 17 Jul 2025.