Post-strokeBRS-TRNCT07435441
Turkish Validity and Reliability of the Bolus Residue Scale in Acute Stroke
An observational study of Post-stroke and Dysphagia, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the validity and reliability of the Turkish version of the Bolus Residue Scale (BRS) in patients with acute stroke. The study has a methodological, observational, and cross-sectional design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke, Dysphagia, Videofluoroscopy
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 20 Feb 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adult patients with acute stroke who were referred for videofluoroscopic swallowing study (VFSS) as part of routine clinical care. All participants underwent swallowing assessment using standardized residue and swallowing scales. No intervention was applied, and all evaluations were conducted within standard clinical practice.
Who may be able to join
- Diagnosis of acute stroke confirmed by neurological and radiological evaluation
- Age 18 years and older
- Undergoing videofluoroscopic swallowing study (VFSS) as part of routine clinical assessment
- Ability to participate in swallowing assessment procedures
- Provision of written informed consent by the patient or a legal representative
Who cannot join
- History of head and neck cancer or head and neck surgery
- Pre-existing neurological diseases affecting swallowing (e.g., Parkinson's disease, amyotrophic lateral sclerosis)
- Structural abnormalities of the upper aerodigestive tract
- Severe cognitive impairment preventing cooperation with assessment procedures
- Incomplete or poor-quality VFSS recordings unsuitable for analysis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Arel University
Istanbul, Zeytinburnu, 34015
About this study
Official title: Turkish Validity and Reliability of the Bolus Residue Scale (BRS) in Patients With Acute Stroke
This study aims to evaluate the validity and reliability of the Turkish version of the Bolus Residue Scale (BRS) in patients with acute stroke. The study has a methodological, observational, and cross-sectional design. Videofluoroscopic swallowing study (VFSS) recordings will be scored independently by trained raters using the BRS. Psychometric properties including construct validity, criterion validity, inter-rater and intra-rater reliability will be analyzed.
- Conditions
- Post-stroke, Dysphagia, Videofluoroscopy, Scale Reliability Validity
- Being tested
- No intervention (observational study)
- Keywords
- Dyshagia, Scale reliability validity, Post-stroke, videofluoroscopy, Bolus residue scale
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
This study does not involve any therapeutic, behavioral, or procedural intervention. All assessments were performed as part of routine clinical care, and no changes were made to standard treatment or clinical management.
| Study group | Role | What they receive |
|---|---|---|
| Acute Stroke Patients | This cohort consists of patients with acute stroke who underwent videofluoroscopic swallowing study (VFSS) as part of routine clinical evaluation. Swallowing function was assessed using the Bolus Residue Scale (BRS) for the purpose of validity and reliability analysis. No intervention was applied, and no changes were made to standard clinical care. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bolus Residue Scale (BRS)
The Bolus Residue Scale (BRS) Turkish version is a videofluoroscopic swallowing assessment tool used to evaluate the severity of pharyngeal residue following swallowing.
The scale consists of six ordinal levels, ranging from Grade 1 (no residue) to Grade 6 (severe residue) based on the presence and extent of bolus residue in the pharynx.
Higher scores indicate greater pharyngeal residue severity and poorer swallowing efficiency.
Measured: Baseline (during videofluoroscopic swallowing study assessment)
Secondary outcomes (3)
Swallowing Safety Assessed by the Penetration-Aspiration Scale
The Penetration-Aspiration Scale (PAS) is an 8-point ordinal scale used during videofluoroscopic swallowing assessment to evaluate the severity of airway invasion.
The scale ranges from Score 1 (material does not enter the airway) to Score 8 (material enters the airway, passes below the vocal folds, and no effort is made to eject it).
Higher scores indicate more severe penetration or aspiration and poorer airway protection during swallowing.
Measured: Baseline (during videofluoroscopic swallowing study assessment)
Pharyngeal Residue Assessed by the Yale Residue Scale
The Yale Pharyngeal Residue Severity Rating Scale (YPRSRS) is a 5-point ordinal scale used to quantify the severity of pharyngeal residue during videofluoroscopic swallowing study (VFSS).
Residue severity is rated separately for the valleculae and pyriform sinuses, with scores ranging from 0 (no residue) to 4 (severe residue) based on the amount of bolus residue remaining after swallowing.
Higher scores indicate greater pharyngeal residue and more severe swallowing impairment.
Measured: Baseline (during videofluoroscopic swallowing study assessment)
Functional Oral Intake Assessment
The Functional Oral Intake Scale (FOIS) is a 7-level ordinal scale used to classify an individual's level of oral intake in patients with dysphagia.
The scale ranges from Level 1 (nothing by mouth) to Level 7 (total oral diet with no restrictions), reflecting the degree of functional oral intake.
Higher FOIS levels indicate better oral intake ability and improved swallowing function.
Measured: Baseline (during videofluoroscopic swallowing study assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Aug 2025
- Primary completion15 Jan 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-strokeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Istinye University, Atlas University
- Responsible party
- Principal investigator, Rabia KUM GULER, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435441
- Sponsor's protocol ID
- IstanbulArelU-ETK-2025/20-10
- Acronym
- BRS-TR
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical restrictions and data protection regulations. The data are collected as part of routine clinical care and include sensitive health information, and no consent for public data sharing has been obtained from participants.
Publications
Soyer T, Arslan SS, Pisiren B, Boybeyi O, Yalcin E, Demir N. The Role of Bolus Residue and Its Relation with Respiratory Problems in Children with Esophageal Atresia. Dysphagia. 2023 Dec;38(6):1546-1550. doi: 10.1007/s00455-023-10582-1. Epub 2023 May 3.
PubMed 37138140Rommel N, Borgers C, Van Beckevoort D, Goeleven A, Dejaeger E, Omari TI. Bolus Residue Scale: An Easy-to-Use and Reliable Videofluoroscopic Analysis Tool to Score Bolus Residue in Patients with Dysphagia. Int J Otolaryngol. 2015;2015:780197. doi: 10.1155/2015/780197. Epub 2015 Nov 12.
PubMed 26640491
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of the Bolus Residue Scale (BRS) in Patients With Acute Stroke
- ClinicalTrials.gov ID
- NCT07435441
- Acronym / sponsor ID
- BRS-TR / IstanbulArelU-ETK-2025/20-10
- Conditions
- Post-stroke, Dysphagia, Videofluoroscopy, Scale Reliability Validity
- Keywords
- Dyshagia, Scale reliability validity, Post-stroke, videofluoroscopy, Bolus residue scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University, Istinye University, Atlas University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 27 Feb 2026 (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 the validity and reliability of the Turkish version of the Bolus Residue Scale (BRS) in patients with acute stroke. The study has a methodological, observational, and cross-sectional design. Videofluoroscopic swallowing study (VFSS) recordings will be scored independently by trained raters using the BRS. Psychometric properties including construct validity, criterion validity, inter-rater and intra-rater reliability will be analyzed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Stroke Patients | – | Other: No intervention (observational study)This cohort consists of patients with acute stroke who underwent videofluoroscopic swallowing study (VFSS) as part of routine clinical evaluation. Swallowing function was assessed using the Bolus Residue Scale (BRS) for the purpose of validity and reliability analysis. No intervention was applied, and no changes were made to standard clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients with acute stroke who were referred for videofluoroscopic swallowing study (VFSS) as part of routine clinical care. All participants underwent swallowing assessment using standardized residue and swallowing scales. No intervention was applied, and all evaluations were conducted within standard clinical practice.
Key inclusion criteria (5 listed)
- Diagnosis of acute stroke confirmed by neurological and radiological evaluation
- Age 18 years and older
- Undergoing videofluoroscopic swallowing study (VFSS) as part of routine clinical assessment
- Ability to participate in swallowing assessment procedures
- Provision of written informed consent by the patient or a legal representative
Key exclusion criteria (5 listed)
- History of head and neck cancer or head and neck surgery
- Pre-existing neurological diseases affecting swallowing (e.g., Parkinson's disease, amyotrophic lateral sclerosis)
- Structural abnormalities of the upper aerodigestive tract
- Severe cognitive impairment preventing cooperation with assessment procedures
- Incomplete or poor-quality VFSS recordings unsuitable for analysis
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 |
|---|---|---|
| No intervention (observational study)This study does not involve any therapeutic, behavioral, or procedural intervention. All assessments were performed as part of routine clinical care, and no changes were made to standard treatment or clinical management. | Other | Acute Stroke Patients |
Primary outcome
Bolus Residue Scale (BRS)
Time frame: Baseline (during videofluoroscopic swallowing study assessment)
The Bolus Residue Scale (BRS) Turkish version is a videofluoroscopic swallowing assessment tool used to evaluate the severity of pharyngeal residue following swallowing. The scale consists of six ordinal levels, ranging from Grade 1 (no residue) to Grade 6 (severe residue) based on the presence and extent of bolus residue in the pharynx. Higher scores indicate greater pharyngeal residue severity and poorer swallowing efficiency.
3 secondary outcomes
Swallowing Safety Assessed by the Penetration-Aspiration Scale
Time frame: Baseline (during videofluoroscopic swallowing study assessment)
Pharyngeal Residue Assessed by the Yale Residue Scale
Time frame: Baseline (during videofluoroscopic swallowing study assessment)
Functional Oral Intake Assessment
Time frame: Baseline (during videofluoroscopic swallowing study assessment)
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 27 Feb 2026.
- Background: PubMed 37138140Soyer T, Arslan SS, Pisiren B, Boybeyi O, Yalcin E, Demir N. The Role of Bolus Residue and Its Relation with Respiratory Problems in Children with Esophageal Atresia. Dysphagia. 2023 Dec;38(6):1546-1550. doi: 10.1007/s00455-023-10582-1. Epub 2023 May 3.
- Results publication: PubMed 26640491Rommel N, Borgers C, Van Beckevoort D, Goeleven A, Dejaeger E, Omari TI. Bolus Residue Scale: An Easy-to-Use and Reliable Videofluoroscopic Analysis Tool to Score Bolus Residue in Patients with Dysphagia. Int J Otolaryngol. 2015;2015:780197. doi: 10.1155/2015/780197. Epub 2015 Nov 12.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical restrictions and data protection regulations. The data are collected as part of routine clinical care and include sensitive health information, and no consent for public data sharing has been obtained from participants.
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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?
An observational study of Post-stroke and Dysphagia, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 27 Feb 2026. 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 Turkey (Türkiye). 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?
Bolus Residue Scale (BRS) (time frame: Baseline (during videofluoroscopic swallowing study assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07435441, which also lists 2 linked publications.
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 27 Feb 2026.