Turkish Validity and Reliability of the Bolus Residue Scale in Acute Stroke (BRS-TR)

February 25, 2026 updated by: Rabia KUM GULER, Istanbul Arel University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turkey (Türkiye), 34015
        • Istanbul Arel University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (during videofluoroscopic swallowing study assessment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Swallowing Safety Assessed by the Penetration-Aspiration Scale
Time Frame: Baseline (during videofluoroscopic swallowing study assessment)

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.
Baseline (during videofluoroscopic swallowing study assessment)
Pharyngeal Residue Assessed by the Yale Residue Scale
Time Frame: Baseline (during videofluoroscopic swallowing study assessment)

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.
Baseline (during videofluoroscopic swallowing study assessment)
Functional Oral Intake Assessment
Time Frame: Baseline (during videofluoroscopic swallowing study 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.
Baseline (during videofluoroscopic swallowing study assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Arel University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hacettepe University
Istinye University
Atlas University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IstanbulArelU-ETK-2025/20-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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