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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

Istanbul Arel University

Collaborators

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)

August 1, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

February 20, 2026

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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