Skip to main content
OpenTrials
Completed

NCT Number: NCT07435441

Turkish Validity and Reliability of the Bolus Residue Scale in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-stroke Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Scale Reliability Validity Videofluoroscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Arel University

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Collaborators

  • Atlas University
  • Hacettepe University
  • Istinye University

Registry information

Official study title

Turkish Validity and Reliability of the Bolus Residue Scale (BRS) in Patients With Acute Stroke

Acronym: BRS-TR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.