NCT07435441

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 20, 2026

Last Update Submit

February 25, 2026

Conditions

Keywords

DyshagiaScale reliability validityPost-strokevideofluoroscopyBolus residue scale

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (during videofluoroscopic swallowing study assessment)

Secondary Outcomes (3)

  • Swallowing Safety Assessed by the Penetration-Aspiration Scale

    Baseline (during videofluoroscopic swallowing study assessment)

  • Pharyngeal Residue Assessed by the Yale Residue Scale

    Baseline (during videofluoroscopic swallowing study assessment)

  • Functional Oral Intake Assessment

    Baseline (during videofluoroscopic swallowing study assessment)

Study Arms (1)

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)

Interventions

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.

Acute Stroke Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Arel University

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 37138140BACKGROUND
  • Rommel 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.

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 27, 2026

Study Start

August 1, 2025

Primary Completion

January 15, 2026

Study Completion

February 20, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations