Actively Recruiting
German Translation and Validation of the Barnes-Jewish-Hospital Stroke Dysphagia Screen (BJH-SDS)
Led by University of Giessen · Updated on 2024-07-12
570
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the German translation of the Barnes-Jewish Hospital Stroke Dysphagia Screen (BJH-SDS) to determine its accuracy and reliability in detecting swallowing difficulties in stroke patients. The study aims to confirm the test's sensitivity, specificity, and consistency across different healthcare professionals. If successful, the screen will also be tested in general neurological patients without stroke to broaden its use. The study uses two main diagnostic tests: the BJH-SDS-G, which assesses consciousness, facial and tongue movement, and a water swallow test to detect signs of aspiration; and the Flexible Endoscopic Evaluation of Swallowing (FEES), a standard procedure that examines swallowing anatomy and function to diagnose dysphagia. The BJH-SDS-G will be validated against FEES results, and then applied to patients in various clinical groups, including acute stroke patients, non-neurologic ICU patients, and other non-neurologic patients. Participants will be screened with the BJH-SDS-G after being informed about the study, and their swallowing will be assessed immediately before and after using the Barthel Index, Modified Rankin Scale, and Penetration-Aspiration Score. The study will monitor how well the translated screen matches the gold standard FEES test. The total duration of participation varies depending on patient status and assessments. The study is sponsored by the University of Giessen and runs until May 2026.
CONDITIONS
Brief Title
BJH-SDS Validation of the German Translation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stroke patients treated in the neurology departments and stroke units of participating clinics
- Patients must be informed and provide consent before screening
- Patients aged 18 to 100 years can be included
You will not qualify if you...
- Lack of informed consent
- Contraindications to flexible endoscopic swallowing examination (FEES)
- History of previous stroke
- Pre-existing swallowing difficulties
- Diseases associated with swallowing problems, such as ear, nose, and throat tumors, Parkinson's disease, or neuromuscular diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Immediately before and after the diagnostic tests
Participants undergo the German translation of the Barnes-Jewish-Hospital Stroke Dysphagia Screen (BJH-SDS) and a flexible endoscopic evaluation of swallowing (FEES) to assess swallowing function and validate the screening test.
1 to 2 visits depending on cohort assignment
Duration - Up to 1 year
Participants are observed to validate the screening test results and monitor for swallowing-related complications.
Follow-up visits as needed depending on patient condition
Trial Site Locations
Total: 1 location
1
University Hospital Giessen and Marburg, Campus Giessen
Giesen, Hesse, Germany, 35392
Actively Recruiting
Research Team
T
Tobias Braun, PD MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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