Clinical Trial

Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia

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Summary
The aim of the study is to evaluate whether the effect of biofeedback treatment is more effective than a control treatment in the recovery of dysphagia. This study will be a multicentric randomized, single-blind controlled study. The investigators intend to recruit 100 patients who have suffered a stroke and have dysphagia. Fifty patients will undergo training with bio-feedback (experimental group) and the other fifty patients will undergo standard training, using only verbal feedback rather than visual feedback (control group). Our hypothesis, based on the results obtained in some previous studies, is that in the control group the efficacy of the treatment will be lower in the absence of immediate visual feedback of strength, timing, coordination and efficacy of the swallowing act.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-10-19; most recent amendment 2026-03-25.
Trial Details
NCT Number NCT05591040
Lead Sponsor IRCCS San Camillo, Venezia, Italy
Collaborators: Ospedale Policlinico San Martino, Azienda Ulss 6 Euganea
Conditions Dysphagia, Rehabilitation, Stroke
Enrollment 100 participants
Start Date 2022-10-30
Primary Completion 2027-12-03 (estimated)
Study Completion 2027-12-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-27