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Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia

RecruitingNAAges 18 Years - 89 YearsAllIRCCS San Camillo, Venezia, Italy
NCT05591040 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * first stroke injury * onset from more than six weeks * presence of dysphagia * good comprehension ( not below PT 53 in Token Test) * good eyesight and hearing, or adequately corrected Exclusion Criteria: * All the elements that hinder a good recording of the electromyographic signal (for instance a cutaneous infection, a wound or a dermatitis in the submandibular area); * Severe concomitant illnesses (fever, infections, metabolic problems, serious cardiac insufficiency) that can influence patient's collaboration; * Serious dystonia or unintentional movements * presence of disorders of consciousness; * encephalopathy due to multiple infarcts; * inability to sustain the experimental treatment; * other neurological diseases (for example Parkinson disease)
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What it tests

  • Biofeedback
  • Conventional
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Where

1 site
Sara Nordio
Venice-Lido, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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