Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia
Launched by IRCCS SAN CAMILLO, VENEZIA, ITALY · Oct 19, 2022
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of biofeedback to help patients recover from dysphagia, which is difficulty swallowing, after having a stroke. Researchers want to find out if using biofeedback, which provides immediate visual feedback about swallowing strength and coordination, is more effective than standard training that only gives verbal instructions. The study will involve 100 participants who have had their first stroke at least six weeks ago and are experiencing dysphagia.
To join the study, participants need to be able to understand instructions and have good eyesight and hearing. Unfortunately, people with certain conditions, such as severe illnesses that affect their ability to participate or other neurological diseases like Parkinson's, cannot take part. Those who are eligible can expect to receive either the biofeedback treatment or the standard training, and the researchers will closely monitor their progress to see which method works better for swallowing recovery.
Gender
ALL
Eligibility criteria
- 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)
About Irccs San Camillo, Venezia, Italy
IRCCS San Camillo, located in Venice, Italy, is a renowned clinical research institute dedicated to advancing medical science through innovative research and high-quality clinical trials. As a recognized Institute of Hospitalization and Care for Scientific Research (IRCCS), it specializes in various fields, including neurology, psychiatry, and rehabilitation. With a commitment to improving patient outcomes, IRCCS San Camillo collaborates with national and international research networks, fostering a multidisciplinary approach to healthcare challenges. The institute emphasizes ethical standards and patient safety, ensuring that all trials adhere to rigorous regulatory guidelines while contributing valuable insights to the medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Venice Lido, , Italy
Patients applied
Trial Officials
Sara Nordio
Principal Investigator
IRCCS San Camillo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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