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Search / Trial NCT05591040

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

Dysphagia Stroke Biofeedback Rehabilitation Randomized Controlled Study

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.

Locations

Venice Lido, , Italy

Patients applied

0 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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