Clinical trial Recruiting at 1 site Interventional Ages 18 to 89

Using biofeedback to help stroke patients with swallowing difficulties

Official title: Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Multicentric Randomized Controlled Trial

Run by IRCCS San Camillo, Venezia, Italy · NCT05591040 · Data updated 2026-11-12

This study tests if using biofeedback can help stroke patients with swallowing difficulties improve their swallowing better than standard verbal instructions.

Quick facts

Study typeInterventional
Ages18 Years to 89 Years
SexAll
Enrollment100 (estimated)
SponsorIRCCS San Camillo, Venezia, Italy
Academic / other
Locations1 site (Venice-Lido)
StatusRecruiting
StartedOctober 30, 2022
Main results expectedDecember 3, 2027
Study endsDecember 3, 2027
Registry record updatedMarch 27, 2026
Trial IDNCT05591040 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are stroke survivors with dysphagia who have had their stroke more than six weeks prior and possess good comprehension.

Probably not a fit

Patients with severe concomitant illnesses or other neurological diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of biofeedback treatment compared to standard verbal feedback in improving swallowing function in stroke patients with dysphagia. It is a multicentric, randomized, single-blind controlled study involving 100 participants, who will be divided into two groups: one receiving biofeedback training and the other receiving conventional training. Participants will undergo clinical evaluations before and after the treatment, as well as a follow-up evaluation two months later. The biofeedback group will receive real-time visual feedback on their swallowing muscle activity to enhance their rehabilitation process.

Why it matters

Potential benefit: If successful, this approach could significantly improve swallowing recovery in stroke patients, enhancing their quality of life.

How similar studies have gone: Previous studies have suggested that biofeedback may enhance rehabilitation outcomes, indicating potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion 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)

Where it's running

  • Sara Nordio
    Venice-Lido, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.