Taking people in ItalyNo phase

Biofeedback Training for Swallowing Recovery After Stroke

Tests visual biofeedback training against standard verbal feedback in adults with swallowing difficulty after stroke.

Key facts

Who runs it: IRCCS San Camillo, Venezia, Italy
Where: Venice-Lido, ItalySee the site
Trial code: NCT05591040
Registry title: Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia
Status: Recruiting
People taking part: 100 people, planned
Started: 30 Oct 2022
Expected to end: 3 Dec 2027
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Biofeedback
Conventional
Record updated: 27 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have had a first stroke and now have swallowing problems (dysphagia). It tests whether biofeedback helps swallowing recovery.

Age: 18 Years to 89 Years
Sex: All sexes can join.
Disease stage: First stroke injury, with the stroke starting more than six weeks ago, and swallowing problems (dysphagia) present.
Biomarker or test result: Good understanding of speech (not below PT 53 in the Token Test) and good eyesight and hearing, or adequately corrected.

Main reasons for not taking part

Skin infection, wound or dermatitis under the chin that hinders good recording of the muscle signal
Severe other illness such as fever, infections, metabolic problems or serious heart insufficiency
Serious dystonia or unintentional movements
Disorder of consciousness, or encephalopathy due to multiple infarcts
Other neurological disease, for example Parkinson disease

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

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

Who cannot take part

Severe concomitant illnesses (fever, infections, metabolic problems, serious cardiac insufficiency) that can influence patient's collaboration
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)
presence of disorders of consciousness
other neurological diseases (for example Parkinson disease)
Serious dystonia or unintentional movements
encephalopathy due to multiple infarcts
inability to sustain the experimental treatment

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 89 years old?

Where in Italy

Sara NordioVenice-Lido, ItalyContact: Sara NordioTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

BiofeedbackTreatment being tested
Each participant will attend 5 sessions per week for a total duration of 4 weeks. The duration of each session will take 1 hour, including bio-feedback preparation. At the beginning of the bio-feedback session, two surface electrodes will be applied to the mylohyoid muscle. The patient will be required to swallow at a given time, with food bolus if possible, and perform maneuvers that favour swallowing strength and efficacy: effortful swallow, specific task for timing and coordination, Masako maneuver. The experimental group will perform this training for 45 minutes, plus they will receive a verbal feedback from the speech and language therapist in relation to the efficacy of the performance.
ConventionalExisting treatment, for comparison
Each participant will attend 5 sessions per week for a total duration of 4 weeks. The patient will be required to swallow at a given time, with food bolus if possible, and perform maneuvers that favour swallowing strength and efficacy: effortful swallow, specific task for timing and coordination, Masako maneuver. The control group will perform this training for 45 minutes, with a verbal feedback from the speech and language therapist in relation to the efficacy of the performance.