NCT05591040Recruiting
Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia
Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Multicentric Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 7 Oct 2022
- Start date
- 30 Oct 2022
- Primary completion date
- 3 Dec 2027
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Diseases
- Stroke
- NCT number
- NCT05591040
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 30 Oct 2022 to the primary completion date, 3 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe concomitant illnesses (fever, infections, metabolic problems, serious cardiac insufficiency) that can influence patient's collaboration;
Other illness
- 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)
Other
- Serious dystonia or unintentional movements
- encephalopathy due to multiple infarcts;
- inability to sustain the experimental treatment;
Who the study is looking for
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sara Nordio Coordinator of this site? Confirm its status | Venice-Lido | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.