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 type | Interventional |
|---|---|
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | IRCCS San Camillo, Venezia, Italy Academic / other |
| Locations | 1 site (Venice-Lido) |
| Status | Recruiting |
| Started | October 30, 2022 |
| Main results expected | December 3, 2027 |
| Study ends | December 3, 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT05591040 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
- Principal investigator: Sara Nordio — IRCCS San Camillo
- Study coordinator: Sara Nordio
- Email: snordio944@gmail.com
- Phone: 3494990310
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Digital Tongue-Pressure Biofeedback Training for Post-Stroke Swallowing
This study tests whether digital tongue-pressure biofeedback training helps people with swallowing difficulties after stroke.
-
Effects of CTAR and a Swallowing Pressure Ball in Older Stroke Adults
This study tests whether home-based CTAR exercises plus a swallowing pressure ball can improve swallowing function and eating-related quality of life for older adults who had a stroke and have dysphagia.
-
Visual biofeedback-assisted oropharyngeal exercises with NMES for post-stroke swallowing problems
This test will try adding real-time visual feedback to swallowing exercises plus NMES in adults with post-stroke dysphagia to see if it improves swallowing function.
-
Wearable microphone patch to detect swallowing problems
We will test whether a thin wearable microphone patch can detect swallowing problems in adults aged 40–85 with stroke during their routine barium swallow (VFSS).
-
Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
-
Kinesiology taping and swallowing exercises for stroke patients with dysphagia
This study is testing if using kinesiology taping along with swallowing exercises can help stroke patients with swallowing difficulties improve their muscle strength and swallowing ability.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.