Using biofeedback to help stroke patients with swallowing difficulties
Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Multicentric Randomized Controlled Trial
NA · IRCCS San Camillo, Venezia, Italy · NCT05591040
This study tests if using biofeedback can help stroke patients with swallowing difficulties improve their swallowing better than standard verbal instructions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | IRCCS San Camillo, Venezia, Italy (other) |
| Locations | 1 site (Venice-Lido) |
| Trial ID | NCT05591040 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are stroke survivors with dysphagia who have had their stroke more than six weeks prior and possess good comprehension.
Not a fit: Patients with severe concomitant illnesses or other neurological diseases may not benefit from this study.
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 performed: Previous studies have suggested that biofeedback may enhance rehabilitation outcomes, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Venice-Lido
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dysphagia, Rehabilitation, Stroke, dysphagia, stroke, biofeedback, rehabilitation, randomized controlled study