NCT05591040 Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia
| NCT ID | NCT05591040 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Camillo, Venezia, Italy |
| Condition | Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-10-30 |
| Primary Completion | 2027-12-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-10-30 with a primary completion date of 2027-12-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Sara Nordio
PRINCIPAL INVESTIGATOR
IRCCS San Camillo
Frequently Asked Questions
Who can join the NCT05591040 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05591040 currently recruiting?
Yes, NCT05591040 is actively recruiting participants. Contact the research team at snordio944@gmail.com for enrollment information.
Where is the NCT05591040 trial being conducted?
This trial is being conducted at Venice-Lido, Italy.
Who is sponsoring the NCT05591040 clinical trial?
NCT05591040 is sponsored by IRCCS San Camillo, Venezia, Italy. The principal investigator is Sara Nordio at IRCCS San Camillo. The trial plans to enroll 100 participants.