Actively Recruiting
Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia
Led by IRCCS San Camillo, Venezia, Italy · Updated on 2026-03-27
100
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
I
IRCCS San Camillo, Venezia, Italy
Lead Sponsor
O
Ospedale Policlinico San Martino
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First stroke injury
- Stroke onset more than six weeks ago
- Presence of dysphagia
- Good comprehension (not below PT 53 in Token Test)
- Good eyesight and hearing, or adequately corrected
You will not qualify if you...
- Conditions preventing good electromyographic signal recording (e.g., infection, wound, dermatitis in submandibular area)
- Severe illnesses affecting patient cooperation (fever, infections, metabolic problems, serious cardiac insufficiency)
- Serious dystonia or unintentional movements
- Disorders of consciousness
- Encephalopathy due to multiple infarcts
- Inability to sustain the experimental treatment
- Other neurological diseases such as Parkinson's disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sara Nordio
Venice-Lido, Italy
Actively Recruiting
Research Team
S
Sara Nordio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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