About this trial
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
Qualifiers
first stroke injury
onset from more than six weeks
presence of dysphagia
good comprehension ( not below PT 53 in Token Test)
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Biofeedback
- Conventional
Treatment groups
Sponsors and collaborators
IRCCS San Camillo, Venezia, Italy
Lead sponsor
Ospedale Policlinico San Martino
Collaborator
Azienda Ulss 6 Euganea
Collaborator