Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorIRCCS San Camillo, Venezia, Italy

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

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

IRCCS San Camillo, Venezia, Italy

Lead sponsor

Ospedale Policlinico San Martino

Collaborator

Azienda Ulss 6 Euganea

Collaborator