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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Biofeedback
DeviceEach participant will attend 5 sessions per week for a total duration of 4 weeks. The duration of each session will take 1 hour, including bio-feedback preparation. At the beginning of the bio-feedback session, two surface electrodes will be applied to the mylohyoid muscle. The patient will be required to swallow at a given time, with food bolus if possible, and perform maneuvers that favour swallowing strength and efficacy: effortful swallow, specific task for timing and coordination, Masako maneuver. The experimental group will perform this training for 45 minutes, plus they will receive a verbal feedback from the speech and language therapist in relation to the efficacy of the performance.
Conventional
Other interventionEach participant will attend 5 sessions per week for a total duration of 4 weeks. The patient will be required to swallow at a given time, with food bolus if possible, and perform maneuvers that favour swallowing strength and efficacy: effortful swallow, specific task for timing and coordination, Masako maneuver. The control group will perform this training for 45 minutes, with a verbal feedback from the speech and language therapist in relation to the efficacy of the performance.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: BiofeedbackExperimental treatment 1 intervention
Group B: ConventionalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Positive changes of efficacy of swallowing
Efficacy of swallowing is defined as patient's ability to start a functional swallowing reflex and to manage deglutition of saliva, then small bolus in ever greater quantities until getting to a full meal in safety. It will be measured by FOIS (Functional Oral Intake Scale- minimum value is the worst: 1; maximum value:7
Time frame
The evaluation of swallowing functions will be done before treatment, then up to 4 weeks (after 20 treatment sessions) finally up to two months2
Changes in penetration/aspiration of saliva or bolus
Penetration is a generic term refering to the action of material penetrating the larynx and entering the airway and remains above the true vocal folds, while aspiration Aspiration is a generic term refering to the action of material penetrating the larynx and entering the airway below the true vocal folds. The presence, entity and gravity of that parameters will be measured by Penetration Aspiration Scale during fibroscopy. The minimum value is 1, and indicates the better performance; the maximum value is 8, that is the worst.
Time frame
The evaluation of swallowing the entity of penetration/aspiration will be done before treatment, then up to 4 weeks (after 20 treatment sessions) finally up to two months]3
Changes in pharyngeal residues
They consist in presence of bolus or saliva post deglutition in the pharyngeal zone. The presence and entity/severity of these parameters will be assessed by Yale Scale during fibroscopy. The minimum value is 1, that means only coating, while 5 is the maximum level that means abundant residues.
Time frame
The evaluation of swallowing the entity of pharyngeal residue will be done before treatment, then up to 4 weeks (after 20 treatment sessions) finally up to two monthsSecondary outcomes
1
Quality of life in relation to swallowing disorders
Dysphagia has an high impact on quality of life. It will be measured through SWAL\_QOL (quality of life in swallowing disorders). 100 indicates the most favorable state, 0 the least favorable.
Time frame
The evaluation of the level of perceived quality of life will be done before treatment, then up to 4 weeks (after 20 treatment sessions), finally up to two months]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS San Camillo, Venezia, Italy
Lead sponsor
Ospedale Policlinico San Martino
Collaborator
Azienda Ulss 6 Euganea
Collaborator
Source ClinicalTrials.gov