An interventional study of Biofeedback and Conventional in Dysphagia, Rehabilitation and Stroke, sponsored by IRCCS San Camillo, Venezia, Italy. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by IRCCS San Camillo, Venezia, Italy · Not applicable, Interventional, and Treatment
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.
The procedure is divided into the following steps:
Data analysis
On the measures collected, a descriptive statistical analyzis and distribution will be studied. Initial instrumental and clinical data will be collected administrating: FOIS scale (Functional Oral Intake Scale), PAS (Penetration-Aspiration Scale), Yale Scale, MASA (Mann Assessment of Swallowing Abilities),SWAL QOL (outcomes tool for oropharyngeal dysphagia in adults), TOMASS (test of masticated and swallowing solids); Cranial nerves. All the tests will be analyzed using parametric (t-test) and non-parametric (Wilcoxon test) tests with a p-value considered significant if \<0.05, while longitudinal variations will be analysed using ANOVA for repeated measurements.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →IRCCS San Camillo, Venezia, Italy is the lead sponsor of 48 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Each 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.
Device: Biofeedback
Each 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.
Other: Conventional
Each 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.
Also known as: Neurotrac myoplus 2
Each 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.
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 months
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]
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 months
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]
Plan to share: No
Started Oct 2022 (actual). Primary completion is estimated for Dec 2027, 61 months after the start.
Of 288 non-industry interventional studies with no phase under Deglutition Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 61 months is above that.
Counting every sponsor, half of 297 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
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IRCCS San Camillo, Venezia, Italy