Clinical trial NCT05591040: Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia
Official title: Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Rehabilitation
Stroke
Keywords: dysphagia
stroke
biofeedback
rehabilitation
randomized controlled study
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: Ospedale Policlinico San Martino
name: ULSS 6 Euganea
First posted: 2022-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: simple randomization in two groups
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The procedure is divided into the following steps:

* Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions before the treatment;
* 20 sessions with bio feedback treatment or 20 session of control treatment;
* Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions after the training;
* Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions after 2 months as follow up. 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 that will take about 10 minutes for assembly and 5 minutes for removal. At the beginning of the bio-feedback session, two surface electrodes will be applied to the mylohyoid muscle. The computer will analyze the electromyographic signal of the patient in real time and will produce visual feedback of the muscular activity on the screen. The patient will be required to swallow at a given time, with food bolus if possible, and perform maneuvers that favor swallowing strength and efficacy. During the first session, participant will be instructed to use the tool before starting the training phase. Patients of both groups will participate in similar sessions, with classical maneuvers favoring swallowing efficacy that is effortful swallow and specific task of timing and coordination (with bolus administration, if possible) and Masako maneuver. The experimental group will perform this training for 45 minutes with the support of visualization of muscle activity on the screen (biofeedback), while the control group will attend the same training for 45 minutes, but receiving verbal feedback from the speech and language therapist.

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.

Eligibility criteria: Inclusion Criteria:

* first stroke injury
* onset from more than six weeks
* presence of dysphagia
* good comprehension ( not below PT 53 in Token Test)
* good eyesight and hearing, or adequately corrected

Exclusion Criteria:

* 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;
* encephalopathy due to multiple infarcts;
* inability to sustain the experimental treatment;
* other neurological diseases (for example Parkinson disease)

Primary outcomes:
measure: Positive changes of efficacy of swallowing
timeFrame: The evaluation of swallowing functions will be done before treatment, then up to 4 weeks (after 20 treatment sessions) finally up to two months
measure: Changes in penetration/aspiration of saliva or bolus
timeFrame: 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]
measure: Changes in pharyngeal residues
timeFrame: 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
Secondary outcomes:
measure: Quality of life in relation to swallowing disorders
timeFrame: 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]
Other outcomes:
Locations:
city: Venice-Lido
country: Italy
facility: Sara Nordio
Study officials:
affiliation: IRCCS San Camillo
name: Sara Nordio
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nordio S, Arcara G, Berta G, Dellai A, Brisotto C, Koch I, Cazzador D, Aspidistria M, Ventura L, Turolla A, D'Imperio D, Battel I. Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Pilot-Randomized Controlled Trial. Dysphagia. 2022 Oct;37(5):1207-1216. doi: 10.1007/s00455-021-10385-2. Epub 2021 Nov 12.