An interventional study of "ProComp5 Infiniti" Biofeedback and Standard Speech and Language Therapy in Dysphagia, Late Effect of Stroke and Deglutition Disorders, sponsored by IRCCS San Camillo, Venezia, Italy. Completed at 1 site in Italy. Open to participants aged 18 Years to 81 Years. Per ClinicalTrials.gov, last updated 2022-10-05.
Sponsored by IRCCS San Camillo, Venezia, Italy · Not applicable, Interventional, and Treatment
The primary purpose of the study is to evaluate whether the effect of bio-feedback dysphagia treatment is more effective than a control treatment in post-stroke patients.
This study will be a randomized, single-blind controlled pilot study. The investigators intend to recruit 40 patients who have suffered a stroke and have dysphagia. Twenty patients will undergo training with bio-feedback (experimental group) and the other 20 patients will undergo standard training, using only verbal feedback rather than visual feedback (control group).
The authors hypothesize that in the control group the efficacy of the treatment will be lower in the absence of immediate visual feedback of strength and coordination of the swallowing act.
The procedure is divided into 5 parts:
Each participant will attend 5 sessions per week for a total duration of 5 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, a surface electrode 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, supraglottic swallow, and "Masako" maneuver, the first two with bolus administration, if possible. 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 analysis and distribution will be studied. Initial instrumental and clinical data from FOIS scale (The Functional Oral Intake Scale), PAS (Penetration-Aspiration Scale), Pooling Score (Farneti et al.); Cranial nerves test 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 analyzed using ANOVA for repeated measurements. In addition, the effect size (Cohen's d) of the difference between the instrumental and clinical evaluation scales average before and after training in both groups will be calculated. This will allow to have an estimate of training effectiveness to perform a power study and plan a wider experimental study for validating the method.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 17 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
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Exclusion Criteria:
Each participant will attend 5 sessions per week for a total duration of 5 weeks. The duration of each session will take 1 hour, including bio-feedback preparation. At the beginning of the bio-feedback session, a surface electrode 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, supraglottic swallow, and "Masako" maneuver, the first two with bolus administration, if possible. The experimental group will perform this training for 45 minutes, plus they will receive a verbal feedback from the speech and language therapist.
Device: "ProComp5 Infiniti" Biofeedback
Each participant will attend 5 sessions per week for a total duration of 5 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, supraglottic swallow, and "Masako" maneuver, the first two with bolus administration, if possible. The control group will attend this training for 45 minutes, receiving verbal feedback from the speech and language therapist.
Other: Standard Speech and Language Therapy
Each participant will attend 5 sessions per week for a total duration of 5 weeks. At the beginning of the bio-feedback session, a surface electrode will be applied to the mylohyoid muscle. The computer 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 favour swallowing strength and efficacy: they are requested to do classical maneuvers that favour swallowing efficacy that is effortful swallow, supraglottic swallow, and "Masako" maneuver. The experimental group will perform this training for 45 minutes.
Each participant will attend 5 sessions per week for a total duration of 5 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 receiving verbal feedback from the speech and language therapist. They are requested to do classical maneuvers that favour swallowing efficacy that is effortful swallow, supraglottic swallow, and "Masako" maneuver. The control group will perform this training for 45 minutes.
Change in Functional Oral Intake Scale (FOIS)
It is a 7-point scale developed to systematically rate the functional severity of dysphagia
Time frame: Baseline , 4 weeks , finally after 3 months from the end of treatment
Change in Pooling Score (P-score)
The scale is used during clinical endoscopic evaluation to evaluate severity of swallowing disorder, considering excess residue in the pharynx and larynx.The score (minimum 4 - maximum 11) is obtained by the sum of the scores given to the site of the bolus, the amount and ability to control residue/bolus pooling, the latter assessed on the basis of cough, raclage, number of dry voluntary or reflex swallowing acts.
Time frame: Baseline , 4 weeks , finally after 3 months from the end of treatment
Change in Penetration-Aspiration Scale (PAS)
It is a 8-point scale used during endoscopic evaluation that describes and measures the severity of airway invasion during swallowing.
Time frame: Baseline , 4 weeks , finally after 3 months from the end of treatment
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IRCCS San Camillo, Venezia, Italy