Clinical Research Directory
Browse clinical research sites, groups, and studies.
Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia
Sponsor: IRCCS San Camillo, Venezia, Italy
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.
Official title: Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Multicentric Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-10-30
Completion Date
2027-12-03
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Biofeedback
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.
Conventional
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.
Locations (1)
Sara Nordio
Venice-Lido, Italy