Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia

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.

Conditions

• Dysphagia
• Rehabilitation
• Stroke

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

• Ospedale Policlinico San Martino

  collaborator OTHER

• Azienda Ulss 6 Euganea

  collaborator OTHER

• IRCCS San Camillo, Venezia, Italy

  lead OTHER

Principal Investigators

• Sara Nordio · IRCCS San Camillo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-30

Primary Completion

2027-12-03

Completion

2027-12-03

Countries

• Italy

Study Locations