Bio-feedback Treatment for Dysphagic Post-stroke Patients
Condition: Dysphagia, Late Effect of Stroke; Deglutition Disorders
MeSH terms: Deglutition Disorders; Stroke
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      The procedure is divided into 5 parts:

        -  Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions before the
           treatment;

        -  25 sessions with bio feedback treatment or 25 sessions of control treatment;

        -  Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions after the
           training;

        -  Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions after 3
           months.

      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.
    

Intervention name(s): "ProComp5 Infiniti" Biofeedback; Standard Speech and Language Therapy
Intervention type(s): Device; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: simple randomization into two groups
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation; treatment; biofeedback; bio-feedback; dysphagia; swallowing disorders; post-stroke; deglutition disorders