<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03247374</url>
  </required_header>
  <id_info>
    <org_study_id>2017.12 - BioDis</org_study_id>
    <nct_id>NCT03247374</nct_id>
  </id_info>
  <brief_title>Bio-feedback Treatment for Dysphagic Post-stroke Patients</brief_title>
  <acronym>BIO_DYS</acronym>
  <official_title>Bio-feedback Treatment Versus Standard Treatment for Dysphagic Post-stroke Patients: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS San Camillo, Venezia, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS San Camillo, Venezia, Italy</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of the study is to evaluate whether the effect of bio-feedback dysphagia&#xD;
      treatment is more effective than a control treatment in post-stroke patients.&#xD;
&#xD;
      This study will be a randomized, single-blind controlled pilot study. The investigators&#xD;
      intend to recruit 40 patients who have suffered a stroke and have dysphagia. Twenty patients&#xD;
      will undergo training with bio-feedback (experimental group) and the other 20 patients will&#xD;
      undergo standard training, using only verbal feedback rather than visual feedback (control&#xD;
      group).&#xD;
&#xD;
      The authors hypothesize that in the control group the efficacy of the treatment will be lower&#xD;
      in the absence of immediate visual feedback of strength and coordination of the swallowing&#xD;
      act.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The procedure is divided into 5 parts:&#xD;
&#xD;
        -  Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions before the&#xD;
           treatment;&#xD;
&#xD;
        -  25 sessions with bio feedback treatment or 25 sessions of control treatment;&#xD;
&#xD;
        -  Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions after the&#xD;
           training;&#xD;
&#xD;
        -  Clinical and instrumental evaluation (fibroendoscopy) of swallowing functions after 3&#xD;
           months.&#xD;
&#xD;
      Each participant will attend 5 sessions per week for a total duration of 5 weeks. The&#xD;
      duration of each session will take 1 hour, including bio-feedback preparation that will take&#xD;
      about 10 minutes for assembly and 5 minutes for removal. At the beginning of the bio-feedback&#xD;
      session, a surface electrode will be applied to the mylohyoid muscle. The computer will&#xD;
      analyze the electromyographic signal of the patient in real time and will produce visual&#xD;
      feedback of the muscular activity on the screen. The patient will be required to swallow at a&#xD;
      given time, with food bolus if possible, and perform maneuvers that favor swallowing strength&#xD;
      and efficacy.&#xD;
&#xD;
      During the first session, participant will be instructed to use the tool before starting the&#xD;
      training phase. Patients of both groups will participate in similar sessions, with classical&#xD;
      maneuvers favoring swallowing efficacy that is effortful swallow, supraglottic swallow, and&#xD;
      &quot;Masako&quot; maneuver, the first two with bolus administration, if possible. The experimental&#xD;
      group will perform this training for 45 minutes with the support of visualization of muscle&#xD;
      activity on the screen (biofeedback), while the control group will attend the same training&#xD;
      for 45 minutes, but receiving verbal feedback from the speech and language therapist.&#xD;
&#xD;
      Data analysis&#xD;
&#xD;
      On the measures collected, a descriptive statistical analysis and distribution will be&#xD;
      studied. Initial instrumental and clinical data from FOIS scale (The Functional Oral Intake&#xD;
      Scale), PAS (Penetration-Aspiration Scale), Pooling Score (Farneti et al.); Cranial nerves&#xD;
      test will be analyzed using parametric (t-test) and non-parametric (Wilcoxon test) tests with&#xD;
      a p-value considered significant if &lt;0.05, while longitudinal variations will be analyzed&#xD;
      using ANOVA for repeated measurements. In addition, the effect size (Cohen's d) of the&#xD;
      difference between the instrumental and clinical evaluation scales average before and after&#xD;
      training in both groups will be calculated. This will allow to have an estimate of training&#xD;
      effectiveness to perform a power study and plan a wider experimental study for validating the&#xD;
      method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2018</start_date>
  <completion_date type="Actual">October 4, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>simple randomization into two groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Functional Oral Intake Scale (FOIS)</measure>
    <time_frame>Baseline , 4 weeks , finally after 3 months from the end of treatment</time_frame>
    <description>It is a 7-point scale developed to systematically rate the functional severity of dysphagia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pooling Score (P-score)</measure>
    <time_frame>Baseline , 4 weeks , finally after 3 months from the end of treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Penetration-Aspiration Scale (PAS)</measure>
    <time_frame>Baseline , 4 weeks , finally after 3 months from the end of treatment</time_frame>
    <description>It is a 8-point scale used during endoscopic evaluation that describes and measures the severity of airway invasion during swallowing.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Dysphagia, Late Effect of Stroke</condition>
  <condition>Deglutition Disorders</condition>
  <arm_group>
    <arm_group_label>&quot;ProComp5 Infiniti&quot; Biofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 &quot;Masako&quot; 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Speech and Language Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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 &quot;Masako&quot; 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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>&quot;ProComp5 Infiniti&quot; Biofeedback</intervention_name>
    <description>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 &quot;Masako&quot; maneuver. The experimental group will perform this training for 45 minutes.</description>
    <arm_group_label>&quot;ProComp5 Infiniti&quot; Biofeedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Speech and Language Therapy</intervention_name>
    <description>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 &quot;Masako&quot; maneuver. The control group will perform this training for 45 minutes.</description>
    <arm_group_label>Standard Speech and Language Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first stroke injury&#xD;
&#xD;
          -  single lesion&#xD;
&#xD;
          -  onset from more than six weeks&#xD;
&#xD;
          -  presence of dysphagia (Dysphagia Outcome and Severity Scale ≥ 4)&#xD;
&#xD;
          -  good comprehension ( not below PT 53 in Token Test)&#xD;
&#xD;
          -  good eyesight and hearing, or adequately corrected&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All the elements that hinder a good recording of the electromyographic signal (for&#xD;
             instance a cutaneous infection, a wound or a dermatitis in the submandibular area);&#xD;
&#xD;
          -  Severe concomitant illnesses (fever, infections, metabolic problems, serious cardiac&#xD;
             insufficiency) that can influence patient's collaboration;&#xD;
&#xD;
          -  Serious dystonia or unintentional movements&#xD;
&#xD;
          -  presence of disorders of consciousness;&#xD;
&#xD;
          -  encephalopathy due to multiple infarcts;&#xD;
&#xD;
          -  inability to sustain the experimental treatment;&#xD;
&#xD;
          -  other neurological diseases (for example Parkinson disease);&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>81 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara Nordio</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS San Camillo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sara Nordio</name>
      <address>
        <city>Venice-Lido</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>October 4, 2022</last_update_submitted>
  <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS San Camillo, Venezia, Italy</investigator_affiliation>
    <investigator_full_name>Sara Nordio</investigator_full_name>
    <investigator_title>Speech and language therapist</investigator_title>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>treatment</keyword>
  <keyword>biofeedback</keyword>
  <keyword>bio-feedback</keyword>
  <keyword>dysphagia</keyword>
  <keyword>swallowing disorders</keyword>
  <keyword>post-stroke</keyword>
  <keyword>deglutition disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03247374
org study id: 2017.12 - BioDis
nct id: NCT03247374
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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:

        -  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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: simple randomization into two groups
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Functional Oral Intake Scale (FOIS)
time frame: Baseline , 4 weeks , finally after 3 months from the end of treatment
description: It is a 7-point scale developed to systematically rate the functional severity of dysphagia
measure: Change in Pooling Score (P-score)
time frame: Baseline , 4 weeks , finally after 3 months from the end of treatment
description: 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.
measure: Change in Penetration-Aspiration Scale (PAS)
time frame: Baseline , 4 weeks , finally after 3 months from the end of treatment
description: It is a 8-point scale used during endoscopic evaluation that describes and measures the severity of airway invasion during swallowing.
arm group label: "ProComp5 Infiniti" Biofeedback
arm group type: Experimental
description: 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.
arm group label: Standard Speech and Language Therapy
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: "ProComp5 Infiniti" Biofeedback
description: 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.
arm group label: "ProComp5 Infiniti" Biofeedback
intervention type: Other
intervention name: Standard Speech and Language Therapy
description: 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.
arm group label: Standard Speech and Language Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 81 Years
healthy volunteers: No
last name: Sara Nordio
role: Principal Investigator
affiliation: IRCCS San Camillo
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS San Camillo, Venezia, Italy
investigator full name: Sara Nordio
investigator title: Speech and language therapist
mesh term: Deglutition Disorders
mesh term: Stroke