<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/NCT02973698</url>
  </required_header>
  <id_info>
    <org_study_id>140263</org_study_id>
    <nct_id>NCT02973698</nct_id>
  </id_info>
  <brief_title>Benefit From the Chin Down Maneuver in the Swallowing Performance and Self-perception of Parkinson's Disease Patients</brief_title>
  <official_title>Effects of a Speech-Language Pathology Intervention on Individuals With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To verify the effectiveness of chin-down posture maneuver in swallowing therapy&#xD;
      for Parkinson's disease (PD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants Participants were PD patients recruited from a Parkinson´s disease and Movement&#xD;
      Disorders Clinic from Hospital de Clínicas de Porto Alegre (HCPA), a reference hospital, in&#xD;
      the Rio Grande do Sul, Brazil. It was obtained from participants the written free and&#xD;
      informed consent to participate in the research. This study was approved by the hospital&#xD;
      central research ethics committee.&#xD;
&#xD;
      Inclusion and exclusion criteria Patient evaluation It was performed cognitive screening&#xD;
      which consists of Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment&#xD;
      (MoCA) in all patients before the intervention. It was also applied the instruments Parkinson&#xD;
      Disease Questionnaire-39 (PDQ-39), translated to Portuguese, and the Beck Depression&#xD;
      Inventory (BDI). These tests were applied to verify the influence of cognitive aspects,&#xD;
      depression and quality of life in the therapeutic process.&#xD;
&#xD;
      To evaluate the intervention's effectiveness, an evaluation of swallowing was conducted in&#xD;
      two moments (before and after intervention). Three kinds of assessments were performed: (1).&#xD;
      Fiberoptic endoscopic evaluation of swallowing (FEES); (2) Clinical evaluation and (3)&#xD;
      assessment of the quality of life related to swallowing (SWALQOL).&#xD;
&#xD;
        -  Fiberoptic endoscopic evaluation of swallowing (FEES): This objective examination of&#xD;
           swallowing was performed according to the following protocol: First, it was tested the&#xD;
           prior state of secretion in the nasopharyngeal structures, oropharynx, and&#xD;
           laryngopharynx. Next, the individual received liquid consistency offered through a&#xD;
           syringe, 3 and 5ml of water with edible blue food coloring. For the pasty consistency, 3&#xD;
           and 5ml of thickened water were provided through a syringe with edible blue food&#xD;
           coloring. It was offered ¼- water and salt biscuits with good blue food coloring to&#xD;
           assess the solid consistency. No anesthetic was used for the examination. The images&#xD;
           were later analyzed by an otolaryngologist physician, experienced in the dysphagia area.&#xD;
           It was observed the presence of thickening on the posterior laryngeal wall, tremor in&#xD;
           structures (base of tongue and vallecula), early escape (characterized by the presence&#xD;
           of food in the hypopharynx or larynx before the swallowing reflex was triggered),&#xD;
           vallecular stasis in glossoepiglottic folds and pyriform sinus (characterized by&#xD;
           accumulation of food after the third swallowing on the mentioned structures),&#xD;
           penetration (characterized by the presence of food in the laryngeal vestibule), tracheal&#xD;
           aspiration (characterized by food intake in the region located below the vocal folds, in&#xD;
           the subglottic region and in the trachea, at any time of swallowing) and cough reflex.&#xD;
           The alterations were classified as present or absent. The equipment used was the&#xD;
           flexible nasopharyngoscope Maschida ENT-III, 3.2mm, with Xerônio Storz light source.&#xD;
&#xD;
        -  Clinical evaluation and Functional Oral Intake Scale (FOIS): clinical evaluation of&#xD;
           swallowing was performed by a certified speech therapist, previously trained to apply&#xD;
           the protocols. All the evaluations were conducted by the same professional. This&#xD;
           assessment had the purpose of checking signs and symptoms of oropharyngeal dysphagia. It&#xD;
           was used solid food consistency (half portion of bread) and liquid (100ml of water)&#xD;
           evaluated by free demand. The analyzed signs and symptoms were: history of aspiration&#xD;
           pneumonia; alert state; interaction attention/ability; awareness of the swallowing&#xD;
           problem; awareness of secretion; ability to manipulate flows; postural control;&#xD;
           fatigability; anatomy and oral, pharyngeal and laryngeal physiology; orofacial tonus;&#xD;
           oral apraxia; orofacial sensitivity; gag pharyngeal contraction; saliva swallowing;&#xD;
           cough and hawk; swallowing apraxia; oral residue; delayed swallowing reflex; reduction&#xD;
           in laryngeal elevation; wet voice; and multiple swallowing. A total of 21 signs and&#xD;
           symptoms were evaluated as present or absent. At the end of the objective and clinical&#xD;
           evaluation, the intake of food was scored according to Functional Oral Intake Scale&#xD;
           (FOIS). This scale scores the level of oral food intake of patients at specific levels,&#xD;
           from 0 (restricted to alternative food pathway) to 7 (total oral intake with no&#xD;
           restrictions), with the aim of monitoring the patients' evolution during the therapeutic&#xD;
           process. A translated and validated version for Brazilian Portuguese was used.&#xD;
&#xD;
        -  The quality of Life in Swallowing Disorders: The questionnaire Quality of Life in&#xD;
           Swallowing Disorders (SWAL-QOL) was applied, to verify the symptoms presented by the&#xD;
           patients, as well as their influence on the quality of life. This instrument has Alpha&#xD;
           Cronbach coefficient higher than 0.80, except in one domain. Thus, it presents excellent&#xD;
           internal consistency and short-term reproducibility. It is a sensitive scale to&#xD;
           differentiate oropharyngeal dysphagia degrees of severity. The version translated and&#xD;
           validated for Brazilian Portuguese was used. All questionnaires were applied in a&#xD;
           waiting room. The questions and possible answers were read by the researcher for all&#xD;
           patients. The questionnaires application was performed individually, for each patient.&#xD;
&#xD;
      Intervention Individuals who agreed to participate in this study were allocated to one of the&#xD;
      three interventions groups: (1) experimental group (patients performed the chin-down posture&#xD;
      maneuver), (2) control group (PD individuals without any intervention) and (3) orientation&#xD;
      group (PD participants that received swallowing orientations).&#xD;
&#xD;
        1. Experimental group (EG) (chin-down posture maneuver group): patients in received an&#xD;
           intervention program consisting of four weekly individual sessions of 30 minutes. In&#xD;
           these sessions, it was performed the training of Chin-down postural maneuver with saliva&#xD;
           and water. The participants were trained to perform the maneuver twice a day, swallowing&#xD;
           saliva, and during meals, throughout the week, at home. The participants received a&#xD;
           form, so they recorded the number of times they performed the maneuver at home. It&#xD;
           allowed the control of adherence, being reinforced at each session the importance of&#xD;
           adherence to treatment. Besides, the subjects received instructions regarding feeding.&#xD;
           All the instructions, as well as the explanation about the maneuver, were submitted to&#xD;
           the patients through a written document.&#xD;
&#xD;
        2. Control group (CG) (PD individuals without any intervention): The participants of this&#xD;
           group underwent evaluation of swallowing, and the same assessment was repeated after&#xD;
           four weeks, without any intervention during that period.&#xD;
&#xD;
        3. Orientations group (OG): the individuals participated in an intervention program which&#xD;
           consisted of four individual sessions a week, with 30 minutes. In these sessions, the&#xD;
           instructions about feeding were performed. The individuals received all the instructions&#xD;
           on a written document. In the sessions, it was verified doubts about the guidelines and&#xD;
           treatment adherence. In this group, it was not applied the Chin-down postural maneuver.&#xD;
&#xD;
      The EG and OG interventions were used by the same researcher, previously trained. After the&#xD;
      end of the research, it was offered to the CG and OG individuals the same swallowing therapy&#xD;
      performed to the GE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical evaluation of swallowing</measure>
    <time_frame>Four weeks</time_frame>
    <description>This assessment had the purpose of checking signs and symptoms of oropharyngeal dysphagia. It was used solid food consistency (half portion of bread) and liquid (100ml of water) evaluated by free demand. A total of 21 signs and symptoms were evaluated as present or absent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fiberoptic endoscopic evaluation of swallowing</measure>
    <time_frame>Four weeks</time_frame>
    <description>This objective examination of swallowing was performed according to the following protocol: First, it was tested the prior state of secretion in the nasopharyngeal structures, oropharynx, and laryngopharynx. Next, the individual received liquid consistency offered through a syringe, 3 and 5ml of water with edible blue food coloring. For the pasty consistency, 3 and 5ml of thickened water were provided through a syringe with edible blue food coloring. It was offered ¼- water and salt biscuits with good blue food coloring to assess the solid consistency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The quality of Life in Swallowing Disorders</measure>
    <time_frame>Four weeks</time_frame>
    <description>The questionnaire Quality of Life in Swallowing Disorders (SWAL-QOL) was applied, to verify the symptoms presented by the patients, as well as their influence on the quality of life.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Dysphagia, Oropharyngeal</condition>
  <condition>Parkinson Disease</condition>
  <condition>Speech Therapy</condition>
  <condition>Orientation</condition>
  <arm_group>
    <arm_group_label>chin-down posture maneuver</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patients in received an intervention program consisting of four weekly individual sessions of 30 minutes. In these sessions, it was performed the training of Chin-down postural maneuver with saliva and water. The participants were trained to perform the maneuver twice a day, swallowing saliva, and during meals, throughout the week, at home. The participants received a form, so they recorded the number of times they performed the maneuver at home. It allowed the control of adherence, being reinforced at each session the importance of adherence to treatment. Besides, the subjects received instructions regarding feeding. All the instructions, as well as the explanation about the maneuver, were submitted to the patients through a written document.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The participants of this group underwent evaluation of swallowing, and the same assessment was repeated after four weeks, without any intervention during that period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orientations about swallowing</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The individuals participated in an intervention program which consisted of four individual sessions a week, with 30 minutes. In these sessions, the instructions about feeding were performed. The individuals received all the instructions on a written document. In the sessions, it was verified doubts about the guidelines and treatment adherence. In this group, it was not applied the Chin-down postural maneuver.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>chin-down posture maneuver</intervention_name>
    <description>it was performed the training of Chin-down postural maneuver with saliva and water. Besides, the subjects received instructions regarding feeding.</description>
    <arm_group_label>chin-down posture maneuver</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Orientations about swallowing</intervention_name>
    <description>The instructions about feeding were performed. The individuals received all the instructions on a written document.</description>
    <arm_group_label>Orientations about swallowing</arm_group_label>
    <arm_group_label>chin-down posture maneuver</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>No intervention will do</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of Parkinson's disease and diagnosis of oropharyngeal dysphagia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presenting language and hearing disorders, which could complicate the understanding of&#xD;
             an intervention program, diagnosis of dementia or other neurological illnesses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maira Olchik</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>November 25, 2016</last_update_submitted>
  <last_update_submitted_qc>November 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Communication Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02973698
org study id: 140263
nct id: NCT02973698
lead sponsor: 
has dmc: No
Objective: To verify the effectiveness of chin-down posture maneuver in swallowing therapy
      for Parkinson's disease (PD).
Participants Participants were PD patients recruited from a Parkinson´s disease and Movement
      Disorders Clinic from Hospital de Clínicas de Porto Alegre (HCPA), a reference hospital, in
      the Rio Grande do Sul, Brazil. It was obtained from participants the written free and
      informed consent to participate in the research. This study was approved by the hospital
      central research ethics committee.

      Inclusion and exclusion criteria Patient evaluation It was performed cognitive screening
      which consists of Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment
      (MoCA) in all patients before the intervention. It was also applied the instruments Parkinson
      Disease Questionnaire-39 (PDQ-39), translated to Portuguese, and the Beck Depression
      Inventory (BDI). These tests were applied to verify the influence of cognitive aspects,
      depression and quality of life in the therapeutic process.

      To evaluate the intervention's effectiveness, an evaluation of swallowing was conducted in
      two moments (before and after intervention). Three kinds of assessments were performed: (1).
      Fiberoptic endoscopic evaluation of swallowing (FEES); (2) Clinical evaluation and (3)
      assessment of the quality of life related to swallowing (SWALQOL).

        -  Fiberoptic endoscopic evaluation of swallowing (FEES): This objective examination of
           swallowing was performed according to the following protocol: First, it was tested the
           prior state of secretion in the nasopharyngeal structures, oropharynx, and
           laryngopharynx. Next, the individual received liquid consistency offered through a
           syringe, 3 and 5ml of water with edible blue food coloring. For the pasty consistency, 3
           and 5ml of thickened water were provided through a syringe with edible blue food
           coloring. It was offered ¼- water and salt biscuits with good blue food coloring to
           assess the solid consistency. No anesthetic was used for the examination. The images
           were later analyzed by an otolaryngologist physician, experienced in the dysphagia area.
           It was observed the presence of thickening on the posterior laryngeal wall, tremor in
           structures (base of tongue and vallecula), early escape (characterized by the presence
           of food in the hypopharynx or larynx before the swallowing reflex was triggered),
           vallecular stasis in glossoepiglottic folds and pyriform sinus (characterized by
           accumulation of food after the third swallowing on the mentioned structures),
           penetration (characterized by the presence of food in the laryngeal vestibule), tracheal
           aspiration (characterized by food intake in the region located below the vocal folds, in
           the subglottic region and in the trachea, at any time of swallowing) and cough reflex.
           The alterations were classified as present or absent. The equipment used was the
           flexible nasopharyngoscope Maschida ENT-III, 3.2mm, with Xerônio Storz light source.

        -  Clinical evaluation and Functional Oral Intake Scale (FOIS): clinical evaluation of
           swallowing was performed by a certified speech therapist, previously trained to apply
           the protocols. All the evaluations were conducted by the same professional. This
           assessment had the purpose of checking signs and symptoms of oropharyngeal dysphagia. It
           was used solid food consistency (half portion of bread) and liquid (100ml of water)
           evaluated by free demand. The analyzed signs and symptoms were: history of aspiration
           pneumonia; alert state; interaction attention/ability; awareness of the swallowing
           problem; awareness of secretion; ability to manipulate flows; postural control;
           fatigability; anatomy and oral, pharyngeal and laryngeal physiology; orofacial tonus;
           oral apraxia; orofacial sensitivity; gag pharyngeal contraction; saliva swallowing;
           cough and hawk; swallowing apraxia; oral residue; delayed swallowing reflex; reduction
           in laryngeal elevation; wet voice; and multiple swallowing. A total of 21 signs and
           symptoms were evaluated as present or absent. At the end of the objective and clinical
           evaluation, the intake of food was scored according to Functional Oral Intake Scale
           (FOIS). This scale scores the level of oral food intake of patients at specific levels,
           from 0 (restricted to alternative food pathway) to 7 (total oral intake with no
           restrictions), with the aim of monitoring the patients' evolution during the therapeutic
           process. A translated and validated version for Brazilian Portuguese was used.

        -  The quality of Life in Swallowing Disorders: The questionnaire Quality of Life in
           Swallowing Disorders (SWAL-QOL) was applied, to verify the symptoms presented by the
           patients, as well as their influence on the quality of life. This instrument has Alpha
           Cronbach coefficient higher than 0.80, except in one domain. Thus, it presents excellent
           internal consistency and short-term reproducibility. It is a sensitive scale to
           differentiate oropharyngeal dysphagia degrees of severity. The version translated and
           validated for Brazilian Portuguese was used. All questionnaires were applied in a
           waiting room. The questions and possible answers were read by the researcher for all
           patients. The questionnaires application was performed individually, for each patient.

      Intervention Individuals who agreed to participate in this study were allocated to one of the
      three interventions groups: (1) experimental group (patients performed the chin-down posture
      maneuver), (2) control group (PD individuals without any intervention) and (3) orientation
      group (PD participants that received swallowing orientations).

        1. Experimental group (EG) (chin-down posture maneuver group): patients in received an
           intervention program consisting of four weekly individual sessions of 30 minutes. In
           these sessions, it was performed the training of Chin-down postural maneuver with saliva
           and water. The participants were trained to perform the maneuver twice a day, swallowing
           saliva, and during meals, throughout the week, at home. The participants received a
           form, so they recorded the number of times they performed the maneuver at home. It
           allowed the control of adherence, being reinforced at each session the importance of
           adherence to treatment. Besides, the subjects received instructions regarding feeding.
           All the instructions, as well as the explanation about the maneuver, were submitted to
           the patients through a written document.

        2. Control group (CG) (PD individuals without any intervention): The participants of this
           group underwent evaluation of swallowing, and the same assessment was repeated after
           four weeks, without any intervention during that period.

        3. Orientations group (OG): the individuals participated in an intervention program which
           consisted of four individual sessions a week, with 30 minutes. In these sessions, the
           instructions about feeding were performed. The individuals received all the instructions
           on a written document. In the sessions, it was verified doubts about the guidelines and
           treatment adherence. In this group, it was not applied the Chin-down postural maneuver.

      The EG and OG interventions were used by the same researcher, previously trained. After the
      end of the research, it was offered to the CG and OG individuals the same swallowing therapy
      performed to the GE.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical evaluation of swallowing
time frame: Four weeks
description: This assessment had the purpose of checking signs and symptoms of oropharyngeal dysphagia. It was used solid food consistency (half portion of bread) and liquid (100ml of water) evaluated by free demand. A total of 21 signs and symptoms were evaluated as present or absent
measure: Fiberoptic endoscopic evaluation of swallowing
time frame: Four weeks
description: This objective examination of swallowing was performed according to the following protocol: First, it was tested the prior state of secretion in the nasopharyngeal structures, oropharynx, and laryngopharynx. Next, the individual received liquid consistency offered through a syringe, 3 and 5ml of water with edible blue food coloring. For the pasty consistency, 3 and 5ml of thickened water were provided through a syringe with edible blue food coloring. It was offered ¼- water and salt biscuits with good blue food coloring to assess the solid consistency.
measure: The quality of Life in Swallowing Disorders
time frame: Four weeks
description: The questionnaire Quality of Life in Swallowing Disorders (SWAL-QOL) was applied, to verify the symptoms presented by the patients, as well as their influence on the quality of life.
arm group label: chin-down posture maneuver
arm group type: Other
description: The patients in received an intervention program consisting of four weekly individual sessions of 30 minutes. In these sessions, it was performed the training of Chin-down postural maneuver with saliva and water. The participants were trained to perform the maneuver twice a day, swallowing saliva, and during meals, throughout the week, at home. The participants received a form, so they recorded the number of times they performed the maneuver at home. It allowed the control of adherence, being reinforced at each session the importance of adherence to treatment. Besides, the subjects received instructions regarding feeding. All the instructions, as well as the explanation about the maneuver, were submitted to the patients through a written document.
arm group label: Control
arm group type: Other
description: The participants of this group underwent evaluation of swallowing, and the same assessment was repeated after four weeks, without any intervention during that period.
arm group label: Orientations about swallowing
arm group type: Other
description: The individuals participated in an intervention program which consisted of four individual sessions a week, with 30 minutes. In these sessions, the instructions about feeding were performed. The individuals received all the instructions on a written document. In the sessions, it was verified doubts about the guidelines and treatment adherence. In this group, it was not applied the Chin-down postural maneuver.
intervention type: Other
intervention name: chin-down posture maneuver
description: it was performed the training of Chin-down postural maneuver with saliva and water. Besides, the subjects received instructions regarding feeding.
arm group label: chin-down posture maneuver
intervention type: Other
intervention name: Orientations about swallowing
description: The instructions about feeding were performed. The individuals received all the instructions on a written document.
arm group label: Orientations about swallowing
arm group label: chin-down posture maneuver
intervention type: Other
intervention name: Control
description: No intervention will do
arm group label: Control
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Maira Olchik
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
responsible party type: Sponsor
mesh term: Deglutition Disorders
mesh term: Parkinson Disease
mesh term: Communication Disorders
sharing ipd: Undecided