<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/NCT04421937</url>
  </required_header>
  <id_info>
    <org_study_id>Istanbul University, Istanbul</org_study_id>
    <nct_id>NCT04421937</nct_id>
  </id_info>
  <brief_title>The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia</brief_title>
  <official_title>The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In our study, our aim is to evaluate the effect of neuromuscular electrical stimulation added&#xD;
      to traditional dysphagia therapy in stroke patients with dysphagia, on functional oral intake&#xD;
      status, dysphagia-related symptoms, quality of life, and complications related to dysphagia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2020</start_date>
  <completion_date type="Actual">February 16, 2022</completion_date>
  <primary_completion_date type="Actual">January 30, 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Functional Oral Intake Scale (FOIS)</measure>
    <time_frame>before intervention, immediately after intervention, 3 months after the intervention</time_frame>
    <description>Functional Oral Intake Scale (FOIS) is a scale that shows the functional oral intake of patients with dysphagia. FOIS used for evaluation is a two part scale consisting of 7 levels. It is used to show whether the individual is dependent on the feeding tube and the level of oral intake. On this scale, 7 shows the best and 1 shows the worst functional oral intake. The change in FOIS will be our primary outcome measure in our research. It has been evaluated as an appropriate tool to demonstrate the change in functional oral intake in stroke patients. It is suitable as an independent measure of functional oral intake in prospective studies of stroke-related dysphagia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Eating Assessment Tool-10 (EAT-10) Score</measure>
    <time_frame>before intervention, immediately after intervention, 3 months after the intervention</time_frame>
    <description>Eating Assessment Tool-10 (EAT-10) is used to assess participants' dysphagia symptoms, symptom severity, and risk of oropharyngeal dysphagia. This scale is a scale of 10 questions that the patient himself answers, which questions the symptoms of dysphagia. The answer points for each question range from 0 (no problem) to 4 (serious problem). If EAT-10 score is ≥3, it is considered as &quot;risk of oropharyngeal dysphagia&quot;. It is a useful tool to evaluate the severity of dysphagia symptom in the clinic, to monitor the progression and effectiveness of the disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Swallowing-related Quality of Life (SWAL-QOL) Score</measure>
    <time_frame>before intervention, immediately after intervention, 3 months after the intervention</time_frame>
    <description>Swallowing-related quality of life scale (SWAL-QOL) is used to evaluate the effect of swallowing disorders on quality of life. It was created to evaluate the quality of life of patients with oropharyngeal dysphagia. It includes a total of 44 questions under eating disorder, eating time, eating desire, food selection, communication, anxiety, mental health, social functionality, fatigue, and sleep subgroups. Each question is evaluated with a score ranging from 1 (worst) to 5 (best). The subgroup scores of the scale and the total score of the scale can be used to assess the change in patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual Analog Scale (VAS)</measure>
    <time_frame>before intervention, immediately after intervention, 3 months after the intervention</time_frame>
    <description>Patients' difficulty in swallowing will be questioned using the Visual Analogue Scale (VAS). On a scale of ten centimeters, patients will be asked to mark the appropriate level of dysphagia 0: No dysphagia, 10: Very severe dysphagia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Laryngostroboscopy Examination</measure>
    <time_frame>before intervention, immediately after intervention</time_frame>
    <description>In the Istanbul Faculty of Medicine Otorhinolaryngology Diseases Clinic, evaluations will be made by the Ear Nose Throat Specialist. Whether there is vocal cord paresis and paralysis and whether glottic patency is evaluated in the laryngostroboscopic examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES)</measure>
    <time_frame>before intervention, immediately after intervention</time_frame>
    <description>Fiberoptic endoscopic swallowing assessment will be performed by the otolaryngologist doctor before and immediately after the treatment. In the fiberoptic endoscopic swallowing assessment, the condition of the patient according to the penetration aspiration scale will be checked. Grade 1 represents the best and grade 7 the worst on the penetration aspiration scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Voice-Related Quality of Life (V-RQOL) Score</measure>
    <time_frame>before intervention, immediately after intervention, 3 months after the intervention</time_frame>
    <description>This ten-item scale is a scale designed for adult populations with voice disorders to measure both social-emotional and physical-functional aspects of voice problems. The answer points for each question range from 1 (few problems) to 5 (serious problems). A total score change on this scale will be used to evaluate patients.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Stroke</condition>
  <condition>Swallowing Disorder</condition>
  <condition>Dysphagia</condition>
  <condition>Stroke, Complication</condition>
  <condition>Cerebrovascular Accident</condition>
  <arm_group>
    <arm_group_label>Neuromuscular Electrical Stimulation (NMES) with TDT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Dysphagia Therapy (TDT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Procedure: Traditional Dysphagia Therapy (TDT)</intervention_name>
    <description>Traditional dysphagia therapy includes diet modification training, teaching postural compensatory methods, training of oral motor control exercises and tongue root exercises, training of swallowing maneuvers, and practice of chin-resistance exercise, which is the exercise of opening the upper esophageal sphincter.&#xD;
Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks.</description>
    <arm_group_label>Traditional Dysphagia Therapy (TDT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Procedure: Neuromuscular Electrical Stimulation with TDT</intervention_name>
    <description>The skin to be treated will be cleaned and dried. NMES will be implemented with signals received from two channels. In the first channel, the upper electrodes will be placed horizontally just above the hyoid bone. This is the place where the cupping is felt when the finger is pressed right under the chin. In the second channel, the lower electrodes will be placed horizontally, just above the thyrohyoid muscle. This is the place where you can feel a cupping when pressed with your finger, on both sides of the apple in the larynx. The device will be set to start at the lowest power, with very short pulses of approximately 700 microseconds, at intervals of 1 second. The power will be gradually increased according to the device and the power that the patient feels vibration will be stopped. The power to be applied will not exceed 25 milliamps. NMES application and Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks.</description>
    <arm_group_label>Neuromuscular Electrical Stimulation (NMES) with TDT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  After the first week after a stroke, detecting dysphagia by using bedside water&#xD;
             assessment test&#xD;
&#xD;
          -  Lesion location is shown by MRI or CT&#xD;
&#xD;
          -  Unsupported sitting balance&#xD;
&#xD;
          -  The score of Mini-mental state examination test (MMSE) 20 and above&#xD;
&#xD;
          -  Over 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Global aphasia or cognitive disorders that may affect the understanding of the&#xD;
             instructions&#xD;
&#xD;
          -  Patients with major medical problems that may affect participation&#xD;
&#xD;
          -  Tracheostomy presence&#xD;
&#xD;
          -  Previous neck surgery&#xD;
&#xD;
          -  To have received radiotherapy in the head or neck area&#xD;
&#xD;
          -  Presence of a cardiac pacemaker or a history of epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elif Tarihçi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation</name>
      <address>
        <city>Istanbul</city>
        <state>Fatih</state>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 20, 2022</last_update_submitted>
  <last_update_submitted_qc>August 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Elif Tarihçi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>swallowing disorder</keyword>
  <keyword>dysphagia</keyword>
  <keyword>stroke rehabilitation</keyword>
  <keyword>neuromuscular electrical stimulation</keyword>
  <keyword>traditional dysphagia therapy</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT04421937/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT04421937/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04421937
org study id: Istanbul University, Istanbul
nct id: NCT04421937
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In our study, our aim is to evaluate the effect of neuromuscular electrical stimulation added
      to traditional dysphagia therapy in stroke patients with dysphagia, on functional oral intake
      status, dysphagia-related symptoms, quality of life, and complications related to dysphagia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Functional Oral Intake Scale (FOIS)
time frame: before intervention, immediately after intervention, 3 months after the intervention
description: Functional Oral Intake Scale (FOIS) is a scale that shows the functional oral intake of patients with dysphagia. FOIS used for evaluation is a two part scale consisting of 7 levels. It is used to show whether the individual is dependent on the feeding tube and the level of oral intake. On this scale, 7 shows the best and 1 shows the worst functional oral intake. The change in FOIS will be our primary outcome measure in our research. It has been evaluated as an appropriate tool to demonstrate the change in functional oral intake in stroke patients. It is suitable as an independent measure of functional oral intake in prospective studies of stroke-related dysphagia.
measure: Change in Eating Assessment Tool-10 (EAT-10) Score
time frame: before intervention, immediately after intervention, 3 months after the intervention
description: Eating Assessment Tool-10 (EAT-10) is used to assess participants' dysphagia symptoms, symptom severity, and risk of oropharyngeal dysphagia. This scale is a scale of 10 questions that the patient himself answers, which questions the symptoms of dysphagia. The answer points for each question range from 0 (no problem) to 4 (serious problem). If EAT-10 score is ≥3, it is considered as "risk of oropharyngeal dysphagia". It is a useful tool to evaluate the severity of dysphagia symptom in the clinic, to monitor the progression and effectiveness of the disease.
measure: Change in Swallowing-related Quality of Life (SWAL-QOL) Score
time frame: before intervention, immediately after intervention, 3 months after the intervention
description: Swallowing-related quality of life scale (SWAL-QOL) is used to evaluate the effect of swallowing disorders on quality of life. It was created to evaluate the quality of life of patients with oropharyngeal dysphagia. It includes a total of 44 questions under eating disorder, eating time, eating desire, food selection, communication, anxiety, mental health, social functionality, fatigue, and sleep subgroups. Each question is evaluated with a score ranging from 1 (worst) to 5 (best). The subgroup scores of the scale and the total score of the scale can be used to assess the change in patients.
measure: Change in Visual Analog Scale (VAS)
time frame: before intervention, immediately after intervention, 3 months after the intervention
description: Patients' difficulty in swallowing will be questioned using the Visual Analogue Scale (VAS). On a scale of ten centimeters, patients will be asked to mark the appropriate level of dysphagia 0: No dysphagia, 10: Very severe dysphagia.
measure: Change in Laryngostroboscopy Examination
time frame: before intervention, immediately after intervention
description: In the Istanbul Faculty of Medicine Otorhinolaryngology Diseases Clinic, evaluations will be made by the Ear Nose Throat Specialist. Whether there is vocal cord paresis and paralysis and whether glottic patency is evaluated in the laryngostroboscopic examination.
measure: Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
time frame: before intervention, immediately after intervention
description: Fiberoptic endoscopic swallowing assessment will be performed by the otolaryngologist doctor before and immediately after the treatment. In the fiberoptic endoscopic swallowing assessment, the condition of the patient according to the penetration aspiration scale will be checked. Grade 1 represents the best and grade 7 the worst on the penetration aspiration scale.
measure: Change in Voice-Related Quality of Life (V-RQOL) Score
time frame: before intervention, immediately after intervention, 3 months after the intervention
description: This ten-item scale is a scale designed for adult populations with voice disorders to measure both social-emotional and physical-functional aspects of voice problems. The answer points for each question range from 1 (few problems) to 5 (serious problems). A total score change on this scale will be used to evaluate patients.
arm group label: Neuromuscular Electrical Stimulation (NMES) with TDT
arm group type: Experimental
arm group label: Traditional Dysphagia Therapy (TDT)
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Procedure: Traditional Dysphagia Therapy (TDT)
description: Traditional dysphagia therapy includes diet modification training, teaching postural compensatory methods, training of oral motor control exercises and tongue root exercises, training of swallowing maneuvers, and practice of chin-resistance exercise, which is the exercise of opening the upper esophageal sphincter.
Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks.
arm group label: Traditional Dysphagia Therapy (TDT)
intervention type: Device
intervention name: Procedure: Neuromuscular Electrical Stimulation with TDT
description: The skin to be treated will be cleaned and dried. NMES will be implemented with signals received from two channels. In the first channel, the upper electrodes will be placed horizontally just above the hyoid bone. This is the place where the cupping is felt when the finger is pressed right under the chin. In the second channel, the lower electrodes will be placed horizontally, just above the thyrohyoid muscle. This is the place where you can feel a cupping when pressed with your finger, on both sides of the apple in the larynx. The device will be set to start at the lowest power, with very short pulses of approximately 700 microseconds, at intervals of 1 second. The power will be gradually increased according to the device and the power that the patient feels vibration will be stopped. The power to be applied will not exceed 25 milliamps. NMES application and Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks.
arm group label: Neuromuscular Electrical Stimulation (NMES) with TDT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elif Tarihçi, MD
role: Principal Investigator
affiliation: Istanbul University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Elif Tarihçi
investigator title: Principal Investigator
mesh term: Deglutition Disorders
mesh term: Stroke
sharing ipd: No
provided document: 
provided document: 