xml: <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/NCT05970406</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00335053</org_study_id>
      <nct_id>NCT05970406</nct_id>
    </id_info>
    <brief_title>High Intensity Dysphagia Rehab for Acute Ischemic Stroke Patients</brief_title>
    <official_title>Effects of High Intensity Dysphagia Rehabilitation on Adults With Dysphagia s/p Acute Ischemic Stroke in an Acute Rehab Facility</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Johns Hopkins University</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 purpose of this study is to determine a standardized protocol for swallowing therapy and&#xD;
        this protocol's effects on recovery after a stroke&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will include adults, aged 18-99, who are admitted to Johns Hopkins Bayview (JHBMC)&#xD;
        Rehabilitation Unit following an acute ischemic stroke with a diagnosis of dysphagia,&#xD;
        determined by instrumental assessment with a Video Fluoroscopic Swallowing Study (VFSS). All&#xD;
        participants will be asked to complete an informed consent form prior to admission to the&#xD;
        study. Initial objective assessment of swallowing with video fluoroscopic swallowing&#xD;
        assessment will be completed within 72 hours of admission to the unit. Participants with PAS&#xD;
        scores of greater than or equal to 3 and FOIS scores of less than or equal to 6 will be&#xD;
        admitted to the study and asked to complete the Eating Assessment Tool (EAT-10) score sheets.&#xD;
        Intensive swallowing interventions with Speech Language Pathologists will begin within 24&#xD;
        hours. Daily treatment will include two 30-minute sessions, 5-6 days a week which will&#xD;
        include the evidence-based dysphagia exercises focusing on tongue resistance, head lift/chin&#xD;
        tuck against resistance and expiratory muscle strength training tasks. Devices utilized will&#xD;
        include the Iowa Oral Performance Instrument (IOPI), and the Positive Expiratory Pressure&#xD;
        (PEP) Respironics device or the Expiratory Muscle Strength Training (EMST150) device. Each&#xD;
        session will involve IOPI measurements of lingual strength with endurance tasks set at 60%&#xD;
        and 75% max strength scores to be completed for total of 10 attempts at each level for&#xD;
        isometric and isokinetic tasks; Expiratory muscle strength training with EMST150 or PEP&#xD;
        Respironics (dependent on strength levels) will be set at 75% max resistance levels per&#xD;
        training method, for 25 completions per session; Shaker or Chin Tuck Against Resistance&#xD;
        (CTAR) using 4.5 inch standard rubber ball - determined by patient positioning restrictions&#xD;
        or tolerance- will be completed with goals of isometric hold for 1 minute x3 attempts and&#xD;
        isokinetic x10 x3 attempts each session. At least one session per day will include&#xD;
        consumption of ice chips and/or food dependent on PAS levels. At least one additional VFSS&#xD;
        will be completed prior to discharge from study, as is standard of care within the JHBMC&#xD;
        Rehab Unit. Outcome measures will be assessed with pre and post PAS scores (comparing initial&#xD;
        and final VFSS results), EAT 10 scores and FOIS scores as well as documented improvements in&#xD;
        IOPI and EMST/PEP levels at two-week intervals and will continue throughout the acute&#xD;
        comprehensive inpatient rehabilitation unit (ACIR) stay as indicated. A follow up phone call&#xD;
        with each participant will occur between 4-6 weeks post discharge from the and be completed&#xD;
        with EAT-10 and FOIS over phone by Speech Language Pathologists or the investigator.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2027</completion_date>
    <primary_completion_date type="Anticipated">October 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with improved swallowing as assessed by the improved Penetration Aspiration Scale (PAS)</measure>
      <time_frame>up to 6 weeks</time_frame>
      <description>Measured with improved Penetration Aspiration Scale (PAS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with improved swallowing as assessed by the Functional Oral Intake Scale (FOIS)</measure>
      <time_frame>up to 6 weeks</time_frame>
      <description>Measured with the Functional Oral Intake Scale (FOIS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with perceived improvements in swallowing</measure>
      <time_frame>up to 6 weeks</time_frame>
      <description>Measured with improved EAT-10 Questionnaire Scores</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Dysphagia Following Cerebrovascular Accident</condition>
    <arm_group>
      <arm_group_label>Active Participants in high intensity dysphagia therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with acute dysphagia who will receive high intensity dysphagia therapy during stay in inpatient rehab facility</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>high intensity dysphagia therapy</intervention_name>
      <description>Intensive swallowing interventions with Speech Language Pathologists to begin within 24 hours of video swallow study results. Daily treatment will include two 30-minute sessions, 5-6 days a week which will include the evidence-based dysphagia exercises focusing on tongue resistance, head lift/chin tuck against resistance and expiratory muscle strength training tasks</description>
      <arm_group_label>Active Participants in high intensity dysphagia therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Ages 18-99&#xD;
  &#xD;
            2. Ischemic Stroke&#xD;
  &#xD;
            3. Identified to have acute dysphagia s/p ischemic stroke&#xD;
  &#xD;
            4. Able to follow 1-step commands for swallowing directions&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Younger than 18, older than 100&#xD;
  &#xD;
            2. Hemorrhagic Stroke, Subarachnoid hemorrhage, subdural hematoma, epidural hematoma&#xD;
  &#xD;
            3. h/o dysphagia&#xD;
  &#xD;
            4. Advanced progressive neurological disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alba M Azola, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jamie S Muhly, MS</last_name>
      <phone>410-925-7393</phone>
      <email>jmuhly1@jhmi.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alexa Taicher, MS</last_name>
      <phone>410-550-0225</phone>
      <email>ataiche1@jhmi.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Johns Hopkins Bayview Medical Center</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21224</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jamie S Muhly, MS</last_name>
        <phone>410-925-7393</phone>
        <email>jmuhly1@jhmi.edu</email>
      </contact>
      <investigator>
        <last_name>Alba M Azola, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Buchholz DW. Dysphagia associated with neurological disorders. Acta Otorhinolaryngol Belg. 1994;48(2):143-55.</citation>
      <PMID>8209677</PMID>
    </reference>
    <reference>
      <citation>Buchholz DW. Oropharyngeal dysphagia due to iatrogenic neurological dysfunction. Dysphagia. 1995 Fall;10(4):248-54. doi: 10.1007/BF00431417.</citation>
      <PMID>7493505</PMID>
    </reference>
    <reference>
      <citation>Lugger KE. Dysphagia in the elderly stroke patient. J Neurosci Nurs. 1994 Apr;26(2):78-84. doi: 10.1097/01376517-199404000-00005.</citation>
      <PMID>8077779</PMID>
    </reference>
    <reference>
      <citation>Mann G, Hankey GJ, Cameron D. Swallowing disorders following acute stroke: prevalence and diagnostic accuracy. Cerebrovasc Dis. 2000 Sep-Oct;10(5):380-6. doi: 10.1159/000016094.</citation>
      <PMID>10971024</PMID>
    </reference>
    <reference>
      <citation>Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.</citation>
      <PMID>16269630</PMID>
    </reference>
    <reference>
      <citation>Gonzalez-Fernandez M, Ottenstein L, Atanelov L, Christian AB. Dysphagia after Stroke: an Overview. Curr Phys Med Rehabil Rep. 2013 Sep;1(3):187-196. doi: 10.1007/s40141-013-0017-y.</citation>
      <PMID>24977109</PMID>
    </reference>
    <reference>
      <citation>Krekeler BN, Rowe LM, Connor NP. Dose in Exercise-Based Dysphagia Therapies: A Scoping Review. Dysphagia. 2021 Feb;36(1):1-32. doi: 10.1007/s00455-020-10104-3. Epub 2020 Mar 5.</citation>
      <PMID>32140905</PMID>
    </reference>
    <reference>
      <citation>Malandraki GA, Rajappa A, Kantarcigil C, Wagner E, Ivey C, Youse K. The Intensive Dysphagia Rehabilitation Approach Applied to Patients With Neurogenic Dysphagia: A Case Series Design Study. Arch Phys Med Rehabil. 2016 Apr;97(4):567-574. doi: 10.1016/j.apmr.2015.11.019. Epub 2015 Dec 19.</citation>
      <PMID>26711168</PMID>
    </reference>
    <reference>
      <citation>Burkhead LM, Sapienza CM, Rosenbek JC. Strength-training exercise in dysphagia rehabilitation: principles, procedures, and directions for future research. Dysphagia. 2007 Jul;22(3):251-65. doi: 10.1007/s00455-006-9074-z. Epub 2007 Apr 25.</citation>
      <PMID>17457549</PMID>
    </reference>
    <reference>
      <citation>Alkhuwaiter M, Davidson K, Hopkins-Rossabi T, Martin-Harris B. Scoring the Penetration-Aspiration Scale (PAS) in Two Conditions: A Reliability Study. Dysphagia. 2022 Apr;37(2):407-416. doi: 10.1007/s00455-021-10292-6. Epub 2021 Apr 21.</citation>
      <PMID>33880656</PMID>
    </reference>
    <reference>
      <citation>Crary MA, Mann GD, Groher ME. Initial psychometric assessment of a functional oral intake scale for dysphagia in stroke patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1516-20. doi: 10.1016/j.apmr.2004.11.049.</citation>
      <PMID>16084801</PMID>
    </reference>
    <reference>
      <citation>Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.</citation>
      <PMID>19140539</PMID>
    </reference>
    <reference>
      <citation>Balou M, Herzberg EG, Kamelhar D, Molfenter SM. An intensive swallowing exercise protocol for improving swallowing physiology in older adults with radiographically confirmed dysphagia. Clin Interv Aging. 2019 Feb 11;14:283-288. doi: 10.2147/CIA.S194723. eCollection 2019.</citation>
      <PMID>30804667</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</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>Ischemic Stroke</mesh_term>
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970406
  org study id: IRB00335053
  nct id: NCT05970406
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine a standardized protocol for swallowing therapy and
        this protocol's effects on recovery after a stroke
  This study will include adults, aged 18-99, who are admitted to Johns Hopkins Bayview (JHBMC)
        Rehabilitation Unit following an acute ischemic stroke with a diagnosis of dysphagia,
        determined by instrumental assessment with a Video Fluoroscopic Swallowing Study (VFSS). All
        participants will be asked to complete an informed consent form prior to admission to the
        study. Initial objective assessment of swallowing with video fluoroscopic swallowing
        assessment will be completed within 72 hours of admission to the unit. Participants with PAS
        scores of greater than or equal to 3 and FOIS scores of less than or equal to 6 will be
        admitted to the study and asked to complete the Eating Assessment Tool (EAT-10) score sheets.
        Intensive swallowing interventions with Speech Language Pathologists will begin within 24
        hours. Daily treatment will include two 30-minute sessions, 5-6 days a week which will
        include the evidence-based dysphagia exercises focusing on tongue resistance, head lift/chin
        tuck against resistance and expiratory muscle strength training tasks. Devices utilized will
        include the Iowa Oral Performance Instrument (IOPI), and the Positive Expiratory Pressure
        (PEP) Respironics device or the Expiratory Muscle Strength Training (EMST150) device. Each
        session will involve IOPI measurements of lingual strength with endurance tasks set at 60%
        and 75% max strength scores to be completed for total of 10 attempts at each level for
        isometric and isokinetic tasks; Expiratory muscle strength training with EMST150 or PEP
        Respironics (dependent on strength levels) will be set at 75% max resistance levels per
        training method, for 25 completions per session; Shaker or Chin Tuck Against Resistance
        (CTAR) using 4.5 inch standard rubber ball - determined by patient positioning restrictions
        or tolerance- will be completed with goals of isometric hold for 1 minute x3 attempts and
        isokinetic x10 x3 attempts each session. At least one session per day will include
        consumption of ice chips and/or food dependent on PAS levels. At least one additional VFSS
        will be completed prior to discharge from study, as is standard of care within the JHBMC
        Rehab Unit. Outcome measures will be assessed with pre and post PAS scores (comparing initial
        and final VFSS results), EAT 10 scores and FOIS scores as well as documented improvements in
        IOPI and EMST/PEP levels at two-week intervals and will continue throughout the acute
        comprehensive inpatient rehabilitation unit (ACIR) stay as indicated. A follow up phone call
        with each participant will occur between 4-6 weeks post discharge from the and be completed
        with EAT-10 and FOIS over phone by Speech Language Pathologists or the investigator.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of participants with improved swallowing as assessed by the improved Penetration Aspiration Scale (PAS)
  time frame: up to 6 weeks
  description: Measured with improved Penetration Aspiration Scale (PAS)
  measure: Number of participants with improved swallowing as assessed by the Functional Oral Intake Scale (FOIS)
  time frame: up to 6 weeks
  description: Measured with the Functional Oral Intake Scale (FOIS)
  measure: Number of participants with perceived improvements in swallowing
  time frame: up to 6 weeks
  description: Measured with improved EAT-10 Questionnaire Scores
  arm group label: Active Participants in high intensity dysphagia therapy
  arm group type: Experimental
  description: Participants with acute dysphagia who will receive high intensity dysphagia therapy during stay in inpatient rehab facility
  intervention type: Other
  intervention name: high intensity dysphagia therapy
  description: Intensive swallowing interventions with Speech Language Pathologists to begin within 24 hours of video swallow study results. Daily treatment will include two 30-minute sessions, 5-6 days a week which will include the evidence-based dysphagia exercises focusing on tongue resistance, head lift/chin tuck against resistance and expiratory muscle strength training tasks
  arm group label: Active Participants in high intensity dysphagia therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Alba M Azola, MD
  role: Principal Investigator
  affiliation: Johns Hopkins University
  last name: Jamie S Muhly, MS
  phone: 410-925-7393
  email: jmuhly1@jhmi.edu
  last name: Alexa Taicher, MS
  phone: 410-550-0225
  email: ataiche1@jhmi.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  citation: Buchholz DW. Dysphagia associated with neurological disorders. Acta Otorhinolaryngol Belg. 1994;48(2):143-55.
  PMID: 8209677
  citation: Buchholz DW. Oropharyngeal dysphagia due to iatrogenic neurological dysfunction. Dysphagia. 1995 Fall;10(4):248-54. doi: 10.1007/BF00431417.
  PMID: 7493505
  citation: Lugger KE. Dysphagia in the elderly stroke patient. J Neurosci Nurs. 1994 Apr;26(2):78-84. doi: 10.1097/01376517-199404000-00005.
  PMID: 8077779
  citation: Mann G, Hankey GJ, Cameron D. Swallowing disorders following acute stroke: prevalence and diagnostic accuracy. Cerebrovasc Dis. 2000 Sep-Oct;10(5):380-6. doi: 10.1159/000016094.
  PMID: 10971024
  citation: Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
  PMID: 16269630
  citation: Gonzalez-Fernandez M, Ottenstein L, Atanelov L, Christian AB. Dysphagia after Stroke: an Overview. Curr Phys Med Rehabil Rep. 2013 Sep;1(3):187-196. doi: 10.1007/s40141-013-0017-y.
  PMID: 24977109
  citation: Krekeler BN, Rowe LM, Connor NP. Dose in Exercise-Based Dysphagia Therapies: A Scoping Review. Dysphagia. 2021 Feb;36(1):1-32. doi: 10.1007/s00455-020-10104-3. Epub 2020 Mar 5.
  PMID: 32140905
  citation: Malandraki GA, Rajappa A, Kantarcigil C, Wagner E, Ivey C, Youse K. The Intensive Dysphagia Rehabilitation Approach Applied to Patients With Neurogenic Dysphagia: A Case Series Design Study. Arch Phys Med Rehabil. 2016 Apr;97(4):567-574. doi: 10.1016/j.apmr.2015.11.019. Epub 2015 Dec 19.
  PMID: 26711168
  citation: Burkhead LM, Sapienza CM, Rosenbek JC. Strength-training exercise in dysphagia rehabilitation: principles, procedures, and directions for future research. Dysphagia. 2007 Jul;22(3):251-65. doi: 10.1007/s00455-006-9074-z. Epub 2007 Apr 25.
  PMID: 17457549
  citation: Alkhuwaiter M, Davidson K, Hopkins-Rossabi T, Martin-Harris B. Scoring the Penetration-Aspiration Scale (PAS) in Two Conditions: A Reliability Study. Dysphagia. 2022 Apr;37(2):407-416. doi: 10.1007/s00455-021-10292-6. Epub 2021 Apr 21.
  PMID: 33880656
  citation: Crary MA, Mann GD, Groher ME. Initial psychometric assessment of a functional oral intake scale for dysphagia in stroke patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1516-20. doi: 10.1016/j.apmr.2004.11.049.
  PMID: 16084801
  citation: Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.
  PMID: 19140539
  citation: Balou M, Herzberg EG, Kamelhar D, Molfenter SM. An intensive swallowing exercise protocol for improving swallowing physiology in older adults with radiographically confirmed dysphagia. Clin Interv Aging. 2019 Feb 11;14:283-288. doi: 10.2147/CIA.S194723. eCollection 2019.
  PMID: 30804667
  responsible party type: Sponsor
  mesh term: Deglutition Disorders
  mesh term: Ischemic Stroke
  mesh term: Stroke
  sharing ipd: No