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/NCT06035198</url>
    </required_header>
    <id_info>
      <org_study_id>RS-2023-00262005</org_study_id>
      <nct_id>NCT06035198</nct_id>
    </id_info>
    <brief_title>Developement of Stroke Prognosis Predictive Precision Medicine Based on a Digital Twin</brief_title>
    <official_title>Developement of Prognosis Predictive Precision Medicine Based on a Digital Twin Reflecting the Motor Patterns in Stroke Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seyoung Shin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CHA 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 realize customized precision medicine for stroke patients and&#xD;
        the visual digitization of patient medical information required in the era of digital&#xD;
        transformation.&#xD;
  &#xD;
        This study will collect large-scale, high-quality clinical data and daily life exercise&#xD;
        pattern data covering the subacute to chronic stages of stroke patients. Based on this, we&#xD;
        will use artificial intelligence analysis technology to predict the functional status of&#xD;
        stroke patients in the chronic stage after their disability is fixed. We aim to develop the&#xD;
        next generation of personalized digital twins by creating a prognostic prediction model.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>Modified Barthel Index (MBI)</measure>
      <time_frame>minimum 6 months to maximum 6 years</time_frame>
      <description>A scale to measure disability or dependence in activities of daily living (ADL) of stroke survivors (range 0-100)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mini Mental Status Examination (MMSE)</measure>
      <time_frame>minimum 6 months to maximum 6 years</time_frame>
      <description>Mini-Mental State Examination (MMSE) is a 30-question assessment of cognitive function that evaluates attention and orientation, memory, registration, recall, calculation, language and ability to draw a complex polygon (range 0-30)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Ambulatory Category (FAC)</measure>
      <time_frame>minimum 6 months to maximum 6 years</time_frame>
      <description>The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. (range 0-5)</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>Stroke patients</arm_group_label>
      <description>Patients diagnosed with stroke at four hospitals in Korea</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Stroke</intervention_name>
      <description>No intervention</description>
      <arm_group_label>Stroke patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Stroke patients receiving treatment at four hospitals in Korea&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults over 20 years of age with a history of stroke onset between 2018.01.01 to&#xD;
               2023.07.31.&#xD;
  &#xD;
            -  Patients who exist rehabilitation medical evaluation after stroke onset&#xD;
  &#xD;
            -  Patients who voluntarily decide to participate in this study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who have severe internal diseases such as unstable conditions of the&#xD;
               cardiovascular system, digestive system, respiratory system, endocrine system, etc.&#xD;
               and are in poor overall condition.&#xD;
  &#xD;
            -  Those who have impaired ability to consent (MMSE score less than 10 points) and not&#xD;
               accompanied by a care-giver.&#xD;
  &#xD;
            -  In any other cases where the researcher determines that participation in this study is&#xD;
               not appropriate.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>CHA University</investigator_affiliation>
      <investigator_full_name>Seyoung Shin</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <!-- 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/NCT06035198
  org study id: RS-2023-00262005
  nct id: NCT06035198
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to realize customized precision medicine for stroke patients and
        the visual digitization of patient medical information required in the era of digital
        transformation.
  
        This study will collect large-scale, high-quality clinical data and daily life exercise
        pattern data covering the subacute to chronic stages of stroke patients. Based on this, we
        will use artificial intelligence analysis technology to predict the functional status of
        stroke patients in the chronic stage after their disability is fixed. We aim to develop the
        next generation of personalized digital twins by creating a prognostic prediction model.
  observational model: Cohort
  time perspective: Other
  measure: Modified Barthel Index (MBI)
  time frame: minimum 6 months to maximum 6 years
  description: A scale to measure disability or dependence in activities of daily living (ADL) of stroke survivors (range 0-100)
  measure: Mini Mental Status Examination (MMSE)
  time frame: minimum 6 months to maximum 6 years
  description: Mini-Mental State Examination (MMSE) is a 30-question assessment of cognitive function that evaluates attention and orientation, memory, registration, recall, calculation, language and ability to draw a complex polygon (range 0-30)
  measure: Functional Ambulatory Category (FAC)
  time frame: minimum 6 months to maximum 6 years
  description: The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. (range 0-5)
  arm group label: Stroke patients
  description: Patients diagnosed with stroke at four hospitals in Korea
  intervention type: Other
  intervention name: Stroke
  description: No intervention
  arm group label: Stroke patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor-Investigator
  investigator affiliation: CHA University
  investigator full name: Seyoung Shin
  investigator title: Principal Investigator
  mesh term: Stroke