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/NCT06027580</url>
    </required_header>
    <id_info>
      <org_study_id>PRO00048530</org_study_id>
      <nct_id>NCT06027580</nct_id>
    </id_info>
    <brief_title>Orthosis to Improve Trunk Control in Infants Age 6-18 Months</brief_title>
    <official_title>Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical College of Wisconsin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>SPIO</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Medical College of Wisconsin</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>
        The purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition&#xD;
        orthosis on an infant's head, trunk and upper limb function.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will observe the difference in outcomes between two courses of standard clinical&#xD;
        care: therapy or therapy with the SPIO® Core-MAX® Expedition orthosis. Families will&#xD;
        self-select that standard care option that works best for their family, and outcomes will be&#xD;
        observed at baseline, 3 months and 6 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in head and trunk position from centerline at baseline, 3-months and 6-months.</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale.</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Cerebral Palsy</condition>
    <arm_group>
      <arm_group_label>SPIO group</arm_group_label>
      <description>Standard Care Therapy option 1: parents may self-select this standard care combined option of therapy and use of SPIO® Core-MAX® Expedition thoracolumbosacral orthosis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SPIO® Core-MAX® Expedition thoracolumbosacral orthosis</intervention_name>
      <description>SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months</description>
      <arm_group_label>SPIO group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children aged 6 months to 18 months age corrected with abnormal muscle tone assessed by a&#xD;
          provider as likely to benefit from use of a compression garment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Study subjects aged 6 months to 18 months age corrected with abnormal muscle tone&#xD;
  &#xD;
            -  No previous use of SPIO® or similar Lycra/compression garments&#xD;
  &#xD;
            -  Assessed by provider as likely to benefit from use of compression garment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-English speaking&#xD;
  &#xD;
            -  Inability for family to bring study subject to assessments&#xD;
  &#xD;
            -  Orthosis or casting that contraindicate SPIO® Core-MAX® during the study period&#xD;
  &#xD;
            -  Botulinum toxin injections within 3 months, or during study participation&#xD;
  &#xD;
            -  Having prior orthopedic or neurosurgery surgeries within one year&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>18 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stacy Stibb, DO</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medical College of Wisconsin</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stacy Stibb, DO</last_name>
      <phone>414-266-2745</phone>
      <email>sstibb@mcw.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Meghann Sytsma</last_name>
      <phone>414-955-1922</phone>
      <email>mesytsma@mcw.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 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 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
      <investigator_full_name>Stacy Stibb</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>abnormal muscle tone</keyword>
    <keyword>cerebral palsy</keyword>
    <keyword>hypotonia</keyword>
    <keyword>muscle tone</keyword>
    <keyword>spasticity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cerebral Palsy</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/NCT06027580
  org study id: PRO00048530
  nct id: NCT06027580
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition
        orthosis on an infant's head, trunk and upper limb function.
  This study will observe the difference in outcomes between two courses of standard clinical
        care: therapy or therapy with the SPIO® Core-MAX® Expedition orthosis. Families will
        self-select that standard care option that works best for their family, and outcomes will be
        observed at baseline, 3 months and 6 months.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in head and trunk position from centerline at baseline, 3-months and 6-months.
  time frame: Through study completion, an average of 2 years
  measure: Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale.
  time frame: Through study completion, an average of 2 years
  arm group label: SPIO group
  description: Standard Care Therapy option 1: parents may self-select this standard care combined option of therapy and use of SPIO® Core-MAX® Expedition thoracolumbosacral orthosis
  arm group label: Control group
  description: Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone
  intervention type: Device
  intervention name: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis
  description: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months
  arm group label: SPIO group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 18 Months
  healthy volunteers: No
  last name: Stacy Stibb, DO
  role: Principal Investigator
  affiliation: Medical College of Wisconsin
  last name: Stacy Stibb, DO
  phone: 414-266-2745
  email: sstibb@mcw.edu
  last name: Meghann Sytsma
  phone: 414-955-1922
  email: mesytsma@mcw.edu
  responsible party type: Principal Investigator
  investigator affiliation: Medical College of Wisconsin
  investigator full name: Stacy Stibb
  investigator title: Assistant Professor
  mesh term: Cerebral Palsy
  sharing ipd: No