<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/NCT02985788</url>
  </required_header>
  <id_info>
    <org_study_id>13-003378</org_study_id>
    <nct_id>NCT02985788</nct_id>
  </id_info>
  <brief_title>Self Digital Photography for Assessing Elbow Range of Motion</brief_title>
  <official_title>Validation of Self Digital Photography for Assessing Elbow Range of Motion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Loss of elbow range of motion can significantly affect activities of daily living. Measuring&#xD;
      elbow range of motion is critical for tracking post surgical outcomes. This study seeks to&#xD;
      validate the ability to validate self photography as a means of followup through long&#xD;
      distance correspondence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Loss of elbow range of motion is common after trauma and can significantly affect activities&#xD;
      of daily living. Patients across the country travel to tertiary referral centers to have this&#xD;
      problem addressed. Followup is critical and can often be difficult given distances between&#xD;
      patients home and their healthcare provider. Measuring postoperative outcomes requires&#xD;
      accurate and reliable documentation of range of motion. Previously, the investigators have&#xD;
      validated digital photography as a means of accurately measuring elbow range of motion. In&#xD;
      that study, photographs were taken by a non-professional photographer. With the advance in&#xD;
      personal technology, patients now have the ability to take photos themselves. This study&#xD;
      seeks to validate self photography, which will ultimately improve patient follow up and&#xD;
      improve clinical monitoring&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">November 15, 2018</completion_date>
  <primary_completion_date type="Actual">November 15, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Digital photo-based elbow range of motion measurement compared to traditional goniometry</measure>
    <time_frame>up to 2 months</time_frame>
    <description>Patients will follow instructions to take a photograph of themselves capturing elbow range of motion (flexion, extension, supination and pronation). Elbow range of motion will then be measured clinically with a goniometer. Patient's active participation will be 1 day. Range of motion will be measured off of photographs 1 month after capturing pictures and repeated 2 weeks later</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Contracture of Elbow Joint</condition>
  <arm_group>
    <arm_group_label>Video Instructions</arm_group_label>
    <description>Instructions on how to take a flexion/extension picture will be delivered in video format. These instructions will be followed by written instruction on how to take pictures examining pronation/supination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Written instructions</arm_group_label>
    <description>Instructions on how to take a flexion/extension picture will be delivered in a written, on paper format. These instructions will be followed by written instruction on how to take pictures examining pronation/supination.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who have an elbow contracture in the sagittal plane&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elbow contracture in the sagittal place&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to read English&#xD;
&#xD;
          -  Unable to forward flex shoulder to 90 degrees or hold their shoulder at 90 degrees for&#xD;
             the duration of the examination&#xD;
&#xD;
          -  Unable to tolerate the exercise due to pain&#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>Shawn O'Driscoll, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Shawn W. O'Driscoll</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Contracture</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/NCT02985788
org study id: 13-003378
nct id: NCT02985788
lead sponsor: 
has dmc: No
Loss of elbow range of motion can significantly affect activities of daily living. Measuring
      elbow range of motion is critical for tracking post surgical outcomes. This study seeks to
      validate the ability to validate self photography as a means of followup through long
      distance correspondence.
Loss of elbow range of motion is common after trauma and can significantly affect activities
      of daily living. Patients across the country travel to tertiary referral centers to have this
      problem addressed. Followup is critical and can often be difficult given distances between
      patients home and their healthcare provider. Measuring postoperative outcomes requires
      accurate and reliable documentation of range of motion. Previously, the investigators have
      validated digital photography as a means of accurately measuring elbow range of motion. In
      that study, photographs were taken by a non-professional photographer. With the advance in
      personal technology, patients now have the ability to take photos themselves. This study
      seeks to validate self photography, which will ultimately improve patient follow up and
      improve clinical monitoring
observational model: Other
time perspective: Prospective
measure: Digital photo-based elbow range of motion measurement compared to traditional goniometry
time frame: up to 2 months
description: Patients will follow instructions to take a photograph of themselves capturing elbow range of motion (flexion, extension, supination and pronation). Elbow range of motion will then be measured clinically with a goniometer. Patient's active participation will be 1 day. Range of motion will be measured off of photographs 1 month after capturing pictures and repeated 2 weeks later
arm group label: Video Instructions
description: Instructions on how to take a flexion/extension picture will be delivered in video format. These instructions will be followed by written instruction on how to take pictures examining pronation/supination.
arm group label: Written instructions
description: Instructions on how to take a flexion/extension picture will be delivered in a written, on paper format. These instructions will be followed by written instruction on how to take pictures examining pronation/supination.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shawn O'Driscoll, PhD MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Shawn W. O'Driscoll
investigator title: PI
mesh term: Contracture
sharing ipd: Undecided