<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/NCT04435093</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0150</org_study_id>
    <secondary_id>2020-A01752-37</secondary_id>
    <nct_id>NCT04435093</nct_id>
  </id_info>
  <brief_title>Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.</brief_title>
  <acronym>MFM-Play pilot</acronym>
  <official_title>Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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 Motor Function Measure (MFM) is a functional rating scale consisting of 32 items&#xD;
      assessing motor functional abilities in a person with neuromuscular disease.&#xD;
&#xD;
      By exploring the potential of digital technologies applied to MFM, for each item completion&#xD;
      we want to create digital animations containing different playful and informative scenarios.&#xD;
      This digital evolution aims to standardize assessment on the therapist's side, but also to&#xD;
      improve acceptance of scale and patient participation.&#xD;
&#xD;
      Despite the modification of the MFM completion by digital animation, the study hypothesis is&#xD;
      that the metrological qualities of the scale are retained.&#xD;
&#xD;
      Through the MFM-Play pilot study, the objective is to test 5 items of the MFM-Play scale&#xD;
      before carrying out a validation study of the total MFM-Play.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Actual">March 4, 2021</completion_date>
  <primary_completion_date type="Actual">March 4, 2021</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>MFM scores item 18 to 22</measure>
    <time_frame>Day 1</time_frame>
    <description>Level of agreement between the scores obtained during the classic mode and during the MFM-Play mode, completed by two different therapists.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">19</enrollment>
  <condition>Neuromuscular Diseases</condition>
  <arm_group>
    <arm_group_label>MFM completion</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MFM-Play</intervention_name>
    <description>Neuromuscular patients will complete five items of the MFM (items 18 to 22) either conventionally or using the MFM-Play with 2 different therapists, on the same day. The order of the MFM type completion will be determined by randomization. Both therapists will rate items 18 to 22 blindly.</description>
    <arm_group_label>MFM completion</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will involve children with a neuromuscular disease, aged 6 to 11 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Girls and boys with a neuromuscular disease&#xD;
&#xD;
          -  Aged 6 to 11 years old&#xD;
&#xD;
          -  With parental assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participating to a therapeutic trial&#xD;
&#xD;
          -  Patients without compartmental capacities to participate normally to the MFM.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominique Vincent-Genod</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>May 27, 2021</last_update_submitted>
  <last_update_submitted_qc>May 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neuromuscular Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuromuscular Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT04435093
org study id: 69HCL20_0150
secondary id: 2020-A01752-37
nct id: NCT04435093
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The Motor Function Measure (MFM) is a functional rating scale consisting of 32 items
      assessing motor functional abilities in a person with neuromuscular disease.

      By exploring the potential of digital technologies applied to MFM, for each item completion
      we want to create digital animations containing different playful and informative scenarios.
      This digital evolution aims to standardize assessment on the therapist's side, but also to
      improve acceptance of scale and patient participation.

      Despite the modification of the MFM completion by digital animation, the study hypothesis is
      that the metrological qualities of the scale are retained.

      Through the MFM-Play pilot study, the objective is to test 5 items of the MFM-Play scale
      before carrying out a validation study of the total MFM-Play.
observational model: Other
time perspective: Prospective
measure: MFM scores item 18 to 22
time frame: Day 1
description: Level of agreement between the scores obtained during the classic mode and during the MFM-Play mode, completed by two different therapists.
arm group label: MFM completion
intervention type: Other
intervention name: MFM-Play
description: Neuromuscular patients will complete five items of the MFM (items 18 to 22) either conventionally or using the MFM-Play with 2 different therapists, on the same day. The order of the MFM type completion will be determined by randomization. Both therapists will rate items 18 to 22 blindly.
arm group label: MFM completion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
last name: Dominique Vincent-Genod
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Neuromuscular Diseases