<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/NCT02218593</url>
  </required_header>
  <id_info>
    <org_study_id>579772-2</org_study_id>
    <nct_id>NCT02218593</nct_id>
  </id_info>
  <brief_title>WREX Outcome Study</brief_title>
  <official_title>WREX Outcome Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nemours Children's Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nemours Children's Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate how the Wilmington Robotic Exoskeleton (WREX) is working for&#xD;
      children who are using the WREX, or have used it in the past. The survey consists of a set of&#xD;
      questions a) performed online and b) performed over the phone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The WREX (Wilmington Robotic EXoskeleton) is being used by many children with neuromuscular&#xD;
      conditions such as arthrogryposis and muscular dystrophy. Nemours/A.I. duPont Hospital for&#xD;
      Children alone has provided a WREX for about 80 children in the last 3 years. This is being&#xD;
      done through the orthopedic and muscle clinics in the hospital. We would like to perform a&#xD;
      retrospective study to see how well the children are doing with the WREX. We propose getting&#xD;
      this feedback through a survey administered to families using the WREX. The survey will be&#xD;
      performed in two parts. 1) A phone survey will use the Canadian Occupational Performance&#xD;
      Measure (COPM). 2) an online survey with additional questions. The parents are asked to&#xD;
      submit answers on behalf of the children if they are unable to.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Activities of daily living</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Muscular Dystrophy</condition>
  <condition>Arthrogryposis</condition>
  <condition>Spinal Muscular Atrophy</condition>
  <arm_group>
    <arm_group_label>WREX orthosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>WREX Orthosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WREX orthosis</intervention_name>
    <description>Upper extremity exoskleton used to assist movement</description>
    <arm_group_label>WREX orthosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Use the Wilmington Robotic Exoskeleton&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  people who do not use the Wilmington Robotic Exoskeleton&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nemours Children's Clinic</investigator_affiliation>
    <investigator_full_name>Tariq Rahman</investigator_full_name>
    <investigator_title>Prinicipal Research Engineer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Dystrophies</mesh_term>
    <mesh_term>Arthrogryposis</mesh_term>
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Muscular Atrophy, Spinal</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>April 20, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02218593
org study id: 579772-2
nct id: NCT02218593
lead sponsor: 
has dmc: No
This study is to evaluate how the Wilmington Robotic Exoskeleton (WREX) is working for
      children who are using the WREX, or have used it in the past. The survey consists of a set of
      questions a) performed online and b) performed over the phone.
The WREX (Wilmington Robotic EXoskeleton) is being used by many children with neuromuscular
      conditions such as arthrogryposis and muscular dystrophy. Nemours/A.I. duPont Hospital for
      Children alone has provided a WREX for about 80 children in the last 3 years. This is being
      done through the orthopedic and muscle clinics in the hospital. We would like to perform a
      retrospective study to see how well the children are doing with the WREX. We propose getting
      this feedback through a survey administered to families using the WREX. The survey will be
      performed in two parts. 1) A phone survey will use the Canadian Occupational Performance
      Measure (COPM). 2) an online survey with additional questions. The parents are asked to
      submit answers on behalf of the children if they are unable to.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Activities of daily living
time frame: 6 months
arm group label: WREX orthosis
arm group type: Experimental
description: WREX Orthosis
intervention type: Device
intervention name: WREX orthosis
description: Upper extremity exoskleton used to assist movement
arm group label: WREX orthosis
criteria: 
gender: All
minimum age: 2 Years
maximum age: 21 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Nemours Children's Clinic
investigator full name: Tariq Rahman
investigator title: Prinicipal Research Engineer
mesh term: Muscular Dystrophies
mesh term: Arthrogryposis
mesh term: Muscular Atrophy
mesh term: Muscular Atrophy, Spinal
submitted: April 20, 2023