<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/NCT03260530</url>
  </required_header>
  <id_info>
    <org_study_id>CASILLAS PROTEOR 2016</org_study_id>
    <nct_id>NCT03260530</nct_id>
  </id_info>
  <brief_title>Overall Functional Evaluation After Amputation of the Lower Limb; Locomotion, Energy Efficiency and Strategies to Adapt to the Prosthesis</brief_title>
  <acronym>PROTEOR</acronym>
  <official_title>Overall Functional Evaluation After Amputation of the Lower Limb; Locomotion, Energy Efficiency and Strategies to Adapt to the Prosthesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      It appears necessary to confront the reality of the contribution of technological progress in&#xD;
      the creation of prostheses with the specific features of lower limb amputees. These&#xD;
      contributions must be clearly identified in their different functional dimensions. This&#xD;
      justifies a quantitative approach to the locomotor abilities of these patients, with regard&#xD;
      to bioenergy parameters (consumption of oxygen while walking) and motor biomechanical&#xD;
      parameters (quantified analysis of movement), so as to measure the real impact of the&#xD;
      proposed prosthesis technology, as a complement to classical qualitative approaches.&#xD;
&#xD;
      In this context, Dijon CHU, thanks to its Technological Investigation Platform (PIT, CIC&#xD;
      1432), and the company PROTEOR established a research partnership aiming to:&#xD;
&#xD;
        -  Refine the indications for the prescription of new products, by ensuring that they&#xD;
           correspond to the profiles of the patients concerned and their true needs,&#xD;
&#xD;
        -  Study the underlying adaptive mechanisms, and establish new recommendations for their&#xD;
           use, depending on the profiles of the users,&#xD;
&#xD;
        -  And ultimately, better evaluate, in a more rigorous and systematic manner, the&#xD;
           prostheses available on the market.&#xD;
&#xD;
      The research protocol presented in this document aims to provide a framework for part of the&#xD;
      explorations that will be conducted in the context of this partnership. Lower-limb amputees&#xD;
      who will be evaluated in this research will wear these prostheses (foot and/or knee&#xD;
      prostheses), which bear the CE logo, and thus present all of the safety and performance&#xD;
      conditions required for their use by these patients (prostheses destined for usual&#xD;
      prescriptions), the objective of the study was not to evaluate the prostheses as such, but to&#xD;
      explore and quantify the impact of these prostheses and their eventual modifications on the&#xD;
      locomotor abilities of the patients concerned.&#xD;
&#xD;
      The investigations will be conducted using non-invasive evaluation tools available on the PIT&#xD;
      platform, with no modification in the usual management of these voluntary patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">May 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>Evolution of self-selected gait speed test, before and after the change or modification of the prosthesis</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Lower Limb Amputation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Locomotor evaluation</intervention_name>
    <description>collection of parameters associated with walking and balance in patients with their usual prosthesis and then equipped with the new prosthesis</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Houghton's scale, PPA-LCI, ABC, QEP, SF-12, SAT-PRO, ESAT</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients attending routine consultations for a prosthesis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients able to understand simple instructions, the fitting instructions and to&#xD;
             provide informed consent&#xD;
&#xD;
          -  Man or woman aged &gt; 18 years)&#xD;
&#xD;
          -  Lower-limb amputee, transtibial or transfemoral amputation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adult under guardianship&#xD;
&#xD;
          -  Subject without national insurance cover&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Patients with hip desarticulation&#xD;
&#xD;
          -  Subjects presenting severe associated diseases affecting gait&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Marie CASILLAS</last_name>
      <phone>03.80.29.38.15</phone>
      <email>jean-marie.casillas@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03260530
org study id: CASILLAS PROTEOR 2016
nct id: NCT03260530
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It appears necessary to confront the reality of the contribution of technological progress in
      the creation of prostheses with the specific features of lower limb amputees. These
      contributions must be clearly identified in their different functional dimensions. This
      justifies a quantitative approach to the locomotor abilities of these patients, with regard
      to bioenergy parameters (consumption of oxygen while walking) and motor biomechanical
      parameters (quantified analysis of movement), so as to measure the real impact of the
      proposed prosthesis technology, as a complement to classical qualitative approaches.

      In this context, Dijon CHU, thanks to its Technological Investigation Platform (PIT, CIC
      1432), and the company PROTEOR established a research partnership aiming to:

        -  Refine the indications for the prescription of new products, by ensuring that they
           correspond to the profiles of the patients concerned and their true needs,

        -  Study the underlying adaptive mechanisms, and establish new recommendations for their
           use, depending on the profiles of the users,

        -  And ultimately, better evaluate, in a more rigorous and systematic manner, the
           prostheses available on the market.

      The research protocol presented in this document aims to provide a framework for part of the
      explorations that will be conducted in the context of this partnership. Lower-limb amputees
      who will be evaluated in this research will wear these prostheses (foot and/or knee
      prostheses), which bear the CE logo, and thus present all of the safety and performance
      conditions required for their use by these patients (prostheses destined for usual
      prescriptions), the objective of the study was not to evaluate the prostheses as such, but to
      explore and quantify the impact of these prostheses and their eventual modifications on the
      locomotor abilities of the patients concerned.

      The investigations will be conducted using non-invasive evaluation tools available on the PIT
      platform, with no modification in the usual management of these voluntary patients.
observational model: Cohort
time perspective: Prospective
measure: Evolution of self-selected gait speed test, before and after the change or modification of the prosthesis
time frame: 12 months
intervention type: Other
intervention name: Locomotor evaluation
description: collection of parameters associated with walking and balance in patients with their usual prosthesis and then equipped with the new prosthesis
intervention type: Other
intervention name: Questionnaires
description: Houghton's scale, PPA-LCI, ABC, QEP, SF-12, SAT-PRO, ESAT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor