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/NCT06017024</url>
    </required_header>
    <id_info>
      <org_study_id>2022-A01266-37</org_study_id>
      <nct_id>NCT06017024</nct_id>
    </id_info>
    <brief_title>New Microprocessor-Controlled Prosthetic Knee Evaluation</brief_title>
    <official_title>Evaluation of a New Microprocessor-Controlled Prosthetic Knee : A Prospective, Multicentered, Randomized Cross-over Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Proteor Group</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Proteor Group</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The target of this clinical investigation is to compare the achievement of personal&#xD;
        functional goals using a new MPK and current MPK. Subjects will also run functional tests and&#xD;
        questionnaires to compare performances and feedback with each prosthetic knee.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 7, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Personal goal achievement</measure>
      <time_frame>test sessions 1 and 2 (20 minutes)</time_frame>
      <description>Patient-specific Functional Scale - PSFS - [0-10], the higher the better</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Functional walking test - mobility capacity</measure>
      <time_frame>test sessions 1 and 2 (8 minutes)</time_frame>
      <description>6-minute walk test (6MWT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional walking test - fast walking speed</measure>
      <time_frame>test sessions 1 and 2 (1 minute)</time_frame>
      <description>10-meter walk test (10mWT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional test - ability to walk downhill</measure>
      <time_frame>test sessions 1 and 2 (3 minutes)</time_frame>
      <description>Hill assessment index (HAI) [0-11], the higher the better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional test - ability to walk downstairs</measure>
      <time_frame>test sessions 1 and 2 (3 minutes)</time_frame>
      <description>Stairs assessment index (SAI) [0-13], the higher the better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Questionnaire to assess comfort in the socket</measure>
      <time_frame>test sessions 1 and 2 (1 minute)</time_frame>
      <description>Socket comfort score (SCS) [0-10], the higher the better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Questionnaire to assess satisfaction</measure>
      <time_frame>test sessions 1 and 2 (5 minutes)</time_frame>
      <description>Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); the higher the better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Questionnaires to assess quality of life</measure>
      <time_frame>test sessions 1 and 2 (5 minutes)</time_frame>
      <description>Short Form (36) health survey (SF-36); the higher the better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prosthesis Evaluation Questionnaire</measure>
      <time_frame>test sessions 1 and 2 (29 minutes)</time_frame>
      <description>PEQ, 8 sub-scales [0-100], the higher the better</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Lower Limb Amputation Above Knee (Injury)</condition>
    <arm_group>
      <arm_group_label>Current microprocessor-controlled knee (MPK) then New MPK</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Start using current MPK for 4 weeks before fitting new MPK and use it for 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>New MPK then Current MPK</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Start using new MPK for 4 weeks before fitting back current MPK and use it for 4 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>microprocessor-controlled knee (MPK) assessment</intervention_name>
      <description>The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests</description>
      <arm_group_label>Current microprocessor-controlled knee (MPK) then New MPK</arm_group_label>
      <arm_group_label>New MPK then Current MPK</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Able to understand and give informed consent&#xD;
  &#xD;
            -  Man or woman, more than 18 y.o&#xD;
  &#xD;
            -  Lower limb amputee KD or AKA, unilateral or bilateral&#xD;
  &#xD;
            -  K3/K4 activity level&#xD;
  &#xD;
            -  Already fitted with FR-reimbursed MPK&#xD;
  &#xD;
            -  Being comfortable in their socket (SCS&gt;=5)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Protected person&#xD;
  &#xD;
            -  Pregnant or breast feeding lady&#xD;
  &#xD;
            -  Person having pathologies affecting their sensitivity&#xD;
  &#xD;
            -  Using walking aids&#xD;
  &#xD;
            -  Weighting more than 136kg&#xD;
  &#xD;
            -  Insufficient hip joint or pelvic voluntary muscle control&#xD;
  &#xD;
            -  Insufficient cognitive ability to charge the knee and care for the device&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Laurine Calistri, MS</last_name>
      <phone>+33779825147</phone>
      <email>laurine.calistri@proteor.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Victoria Spartacus, PhD</last_name>
      <email>victoria.spartacus@proteor.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hôpital Léon Bérard</name>
        <address>
          <city>Hyères</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinique du Dr Ster</name>
        <address>
          <city>Lamalou-les-Bains</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>UGECAM Nord-Est IRR</name>
        <address>
          <city>Nancy</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Centre Mutualiste de Kerpape</name>
        <address>
          <city>Ploemeur</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>UGECAM La Tourmaline</name>
        <address>
          <city>Saint-Herblain</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Micro-processor controlled knee</keyword>
    <keyword>Lower Limb prosthesis</keyword>
    <keyword>Patient-specific Functional Scale</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 16, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT06017024/SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06017024
  org study id: 2022-A01266-37
  nct id: NCT06017024
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The target of this clinical investigation is to compare the achievement of personal
        functional goals using a new MPK and current MPK. Subjects will also run functional tests and
        questionnaires to compare performances and feedback with each prosthetic knee.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Personal goal achievement
  time frame: test sessions 1 and 2 (20 minutes)
  description: Patient-specific Functional Scale - PSFS - [0-10], the higher the better
  measure: Functional walking test - mobility capacity
  time frame: test sessions 1 and 2 (8 minutes)
  description: 6-minute walk test (6MWT)
  measure: Functional walking test - fast walking speed
  time frame: test sessions 1 and 2 (1 minute)
  description: 10-meter walk test (10mWT)
  measure: Functional test - ability to walk downhill
  time frame: test sessions 1 and 2 (3 minutes)
  description: Hill assessment index (HAI) [0-11], the higher the better
  measure: Functional test - ability to walk downstairs
  time frame: test sessions 1 and 2 (3 minutes)
  description: Stairs assessment index (SAI) [0-13], the higher the better
  measure: Questionnaire to assess comfort in the socket
  time frame: test sessions 1 and 2 (1 minute)
  description: Socket comfort score (SCS) [0-10], the higher the better
  measure: Questionnaire to assess satisfaction
  time frame: test sessions 1 and 2 (5 minutes)
  description: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); the higher the better
  measure: Questionnaires to assess quality of life
  time frame: test sessions 1 and 2 (5 minutes)
  description: Short Form (36) health survey (SF-36); the higher the better
  measure: Prosthesis Evaluation Questionnaire
  time frame: test sessions 1 and 2 (29 minutes)
  description: PEQ, 8 sub-scales [0-100], the higher the better
  arm group label: Current microprocessor-controlled knee (MPK) then New MPK
  arm group type: Experimental
  description: Start using current MPK for 4 weeks before fitting new MPK and use it for 4 weeks
  arm group label: New MPK then Current MPK
  arm group type: Experimental
  description: Start using new MPK for 4 weeks before fitting back current MPK and use it for 4 weeks
  intervention type: Device
  intervention name: microprocessor-controlled knee (MPK) assessment
  description: The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests
  arm group label: Current microprocessor-controlled knee (MPK) then New MPK
  arm group label: New MPK then Current MPK
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Laurine Calistri, MS
  phone: +33779825147
  email: laurine.calistri@proteor.com
  last name: Victoria Spartacus, PhD
  email: victoria.spartacus@proteor.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: France
  responsible party type: Sponsor
  sharing ipd: No
  provided document: 