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/NCT05989243</url>
    </required_header>
    <id_info>
      <org_study_id>A3643-R</org_study_id>
      <nct_id>NCT05989243</nct_id>
    </id_info>
    <brief_title>Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation</brief_title>
    <acronym>SocketFit</acronym>
    <official_title>Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VA Office of Research and Development</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators do not yet know how a prosthetic socket with adjustable panels affects the&#xD;
        performance of people with a lower limb amputation compared to a conventional prosthetic&#xD;
        socket. The primary objective of this study is to compare an adjustable and conventional&#xD;
        prosthetic socket and use this information to determine the optimal socket that would improve&#xD;
        rehabilitation and function in people with lower limb amputation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of the project is to determine the effects of using different prosthetic socket&#xD;
        designs with the same suspension and components on the biomechanical asymmetry, residual limb&#xD;
        movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a&#xD;
        transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10&#xD;
        females per group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 31, 2022</start_date>
    <completion_date type="Anticipated">January 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 30, 2026</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Biomechanical Asymmetry</measure>
      <time_frame>through study completion, an average of 4 years</time_frame>
      <description>The assessments of ground reaction forces, and joint motion, torque, power, and work will be aggregated into a measure of asymmetry that compares the percentage difference between the affected and unaffected legs of each participant. We will compare asymmetry between groups and sockets.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prosthetic Evaluation Questionnaire</measure>
      <time_frame>through study completion, an average of 4 years</time_frame>
      <description>The prosthetic evaluation questionnaire assesses comfort and satisfaction. This questionnaire asks participants to rate their comfort and satisfaction based on a 10-point scale and contains 54 questions organized into 9 domain scales, where each scale can be used to independently measure a domain. We will compare overall and domain-specific scores between groups and sockets.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Socket pistoning</measure>
      <time_frame>through study completion, an average of 4 years</time_frame>
      <description>Movement of the residual limb within the socket. We will compared socket pistoning between groups and sockets.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Transtibial Amputation</condition>
    <condition>Transfemoral Amputation</condition>
    <arm_group>
      <arm_group_label>Veterans with a transtibial amputation</arm_group_label>
      <description>20 Veterans with a transtibial amputation, 10 females and 10 males</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Veterans with a transfemoral amputation</arm_group_label>
      <description>20 Veterans with a transfemoral amputation, 10 females and 10 males</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Conventional prosthetic socket</intervention_name>
      <description>Participants will use their own conventional rigid socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.</description>
      <arm_group_label>Veterans with a transfemoral amputation</arm_group_label>
      <arm_group_label>Veterans with a transtibial amputation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Adjustable Quatro socket</intervention_name>
      <description>Participants will use an adjustable Quatro socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.</description>
      <arm_group_label>Veterans with a transfemoral amputation</arm_group_label>
      <arm_group_label>Veterans with a transtibial amputation</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          20 Veterans with unilateral transtibial amputation and 20 Veterans with unilateral&#xD;
          transfemoral amputation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The investigators will enroll up to 40 Veterans&#xD;
  &#xD;
                 -  20 with unilateral transtibial amputation&#xD;
  &#xD;
                 -  20 with unilateral transfemoral amputation who are at or above a K2 Medicare&#xD;
                    functional classification level (MFCL) and who are 18-65 years old&#xD;
  &#xD;
            -  All participants will have no current problems with their prosthesis or residual limb,&#xD;
               and be at least 6-months post-amputation&#xD;
  &#xD;
            -  Participants will be at or above a K2 MFCL, defined as a person who has the ability or&#xD;
               potential for ambulation with the ability to traverse low level environmental barriers&#xD;
               such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an&#xD;
               assistive device for their unaffected leg (i.e. orthosis, cane)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alena Grabowski, PhD BA</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rocky Mountain Regional VA Medical Center, Aurora, CO</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alena Grabowski, PhD BA</last_name>
      <phone>(720) 435-4270</phone>
      <email>Alena.Grabowski@va.gov</email>
    </overall_contact>
    <location>
      <facility>
        <name>Rocky Mountain Regional VA Medical Center, Aurora, CO</name>
        <address>
          <city>Aurora</city>
          <state>Colorado</state>
          <zip>80045</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alena Grabowski, PhD BA</last_name>
        <phone>720-435-4270</phone>
        <email>Alena.Grabowski@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Alena Grabowski, PhD BA</last_name>
        <phone>(720) 435-4270</phone>
        <email>Alena.Grabowski@va.gov</email>
      </contact_backup>
      <investigator>
        <last_name>Alena Grabowski, PhD BA</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Biomechanics</keyword>
    <keyword>Kinematics</keyword>
    <keyword>Walking</keyword>
    <keyword>Prostheses</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05989243
  org study id: A3643-R
  nct id: NCT05989243
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The investigators do not yet know how a prosthetic socket with adjustable panels affects the
        performance of people with a lower limb amputation compared to a conventional prosthetic
        socket. The primary objective of this study is to compare an adjustable and conventional
        prosthetic socket and use this information to determine the optimal socket that would improve
        rehabilitation and function in people with lower limb amputation.
  The purpose of the project is to determine the effects of using different prosthetic socket
        designs with the same suspension and components on the biomechanical asymmetry, residual limb
        movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a
        transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10
        females per group.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Biomechanical Asymmetry
  time frame: through study completion, an average of 4 years
  description: The assessments of ground reaction forces, and joint motion, torque, power, and work will be aggregated into a measure of asymmetry that compares the percentage difference between the affected and unaffected legs of each participant. We will compare asymmetry between groups and sockets.
  measure: Prosthetic Evaluation Questionnaire
  time frame: through study completion, an average of 4 years
  description: The prosthetic evaluation questionnaire assesses comfort and satisfaction. This questionnaire asks participants to rate their comfort and satisfaction based on a 10-point scale and contains 54 questions organized into 9 domain scales, where each scale can be used to independently measure a domain. We will compare overall and domain-specific scores between groups and sockets.
  measure: Socket pistoning
  time frame: through study completion, an average of 4 years
  description: Movement of the residual limb within the socket. We will compared socket pistoning between groups and sockets.
  arm group label: Veterans with a transtibial amputation
  description: 20 Veterans with a transtibial amputation, 10 females and 10 males
  arm group label: Veterans with a transfemoral amputation
  description: 20 Veterans with a transfemoral amputation, 10 females and 10 males
  intervention type: Device
  intervention name: Conventional prosthetic socket
  description: Participants will use their own conventional rigid socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.
  arm group label: Veterans with a transfemoral amputation
  arm group label: Veterans with a transtibial amputation
  intervention type: Device
  intervention name: Adjustable Quatro socket
  description: Participants will use an adjustable Quatro socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for ~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.
  arm group label: Veterans with a transfemoral amputation
  arm group label: Veterans with a transtibial amputation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alena Grabowski, PhD BA
  role: Principal Investigator
  affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
  last name: Alena Grabowski, PhD BA
  phone: (720) 435-4270
  email: Alena.Grabowski@va.gov
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No