<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/NCT02234505</url>
  </required_header>
  <id_info>
    <org_study_id>PRO14040403</org_study_id>
    <nct_id>NCT02234505</nct_id>
  </id_info>
  <brief_title>Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces During Walking</brief_title>
  <official_title>Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Orthotic and Prosthetic Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In human gait there is a certain amount of variation between steps; some considered&#xD;
      physiological and owed to variations in environment or posture, and some severe enough to be&#xD;
      indicative of gait instabilities that may lead to stumbling and falling. In users of lower&#xD;
      limb prosthetics, such gait instabilities are of especially great interest.&#xD;
&#xD;
      The study investigates the correlation between socket alignment quality and gait step-by-step&#xD;
      variability in users of trans-tibial-prosthetics. It is hypothesized that a clearly defined&#xD;
      range of step-by-step variability exists, and that therefore step-by-step variability is&#xD;
      suitable as an outcome variable for the assessment of socket alignment.&#xD;
&#xD;
      A sample of ten persons with trans-tibial amputation will be recruited for this pilot study.&#xD;
      Subjects will be asked to walk on different natural surfaces while the socket alignment is&#xD;
      successively perturbed. Step-by-step variations in horizontal ground reaction forces and&#xD;
      torsional moments will be measured and statistically compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Step-by-step variability</measure>
    <time_frame>2 hours</time_frame>
    <description>Peak horizontal ground reaction force (Fx and Fy) as well as peak axial torsion moment (Mz) will be extracted for 10 consecutive intermediary steps for each testing condition. Total range in Newtons over the 10 step sample, as well as maximal difference between consecutive steps in Newtons and percent will be reported for statistical analysis.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Trans-tibial Limb Loss</condition>
  <arm_group>
    <arm_group_label>Trans-tibial prosthesis users</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>prosthetic alignment perturbation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Prosthetic alignment perturbation</intervention_name>
    <description>Prosthetic ankle plantar-flexion will be modified in different degrees, devices (prosthetic components) will not be modified from baseline condition</description>
    <arm_group_label>Trans-tibial prosthesis users</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  activity classification of K2 to K4&#xD;
&#xD;
          -  experience in prosthesis use of at least one year&#xD;
&#xD;
          -  stated ability to walk pain free for at least 30 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age of less than 18 years&#xD;
&#xD;
          -  acute or ongoing residual limb pain&#xD;
&#xD;
          -  use of a prosthesis that is not suitable for installation of the load cell (e.g. is&#xD;
             too short, or has non-removable cosmesis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bakery Square MSPO labs</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>December 3, 2015</last_update_submitted>
  <last_update_submitted_qc>December 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Goeran Fiedler</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>prosthetics</keyword>
  <keyword>amputation</keyword>
  <keyword>gait stability</keyword>
  <keyword>step variability</keyword>
  <keyword>load cell</keyword>
  <!-- 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/NCT02234505
org study id: PRO14040403
nct id: NCT02234505
lead sponsor: 
collaborator: 
has dmc: No
In human gait there is a certain amount of variation between steps; some considered
      physiological and owed to variations in environment or posture, and some severe enough to be
      indicative of gait instabilities that may lead to stumbling and falling. In users of lower
      limb prosthetics, such gait instabilities are of especially great interest.

      The study investigates the correlation between socket alignment quality and gait step-by-step
      variability in users of trans-tibial-prosthetics. It is hypothesized that a clearly defined
      range of step-by-step variability exists, and that therefore step-by-step variability is
      suitable as an outcome variable for the assessment of socket alignment.

      A sample of ten persons with trans-tibial amputation will be recruited for this pilot study.
      Subjects will be asked to walk on different natural surfaces while the socket alignment is
      successively perturbed. Step-by-step variations in horizontal ground reaction forces and
      torsional moments will be measured and statistically compared.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Step-by-step variability
time frame: 2 hours
description: Peak horizontal ground reaction force (Fx and Fy) as well as peak axial torsion moment (Mz) will be extracted for 10 consecutive intermediary steps for each testing condition. Total range in Newtons over the 10 step sample, as well as maximal difference between consecutive steps in Newtons and percent will be reported for statistical analysis.
arm group label: Trans-tibial prosthesis users
arm group type: Experimental
description: prosthetic alignment perturbation
intervention type: Procedure
intervention name: Prosthetic alignment perturbation
description: Prosthetic ankle plantar-flexion will be modified in different degrees, devices (prosthetic components) will not be modified from baseline condition
arm group label: Trans-tibial prosthesis users
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Goeran Fiedler
investigator title: Assistant Professor