<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/NCT01684501</url>
  </required_header>
  <id_info>
    <org_study_id>2010-P-000951</org_study_id>
    <nct_id>NCT01684501</nct_id>
  </id_info>
  <brief_title>Comparing Active and Passive Ankle-foot Prostheses</brief_title>
  <official_title>Comparing Active and Passive Ankle-foot Prostheses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spaulding Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spaulding Rehabilitation Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot&#xD;
      and evaluate if it provides a physiological generation of power at the ankle in transtibial&#xD;
      amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e.&#xD;
      robotic system).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be studied during level-ground walking. A camera-based motion capture system&#xD;
      will be used to study the biomechanics of motion and evaluate if the pattern of ankle power&#xD;
      generation by the prosthetic foot is physiological. In addition, the metabolic cost of&#xD;
      ambulation will be monitored during walking at constant speed over a period of several&#xD;
      minutes. The data will allow us to assess if the prosthetic foot leads to a decreased&#xD;
      metabolic cost of ambulation compared to passive prosthetic feet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2010</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ankle power generation</measure>
    <time_frame>During the session trial (approx 10 minutes)</time_frame>
    <description>Ankle power derived using a camera-based motion capture system during walking</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolic cost of ambulation</measure>
    <time_frame>During the session trial (approx 10 minutes)</time_frame>
    <description>Oxygen consumption during level-ground walking</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">6</enrollment>
  <condition>Trans-tibial Amputation</condition>
  <arm_group>
    <arm_group_label>Amputees</arm_group_label>
    <description>Adults with history of traumatic unilateral transtibial amputation</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with history of traumatic unilateral transtibial amputation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  weigh more than 200 lbs&#xD;
&#xD;
          -  are high level ambulators corresponding to levels E to F of the Special Interest Group&#xD;
             of Amputee Medicine (SIGAM) mobility grade&#xD;
&#xD;
          -  have the ability to follow multi-step commands.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  score level D on the SIGAM mobility grade&#xD;
&#xD;
          -  have experienced 1 or more falls in the last month before the study&#xD;
&#xD;
          -  have a residual limb length which does not allow for seven inches clearance of bracket&#xD;
             attachment for the PowerFoot&#xD;
&#xD;
          -  the residual limb must be stable in volume (no change in socket or socket padding in&#xD;
             last 6 months) and without pain that limits function&#xD;
&#xD;
          -  the sound-side (contralateral) lower extremity must be free of impediments that affect&#xD;
             gait, range of motion, or limb muscle activity&#xD;
&#xD;
          -  Any diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions&#xD;
             that would interfere with subject participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paolo Bonato</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spaulding Rehabilitation Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spaulding Rehabilitation Hospital Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>April 10, 2017</last_update_submitted>
  <last_update_submitted_qc>April 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spaulding Rehabilitation Hospital</investigator_affiliation>
    <investigator_full_name>Paolo Bonato</investigator_full_name>
    <investigator_title>Director, Motion Analysis Laboratory</investigator_title>
  </responsible_party>
  <keyword>prosthesis</keyword>
  <keyword>amputees</keyword>
  <keyword>gait</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01684501
org study id: 2010-P-000951
nct id: NCT01684501
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot
      and evaluate if it provides a physiological generation of power at the ankle in transtibial
      amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e.
      robotic system).
Subjects will be studied during level-ground walking. A camera-based motion capture system
      will be used to study the biomechanics of motion and evaluate if the pattern of ankle power
      generation by the prosthetic foot is physiological. In addition, the metabolic cost of
      ambulation will be monitored during walking at constant speed over a period of several
      minutes. The data will allow us to assess if the prosthetic foot leads to a decreased
      metabolic cost of ambulation compared to passive prosthetic feet.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Ankle power generation
time frame: During the session trial (approx 10 minutes)
description: Ankle power derived using a camera-based motion capture system during walking
measure: Metabolic cost of ambulation
time frame: During the session trial (approx 10 minutes)
description: Oxygen consumption during level-ground walking
arm group label: Amputees
description: Adults with history of traumatic unilateral transtibial amputation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Paolo Bonato
role: Principal Investigator
affiliation: Spaulding Rehabilitation Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Spaulding Rehabilitation Hospital
investigator full name: Paolo Bonato
investigator title: Director, Motion Analysis Laboratory
sharing ipd: No