<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/NCT04431817</url>
  </required_header>
  <id_info>
    <org_study_id>189608</org_study_id>
    <nct_id>NCT04431817</nct_id>
  </id_info>
  <brief_title>KinetiGait- Analysis of Depth Camera to Assist Gait Analysis for Unilateral Transtibial/Transfemoral Amputees</brief_title>
  <official_title>Operational Analysis of Depth Camera to Assist Gait Analysis in Outpatient Rehabilitation for Unilateral Transtibial and Transfemoral Amputees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry M. Jackson Foundation for the Advancement of Military Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Telemedicine &amp; Advanced Technology Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Henry M. Jackson Foundation for the Advancement of Military Medicine</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>
      This is a feasibility study about implementing and using the KinetiGait gait analysis system&#xD;
      in clinical practice to enhance the rehabilitation of service members with lower limb&#xD;
      disfunction. There will be questionnaires completed by participants and surveys completed by&#xD;
      both participant and provider.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We propose a feasibility study about implementing and using the KinetiGait gait analysis&#xD;
      system in clinical practice to enhance the rehabilitation of service members with lower limb&#xD;
      dysfunction. Up to 100 subjects will be consented, with the expectation that 80% (e.g., n=80)&#xD;
      will complete the study with a complete dataset. Baseline sessions will consist of 7 minutes&#xD;
      of walking at a self-selected speed between 0.7 and 1.3 m/s, after which participants will&#xD;
      take the PLUS-M 12 Item Short Form and PROMIS-29 questionnaires, as well as a short survey.&#xD;
      Participants will complete the questionnaires again at 1 month and 3 month. Providers who&#xD;
      observed/operated the KinetiGait system will also take a short survey on ease of use and&#xD;
      satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prosthetic Limb Users Survey of Mobility (PLUS-M)</measure>
    <time_frame>5-10 minutes</time_frame>
    <description>12-item short form to assess functional status, quality of life and perceived mobility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS)-29</measure>
    <time_frame>5-10 minutes</time_frame>
    <description>Measures self-reported capability rather than actual performance of physical capabilities.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Provider survey</measure>
    <time_frame>5-10 minutes</time_frame>
    <description>Survey for providers indicating age, level of clinical training, experience with gait analysis and views on integrating technology into the clinical environment.</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">115</enrollment>
  <condition>Lower Limb Amputation</condition>
  <arm_group>
    <arm_group_label>Left transtibial</arm_group_label>
    <description>Left below knee amputation- 25</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Right transtibial</arm_group_label>
    <description>Right below knee amputation- 25</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Left transfemoral</arm_group_label>
    <description>Left above knee amputation- 25</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Right transfemoral</arm_group_label>
    <description>Right above knee amputation- 25</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Provider</arm_group_label>
    <description>Provider- 15</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>KinetiGait</intervention_name>
    <description>This device is an Intel RGB depth camera that relays video to gait analysis software. The images will be taken from amputees walking at a self-selected pace on a treadmill.</description>
    <arm_group_label>Left transfemoral</arm_group_label>
    <arm_group_label>Left transtibial</arm_group_label>
    <arm_group_label>Provider</arm_group_label>
    <arm_group_label>Right transfemoral</arm_group_label>
    <arm_group_label>Right transtibial</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include individuals who are DEERS-eligible between the ages of 18&#xD;
        and 65 and in K2-K4 Medical Functional Classification levels. The providers must be MHS&#xD;
        providers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral transfemoral or transtibial amputee&#xD;
&#xD;
          -  Fitted by a prosthetist at a Military Treatment Facility&#xD;
&#xD;
          -  K2-K4 Medicare Functional Classification Levels&#xD;
&#xD;
          -  DEERS-eligible.&#xD;
&#xD;
          -  For providers: MHS provider&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  K0-K1 Medicare Functional Classification Levels&#xD;
&#xD;
          -  Physically unstable or requires an ambulatory device&#xD;
&#xD;
          -  Pregnant women&#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>Gabriel M Kim, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>WRNMMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tiffany R Riggleman, AAS</last_name>
    <phone>(301)707-9681</phone>
    <email>tiffany.r.riggleman.ctr@mail.mil</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gabriel M Kim, M.D.</last_name>
    <email>gabriel.m.kim.mil@mail.mil</email>
  </overall_contact_backup>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>depth camera, gait analysis, LE loss, SMs and Veterans</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/NCT04431817
org study id: 189608
nct id: NCT04431817
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a feasibility study about implementing and using the KinetiGait gait analysis system
      in clinical practice to enhance the rehabilitation of service members with lower limb
      disfunction. There will be questionnaires completed by participants and surveys completed by
      both participant and provider.
We propose a feasibility study about implementing and using the KinetiGait gait analysis
      system in clinical practice to enhance the rehabilitation of service members with lower limb
      dysfunction. Up to 100 subjects will be consented, with the expectation that 80% (e.g., n=80)
      will complete the study with a complete dataset. Baseline sessions will consist of 7 minutes
      of walking at a self-selected speed between 0.7 and 1.3 m/s, after which participants will
      take the PLUS-M 12 Item Short Form and PROMIS-29 questionnaires, as well as a short survey.
      Participants will complete the questionnaires again at 1 month and 3 month. Providers who
      observed/operated the KinetiGait system will also take a short survey on ease of use and
      satisfaction.
observational model: Case-Control
time perspective: Prospective
measure: Prosthetic Limb Users Survey of Mobility (PLUS-M)
time frame: 5-10 minutes
description: 12-item short form to assess functional status, quality of life and perceived mobility.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-29
time frame: 5-10 minutes
description: Measures self-reported capability rather than actual performance of physical capabilities.
measure: Provider survey
time frame: 5-10 minutes
description: Survey for providers indicating age, level of clinical training, experience with gait analysis and views on integrating technology into the clinical environment.
arm group label: Left transtibial
description: Left below knee amputation- 25
arm group label: Right transtibial
description: Right below knee amputation- 25
arm group label: Left transfemoral
description: Left above knee amputation- 25
arm group label: Right transfemoral
description: Right above knee amputation- 25
arm group label: Provider
description: Provider- 15
intervention type: Device
intervention name: KinetiGait
description: This device is an Intel RGB depth camera that relays video to gait analysis software. The images will be taken from amputees walking at a self-selected pace on a treadmill.
arm group label: Left transfemoral
arm group label: Left transtibial
arm group label: Provider
arm group label: Right transfemoral
arm group label: Right transtibial
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: Gabriel M Kim, M.D.
role: Principal Investigator
affiliation: WRNMMC
last name: Tiffany R Riggleman, AAS
phone: (301)707-9681
email: tiffany.r.riggleman.ctr@mail.mil
last name: Gabriel M Kim, M.D.
email: gabriel.m.kim.mil@mail.mil
responsible party type: Sponsor
sharing ipd: No