<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/NCT04494555</url>
  </required_header>
  <id_info>
    <org_study_id>BAMC C.2020.007</org_study_id>
    <nct_id>NCT04494555</nct_id>
  </id_info>
  <brief_title>Do Adaptable Sockets Improve Military Performance?</brief_title>
  <official_title>Do Adaptable Sockets Improve Military Performance?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brooke Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brooke Army Medical Center</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 repeated measures prospective study and is no greater than a minimal risk study.&#xD;
      All study procedures will be conducted at the Center for the Intrepid (CFI) through&#xD;
      collaborative efforts of the Military Performance Lab at the CFI and the Sanders lab at the&#xD;
      University of Washington. Data collected at the CFI will be coded, compiled, and shared with&#xD;
      the University of Washington investigators.The objective of the research is to test if&#xD;
      microprocessor-adjusting sockets improve Service member performance in Military specific&#xD;
      activities compared to (a) user- operated, motor-driven adjustable sockets (i.e. sockets&#xD;
      users adjust themselves), and (b) static (traditional) sockets. Investigators also test if&#xD;
      microprocessor-adjusting sockets better maintain socket fit and limb fluid volume, and if&#xD;
      self-reported outcomes are more favorable than for user-operated or static sockets. The&#xD;
      hypotheses to be tested include:&#xD;
&#xD;
      During intense Military specific tasks, compared to the user-adjusted socket and the static&#xD;
      socket, the microprocessor-adjusting socket will:&#xD;
&#xD;
        1. minimize translational movement between the residual limb and the prosthetic socket;&#xD;
&#xD;
        2. maintain residual limb fluid volume; and&#xD;
&#xD;
        3. maximize prosthetic socket comfort.&#xD;
&#xD;
      When using the microprocessor-adjusting socket compared to the user-adjusted socket and the&#xD;
      static socket, participants will:&#xD;
&#xD;
        1. cover the greatest distance during a simulated combat patrol;&#xD;
&#xD;
        2. perform all high intensity Military specific tasks with less pain;&#xD;
&#xD;
        3. perform a simulated combat patrol nearer to uninjured levels of performance; and&#xD;
&#xD;
        4. rank usability at a level similar to the static socket.&#xD;
&#xD;
      The specific aims are to:&#xD;
&#xD;
        1. Fabricate microprocessor-adjusting sockets specific for Service members and Veterans&#xD;
           with goals of returning to high-level physical activities&#xD;
&#xD;
        2. Evaluate Military task performance in Service members with transtibial amputation using&#xD;
           &quot;Readiness Assessments,&quot; while wearing three socket configurations:&#xD;
           microprocessor-adjusting, user-adjusting, and static&#xD;
&#xD;
             -  Simulated combat patrol in a Virtual Realty Environment&#xD;
&#xD;
             -  Military version of a Functional Capacity Evaluation&#xD;
&#xD;
        3. Characterize user preference and usability of different socket configurations&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the proposed research is to evaluate the use of microprocessor-adjusting&#xD;
      sockets during &quot;Readiness Assessments&quot; of Military tasks performed by Service members with&#xD;
      transtibial amputation.&#xD;
&#xD;
      Participants will come to the Center For the Intrepid (CFI) for up to 10 visits to complete a&#xD;
      pre-monitoring session (assess residual limb health and gather information regarding limb&#xD;
      fluid volume); socket fitting session(s) (fitting of three sockets- static socket, a&#xD;
      user-adjusted socket, and microprocessor-adjusting socket); and for military readiness&#xD;
      assessments for each of the three socket conditions.&#xD;
&#xD;
      Data across the three socket conditions (static socket, user adjusted socket, and&#xD;
      Microprocessor-adjusting sockets) will be tested for normality. When it normality can be&#xD;
      assumed, a single factor repeated measures ANOVA will test between socket conditions.&#xD;
      Mauchly's Test of Sphericity was be used to test if the variance is significantly different&#xD;
      across all of the conditions. If the sphericity condition is violated, a Greenhouse-Geisser&#xD;
      adjustment will be applied. When a significance effect is detected, pairwise comparisons&#xD;
      using a Tukey post-hoc will be performed to determine which conditions are significantly&#xD;
      different. When normality cannot be assumed, a Kruskal-Wallis H test will be used. When a&#xD;
      significance effect is detected, pairwise comparisons using a Mann-Whitney post-hoc while&#xD;
      adjusting the p-value for multiple comparisons will be performed to determine which&#xD;
      conditions are significantly different. Statistical significance will be set to p&lt;0.05&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 4, 2020</start_date>
  <completion_date type="Anticipated">August 14, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 14, 2023</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>
    <intervention_model_description>This is a repeated measures prospective study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motion of the Residual Limb in the Socket</measure>
    <time_frame>Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.</time_frame>
    <description>Angular movement between the residual limb and the prosthetic socket in the sagittal plane.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motion of Residual Limb in the Socket</measure>
    <time_frame>Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.</time_frame>
    <description>Translational movement between the residual limb and the prosthetic socket about the longitudinal axis of the prosthetic socket.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-report questionnaires of socket comfort</measure>
    <time_frame>SCS recorded before after after each task during REDoP and FCE-M. Approximately 3 hours.</time_frame>
    <description>Change in Socket Comfort Score (SCS) across the Readiness Evaluation during Simulated Dismounted Operations (REDoP) and modified Functional Capacity Evaluation-Military (FCE-M), 0-10 scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics</measure>
    <time_frame>Assessment administered per condition. Approximately 55 minutes.</time_frame>
    <description>Total distance traversed during REDoP assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics</measure>
    <time_frame>Recorded after each task during REDoP. Approximately 55 minutes.</time_frame>
    <description>An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout REDoP.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Capacity Evaluation-Military (FCE-M) performance metrics</measure>
    <time_frame>Assessment administered per condition. Approximately 30 minutes.</time_frame>
    <description>Time to complete each sub-task of the FCE-M.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Capacity Evaluation-Military (FCE-M) performance metrics</measure>
    <time_frame>Recorded after each task during REDoP. Approximately 30 minutes.</time_frame>
    <description>An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout FCE-M.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total score on the Post-Study System Usability Questionnaire</measure>
    <time_frame>After each of the sessions with each socket condition, approximately 3 hours.</time_frame>
    <description>This is a 19-item instrument for assessing user satisfaction with system usability. The items are 7-point graphic scales, anchored at the ends with the terms &quot;Strongly agree&quot; for 1, &quot;Strongly disagree&quot; for 7, and a &quot;Not applicable&quot; (N/A) point outside the scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics</measure>
    <time_frame>Recorded after each task during REDoP. Approximately 55 minutes.</time_frame>
    <description>Marksmanship during the simulated ambushes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics</measure>
    <time_frame>Recorded during REDoP. Approximately 55 minutes.</time_frame>
    <description>Heart rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics</measure>
    <time_frame>Recorded after each task during REDoP. 5-10 sec to respond and approximately 55 minutes in total.</time_frame>
    <description>Rating of perceived exertion. A standard 6-20 Borg scale will be used to collect the individual's Rating of Perceived Exertion. Subject's will be asked throughout the session to &quot;rate the difficulty of the task&quot; based on their fatigue level using the Borg scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Capacity Evaluation-Military (FCE-M) performance metrics</measure>
    <time_frame>Recorded during FCE-M. Approximately 30 minutes.</time_frame>
    <description>Heart rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Capacity Evaluation-Military (FCE-M) performance metrics</measure>
    <time_frame>Recorded after each task during FCE-M. 5-10 sec to respond and approximately 30 minutes in total.</time_frame>
    <description>Rating of perceived exertion. A standard 6-20 Borg scale will be used to collect the individual's Rating of Perceived Exertion. Subject's will be asked throughout the session to &quot;rate the difficulty of the task&quot; based on their fatigue level using the Borg scale.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Amputation Stump</condition>
  <arm_group>
    <arm_group_label>Adaptable Prosthetic Socket</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using measurements of limb-socket displacements from sensors embedded within the socket wall, adaptable sockets make small adjustments to socket size so as to maintain consistent displacements while prosthesis users are active. They do not require the user to stop activity or to touch or modify the prosthesis, and they do not distract users from their objectives.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Static socket</intervention_name>
    <description>For the static socket configuration, both the microprocessor control and user control are disabled, and the panels are positioned in their flush configuration to create the user's as-prescribed socket shape.</description>
    <arm_group_label>Adaptable Prosthetic Socket</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>User adjusted socket</intervention_name>
    <description>Sockets are configured for user control by disabling automated control and enabling push buttons on the side of the socket to adjust socket size. Each button push effects a socket size change of approximately 0.3% volume. An upper button effects a socket size increase, and a lower button a socket size decrease. The buttons are countersunk so reduce risk of accidental pushes, and they do not function unless the user is stationary. An additional button push will not be executed until motor motion from the prior push has been completed. If a button is continuously held then the motor will continue moving until the button is released. Limits are set on cable length to ensure that sockets sizes threatening to the user's residual limb (too tight) are avoided. The push buttons effect inner-loop control that operates completely within the mechanism, achieving high-resolution adjustment of cable length with minimal error.</description>
    <arm_group_label>Adaptable Prosthetic Socket</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microprocessor-adjusting sockets</intervention_name>
    <description>A strategy for automatically controlling the size of the socket during walking to compensate for unknown changes in limb volume will be used. The controller is essentially a regulator that continuously measures socket &quot;fit,&quot; and adjusts the socket to maintain a prescribed reference set point. Because the fit is automatically sustained, the prosthesis user is unaware of its operation.</description>
    <arm_group_label>Adaptable Prosthetic Socket</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females age 18 - 55 years&#xD;
&#xD;
          -  Authorized to receive care at the Center for the Intrepid&#xD;
&#xD;
          -  Unilateral or bilateral transtibial amputation&#xD;
&#xD;
          -  Have experience performing military relevant tasks (e.g., Active duty Service Member&#xD;
             or Veteran)&#xD;
&#xD;
          -  Current prosthesis user&#xD;
&#xD;
          -  Ability to comply with instructions associated with functional testing&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-reported inability to safely ambulate for a minimum of twenty minutes&#xD;
             continuously and unassisted&#xD;
&#xD;
          -  History of medical or psychological disease that would preclude safe gait, load&#xD;
             carriage, physical, or cognitive functional training or testing within a virtual&#xD;
             reality environment as determined by the provider screening the subject (i.e.&#xD;
             moderate/severe traumatic brain injury, stroke, renal failure, cardiac or pulmonary&#xD;
             problems disease, severe anemia, and other medical conditions)&#xD;
&#xD;
          -  Any injury sustained to the upper extremity which would preclude safe physical&#xD;
             performance testing&#xD;
&#xD;
          -  Self-reported Blindness&#xD;
&#xD;
          -  Self-reported Pregnancy&#xD;
&#xD;
          -  Self-reported Active infection&#xD;
&#xD;
          -  Weight above 250 lbs (114 kg)&#xD;
&#xD;
          -  Residual limb length shorter than 9cm as this is the minimum distance necessary to&#xD;
             attach the bio-impendence sensors&#xD;
&#xD;
          -  Score greater than 20% on the Modified Oswestry Low Back Pain Questionnaire as this&#xD;
             will indicate greater than minimal disability due to low back pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Walter L Childers, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Extremity Trauma and Amputation Center of Excellence (EACE)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Molly Baumann, PhD</last_name>
    <phone>6144297945</phone>
    <email>molly.baumann.civ@mail.mil</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cynthia Chaiyanam</last_name>
    <phone>(210) 916-9194</phone>
    <email>cynthia.a.chaiyanam.civ@mail.mil</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Brooke Army Medical Center, Center for the Intrepid</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Walter L Childers, PhD</last_name>
      <phone>210-422-8695</phone>
      <email>walter.l.childers.civ@mail.mil</email>
    </contact>
    <contact_backup>
      <last_name>Molly Baumann, PhD</last_name>
      <email>molly.baumann.civ@mail.mil</email>
    </contact_backup>
    <investigator>
      <last_name>Molly Baumann, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Walter L Childers, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  </reference>
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  </reference>
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  </reference>
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  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brooke Army Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Walter Lee Childers</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>amputation</keyword>
  <keyword>bioimpedance</keyword>
  <keyword>prosthetic socket</keyword>
  <keyword>transtibial</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/NCT04494555
org study id: BAMC C.2020.007
nct id: NCT04494555
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a repeated measures prospective study and is no greater than a minimal risk study.
      All study procedures will be conducted at the Center for the Intrepid (CFI) through
      collaborative efforts of the Military Performance Lab at the CFI and the Sanders lab at the
      University of Washington. Data collected at the CFI will be coded, compiled, and shared with
      the University of Washington investigators.The objective of the research is to test if
      microprocessor-adjusting sockets improve Service member performance in Military specific
      activities compared to (a) user- operated, motor-driven adjustable sockets (i.e. sockets
      users adjust themselves), and (b) static (traditional) sockets. Investigators also test if
      microprocessor-adjusting sockets better maintain socket fit and limb fluid volume, and if
      self-reported outcomes are more favorable than for user-operated or static sockets. The
      hypotheses to be tested include:

      During intense Military specific tasks, compared to the user-adjusted socket and the static
      socket, the microprocessor-adjusting socket will:

        1. minimize translational movement between the residual limb and the prosthetic socket;

        2. maintain residual limb fluid volume; and

        3. maximize prosthetic socket comfort.

      When using the microprocessor-adjusting socket compared to the user-adjusted socket and the
      static socket, participants will:

        1. cover the greatest distance during a simulated combat patrol;

        2. perform all high intensity Military specific tasks with less pain;

        3. perform a simulated combat patrol nearer to uninjured levels of performance; and

        4. rank usability at a level similar to the static socket.

      The specific aims are to:

        1. Fabricate microprocessor-adjusting sockets specific for Service members and Veterans
           with goals of returning to high-level physical activities

        2. Evaluate Military task performance in Service members with transtibial amputation using
           "Readiness Assessments," while wearing three socket configurations:
           microprocessor-adjusting, user-adjusting, and static

             -  Simulated combat patrol in a Virtual Realty Environment

             -  Military version of a Functional Capacity Evaluation

        3. Characterize user preference and usability of different socket configurations
The purpose of the proposed research is to evaluate the use of microprocessor-adjusting
      sockets during "Readiness Assessments" of Military tasks performed by Service members with
      transtibial amputation.

      Participants will come to the Center For the Intrepid (CFI) for up to 10 visits to complete a
      pre-monitoring session (assess residual limb health and gather information regarding limb
      fluid volume); socket fitting session(s) (fitting of three sockets- static socket, a
      user-adjusted socket, and microprocessor-adjusting socket); and for military readiness
      assessments for each of the three socket conditions.

      Data across the three socket conditions (static socket, user adjusted socket, and
      Microprocessor-adjusting sockets) will be tested for normality. When it normality can be
      assumed, a single factor repeated measures ANOVA will test between socket conditions.
      Mauchly's Test of Sphericity was be used to test if the variance is significantly different
      across all of the conditions. If the sphericity condition is violated, a Greenhouse-Geisser
      adjustment will be applied. When a significance effect is detected, pairwise comparisons
      using a Tukey post-hoc will be performed to determine which conditions are significantly
      different. When normality cannot be assumed, a Kruskal-Wallis H test will be used. When a
      significance effect is detected, pairwise comparisons using a Mann-Whitney post-hoc while
      adjusting the p-value for multiple comparisons will be performed to determine which
      conditions are significantly different. Statistical significance will be set to p<0.05
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a repeated measures prospective study.
primary purpose: Treatment
masking: None (Open Label)
measure: Motion of the Residual Limb in the Socket
time frame: Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.
description: Angular movement between the residual limb and the prosthetic socket in the sagittal plane.
measure: Motion of Residual Limb in the Socket
time frame: Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.
description: Translational movement between the residual limb and the prosthetic socket about the longitudinal axis of the prosthetic socket.
measure: Self-report questionnaires of socket comfort
time frame: SCS recorded before after after each task during REDoP and FCE-M. Approximately 3 hours.
description: Change in Socket Comfort Score (SCS) across the Readiness Evaluation during Simulated Dismounted Operations (REDoP) and modified Functional Capacity Evaluation-Military (FCE-M), 0-10 scale.
measure: Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
time frame: Assessment administered per condition. Approximately 55 minutes.
description: Total distance traversed during REDoP assessment.
measure: Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
time frame: Recorded after each task during REDoP. Approximately 55 minutes.
description: An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout REDoP.
measure: Functional Capacity Evaluation-Military (FCE-M) performance metrics
time frame: Assessment administered per condition. Approximately 30 minutes.
description: Time to complete each sub-task of the FCE-M.
measure: Functional Capacity Evaluation-Military (FCE-M) performance metrics
time frame: Recorded after each task during REDoP. Approximately 30 minutes.
description: An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout FCE-M.
measure: Total score on the Post-Study System Usability Questionnaire
time frame: After each of the sessions with each socket condition, approximately 3 hours.
description: This is a 19-item instrument for assessing user satisfaction with system usability. The items are 7-point graphic scales, anchored at the ends with the terms "Strongly agree" for 1, "Strongly disagree" for 7, and a "Not applicable" (N/A) point outside the scale.
measure: Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
time frame: Recorded after each task during REDoP. Approximately 55 minutes.
description: Marksmanship during the simulated ambushes.
measure: Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
time frame: Recorded during REDoP. Approximately 55 minutes.
description: Heart rate.
measure: Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
time frame: Recorded after each task during REDoP. 5-10 sec to respond and approximately 55 minutes in total.
description: Rating of perceived exertion. A standard 6-20 Borg scale will be used to collect the individual's Rating of Perceived Exertion. Subject's will be asked throughout the session to "rate the difficulty of the task" based on their fatigue level using the Borg scale.
measure: Functional Capacity Evaluation-Military (FCE-M) performance metrics
time frame: Recorded during FCE-M. Approximately 30 minutes.
description: Heart rate.
measure: Functional Capacity Evaluation-Military (FCE-M) performance metrics
time frame: Recorded after each task during FCE-M. 5-10 sec to respond and approximately 30 minutes in total.
description: Rating of perceived exertion. A standard 6-20 Borg scale will be used to collect the individual's Rating of Perceived Exertion. Subject's will be asked throughout the session to "rate the difficulty of the task" based on their fatigue level using the Borg scale.
arm group label: Adaptable Prosthetic Socket
arm group type: Experimental
description: Using measurements of limb-socket displacements from sensors embedded within the socket wall, adaptable sockets make small adjustments to socket size so as to maintain consistent displacements while prosthesis users are active. They do not require the user to stop activity or to touch or modify the prosthesis, and they do not distract users from their objectives.
intervention type: Device
intervention name: Static socket
description: For the static socket configuration, both the microprocessor control and user control are disabled, and the panels are positioned in their flush configuration to create the user's as-prescribed socket shape.
arm group label: Adaptable Prosthetic Socket
intervention type: Device
intervention name: User adjusted socket
description: Sockets are configured for user control by disabling automated control and enabling push buttons on the side of the socket to adjust socket size. Each button push effects a socket size change of approximately 0.3% volume. An upper button effects a socket size increase, and a lower button a socket size decrease. The buttons are countersunk so reduce risk of accidental pushes, and they do not function unless the user is stationary. An additional button push will not be executed until motor motion from the prior push has been completed. If a button is continuously held then the motor will continue moving until the button is released. Limits are set on cable length to ensure that sockets sizes threatening to the user's residual limb (too tight) are avoided. The push buttons effect inner-loop control that operates completely within the mechanism, achieving high-resolution adjustment of cable length with minimal error.
arm group label: Adaptable Prosthetic Socket
intervention type: Device
intervention name: Microprocessor-adjusting sockets
description: A strategy for automatically controlling the size of the socket during walking to compensate for unknown changes in limb volume will be used. The controller is essentially a regulator that continuously measures socket "fit," and adjusts the socket to maintain a prescribed reference set point. Because the fit is automatically sustained, the prosthesis user is unaware of its operation.
arm group label: Adaptable Prosthetic Socket
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Walter L Childers, PhD
role: Principal Investigator
affiliation: Extremity Trauma and Amputation Center of Excellence (EACE)
last name: Molly Baumann, PhD
phone: 6144297945
email: molly.baumann.civ@mail.mil
last name: Cynthia Chaiyanam
phone: (210) 916-9194
email: cynthia.a.chaiyanam.civ@mail.mil
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
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PMID: 29229405
citation: Cancio JM, Oliver RA, Yancosek KE. Functional Capacity Evaluation-Military: Program Description and Case Series. Mil Med. 2017 Jan;182(1):e1658-e1664. doi: 10.7205/MILMED-D-16-00072.
PMID: 28051990
citation: Gailey R, Kristal A, Lucarevic J, Harris S, Applegate B, Gaunaurd I. The development and internal consistency of the comprehensive lower limb amputee socket survey in active lower limb amputees. Prosthet Orthot Int. 2019 Feb;43(1):80-87. doi: 10.1177/0309364618791620. Epub 2018 Aug 10.
PMID: 30095355
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PMID: 7154893
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responsible party type: Principal Investigator
investigator affiliation: Brooke Army Medical Center
investigator full name: Dr. Walter Lee Childers
investigator title: Principle Investigator
sharing ipd: No