<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/NCT02189031</url>
  </required_header>
  <id_info>
    <org_study_id>11061-H39</org_study_id>
    <secondary_id>R01NS081710-01</secondary_id>
    <nct_id>NCT02189031</nct_id>
  </id_info>
  <brief_title>Sensory Feedback for Touch and Proprioception With Prosthetic Limbs</brief_title>
  <official_title>Sensory Feedback Tactor Systems for Implementation of Physiologically Relevant Cutaneous Touch and Proprioception With Prosthetic Limbs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louis Stokes VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HDT Global</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Defense Advanced Research Projects Agency</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Louis Stokes VA Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Upper limb amputation is a devastating injury that leaves many thousands of typically young&#xD;
      and active individuals in the US to rely on artificial arms and hands to help restore their&#xD;
      lost function. The investigators research is focused on helping these individuals to feel&#xD;
      where their prosthetic limbs are moving without having to look at them by developing devices&#xD;
      and approaches to provide sensory feedback of limb movement through the nerves that once&#xD;
      served the missing limb.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the investigators research the investigators seek to understand the organization and&#xD;
      (function/operation) of sensory neural systems in order to develop methods for restoring&#xD;
      function to injured populations. One of the primary focus areas of the investigators research&#xD;
      is working to integrate physiologically relevant sensory feedback with prosthetic limbs. To&#xD;
      this end the investigators employ a variety of approaches that interweave disciplines such as&#xD;
      electrophysiology, psychophysics, biomedical engineering and cognition. The investigators&#xD;
      research team is composed of an interconnected and communicative network of clinicians,&#xD;
      engineers, and scientists. This helps us to provide pathways from basic science discoveries&#xD;
      that can be used to address clinical needs with transition directly to patient care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Embodiment of the Prosthetic limb</measure>
    <time_frame>Ten months</time_frame>
    <description>Visual loading for fine motor tasks,questionnaires, and residual limb temperature will be assessed after 10 months of in home every day use of a custom robust tactor array for sensory feedback.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigate the perceptions of limb movement</measure>
    <time_frame>6 months</time_frame>
    <description>Test how closely both targeted reinnervation amputees and able bodied study participants are able to interpret limb movement using the kinesthetic perceptual illusion and physiologically relevant kinesthetic feedback.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">49</enrollment>
  <condition>Prosthetic</condition>
  <arm_group>
    <arm_group_label>Upper Extremity Amputee</arm_group_label>
    <description>Robust custom tactor to facilitate embodiment and proprioception</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Able Bodied</arm_group_label>
    <description>Bypass tactor</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tactor array</intervention_name>
    <arm_group_label>Upper Extremity Amputee</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bypass Tactor</intervention_name>
    <arm_group_label>Able Bodied</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Amputees who have undergone targeted sensory reinnervation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Amputee criteria:&#xD;
&#xD;
          -  Must be over 18 years of age&#xD;
&#xD;
          -  Must be upper extremity amputee who has undergone targeted sensory reinnervation.&#xD;
&#xD;
        Able Bodied participants:&#xD;
&#xD;
          -  Must be over 18 years of age&#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>
  <overall_official>
    <last_name>Paul Marasco, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Louis Stokes VA Medical Center, Cleveland Clinic Lerner Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rehabilitation Institute of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louis Stokes VA Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Lerner Research Institute</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta Glenrose Rehabilitation Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5B0B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.aptcenter.research.va.gov/</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louis Stokes VA Medical Center</investigator_affiliation>
    <investigator_full_name>Paul Marasco</investigator_full_name>
    <investigator_title>Director of Amputee Research</investigator_title>
  </responsible_party>
  <keyword>Upper limb Amputee</keyword>
  <keyword>Targeted Muscle Reinnervation</keyword>
  <keyword>Prosthetic</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/NCT02189031
org study id: 11061-H39
secondary id: R01NS081710-01
nct id: NCT02189031
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Upper limb amputation is a devastating injury that leaves many thousands of typically young
      and active individuals in the US to rely on artificial arms and hands to help restore their
      lost function. The investigators research is focused on helping these individuals to feel
      where their prosthetic limbs are moving without having to look at them by developing devices
      and approaches to provide sensory feedback of limb movement through the nerves that once
      served the missing limb.
In the investigators research the investigators seek to understand the organization and
      (function/operation) of sensory neural systems in order to develop methods for restoring
      function to injured populations. One of the primary focus areas of the investigators research
      is working to integrate physiologically relevant sensory feedback with prosthetic limbs. To
      this end the investigators employ a variety of approaches that interweave disciplines such as
      electrophysiology, psychophysics, biomedical engineering and cognition. The investigators
      research team is composed of an interconnected and communicative network of clinicians,
      engineers, and scientists. This helps us to provide pathways from basic science discoveries
      that can be used to address clinical needs with transition directly to patient care.
observational model: Case-Only
time perspective: Prospective
measure: Embodiment of the Prosthetic limb
time frame: Ten months
description: Visual loading for fine motor tasks,questionnaires, and residual limb temperature will be assessed after 10 months of in home every day use of a custom robust tactor array for sensory feedback.
measure: Investigate the perceptions of limb movement
time frame: 6 months
description: Test how closely both targeted reinnervation amputees and able bodied study participants are able to interpret limb movement using the kinesthetic perceptual illusion and physiologically relevant kinesthetic feedback.
arm group label: Upper Extremity Amputee
description: Robust custom tactor to facilitate embodiment and proprioception
arm group label: Able Bodied
description: Bypass tactor
intervention type: Device
intervention name: Tactor array
arm group label: Upper Extremity Amputee
intervention type: Device
intervention name: Bypass Tactor
arm group label: Able Bodied
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paul Marasco, PhD
role: Principal Investigator
affiliation: Louis Stokes VA Medical Center, Cleveland Clinic Lerner Research Institute
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
url: http://www.aptcenter.research.va.gov/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Louis Stokes VA Medical Center
investigator full name: Paul Marasco
investigator title: Director of Amputee Research