<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/NCT01691443</url>
  </required_header>
  <id_info>
    <org_study_id>DCIC 11 17</org_study_id>
    <secondary_id>2012-A00457-36</secondary_id>
    <nct_id>NCT01691443</nct_id>
  </id_info>
  <brief_title>Functional Assessment of a Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve</brief_title>
  <acronym>TEXIGLOVE</acronym>
  <official_title>Preliminary Study of the Substitution of Sensory Deficits of the Hand by a Medical Device Embedded : a Functional Assessment of Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the effect of vibration feedback on the&#xD;
      gripping pressure in the territory of the median nerve.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Technical problem with one of the medical device used for the study.&#xD;
  </why_stopped>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intra-and inter-individual variance in pressure.</measure>
    <time_frame>one year</time_frame>
    <description>pressures are recorded during a test clamping with and without vibration feedback for the entire population</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Sensory Deficit</condition>
  <arm_group>
    <arm_group_label>Use of the glove</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subject wear the glove for the time of the trial</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pressure sensor and wrist shaker, not marked CE, developped by Texisense</intervention_name>
    <arm_group_label>Use of the glove</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  person between 18 and 45 years old&#xD;
&#xD;
          -  affiliation to the french social security system or equivalent&#xD;
&#xD;
          -  person signed a consent to participate&#xD;
&#xD;
          -  for the patient group: person with post-traumatic sensory deficit in the territory of&#xD;
             the right median nerve above the wrist (&lt;S3 according Zachary modified Dellon).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  person with a cognitive pathology incompatible with the use of the device,&#xD;
             understanding and implementation of the protocol&#xD;
&#xD;
          -  person with a concomitant nerve injury of any other nerve territory,&#xD;
&#xD;
          -  person with pain or stiffness inconsistent with the achievement tests&#xD;
&#xD;
          -  person with an allergy to any component of the device: polyamide, cotton, nickel,&#xD;
             textile glue, rubber, plastic or latex,&#xD;
&#xD;
          -  person with an infectious disease or dermatology of the right hand&#xD;
&#xD;
          -  person deprived of freedom by judicial or administrative decision&#xD;
&#xD;
          -  person hospitalized without their consent&#xD;
&#xD;
          -  person under legal protection&#xD;
&#xD;
          -  person hospitalized for psychiatric care&#xD;
&#xD;
          -  pregnant and parturient women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Denis Corcella, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Plastic Surgery of the Hand and Burned - University Hospital Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.CIC-IT-grenoble.fr</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>October 17, 2016</last_update_submitted>
  <last_update_submitted_qc>October 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Grenoble</investigator_affiliation>
    <investigator_full_name>AdministrateurCIC</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT01691443
org study id: DCIC 11 17
secondary id: 2012-A00457-36
nct id: NCT01691443
lead sponsor: 
has dmc: Yes
The objective of this study is to investigate the effect of vibration feedback on the
      gripping pressure in the territory of the median nerve.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: intra-and inter-individual variance in pressure.
time frame: one year
description: pressures are recorded during a test clamping with and without vibration feedback for the entire population
arm group label: Use of the glove
arm group type: Experimental
description: The subject wear the glove for the time of the trial
intervention type: Procedure
intervention name: pressure sensor and wrist shaker, not marked CE, developped by Texisense
arm group label: Use of the glove
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Denis Corcella, MD
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
url: http://www.CIC-IT-grenoble.fr
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Grenoble
investigator full name: AdministrateurCIC
investigator title: principal investigator