<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/NCT02197507</url>
  </required_header>
  <id_info>
    <org_study_id>9385</org_study_id>
    <nct_id>NCT02197507</nct_id>
  </id_info>
  <brief_title>Digitized Grip Strength</brief_title>
  <official_title>Evaluation of Grip Strength With Digitized Sensor in Adults With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rheumatoid arthritis (RA) is the most common chronic inflammatory arthritis in adults.&#xD;
      Monitoring of disease activity is based on Disease Activity Score 28 (DAS 28). There are also&#xD;
      validated questionnaires for self-assessment of the disease by the patient. Grip strength&#xD;
      measured using a digitized sensor used by the patient could be an additional tool to the&#xD;
      remote monitoring of patients with RA.&#xD;
&#xD;
      Main Objective : To evaluate the correlation between the measurement of grip strength in the&#xD;
      dominant hand measured by a digital sensor and activity of RA assessed by DAS 28&#xD;
&#xD;
      Secondary objective : Evaluate the correlation between grip strength of the dominant hand and&#xD;
      :&#xD;
&#xD;
        -  scores of fatigue and pain (VAS and FACIT)&#xD;
&#xD;
        -  the self-assessment scores known in RA : functional index Health Assessment&#xD;
           Questionnaire (HAQ) and scores of activity RAPID3 and RADAI5.&#xD;
&#xD;
      It is a cross-sectional study involving 150 patients followed in our department for RA. Grip&#xD;
      strength of the dominant hand will be measured by a digitalized sensor during a single visit&#xD;
      integrating into the routine monitoring of patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>grip strength</measure>
    <time_frame>visit 1</time_frame>
    <description>Evaluate the correlation between the measurement of grip strength in the dominant hand measured by a digital sensor and activity of RA assessed by DAS 28</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>RA patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Digitized sensor</intervention_name>
    <description>Measure of grip strength of the dominant hand</description>
    <arm_group_label>RA patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid arthritis whatever its activity&#xD;
&#xD;
          -  Above 18 years old patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other condition that may affect the level of fatigue and / or grip strength&#xD;
&#xD;
          -  Insufficient level of understanding to perform the measurement and self-report&#xD;
             questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Christian Jorgensen, MD</last_name>
    <phone>04 67 33 72 31</phone>
    <email>c-jorgensen@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>UH Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Christian Jorgensen, MD</last_name>
      <phone>04 67 33 72 31</phone>
      <email>c-jorgensen@chu-montpellier.fr</email>
    </contact>
    <investigator>
      <last_name>Christian Jorgensen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre LEBLAY, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rosanna Ferreira, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yves Marie PERS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <!-- 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/NCT02197507
org study id: 9385
nct id: NCT02197507
lead sponsor: 
has dmc: Yes
Rheumatoid arthritis (RA) is the most common chronic inflammatory arthritis in adults.
      Monitoring of disease activity is based on Disease Activity Score 28 (DAS 28). There are also
      validated questionnaires for self-assessment of the disease by the patient. Grip strength
      measured using a digitized sensor used by the patient could be an additional tool to the
      remote monitoring of patients with RA.

      Main Objective : To evaluate the correlation between the measurement of grip strength in the
      dominant hand measured by a digital sensor and activity of RA assessed by DAS 28

      Secondary objective : Evaluate the correlation between grip strength of the dominant hand and
      :

        -  scores of fatigue and pain (VAS and FACIT)

        -  the self-assessment scores known in RA : functional index Health Assessment
           Questionnaire (HAQ) and scores of activity RAPID3 and RADAI5.

      It is a cross-sectional study involving 150 patients followed in our department for RA. Grip
      strength of the dominant hand will be measured by a digitalized sensor during a single visit
      integrating into the routine monitoring of patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: grip strength
time frame: visit 1
description: Evaluate the correlation between the measurement of grip strength in the dominant hand measured by a digital sensor and activity of RA assessed by DAS 28
arm group label: RA patients
arm group type: Experimental
intervention type: Device
intervention name: Digitized sensor
description: Measure of grip strength of the dominant hand
arm group label: RA patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Christian Jorgensen, MD
phone: 04 67 33 72 31
email: c-jorgensen@chu-montpellier.fr
facility: 
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid