<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/NCT01705834</url>
  </required_header>
  <id_info>
    <org_study_id>Dataglove-01</org_study_id>
    <nct_id>NCT01705834</nct_id>
  </id_info>
  <brief_title>Dataglove to Measure Joint Stiffness in Patients With Arthritis</brief_title>
  <official_title>The Evaluation of a Dataglove to Measure Joint Stiffness in Patients With Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Health and Social Care Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Ulster</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Western Health and Social Care Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate if an electronic dataglove can be used to measure joint stiffness&#xD;
      in patients with Rheumatoid Arthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will use a dataglove to record joint movements in a small number of patients with&#xD;
      rheumatoid arthritis. The aim of the study is to find out if changes in dynamic movements&#xD;
      measured by the glove will correlate with symptoms of joint stiffness in the hands of&#xD;
      patients with rheumatoid arthritis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study protocol has been replaced with a two-glove protocol NCT02026245&#xD;
  </why_stopped>
  <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>Correlation between maximum velocity of movement and the patient reported severity of joint stiffness</measure>
    <time_frame>Maximum of 7 days</time_frame>
    <description>A significant inverse correlation is expected to be found between the patient's assessment of the severity and/or duration of stiffness and the maximum velocity of movement at the main finger joints.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients withdrawing from the study</measure>
    <time_frame>Over the period of testing of the dataglove - 7 day timeframe</time_frame>
    <description>We are expecting that no more than 30% of patients will withdraw from the study due to discomfort fitting or using the dataglove.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <arm_group>
    <arm_group_label>Arthritis patients</arm_group_label>
    <description>Patients with Rheumatoid Arthritis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Rheumatoid arthritis causing pain and stiffness in their hands.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients aged 18 to 80&#xD;
&#xD;
          -  Diagnosis of Rheumatoid arthritis&#xD;
&#xD;
          -  Patients who have significant pain and stiffness in their hands&#xD;
&#xD;
          -  Correct hand size to achieve a good fit to the dataglove&#xD;
&#xD;
          -  Able to follow instructions for use of dataglove/computer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe pain in the right hand&#xD;
&#xD;
          -  Severe swelling in the right hand (rated as such by the investigator)&#xD;
&#xD;
          -  Severe permanent deformity or loss of function in the fingers of the right hand&#xD;
&#xD;
          -  Broken or infected skin in the right hand&#xD;
&#xD;
          -  Known to have been MRSA positive currently or in the past&#xD;
&#xD;
          -  Unable to don and doff the disposable lining glove and the dataglove without&#xD;
             significant discomfort&#xD;
&#xD;
          -  Poor fit for the disposable lining glove or the dataglove&#xD;
&#xD;
          -  History of latex allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Gardiner, MB BCh BAO MD</last_name>
    <role>Study Chair</role>
    <affiliation>Western Health and Social Services Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kevin Curran, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ulster</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joan Condell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ulster</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James Connolly, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ulster</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Rheumatology, Altnagelvin Hospital</name>
      <address>
        <city>Londonderry</city>
        <state>N.Ireland</state>
        <zip>BT47 6SB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>April 8, 2014</last_update_submitted>
  <last_update_submitted_qc>April 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Health and Social Care Trust</investigator_affiliation>
    <investigator_full_name>Dr Philip Gardiner</investigator_full_name>
    <investigator_title>Consultant Rheumatologist</investigator_title>
  </responsible_party>
  <keyword>Arthritis</keyword>
  <keyword>Stiffness</keyword>
  <keyword>Range of movement</keyword>
  <keyword>Goniometry</keyword>
  <keyword>Digital</keyword>
  <keyword>Dataglove</keyword>
  <keyword>Outcome</keyword>
  <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/NCT01705834
org study id: Dataglove-01
nct id: NCT01705834
lead sponsor: 
collaborator: 
has dmc: No
This study will investigate if an electronic dataglove can be used to measure joint stiffness
      in patients with Rheumatoid Arthritis.
We will use a dataglove to record joint movements in a small number of patients with
      rheumatoid arthritis. The aim of the study is to find out if changes in dynamic movements
      measured by the glove will correlate with symptoms of joint stiffness in the hands of
      patients with rheumatoid arthritis.
observational model: Case-Only
time perspective: Prospective
measure: Correlation between maximum velocity of movement and the patient reported severity of joint stiffness
time frame: Maximum of 7 days
description: A significant inverse correlation is expected to be found between the patient's assessment of the severity and/or duration of stiffness and the maximum velocity of movement at the main finger joints.
measure: Number of patients withdrawing from the study
time frame: Over the period of testing of the dataglove - 7 day timeframe
description: We are expecting that no more than 30% of patients will withdraw from the study due to discomfort fitting or using the dataglove.
arm group label: Arthritis patients
description: Patients with Rheumatoid Arthritis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Philip Gardiner, MB BCh BAO MD
role: Study Chair
affiliation: Western Health and Social Services Trust
last name: Kevin Curran, PhD
role: Principal Investigator
affiliation: University of Ulster
last name: Joan Condell, PhD
role: Principal Investigator
affiliation: University of Ulster
last name: James Connolly, BSc
role: Principal Investigator
affiliation: University of Ulster
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Western Health and Social Care Trust
investigator full name: Dr Philip Gardiner
investigator title: Consultant Rheumatologist
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid