<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/NCT02260999</url>
  </required_header>
  <id_info>
    <org_study_id>BHL-2113</org_study_id>
    <nct_id>NCT02260999</nct_id>
  </id_info>
  <brief_title>Experimental Study of Detection an Intentional Performance Degradation in Grip Strength</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christoph Maier, Prof. Dr.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruhr University of Bochum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the detection of the feigning weakness in grip strength is measured using&#xD;
      different grip strength testing instruments. Patients with injury of the upper limb are&#xD;
      compared to patients with injury of the lower limb as well as healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>grip strength</measure>
    <time_frame>1 hour</time_frame>
    <description>mean and maximum grip strength measured by rapid exchange grip and isometric grip strength testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>range of motion</measure>
    <time_frame>1 hour</time_frame>
    <description>measured by the handtutor</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">136</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>healthy</arm_group_label>
    <description>&gt; 18 years old sufficient language knowledge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chronic pain patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with injury at the upper etxremity</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        chronic pain patients patients with injury at the upper extremity healthy subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - &gt;18 years, signed consent form, stable pain mediaction for 48 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - &lt;18, unsigned consent form, dose change of the pain medication during the last 48&#xD;
        hours...&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ruhr University of Bochum</investigator_affiliation>
    <investigator_full_name>Christoph Maier, Prof. Dr.</investigator_full_name>
    <investigator_title>Prof. Dr.med. C. Maier</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/NCT02260999
org study id: BHL-2113
nct id: NCT02260999
lead sponsor: 
has dmc: No
In this study, the detection of the feigning weakness in grip strength is measured using
      different grip strength testing instruments. Patients with injury of the upper limb are
      compared to patients with injury of the lower limb as well as healthy controls.
observational model: Case-Control
time perspective: Prospective
measure: grip strength
time frame: 1 hour
description: mean and maximum grip strength measured by rapid exchange grip and isometric grip strength testing
measure: range of motion
time frame: 1 hour
description: measured by the handtutor
arm group label: healthy
description: > 18 years old sufficient language knowledge
arm group label: chronic pain patients
arm group label: patients with injury at the upper etxremity
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Ruhr University of Bochum
investigator full name: Christoph Maier, Prof. Dr.
investigator title: Prof. Dr.med. C. Maier