<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/NCT01685788</url>
  </required_header>
  <id_info>
    <org_study_id>KUL - FaBeR - Stroke - Meyer</org_study_id>
    <nct_id>NCT01685788</nct_id>
  </id_info>
  <brief_title>Study of Sensory Deficits in the Upper Limb After Stroke</brief_title>
  <official_title>Prospective Longitudinal Study: Sensory Deficits in the Upper Limb After Stroke.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim of the project is to gain insight in sensory deficits and recovery patterns&#xD;
      in the upper limb post stroke and its association with brain lesion localisation.&#xD;
      Furthermore, the investigators will identify associations of deficits in sensory modalities&#xD;
      with upper limb impairments, activities and participation at different time points after&#xD;
      stroke. Identification of the sensory deficits, along with further insights in their relation&#xD;
      with objective neurophysiological and neuroanatomical measures will contribute to the&#xD;
      amelioration of goal-setting for the rehabilitation of upper extremity function after stroke.&#xD;
      These functions are indispensable during several daily activities as well in different sports&#xD;
      and leisure activities. This project is an important step towards a better delineating of&#xD;
      treatment interventions for the upper limb and to a better guiding of individual needs for&#xD;
      post-stroke treatment in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Change in sensory function in upper limb from baseline up to 6 months post stroke</measure>
    <time_frame>6 months post stroke</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in motor function in upper limb from baseline up to 6 months post stroke</measure>
    <time_frame>6 months post stroke</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>activity measure</measure>
    <time_frame>6 months post stroke</time_frame>
    <description>The investigators will use the ABILHAND Questionnaire, a measure of how well the hemiplegic arm and hand can be used in daily activities.</description>
  </other_outcome>
  <other_outcome>
    <measure>Activity measure</measure>
    <time_frame>6 months after stroke</time_frame>
    <description>The Assisting Hand Assessment (AHA) will be used to investigate the use of the hemiplegic arm in bimanual tasks after stroke.</description>
  </other_outcome>
  <other_outcome>
    <measure>Participation measure</measure>
    <time_frame>6 months after stroke</time_frame>
    <description>The quality of life will be measured using the Stroke Impact Scale.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>study participants</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <arm_group_label>study participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        stroke patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first-ever stroke as defined by WHO&#xD;
&#xD;
          -  ≤ 5 days post stroke&#xD;
&#xD;
          -  motor impairment and/or a sensory impairment&#xD;
&#xD;
          -  ≥ 18 years old&#xD;
&#xD;
          -  sufficient cooperation to execute evaluations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other neurological impairments such as previous stroke, head injury or multiple&#xD;
             sclerosis (these might affect sensory ability independently of the stroke)&#xD;
&#xD;
          -  stroke-like symptoms caused by subdural hematoma, tumour, encephalitis or trauma&#xD;
&#xD;
          -  no informed consent&#xD;
&#xD;
          -  pre-stroke Barthel Index &lt; 95 out of 100 points (to be able to distinguish between&#xD;
             pre-existing disabilities and disabilities resulting from the stroke)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geert Verheyden, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catholic University Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sarah Meyer, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catholic University Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>October 25, 2016</last_update_submitted>
  <last_update_submitted_qc>October 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Sarah Meyer</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT01685788
org study id: KUL - FaBeR - Stroke - Meyer
nct id: NCT01685788
lead sponsor: 
collaborator: 
has dmc: Yes
The overall aim of the project is to gain insight in sensory deficits and recovery patterns
      in the upper limb post stroke and its association with brain lesion localisation.
      Furthermore, the investigators will identify associations of deficits in sensory modalities
      with upper limb impairments, activities and participation at different time points after
      stroke. Identification of the sensory deficits, along with further insights in their relation
      with objective neurophysiological and neuroanatomical measures will contribute to the
      amelioration of goal-setting for the rehabilitation of upper extremity function after stroke.
      These functions are indispensable during several daily activities as well in different sports
      and leisure activities. This project is an important step towards a better delineating of
      treatment interventions for the upper limb and to a better guiding of individual needs for
      post-stroke treatment in the future.
observational model: Case-Only
time perspective: Prospective
measure: Change in sensory function in upper limb from baseline up to 6 months post stroke
time frame: 6 months post stroke
measure: Change in motor function in upper limb from baseline up to 6 months post stroke
time frame: 6 months post stroke
measure: activity measure
time frame: 6 months post stroke
description: The investigators will use the ABILHAND Questionnaire, a measure of how well the hemiplegic arm and hand can be used in daily activities.
measure: Activity measure
time frame: 6 months after stroke
description: The Assisting Hand Assessment (AHA) will be used to investigate the use of the hemiplegic arm in bimanual tasks after stroke.
measure: Participation measure
time frame: 6 months after stroke
description: The quality of life will be measured using the Stroke Impact Scale.
arm group label: study participants
intervention type: Other
intervention name: No intervention
arm group label: study participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Geert Verheyden, Professor
role: Principal Investigator
affiliation: Catholic University Leuven
last name: Sarah Meyer, PhD student
role: Principal Investigator
affiliation: Catholic University Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Sarah Meyer
investigator title: PhD Student
mesh term: Stroke