<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/NCT03233789</url>
  </required_header>
  <id_info>
    <org_study_id>ANQ-FIM-EBI</org_study_id>
    <secondary_id>U1111-1223-6650</secondary_id>
    <nct_id>NCT03233789</nct_id>
  </id_info>
  <brief_title>Development and Validation of an ADL-score Based on FIM and EBI</brief_title>
  <acronym>EVA</acronym>
  <official_title>Entwicklung Und Validierung Eines ADL-Scores (Activities of Daily Life) Auf Basis Von FIM (Functional Independence Measure) Und EBI (Erweiterter Barthel-Index)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Martin Brünger</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Association nationale pour le développement de la qualité dans les hôpitaux et les cliniques (ANQ), Bern, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this mixed-methods-study is to develop and validate an algorithm to transform FIM&#xD;
      (Functional Independence Measure) and EBI (Extended Barthel Index) into an ADL score&#xD;
      (Activities of Daily Life) that can be used to compare outcome quality of rehabilitation&#xD;
      clinics.&#xD;
&#xD;
      The following steps are performed:&#xD;
&#xD;
        1. Development of an ADL-algorithms by experts&#xD;
&#xD;
        2. Validation of the ADL-algorithms in a quantitative approach&#xD;
&#xD;
        3. Finalization of the ADL-algorithms by experts based on study results&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">February 24, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Agreement FIM-based ADL-score vs. EBI-based ADL-score</measure>
    <time_frame>within 3 days of admission to rehabilitation clinic</time_frame>
    <description>Agreement according to Cohens kappa (FIM-based ADL-score vs. EBI-based ADL-score)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation FIM-based ADL-score vs. EBI-based ADL-score</measure>
    <time_frame>within 3 days of admission to rehabilitation clinic</time_frame>
    <description>Spearman's correlation (FIM-based ADL-score vs. EBI-based ADL-score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in FIM-based ADL-score vs. EBI-based ADL-score</measure>
    <time_frame>within 3 days of admission to rehabilitation clinic</time_frame>
    <description>Delta in points FIM-based ADL-score vs. EBI-based ADL-score</description>
  </secondary_outcome>
  <enrollment type="Actual">265</enrollment>
  <condition>Neurologic Disorder</condition>
  <condition>ICF</condition>
  <condition>Medical Rehabilitation</condition>
  <condition>Assessment</condition>
  <condition>Functional Independence</condition>
  <condition>Observational Study</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>neurologic rehabilitation</intervention_name>
    <description>in-patient rehabilitation of neurologic disorders</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with neurologic disorders in in-patient rehabilitation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission to in-patient neurologic rehabilitation clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No sufficient language skills (German, French or Italian)&#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>Karla Spyra, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Martin Brünger</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03233789
org study id: ANQ-FIM-EBI
secondary id: U1111-1223-6650
nct id: NCT03233789
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this mixed-methods-study is to develop and validate an algorithm to transform FIM
      (Functional Independence Measure) and EBI (Extended Barthel Index) into an ADL score
      (Activities of Daily Life) that can be used to compare outcome quality of rehabilitation
      clinics.

      The following steps are performed:

        1. Development of an ADL-algorithms by experts

        2. Validation of the ADL-algorithms in a quantitative approach

        3. Finalization of the ADL-algorithms by experts based on study results
observational model: Other
time perspective: Cross-Sectional
measure: Agreement FIM-based ADL-score vs. EBI-based ADL-score
time frame: within 3 days of admission to rehabilitation clinic
description: Agreement according to Cohens kappa (FIM-based ADL-score vs. EBI-based ADL-score)
measure: Correlation FIM-based ADL-score vs. EBI-based ADL-score
time frame: within 3 days of admission to rehabilitation clinic
description: Spearman's correlation (FIM-based ADL-score vs. EBI-based ADL-score)
measure: Difference in FIM-based ADL-score vs. EBI-based ADL-score
time frame: within 3 days of admission to rehabilitation clinic
description: Delta in points FIM-based ADL-score vs. EBI-based ADL-score
intervention type: Behavioral
intervention name: neurologic rehabilitation
description: in-patient rehabilitation of neurologic disorders
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karla Spyra, Prof. Dr.
role: Study Director
affiliation: Charite University, Berlin, Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Martin Brünger
investigator title: Investigator
mesh term: Nervous System Diseases
sharing ipd: No