<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/NCT03274843</url>
  </required_header>
  <id_info>
    <org_study_id>35RC15_3021_EVIC-AVC</org_study_id>
    <nct_id>NCT03274843</nct_id>
  </id_info>
  <brief_title>Evaluation of the Improvement of Independence by the Resumption of a Significant Activity Such as a Cooking Workshop in Adult Patients With Stroke Benefiting From Traditional Rehabilitation</brief_title>
  <acronym>EVIC-AVC</acronym>
  <official_title>Evaluation of the Improvement of Independence by the Resumption of a Significant Activity Such as a Cooking Workshop in Adult Patients With Stroke Benefiting From Traditional Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      A non-randomized, monocentric, pilot study comparing the level of independence for each&#xD;
      individual with significant resumption of activity in adult patients with stroke&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2016</start_date>
  <completion_date type="Actual">November 9, 2016</completion_date>
  <primary_completion_date type="Actual">November 9, 2016</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline level of independence in a population of adult patients with stroke having participated in cooking workshop at week 3</measure>
    <time_frame>Day 0, Week 3</time_frame>
    <description>Evaluation of independence by Functional Independence Measure score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the patient's quality of life</measure>
    <time_frame>Day 0, Week 3</time_frame>
    <description>Evaluation of the patient's quality of life by the Medical Outcome Study (MOS)Short Form (SF-36 ) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the patient's self-esteem</measure>
    <time_frame>Day 0, Week 3</time_frame>
    <description>Evaluation of the patient's self-esteem by Rosenberg Self Estimate Scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Patient with stroke</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Activity of everyday life</intervention_name>
    <description>Kitchen workshop</description>
    <arm_group_label>Patient with stroke</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18 years old&#xD;
&#xD;
          -  Primary stroke or recurrence on stroke having no previous sequelae&#xD;
&#xD;
          -  Stroke older than 3 weeks&#xD;
&#xD;
          -  Ability to understand treatment and sufficient motivation&#xD;
&#xD;
          -  Problem Activity Indicated in CMOP (Canadian Measure of Occupational Performance)&#xD;
&#xD;
          -  Barthel Index &gt; 60&#xD;
&#xD;
          -  Patient who received oral and written information about the protocol and who did not&#xD;
             show opposition to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dermatological pathology with wounds on the unhealed upper limbs&#xD;
&#xD;
          -  Patient in contact and droplet isolation&#xD;
&#xD;
          -  A psychiatric history requiring hospitalization in specialized settings for more than&#xD;
             2 months&#xD;
&#xD;
          -  Any condition that may limit participation or interfere with analysis of results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>June 9, 2021</last_update_submitted>
  <last_update_submitted_qc>June 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</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>Stroke</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/NCT03274843
org study id: 35RC15_3021_EVIC-AVC
nct id: NCT03274843
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A non-randomized, monocentric, pilot study comparing the level of independence for each
      individual with significant resumption of activity in adult patients with stroke
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change from baseline level of independence in a population of adult patients with stroke having participated in cooking workshop at week 3
time frame: Day 0, Week 3
description: Evaluation of independence by Functional Independence Measure score
measure: Evaluation of the patient's quality of life
time frame: Day 0, Week 3
description: Evaluation of the patient's quality of life by the Medical Outcome Study (MOS)Short Form (SF-36 ) questionnaire
measure: Evaluation of the patient's self-esteem
time frame: Day 0, Week 3
description: Evaluation of the patient's self-esteem by Rosenberg Self Estimate Scale
arm group label: Patient with stroke
arm group type: Experimental
intervention type: Other
intervention name: Activity of everyday life
description: Kitchen workshop
arm group label: Patient with stroke
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No