<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/NCT02971774</url>
  </required_header>
  <id_info>
    <org_study_id>2005997</org_study_id>
    <nct_id>NCT02971774</nct_id>
  </id_info>
  <brief_title>Development of a Multimodal Approach to Assess Stroke Patients Daily Life Activities</brief_title>
  <official_title>Development of a Multimodal Approach to Assess Stroke Persons Daily Life Activities and Development of a New Tool to Evaluate the Impact of Functional Activites on Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study consists in enriching knowledge of health professionals, on the&#xD;
      functional difficulties encountered by hemiplegic patients outside the hospital, in&#xD;
      particular on hobbies, going out with friends or family, work, daily life and the personal&#xD;
      projects. Another objective is to evaluate the diversity of the attitudes and representations&#xD;
      of the patients about their body damage. Lastly, the study seeks to develop a new grid of&#xD;
      evaluation of the quality of life of the patients, which determines more fields of the&#xD;
      existence significantly impacted by the hemiparesy, from the point of view of the patients.&#xD;
      It is a question of improving the therapeutic care of the patients and to determine if&#xD;
      various therapeutic approaches (occupational, pharmacological, surgical) have an impact on&#xD;
      these various fields. The study will be based on qualitative data (interviews) and&#xD;
      quantitative (questionnaires).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To conduct the research, a sociologist will collaborate with Doctor Nicolas Roche, the&#xD;
           study director. The contribution of a sociologist will offer a viewpoint from outside&#xD;
           the medical aspect, which will allow more global identification of the areas of the&#xD;
           lives of patients that are affected by hemiparesis. Furthermore, the sociological&#xD;
           perspective will seek to demonstrate the social aspects, which have heretofore been&#xD;
           explored little or not at all in medical and public health studies, such as, for&#xD;
           example, in terms of intimacy or self-image. It must delicately capture the practices,&#xD;
           logic of action and though of the patients, by placing them in the social contexts in&#xD;
           which they evolve and develop. Therefore, attention will be paid to certain &quot;social&#xD;
           determinants&quot; (such as sociocultural setting, age or gender) and certain resources&#xD;
           (particularly economic, relational and material), which can have an effect on the ways&#xD;
           in which patients perceive and cope with the consequences of their hemiparesis. The role&#xD;
           of loved ones (partner, family members, friends) will also be examined, since many&#xD;
           sociological works have shown that they are usually on the front line to accompany,&#xD;
           shape and manage the effects of the motor impairment.&#xD;
&#xD;
        2. The study will target adults regularly followed in the department of physical medicine&#xD;
           and rehabilitation of the Raymond-Poincaré hospital. These individuals must present with&#xD;
           hemiparesis secondary to a single, hemispheric cerebrovascular accident, be living at&#xD;
           home and be able to move inside and outside of the home.&#xD;
&#xD;
      Patients having several severe cognitive disorders or aphasia will not be interviewed.&#xD;
&#xD;
      The study will include an exploration phase (a corpus of approximatively 30 examinations) and&#xD;
      a quantitative component (approximatively 100 questionnaires).&#xD;
&#xD;
      Once the examinations have been completed, the preparation of the questionnaire will be done&#xD;
      with the validation of clinical experts. The questionnaire will include approximately 20&#xD;
      items, distributed over several dimensions of patients' lives. The participants' response&#xD;
      time to the questionnaire should be in a range from 8 to 12 minutes, in order to facilitate&#xD;
      its insertion in the professional practices when the patients are at a hospital visit.&#xD;
&#xD;
      The researcher will be in charge of completion of the questionnaire. This will be performed&#xD;
      around or during the consultation of patients at Raymond-Poincaré hospital. The first&#xD;
      completions will be recorded (with the written approval of surveyed patients) in order to be&#xD;
      able to work on possible improvements, particularly in terms of the order of questions or in&#xD;
      their understanding and response options. After ten completions, the questionnaire will be&#xD;
      slightly revised if modifications appear necessary, then will remain the same until the&#xD;
      desired volume of questionnaires is received (approximatively 100).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>daily life questionnary</measure>
    <time_frame>45 minutes</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stroke in Patients: New Tool to Evaluate the Impact in Their Life</condition>
  <arm_group>
    <arm_group_label>questionnary</arm_group_label>
    <description>self administered questionnary</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study will target adults regularly followed in the department of physical medicine and&#xD;
        rehabilitation of the Raymond-Poincaré hospital. These individuals must present with&#xD;
        hemiparesis secondary to a single, hemispheric cerebrovascular accident, be living at home&#xD;
        and be able to move inside and outside of the home.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18 years old&#xD;
&#xD;
          -  patient with hemiparesis secondary to a single hemispheric cerebrovascular accident&#xD;
&#xD;
          -  be living at home&#xD;
&#xD;
          -  be able to move inside and outside of the home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having several severe cognitive disorders&#xD;
&#xD;
          -  Patients having severe aphasia&#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>Nicolas ROCHE, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Raymond Poincare Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicolas ROCHE, MD PhD</last_name>
    <phone>0033147105409</phone>
    <email>roche.nicolas@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Raymond Poincaré Hospital</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas Roche, MD PhD</last_name>
      <phone>0033147105409</phone>
      <email>roche.nicolas@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>botulinum toxin injection</keyword>
  <keyword>daily life</keyword>
  <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/NCT02971774
org study id: 2005997
nct id: NCT02971774
lead sponsor: 
has dmc: No
The aim of the study consists in enriching knowledge of health professionals, on the
      functional difficulties encountered by hemiplegic patients outside the hospital, in
      particular on hobbies, going out with friends or family, work, daily life and the personal
      projects. Another objective is to evaluate the diversity of the attitudes and representations
      of the patients about their body damage. Lastly, the study seeks to develop a new grid of
      evaluation of the quality of life of the patients, which determines more fields of the
      existence significantly impacted by the hemiparesy, from the point of view of the patients.
      It is a question of improving the therapeutic care of the patients and to determine if
      various therapeutic approaches (occupational, pharmacological, surgical) have an impact on
      these various fields. The study will be based on qualitative data (interviews) and
      quantitative (questionnaires).
1. To conduct the research, a sociologist will collaborate with Doctor Nicolas Roche, the
           study director. The contribution of a sociologist will offer a viewpoint from outside
           the medical aspect, which will allow more global identification of the areas of the
           lives of patients that are affected by hemiparesis. Furthermore, the sociological
           perspective will seek to demonstrate the social aspects, which have heretofore been
           explored little or not at all in medical and public health studies, such as, for
           example, in terms of intimacy or self-image. It must delicately capture the practices,
           logic of action and though of the patients, by placing them in the social contexts in
           which they evolve and develop. Therefore, attention will be paid to certain "social
           determinants" (such as sociocultural setting, age or gender) and certain resources
           (particularly economic, relational and material), which can have an effect on the ways
           in which patients perceive and cope with the consequences of their hemiparesis. The role
           of loved ones (partner, family members, friends) will also be examined, since many
           sociological works have shown that they are usually on the front line to accompany,
           shape and manage the effects of the motor impairment.

        2. The study will target adults regularly followed in the department of physical medicine
           and rehabilitation of the Raymond-Poincaré hospital. These individuals must present with
           hemiparesis secondary to a single, hemispheric cerebrovascular accident, be living at
           home and be able to move inside and outside of the home.

      Patients having several severe cognitive disorders or aphasia will not be interviewed.

      The study will include an exploration phase (a corpus of approximatively 30 examinations) and
      a quantitative component (approximatively 100 questionnaires).

      Once the examinations have been completed, the preparation of the questionnaire will be done
      with the validation of clinical experts. The questionnaire will include approximately 20
      items, distributed over several dimensions of patients' lives. The participants' response
      time to the questionnaire should be in a range from 8 to 12 minutes, in order to facilitate
      its insertion in the professional practices when the patients are at a hospital visit.

      The researcher will be in charge of completion of the questionnaire. This will be performed
      around or during the consultation of patients at Raymond-Poincaré hospital. The first
      completions will be recorded (with the written approval of surveyed patients) in order to be
      able to work on possible improvements, particularly in terms of the order of questions or in
      their understanding and response options. After ten completions, the questionnaire will be
      slightly revised if modifications appear necessary, then will remain the same until the
      desired volume of questionnaires is received (approximatively 100).
observational model: Other
time perspective: Prospective
measure: daily life questionnary
time frame: 45 minutes
arm group label: questionnary
description: self administered questionnary
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas ROCHE, MD PhD
role: Principal Investigator
affiliation: Raymond Poincare Hospital
last name: Nicolas ROCHE, MD PhD
phone: 0033147105409
email: roche.nicolas@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No