<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/NCT03009773</url>
  </required_header>
  <id_info>
    <org_study_id>PI2016_843_0007</org_study_id>
    <nct_id>NCT03009773</nct_id>
  </id_info>
  <brief_title>The Multitasking Rehabilitation She Enhanced Walking Speed Compared to the Simple Post Stroke Rehabilitation Task (AVC)?</brief_title>
  <acronym>SYNCOMOT</acronym>
  <official_title>The Multitasking Rehabilitation She Enhanced Walking Speed Compared to the Simple Post Stroke Rehabilitation Task (AVC)?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CENTRE DE REEDUCATION FONCTIONNELLE L'ESPOIR LILLE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CENTRE DE REEDUCATION FONCTIONNELLE SAINT-LAZARE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Régional de Médecine Physique et de Réadaptation - Les herbiers</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Arras</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH COMPIEGNE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH CORBIE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH Le Havre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinique de rééducation fonctionnelle Le Belloy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondation Hopale</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut Médical de Breteuil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</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>
      Stroke is the leading cause of severe disability in adults. The first cause of alterations in&#xD;
      the quality of life and autonomy in these patients are disorders of walking and the balance.&#xD;
      They are the leading cause of falls responsible for important medical, surgical and economic&#xD;
      complications as well as a reactionary social isolation.&#xD;
&#xD;
      The techniques of rehabilitation of walking to the subacute phase of a stroke are usually&#xD;
      based on automatic walking.Off walking is a complex activity usually performed in everyday&#xD;
      life in association with multiple tasks. It is therefore interesting to re-educate walking in&#xD;
      dual task or even in multitasking.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Anticipated">May 10, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 10, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure walking speed</measure>
    <time_frame>6 months</time_frame>
    <description>Speed of the simple task of walking 10 meters testing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of different types of walking disorders and balance in the subacute phase of stroke</measure>
    <time_frame>inclusion</time_frame>
    <description>Currently no clinical scale exists in the literature at our knowledge. The walk of the patients will be qualitatively analyzed by the investigator in order to measure the prevalence of the different clinical categories of walking disorders according to their semiological characteristics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score neuromotor the lower limb</measure>
    <time_frame>6 months</time_frame>
    <description>Score neuromotor the lower limb: Fugl Meyer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic equilibrium to TUG single and double cognitive task</measure>
    <time_frame>6 months</time_frame>
    <description>Dynamic equilibrium to TUG single and double cognitive task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking speed double cognitive task</measure>
    <time_frame>6 months</time_frame>
    <description>Walking speed double cognitive task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive functions: a battery of neuropsychological</measure>
    <time_frame>6 months</time_frame>
    <description>Executive functions: a battery of neuropsychological</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT</measure>
    <time_frame>6 months</time_frame>
    <description>Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EVA Quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>EVA (Visual Analogic Scale) quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of cognitive gains with the gain of the walking speed of 10 meters</measure>
    <time_frame>6 months</time_frame>
    <description>Correlation of cognitive gains with the gain of the walking speed of 10 meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anatomoclinical correlations</measure>
    <time_frame>6 months</time_frame>
    <description>Lesion score of gray matter and white matter (Volumetry on sequences 3DT1 and Flair) Cerebral</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Subacute Stroke</condition>
  <arm_group>
    <arm_group_label>multitasking walking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multitasking Group: rehabilitation multitasking walking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>walking simple task</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Simple task group : Traditional walking rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>rehabilitation multitasking walking.</intervention_name>
    <description>rehabilitation multitasking walking.</description>
    <arm_group_label>multitasking walking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional walking rehabilitation</intervention_name>
    <description>Traditional walking rehabilitation</description>
    <arm_group_label>walking simple task</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major: age between 18 and 90 years&#xD;
&#xD;
          -  Hospitalized for ischemic or hemorrhagic hemispheric stroke confirmed by CT or MRI&#xD;
             &lt;6months&#xD;
&#xD;
          -  walking disorder with the possibility of walking 10 meters with or without technical&#xD;
             assistance (speed &lt;1.2m / s)&#xD;
&#xD;
          -  verbal understanding with complex orders&#xD;
&#xD;
          -  Affiliates to social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brainstem stroke or cerebellar&#xD;
&#xD;
          -  Hypoacusia annoying understanding&#xD;
&#xD;
          -  Visual gene embarrassing awarding&#xD;
&#xD;
          -  severe aphasia: no understanding of complex orders&#xD;
&#xD;
          -  neurological or musculoskeletal history affecting walking&#xD;
&#xD;
          -  Participation in interventional research protocol in motor rehabilitation of the lower&#xD;
             limb or cognitive&#xD;
&#xD;
          -  Patient under guardianship or deprived of liberty&#xD;
&#xD;
          -  pregnant women, parturient women or lactating (art L.1121-5)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sophie TASSEEL-PONCHE, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>CHU Amiens-Picardie France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric VERIN, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Rouen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Etienne ALLART, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU de Lille</affiliation>
  </overall_official>
  <overall_official>
    <last_name>DEMAILLE Samantha, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CRF 4Espoir Lille</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Valérie LECLERCQ-DONTGEZ, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Les 3 vallées</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Haykal ELLEUCH, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH Arras</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marie DECOCQ-DEMICHEL, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH Le Belloy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pascal RIGAUX, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH Berck Sur Mer</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sabine POL-ROUX, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH Compiègne</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sofiane LARIBI, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH Breteuil</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Skander MOALLA, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier de Beauvais</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sophie TASSEEL-PONCHE, Doctor</last_name>
    <phone>+33 322 455 735</phone>
    <email>tasseel-ponche.sophie@chu-amiens.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed AIT AMER MEZIANE, PHD</last_name>
    <phone>+ 33 322 088 384</phone>
    <email>aitamermeziane.mohamed@chu-amiens.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Amiens Picardie</name>
      <address>
        <city>Amiens</city>
        <state>Picardie</state>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sophie TASSEEL-PONCHE, Dr</last_name>
      <phone>+33322455735</phone>
      <email>tasseel-ponche.sophie@chu-amiens.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>subacute stroke</keyword>
  <keyword>multitasking rehabilitation</keyword>
  <keyword>walking</keyword>
  <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/NCT03009773
org study id: PI2016_843_0007
nct id: NCT03009773
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke is the leading cause of severe disability in adults. The first cause of alterations in
      the quality of life and autonomy in these patients are disorders of walking and the balance.
      They are the leading cause of falls responsible for important medical, surgical and economic
      complications as well as a reactionary social isolation.

      The techniques of rehabilitation of walking to the subacute phase of a stroke are usually
      based on automatic walking.Off walking is a complex activity usually performed in everyday
      life in association with multiple tasks. It is therefore interesting to re-educate walking in
      dual task or even in multitasking.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Measure walking speed
time frame: 6 months
description: Speed of the simple task of walking 10 meters testing.
measure: Description of different types of walking disorders and balance in the subacute phase of stroke
time frame: inclusion
description: Currently no clinical scale exists in the literature at our knowledge. The walk of the patients will be qualitatively analyzed by the investigator in order to measure the prevalence of the different clinical categories of walking disorders according to their semiological characteristics
measure: Score neuromotor the lower limb
time frame: 6 months
description: Score neuromotor the lower limb: Fugl Meyer
measure: Dynamic equilibrium to TUG single and double cognitive task
time frame: 6 months
description: Dynamic equilibrium to TUG single and double cognitive task
measure: Walking speed double cognitive task
time frame: 6 months
description: Walking speed double cognitive task
measure: Executive functions: a battery of neuropsychological
time frame: 6 months
description: Executive functions: a battery of neuropsychological
measure: Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT
time frame: 6 months
description: Autonomy: FUNCTIONAL INDEPENDENCE MEASUREMENT
measure: EVA Quality of life
time frame: 6 months
description: EVA (Visual Analogic Scale) quality of life
measure: Correlation of cognitive gains with the gain of the walking speed of 10 meters
time frame: 6 months
description: Correlation of cognitive gains with the gain of the walking speed of 10 meters
measure: anatomoclinical correlations
time frame: 6 months
description: Lesion score of gray matter and white matter (Volumetry on sequences 3DT1 and Flair) Cerebral
arm group label: multitasking walking
arm group type: Experimental
description: Multitasking Group: rehabilitation multitasking walking.
arm group label: walking simple task
arm group type: Active Comparator
description: Simple task group : Traditional walking rehabilitation
intervention type: Other
intervention name: rehabilitation multitasking walking.
description: rehabilitation multitasking walking.
arm group label: multitasking walking
intervention type: Other
intervention name: Traditional walking rehabilitation
description: Traditional walking rehabilitation
arm group label: walking simple task
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sophie TASSEEL-PONCHE, Doctor
role: Study Director
affiliation: CHU Amiens-Picardie France
last name: Eric VERIN, professor
role: Principal Investigator
affiliation: CHU de Rouen
last name: Etienne ALLART, Doctor
role: Principal Investigator
affiliation: CHRU de Lille
last name: DEMAILLE Samantha, professor
role: Principal Investigator
affiliation: CRF 4Espoir Lille
last name: Valérie LECLERCQ-DONTGEZ, Doctor
role: Principal Investigator
affiliation: Les 3 vallées
last name: Haykal ELLEUCH, Doctor
role: Principal Investigator
affiliation: CH Arras
last name: Marie DECOCQ-DEMICHEL, Doctor
role: Principal Investigator
affiliation: CH Le Belloy
last name: Pascal RIGAUX, Doctor
role: Principal Investigator
affiliation: CH Berck Sur Mer
last name: Sabine POL-ROUX, Doctor
role: Principal Investigator
affiliation: CH Compiègne
last name: Sofiane LARIBI, Doctor
role: Principal Investigator
affiliation: CH Breteuil
last name: Skander MOALLA, Doctor
role: Principal Investigator
affiliation: Centre Hospitalier de Beauvais
last name: Sophie TASSEEL-PONCHE, Doctor
phone: +33 322 455 735
email: tasseel-ponche.sophie@chu-amiens.fr
last name: Mohamed AIT AMER MEZIANE, PHD
phone: + 33 322 088 384
email: aitamermeziane.mohamed@chu-amiens.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Stroke