<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/NCT03287544</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/16/0018</org_study_id>
    <secondary_id>2017-A02163-50</secondary_id>
    <nct_id>NCT03287544</nct_id>
  </id_info>
  <brief_title>Efficacy of a Combined Linguistic/Communication Therapy in Acute Aphasia After Stroke</brief_title>
  <acronym>ORACLE</acronym>
  <official_title>Effect of a Combined Language Therapy (Linguistic/Communication) on Aphasia After Stroke in Acute Phase: A Prospective, Controlled, Monocentric Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      Linguistic training is traditionally the gold standard for rehabilitation of aphasia after&#xD;
      stroke and efficacy criteria count early stage, intensity as well as personalized treatment.&#xD;
      To date, no clear evidence showed a specific effect of any therapy in the acute phase of&#xD;
      aphasia after stroke. This study aims to compare the effect of a combined therapy&#xD;
      (linguistic/communication) versus a linguistic therapy on communication performance in&#xD;
      patients in the acute phase of aphasia after a first stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty to 25% of strokes cause aphasia. Speech and language therapy is the well-known&#xD;
      standard treatment of aphasia after stroke although it is based on weak scientific evidence.&#xD;
      To date, the efficacy criteria of aphasia rehabilitation are early stage, intensity as well&#xD;
      as personalized treatment. Usually these patients receive in acute phase a linguistic&#xD;
      training focused on the linguistic impairment. This approach is based on the cerebral&#xD;
      plasticity postulate. However the superiority of this practice compared to other methods has&#xD;
      never been shown. Moreover the benefit of the combination gathering linguistic treatment with&#xD;
      communication treatment has to our knowledge never been studied.&#xD;
&#xD;
      In the present study investigators propose to compare the effect of a combined&#xD;
      linguistic/communication rehabilitation versus a linguistic treatment. To do so,&#xD;
      investigators will recruit patients with aphasia after a first stroke, in the acute phase.&#xD;
      After a allocation to the &quot; combined &quot; and &quot; linguistic &quot; groups, all the patients will have&#xD;
      a comprehensive language and neuropsychological assessment before and after 3 months of&#xD;
      rehabilitation, and finally 6 months after the onset.&#xD;
&#xD;
      The &quot;linguistic&quot; group will have a rehabilitation only focused on linguistic processes&#xD;
      whereas the &quot;combined&quot; group will have a linguistic training as well as communication&#xD;
      training. The therapy will be personalized and the therapists will exclusively use&#xD;
      standardized linguistic and/or communication toolboxes of rehabilitation containing dedicated&#xD;
      activities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>There are two arms in the protocol: one experimental arm corresponding to the &quot;combined&quot; rehabilitation (linguistic/communication) compared with another arm corresponding to the &quot;linguistic&quot; rehabilitation.&#xD;
All included patients, after allocation based on aphasia severity to the &quot; combined &quot; and &quot; linguistic &quot; groups, will have a first evaluation (E1: language, neurologic and neuropsychological exams) within 7 days after the onset. Then after a 3 months rehabilitation period they will be assessed (E2: language, neurologic and neuropsychological exams). At 6 months after the onset they will finally have the last assessment (E3: language, neurologic and neuropsychological exams).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>After the allocation in the groups, rehabilitation is not done blindly since the speech therapist knows what activities he offers to patients. However, the evaluations carried out by a speech therapist, are done without the knowledge of the rehabilitation group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the communication performance.</measure>
    <time_frame>Month 3</time_frame>
    <description>Assessed by the Lillois communication test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the communication performance.</measure>
    <time_frame>Month 6</time_frame>
    <description>Assessed by the Lillois communication test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the linguistic performance.</measure>
    <time_frame>Month 3; Month 6</time_frame>
    <description>Assessed by the &quot;Score at understanding task&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the quality of life.</measure>
    <time_frame>Month 3; Month 6</time_frame>
    <description>Assessed by the &quot;Score at a specific quality of life scale &quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Aphasia, Acquired</condition>
  <arm_group>
    <arm_group_label>Combined rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Linguistic training as well as communication training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Linguistic rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rehabilitation only focused on linguistic processes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Combined rehabilitation</intervention_name>
    <description>Linguistic training as well as communication training.</description>
    <arm_group_label>Combined rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Linguistic rehabilitation</intervention_name>
    <description>Rehabilitation only focused on linguistic processes.</description>
    <arm_group_label>Linguistic rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First stroke&#xD;
&#xD;
          -  Inclusion at the acute phase (&lt; 7 days)&#xD;
&#xD;
          -  Patient registered at the social security system&#xD;
&#xD;
          -  French as usual language&#xD;
&#xD;
          -  Aphasia severity score measured by the Boston Diagnostic Aphasia Examination (BDAE)&#xD;
             scale ≥ 1 and ≤ 4&#xD;
&#xD;
          -  Consent signed by the patient or if not, by the caregiver&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment before the onset (IQCode &gt; 3.4)&#xD;
&#xD;
          -  Alcohol or drug addiction&#xD;
&#xD;
          -  Untreated psychiatric disease,&#xD;
&#xD;
          -  Uncorrected sensory impairment&#xD;
&#xD;
          -  Evolutive pathology&#xD;
&#xD;
          -  Adults protected by Law&#xD;
&#xD;
          -  Participation to another research&#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>Lola Danet, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lola Danet, PhD</last_name>
    <phone>5 61 77 95 17</phone>
    <phone_ext>33</phone_ext>
    <email>danet.l@chu-toulouse.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stéphanie Delrutte, PhD</last_name>
    <phone>5 61 77 56 13</phone>
    <phone_ext>33</phone_ext>
    <email>delrutte.s@chu-toulouse.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Pierre Paul Riquet</name>
      <address>
        <city>Toulouse</city>
        <state>Midi-Pyrénées</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lola Danet, PhD</last_name>
      <phone>5 61 77 95 17</phone>
      <phone_ext>33</phone_ext>
      <email>danet.l@chu-toulouse.fr</email>
    </contact>
    <contact_backup>
      <last_name>Stéphanie Delrutte</last_name>
      <phone>5 61 77 56 13</phone>
      <phone_ext>33</phone_ext>
      <email>delrutte.s@chu-toulouse.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Lola Danet, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stéphanie Delrutte</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eila Rodilla-Lange</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Séverine Bodin</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Catherine Bezy</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Galletta EE, Barrett AM. Impairment and Functional Interventions for Aphasia: Having it All. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):114-120. doi: 10.1007/s40141-014-0050-5.</citation>
    <PMID>25133085</PMID>
  </reference>
  <reference>
    <citation>Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. doi: 10.1161/01.STR.0000062343.64383.D0. Epub 2003 Mar 20.</citation>
    <PMID>12649521</PMID>
  </reference>
  <reference>
    <citation>Tippett DC, Niparko JK, Hillis AE. Aphasia: Current Concepts in Theory and Practice. J Neurol Transl Neurosci. 2014 Jan;2(1):1042.</citation>
    <PMID>24904925</PMID>
  </reference>
  <reference>
    <citation>Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989 Nov;19(4):1015-22. doi: 10.1017/s0033291700005742.</citation>
    <PMID>2594878</PMID>
  </reference>
  <reference>
    <citation>Behrmann M, Lieberthal T. Category-specific treatment of a lexical-semantic deficit: a single case study of global aphasia. Br J Disord Commun. 1989 Dec;24(3):281-99. doi: 10.3109/13682828909019892.</citation>
    <PMID>2627547</PMID>
  </reference>
  <reference>
    <citation>Crosson B. An intention manipulation to change lateralization of word production in nonfluent aphasia: current status. Semin Speech Lang. 2008 Aug;29(3):188-200; quiz C-4. doi: 10.1055/s-0028-1082883.</citation>
    <PMID>18720316</PMID>
  </reference>
  <reference>
    <citation>Jones EV. Building the foundations for sentence production in a non-fluent aphasic. Br J Disord Commun. 1986 Apr;21(1):63-82. doi: 10.3109/13682828609018544. No abstract available.</citation>
    <PMID>3730272</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aphasia</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Communication</keyword>
  <keyword>Linguistics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</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/NCT03287544
org study id: RC31/16/0018
secondary id: 2017-A02163-50
nct id: NCT03287544
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Linguistic training is traditionally the gold standard for rehabilitation of aphasia after
      stroke and efficacy criteria count early stage, intensity as well as personalized treatment.
      To date, no clear evidence showed a specific effect of any therapy in the acute phase of
      aphasia after stroke. This study aims to compare the effect of a combined therapy
      (linguistic/communication) versus a linguistic therapy on communication performance in
      patients in the acute phase of aphasia after a first stroke.
Twenty to 25% of strokes cause aphasia. Speech and language therapy is the well-known
      standard treatment of aphasia after stroke although it is based on weak scientific evidence.
      To date, the efficacy criteria of aphasia rehabilitation are early stage, intensity as well
      as personalized treatment. Usually these patients receive in acute phase a linguistic
      training focused on the linguistic impairment. This approach is based on the cerebral
      plasticity postulate. However the superiority of this practice compared to other methods has
      never been shown. Moreover the benefit of the combination gathering linguistic treatment with
      communication treatment has to our knowledge never been studied.

      In the present study investigators propose to compare the effect of a combined
      linguistic/communication rehabilitation versus a linguistic treatment. To do so,
      investigators will recruit patients with aphasia after a first stroke, in the acute phase.
      After a allocation to the " combined " and " linguistic " groups, all the patients will have
      a comprehensive language and neuropsychological assessment before and after 3 months of
      rehabilitation, and finally 6 months after the onset.

      The "linguistic" group will have a rehabilitation only focused on linguistic processes
      whereas the "combined" group will have a linguistic training as well as communication
      training. The therapy will be personalized and the therapists will exclusively use
      standardized linguistic and/or communication toolboxes of rehabilitation containing dedicated
      activities.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: There are two arms in the protocol: one experimental arm corresponding to the "combined" rehabilitation (linguistic/communication) compared with another arm corresponding to the "linguistic" rehabilitation.
All included patients, after allocation based on aphasia severity to the " combined " and " linguistic " groups, will have a first evaluation (E1: language, neurologic and neuropsychological exams) within 7 days after the onset. Then after a 3 months rehabilitation period they will be assessed (E2: language, neurologic and neuropsychological exams). At 6 months after the onset they will finally have the last assessment (E3: language, neurologic and neuropsychological exams).
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: After the allocation in the groups, rehabilitation is not done blindly since the speech therapist knows what activities he offers to patients. However, the evaluations carried out by a speech therapist, are done without the knowledge of the rehabilitation group.
measure: Assessment of the communication performance.
time frame: Month 3
description: Assessed by the Lillois communication test
measure: Assessment of the communication performance.
time frame: Month 6
description: Assessed by the Lillois communication test
measure: Assessment of the linguistic performance.
time frame: Month 3; Month 6
description: Assessed by the "Score at understanding task".
measure: Assessment of the quality of life.
time frame: Month 3; Month 6
description: Assessed by the "Score at a specific quality of life scale ".
arm group label: Combined rehabilitation
arm group type: Experimental
description: Linguistic training as well as communication training.
arm group label: Linguistic rehabilitation
arm group type: Active Comparator
description: Rehabilitation only focused on linguistic processes.
intervention type: Other
intervention name: Combined rehabilitation
description: Linguistic training as well as communication training.
arm group label: Combined rehabilitation
intervention type: Other
intervention name: Linguistic rehabilitation
description: Rehabilitation only focused on linguistic processes.
arm group label: Linguistic rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lola Danet, Phd
role: Principal Investigator
affiliation: University Hospital, Toulouse
last name: Lola Danet, PhD
phone: 5 61 77 95 17
phone ext: 33
email: danet.l@chu-toulouse.fr
last name: Stéphanie Delrutte, PhD
phone: 5 61 77 56 13
phone ext: 33
email: delrutte.s@chu-toulouse.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
citation: Galletta EE, Barrett AM. Impairment and Functional Interventions for Aphasia: Having it All. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):114-120. doi: 10.1007/s40141-014-0050-5.
PMID: 25133085
citation: Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. doi: 10.1161/01.STR.0000062343.64383.D0. Epub 2003 Mar 20.
PMID: 12649521
citation: Tippett DC, Niparko JK, Hillis AE. Aphasia: Current Concepts in Theory and Practice. J Neurol Transl Neurosci. 2014 Jan;2(1):1042.
PMID: 24904925
citation: Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989 Nov;19(4):1015-22. doi: 10.1017/s0033291700005742.
PMID: 2594878
citation: Behrmann M, Lieberthal T. Category-specific treatment of a lexical-semantic deficit: a single case study of global aphasia. Br J Disord Commun. 1989 Dec;24(3):281-99. doi: 10.3109/13682828909019892.
PMID: 2627547
citation: Crosson B. An intention manipulation to change lateralization of word production in nonfluent aphasia: current status. Semin Speech Lang. 2008 Aug;29(3):188-200; quiz C-4. doi: 10.1055/s-0028-1082883.
PMID: 18720316
citation: Jones EV. Building the foundations for sentence production in a non-fluent aphasic. Br J Disord Commun. 1986 Apr;21(1):63-82. doi: 10.3109/13682828609018544. No abstract available.
PMID: 3730272
responsible party type: Sponsor
mesh term: Aphasia