<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/NCT03280810</url>
  </required_header>
  <id_info>
    <org_study_id>1708158</org_study_id>
    <nct_id>NCT03280810</nct_id>
  </id_info>
  <brief_title>Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia</brief_title>
  <official_title>Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Beside these well-known symptoms (positive symptoms (such as delirium and delusions),&#xD;
      negative symptoms (such as affective flattening and impoverishment of speech), disorganized&#xD;
      behavior, patients with schizophrenia show different kinds of cognitive alterations and motor&#xD;
      abnormalities. In schizophrenia, postural impairment could increase the attentional cost of&#xD;
      daily motor tasks, leading to a lack of attentional resources, essential to achieve complex&#xD;
      cognitive tasks. The intrication of cognitive and postural processings (both impaired in&#xD;
      schizophrenia) can be explored by using of a dual-task paradigm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study assesses a psycho-corporal training (8 weeks psycho-corporal training) benefits on&#xD;
      both postural (increased automation of balance control) and cognitive processings (smaller&#xD;
      impact of the dual-task condition on attentional performances) in population of patients&#xD;
      suffering from schizophrenia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the losses of postural and attentional control</measure>
    <time_frame>At 8 weeks</time_frame>
    <description>To analyze the losses of postural and attentional control under dual-task condition.&#xD;
Losses of postural and attentional control are calculated by one composite score named mu (Baddeley, Della Sala, Papagno, &amp; Spinnler, 1997).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cognitive decrement</measure>
    <time_frame>At 8 weeks</time_frame>
    <description>To compare mean values of the cognitive decrement between baseline and 8 weeks in which the Redundancy value of the responses sequence to the random number generation task were analyzed using RgCalc® software (Towse &amp; Neil, 1998).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postural decrement</measure>
    <time_frame>At 8 weeks</time_frame>
    <description>To compare mean values of the postural decrement between baseline and 8 weeks in which the confidence Ellipse is used as main criteria to evaluate the participants balance ability postural sway platform (WIN-POSTURO Médicapteurs®).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Movement group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with schizophrenia (experimental group) have psycho-corporal training once a week, during 1 hour and a half for a period of two months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervervention : patients with schizophrenia (comparator group) who don't have psycho-corporal training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Movement group</intervention_name>
    <description>Experimental group : patients with schizophrenia who realise psycho-corporal training once a week, during 1 hour and a half for a period of two months</description>
    <arm_group_label>Movement group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of&#xD;
             schizophrenia (men or women)&#xD;
&#xD;
          -  Men or woman aged 18-55&#xD;
&#xD;
          -  Patients with no change in antipsychotic medication and clinical status within four&#xD;
             weeks prior to the study&#xD;
&#xD;
          -  Affiliates or entitled to a social security scheme&#xD;
&#xD;
          -  Have given their informed consent before participating in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intelligence Quotient below 70 (score PM38)&#xD;
&#xD;
          -  History of head trauma, neurological disease or not stabilized serious physical&#xD;
             illness&#xD;
&#xD;
          -  Disorders related to the use of a psychoactive substance, as defined by the DSM-IV&#xD;
             (abuse, dependence or withdrawal) within 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine MASSOUBRE, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Saint-Etienne</name>
      <address>
        <city>St Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Postural</keyword>
  <keyword>Cognitive</keyword>
  <keyword>task</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</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/NCT03280810
org study id: 1708158
nct id: NCT03280810
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Beside these well-known symptoms (positive symptoms (such as delirium and delusions),
      negative symptoms (such as affective flattening and impoverishment of speech), disorganized
      behavior, patients with schizophrenia show different kinds of cognitive alterations and motor
      abnormalities. In schizophrenia, postural impairment could increase the attentional cost of
      daily motor tasks, leading to a lack of attentional resources, essential to achieve complex
      cognitive tasks. The intrication of cognitive and postural processings (both impaired in
      schizophrenia) can be explored by using of a dual-task paradigm.
This study assesses a psycho-corporal training (8 weeks psycho-corporal training) benefits on
      both postural (increased automation of balance control) and cognitive processings (smaller
      impact of the dual-task condition on attentional performances) in population of patients
      suffering from schizophrenia.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: the losses of postural and attentional control
time frame: At 8 weeks
description: To analyze the losses of postural and attentional control under dual-task condition.
Losses of postural and attentional control are calculated by one composite score named mu (Baddeley, Della Sala, Papagno, & Spinnler, 1997).
measure: cognitive decrement
time frame: At 8 weeks
description: To compare mean values of the cognitive decrement between baseline and 8 weeks in which the Redundancy value of the responses sequence to the random number generation task were analyzed using RgCalc® software (Towse & Neil, 1998).
measure: postural decrement
time frame: At 8 weeks
description: To compare mean values of the postural decrement between baseline and 8 weeks in which the confidence Ellipse is used as main criteria to evaluate the participants balance ability postural sway platform (WIN-POSTURO Médicapteurs®).
arm group label: Movement group
arm group type: Experimental
description: patients with schizophrenia (experimental group) have psycho-corporal training once a week, during 1 hour and a half for a period of two months
arm group label: Control group
arm group type: No Intervention
description: No intervervention : patients with schizophrenia (comparator group) who don't have psycho-corporal training
intervention type: Other
intervention name: Movement group
description: Experimental group : patients with schizophrenia who realise psycho-corporal training once a week, during 1 hour and a half for a period of two months
arm group label: Movement group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Catherine MASSOUBRE, PhD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: No