<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/NCT04495998</url>
  </required_header>
  <id_info>
    <org_study_id>32/2017</org_study_id>
    <nct_id>NCT04495998</nct_id>
  </id_info>
  <brief_title>The Motor Neurological Soft Signs (MNSS) in Persons With Schizophrenia</brief_title>
  <acronym>MNSS</acronym>
  <official_title>The Motor Neurological Soft Signs (MNSS) in Persons With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculdade de Motricidade Humana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculdade de Motricidade Humana</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim is to contribute to the knowledge of the relationship between Motor Neurological Soft&#xD;
      Signs (MNSS) and schizophrenia, as well as to point out the implications and recommendations&#xD;
      for clinical and rehabilitative practices, in order to contribute to the identification of&#xD;
      these signs as potential facilitators of prevention and a better follow-up in the&#xD;
      psychosocial rehabilitation processes of the person with schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim is to contribute to the knowledge of the relationship between Motor Neurological Soft&#xD;
      Signs (MNSS) and schizophrenia, as well as to point out the implications and recommendations&#xD;
      for clinical and rehabilitative practices, in order to contribute to the identification of&#xD;
      these signs as potential facilitators of prevention and a better follow-up in the&#xD;
      psychosocial rehabilitation processes of the person with schizophrenia.&#xD;
&#xD;
      It is therefore important to answer the following starting questions:&#xD;
&#xD;
        -  How can MNSS be assessed and analysed in the Portuguese population with schizophrenia?&#xD;
&#xD;
        -  How does the manifestation of MNSS differ between people with and without schizophrenia?&#xD;
&#xD;
        -  Do the MNSS of people with schizophrenia vary according to their functionality level&#xD;
           including the following areas of activity (Cognition, Mobility, Self-Care, Interpersonal&#xD;
           Relations, Daily Activities and Participation) and their motor experiences?&#xD;
&#xD;
        -  How can the information obtained by applying a validated assessment tool for this&#xD;
           purpose be made operational as a procedure for psychomotor assessment and intervention&#xD;
           with this population?&#xD;
&#xD;
      The following objectives have been defined to answer these questions, which guide the work:&#xD;
&#xD;
        1. Translate, adapt and validate the BMS instrument (Jahn et al., 2006) for the Portuguese&#xD;
           population with schizophrenia;&#xD;
&#xD;
        2. Explore the relationship of MNSS with demographic variables (e.g.: age, gender,&#xD;
           education), clinical-therapeutic variables (e.g.: age of diagnosis, number of&#xD;
           hospitalizations, medication, type of support) and psychosocial variables (e.g.:&#xD;
           functionality, satisfaction and well-being, motor experiences);&#xD;
&#xD;
        3. Test a multifactorial model of the relationships between MNSS, demographic variables,&#xD;
           functional clinical-therapeutic and psychosocial;&#xD;
&#xD;
        4. Compare MNSS in people with schizophrenia and people from a healthy control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">December 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of persons with schizophrenia with Brief Motor Scale - Portuguese version (BMS_pt) instrument</measure>
    <time_frame>6 weeks</time_frame>
    <description>The aim of this study was to translate, adapt and validate a Portuguese version of the Brief Motor Scale (BMS_pt) in people with schizophrenia (Jahn et al, 2006).&#xD;
The participants (N=43) were evaluated twice with an interval of two weeks. In total, the sample collection lasted 6 weeks.&#xD;
Scale used and caracteristics:&#xD;
Unabbreviate title - Brief Motor Scale - Portuguese version Abbreviate title - BMS_pt Minimum value = 0; Maximum value = 2 Higher scores mean a worse outcome.&#xD;
Scale description:&#xD;
BMS_pt is a quantative test, which assessed motor neurological soft signs (MNSS) in two domains: motor coordination and motor sequencing. BMS_pt have a range score between 0 and 2 points for each item, domains and total score.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Psychomotor Status</condition>
  <condition>Schizophrenia</condition>
  <condition>Motor Skills Disorders</condition>
  <arm_group>
    <arm_group_label>Motor Neurological Soft Signs</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>motor test and an interview for the participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Brief Motor Scale_portuguese version (BMS_pt)</intervention_name>
    <description>translate, adapt and validate Brief Motor Scale for portuguese population with schizophrenia</description>
    <arm_group_label>Motor Neurological Soft Signs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a schizophrenia diagnoses&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a motor disability&#xD;
&#xD;
          -  Drugs consumer&#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>Susana Guimarães, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculdade Motricidade Humana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Susana Guimarães</name>
      <address>
        <city>Lisbon</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <link>
    <url>https://www.revistapsiquiatria.pt/index.php/sppsm/article/view/160</url>
    <description>Validity and Reliability of the Portuguese Version of Brief Motor Scale in Persons with Schizophrenia: A Preliminary Study</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>May 31, 2023</last_update_submitted>
  <last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Faculdade de Motricidade Humana</investigator_affiliation>
    <investigator_full_name>Susana Guimarães, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Motor Skills Disorders</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/NCT04495998
org study id: 32/2017
nct id: NCT04495998
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim is to contribute to the knowledge of the relationship between Motor Neurological Soft
      Signs (MNSS) and schizophrenia, as well as to point out the implications and recommendations
      for clinical and rehabilitative practices, in order to contribute to the identification of
      these signs as potential facilitators of prevention and a better follow-up in the
      psychosocial rehabilitation processes of the person with schizophrenia.
The aim is to contribute to the knowledge of the relationship between Motor Neurological Soft
      Signs (MNSS) and schizophrenia, as well as to point out the implications and recommendations
      for clinical and rehabilitative practices, in order to contribute to the identification of
      these signs as potential facilitators of prevention and a better follow-up in the
      psychosocial rehabilitation processes of the person with schizophrenia.

      It is therefore important to answer the following starting questions:

        -  How can MNSS be assessed and analysed in the Portuguese population with schizophrenia?

        -  How does the manifestation of MNSS differ between people with and without schizophrenia?

        -  Do the MNSS of people with schizophrenia vary according to their functionality level
           including the following areas of activity (Cognition, Mobility, Self-Care, Interpersonal
           Relations, Daily Activities and Participation) and their motor experiences?

        -  How can the information obtained by applying a validated assessment tool for this
           purpose be made operational as a procedure for psychomotor assessment and intervention
           with this population?

      The following objectives have been defined to answer these questions, which guide the work:

        1. Translate, adapt and validate the BMS instrument (Jahn et al., 2006) for the Portuguese
           population with schizophrenia;

        2. Explore the relationship of MNSS with demographic variables (e.g.: age, gender,
           education), clinical-therapeutic variables (e.g.: age of diagnosis, number of
           hospitalizations, medication, type of support) and psychosocial variables (e.g.:
           functionality, satisfaction and well-being, motor experiences);

        3. Test a multifactorial model of the relationships between MNSS, demographic variables,
           functional clinical-therapeutic and psychosocial;

        4. Compare MNSS in people with schizophrenia and people from a healthy control group.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Assessment of persons with schizophrenia with Brief Motor Scale - Portuguese version (BMS_pt) instrument
time frame: 6 weeks
description: The aim of this study was to translate, adapt and validate a Portuguese version of the Brief Motor Scale (BMS_pt) in people with schizophrenia (Jahn et al, 2006).
The participants (N=43) were evaluated twice with an interval of two weeks. In total, the sample collection lasted 6 weeks.
Scale used and caracteristics:
Unabbreviate title - Brief Motor Scale - Portuguese version Abbreviate title - BMS_pt Minimum value = 0; Maximum value = 2 Higher scores mean a worse outcome.
Scale description:
BMS_pt is a quantative test, which assessed motor neurological soft signs (MNSS) in two domains: motor coordination and motor sequencing. BMS_pt have a range score between 0 and 2 points for each item, domains and total score.
arm group label: Motor Neurological Soft Signs
arm group type: Other
description: motor test and an interview for the participants
intervention type: Diagnostic Test
intervention name: Brief Motor Scale_portuguese version (BMS_pt)
description: translate, adapt and validate Brief Motor Scale for portuguese population with schizophrenia
arm group label: Motor Neurological Soft Signs
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susana Guimarães, MD
role: Principal Investigator
affiliation: Faculdade Motricidade Humana
facility: 
country: Portugal
url: https://www.revistapsiquiatria.pt/index.php/sppsm/article/view/160
description: Validity and Reliability of the Portuguese Version of Brief Motor Scale in Persons with Schizophrenia: A Preliminary Study
responsible party type: Principal Investigator
investigator affiliation: Faculdade de Motricidade Humana
investigator full name: Susana Guimarães, MD
investigator title: Principal Investigator
mesh term: Schizophrenia
mesh term: Motor Skills Disorders
sharing ipd: No