xml: <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/NCT05998473</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A01762-43</org_study_id>
      <nct_id>NCT05998473</nct_id>
    </id_info>
    <brief_title>Characterization of Dynamic Stability in Normal Pressure Hydrocephalus and Parkinson's Disease</brief_title>
    <acronym>HPGAIT</acronym>
    <official_title>Characterization of Dynamic Stability in Normal Pressure Hydrocephalus and Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Henri Mondor University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Henri Mondor University Hospital</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>
        This study aims to characterize dynamic stability disorders in two conditions mainly&#xD;
        affecting the elderly and with similar walking deficits: hydrocephalus at normal pressure and&#xD;
        Parkinson's disease, to provide the most relevant monitoring criteria in usual care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Walking disorders in normal pressure hydrocephalus are manifested by slowing and ataxic gait,&#xD;
        similar to disorders in Parkinson's disease. No studies in the literature have focused on&#xD;
        advanced measures of dynamic stability in hydrocephalus at normal pressure, compared to&#xD;
        Parkinson's disease, on large samples. The Laboratory of Analysis and Restoration of&#xD;
        Movement, located in a Neurorehabilitation Department, provides quantitative data on gait and&#xD;
        in particular dynamic stability as part of additional assessments to help patients follow up.&#xD;
        Since 2010, people with normal pressure hydrocephalus or Parkinson's disease regularly&#xD;
        benefit from these assessments. Retrospective analysis of all these data would help to better&#xD;
        characterize motor disorders in hydrocephalus at normal pressure, by discriminating them from&#xD;
        those associated with Parkinson's disease. It would lead to the definition of relevant&#xD;
        indices to be used for patient follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Coefficient of variation in step length</measure>
      <time_frame>30 seconds</time_frame>
      <description>Coefficient of variation in step length during 8-meter comfortable walking test</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Hydrocephalus</condition>
    <condition>Parkinson Disease</condition>
    <condition>Walking, Difficulty</condition>
    <condition>Movement Disorders</condition>
    <condition>Gait Ataxia</condition>
    <condition>Diagnoses Disease</condition>
    <arm_group>
      <arm_group_label>Normal pressure hydrocephalus</arm_group_label>
      <description>Patients with a diagnosis of normal pressure hydrocephalus and who performed a gait analysis in laboratories</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Parkinson's disease</arm_group_label>
      <description>Patients with a diagnosis of Parkinson's disease and who performed a gait analysis in laboratories</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Dynamic stability measurement</intervention_name>
      <description>The subject is asked to walk 8 meters 3 times: at free speed, at fast speed, and with large steps.</description>
      <arm_group_label>Normal pressure hydrocephalus</arm_group_label>
      <arm_group_label>Parkinson's disease</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with normal pressure hydrocephalus or Parkinson's disease.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;18 years&#xD;
  &#xD;
            -  Patient who performed a walking test in the Laboratory Analysis and Restoration of&#xD;
               Movement&#xD;
  &#xD;
            -  Diagnosis of normal pressure hydrocephalus or Parkinson's disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Levodopa drugs administrated during a delay of 12 hours before walking test&#xD;
  &#xD;
            -  Presence of an other neurologic disease or of any disease associated with motor&#xD;
               disorders in lower limb.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Emilie Hutin</last_name>
      <role>Principal Investigator</role>
      <affiliation>Henri Mondor University Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Laboratoire Analyse et Restauration du Mouvement</name>
        <address>
          <city>Créteil</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Henri Mondor University Hospital</investigator_affiliation>
      <investigator_full_name>Emilie Hutin</investigator_full_name>
      <investigator_title>Co-director of laboratory</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Movement Disorders</mesh_term>
      <mesh_term>Hydrocephalus</mesh_term>
      <mesh_term>Hydrocephalus, Normal Pressure</mesh_term>
      <mesh_term>Gait Ataxia</mesh_term>
      <mesh_term>Mobility Limitation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05998473
  org study id: 2023-A01762-43
  nct id: NCT05998473
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to characterize dynamic stability disorders in two conditions mainly
        affecting the elderly and with similar walking deficits: hydrocephalus at normal pressure and
        Parkinson's disease, to provide the most relevant monitoring criteria in usual care.
  Walking disorders in normal pressure hydrocephalus are manifested by slowing and ataxic gait,
        similar to disorders in Parkinson's disease. No studies in the literature have focused on
        advanced measures of dynamic stability in hydrocephalus at normal pressure, compared to
        Parkinson's disease, on large samples. The Laboratory of Analysis and Restoration of
        Movement, located in a Neurorehabilitation Department, provides quantitative data on gait and
        in particular dynamic stability as part of additional assessments to help patients follow up.
        Since 2010, people with normal pressure hydrocephalus or Parkinson's disease regularly
        benefit from these assessments. Retrospective analysis of all these data would help to better
        characterize motor disorders in hydrocephalus at normal pressure, by discriminating them from
        those associated with Parkinson's disease. It would lead to the definition of relevant
        indices to be used for patient follow-up.
  observational model: Cohort
  time perspective: Retrospective
  measure: Coefficient of variation in step length
  time frame: 30 seconds
  description: Coefficient of variation in step length during 8-meter comfortable walking test
  arm group label: Normal pressure hydrocephalus
  description: Patients with a diagnosis of normal pressure hydrocephalus and who performed a gait analysis in laboratories
  arm group label: Parkinson's disease
  description: Patients with a diagnosis of Parkinson's disease and who performed a gait analysis in laboratories
  intervention type: Diagnostic Test
  intervention name: Dynamic stability measurement
  description: The subject is asked to walk 8 meters 3 times: at free speed, at fast speed, and with large steps.
  arm group label: Normal pressure hydrocephalus
  arm group label: Parkinson's disease
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Emilie Hutin
  role: Principal Investigator
  affiliation: Henri Mondor University Hospital
  facility: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: Henri Mondor University Hospital
  investigator full name: Emilie Hutin
  investigator title: Co-director of laboratory
  mesh term: Parkinson Disease
  mesh term: Movement Disorders
  mesh term: Hydrocephalus
  mesh term: Hydrocephalus, Normal Pressure
  mesh term: Gait Ataxia
  mesh term: Mobility Limitation
  sharing ipd: No