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/NCT05982119</url>
    </required_header>
    <id_info>
      <org_study_id>ActiLiege Next</org_study_id>
      <nct_id>NCT05982119</nct_id>
    </id_info>
    <brief_title>Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study</brief_title>
    <official_title>Gait Analysis Parameter, Stair Climbing and Upper Limb Evaluation in Patients With Muscular Pathology and in Control Subjects: The ActiLiège Next Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Laurent Servais</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sysnav</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre Hospitalier Régional de la Citadelle</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of ActiLiège Next Study is to collect natural history data in Duchenne muscular&#xD;
        dystrophy (DMD) (ambulatory and non-ambulatory patients), and in affected patients with&#xD;
        Facio-Scapulo-Humeral dystrophy (FSHD), a disease in which results are currently lacking. It&#xD;
        consists of obtaining longitudinal data for the patients, as well as normative data for the&#xD;
        control subjects, with a particular emphasis on pediatric subjects using the device on both&#xD;
        ankles (for walking) in order to qualify the ascent rate of staircase.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2020</start_date>
    <completion_date type="Anticipated">March 2026</completion_date>
    <primary_completion_date type="Anticipated">March 2026</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Stride velocity</measure>
      <time_frame>through study completion (3 year)</time_frame>
      <description>Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stride length</measure>
      <time_frame>through study completion (3 year)</time_frame>
      <description>Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stairs number</measure>
      <time_frame>through study completion (3 year)</time_frame>
      <description>Total number of strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stairs speed</measure>
      <time_frame>through study completion (3 year)</time_frame>
      <description>Vertical speed during strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stairs height</measure>
      <time_frame>through study completion (3 year)</time_frame>
      <description>Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">130</enrollment>
    <condition>Duchenne Muscular Dystrophy</condition>
    <condition>Fascioscapulohumeral Muscular Dystrophy</condition>
    <arm_group>
      <arm_group_label>Patients with DMD/FSHD or control subjects</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients and control subjects will be included over a one-year study period. Patients will be examined by a neuropaediatrician or neurologist and perform standardized assessments (timed tests, motor function tests, and strength tests) at baseline, 6 and 12 months. Patients will be asked to wear the device during one year.&#xD;
  Control subjects will be examined by a physician and perform the same tests than those for ambulant patients at baseline and 12 months. Control subjects will be asked to wear the device for two months (one month at inclusion, one month 11 months after inclusion).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ActiMyo</intervention_name>
      <description>The two &quot;watches&quot; can be worn as wristwatch or placed near the ankle and on the wheelchair. Patients will wear the ActiMyo° during one year in order to collect natural history data in DMD and FSHD. Control subjects will wear the ActiMyo° during one month after inclusion and during one other month 11 months after inclusion.</description>
      <arm_group_label>Patients with DMD/FSHD or control subjects</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Genetically confirmed diagnosis of DMD or FSHD.&#xD;
  &#xD;
            -  Between 5 and 20 years of age for patients with DMD, or between 5 and 80 years of age&#xD;
               for patients with FSHD.&#xD;
  &#xD;
            -  Ambulant (as defined by having the ability to walk without assistance for 10 meters)&#xD;
               or non-ambulant DMD patients.&#xD;
  &#xD;
            -  Ambulant FSHD patients&#xD;
  &#xD;
            -  Non-ambulant DMD patients must be able to remain seated in an arm- or a wheel-chair&#xD;
               for at least one hour.&#xD;
  &#xD;
            -  Signed informed consent form by patient himself or, in case of minor patients, signed&#xD;
               informed consent form by patient's parents or legal guardians.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with extreme cognitive disorders that limit their understanding of the&#xD;
               exercises to be performed.&#xD;
  &#xD;
            -  Patients treated with corticosteroids for less than 6 months.&#xD;
  &#xD;
            -  Patients who have undergone a surgical procedure or who have experienced recent trauma&#xD;
               (within fewer than 6 months) affecting the upper or lower limbs (for ambulant&#xD;
               patients).&#xD;
  &#xD;
            -  A concomitant chronic or acute neurological, endocrine, infectious, allergic, or&#xD;
               inflammatory pathology within the 3-week period immediately prior to inclusion.&#xD;
  &#xD;
            -  Patients who are participating in an interventional clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Manon Duclos</last_name>
      <phone>003243215586</phone>
      <email>manon.duclos@chrcitadelle.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Charline Dubois</last_name>
      <phone>003243215695</phone>
      <email>charline.dubois@chrcitadelle.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHR de la Citadelle</name>
        <address>
          <city>Liège</city>
          <zip>4000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Manon Duclos</last_name>
        <phone>003243215586</phone>
        <email>manon.duclos@chrcitadelle.be</email>
      </contact>
      <contact_backup>
        <last_name>Charline Dubois</last_name>
        <phone>003243215695</phone>
        <email>charline.dubois@chrcitadelle.be</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2021</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Centre Hospitalier Régional de la Citadelle</investigator_affiliation>
      <investigator_full_name>Laurent Servais</investigator_full_name>
      <investigator_title>Professor Laurent Servais</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscular Dystrophies</mesh_term>
      <mesh_term>Muscular Dystrophy, Duchenne</mesh_term>
      <mesh_term>Muscular Dystrophy, Facioscapulohumeral</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/NCT05982119
  org study id: ActiLiege Next
  nct id: NCT05982119
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective of ActiLiège Next Study is to collect natural history data in Duchenne muscular
        dystrophy (DMD) (ambulatory and non-ambulatory patients), and in affected patients with
        Facio-Scapulo-Humeral dystrophy (FSHD), a disease in which results are currently lacking. It
        consists of obtaining longitudinal data for the patients, as well as normative data for the
        control subjects, with a particular emphasis on pediatric subjects using the device on both
        ankles (for walking) in order to qualify the ascent rate of staircase.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Stride velocity
  time frame: through study completion (3 year)
  description: Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
  measure: Stride length
  time frame: through study completion (3 year)
  description: Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
  measure: Stairs number
  time frame: through study completion (3 year)
  description: Total number of strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
  measure: Stairs speed
  time frame: through study completion (3 year)
  description: Vertical speed during strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
  measure: Stairs height
  time frame: through study completion (3 year)
  description: Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
  arm group label: Patients with DMD/FSHD or control subjects
  arm group type: Other
  description: Patients and control subjects will be included over a one-year study period. Patients will be examined by a neuropaediatrician or neurologist and perform standardized assessments (timed tests, motor function tests, and strength tests) at baseline, 6 and 12 months. Patients will be asked to wear the device during one year.
  Control subjects will be examined by a physician and perform the same tests than those for ambulant patients at baseline and 12 months. Control subjects will be asked to wear the device for two months (one month at inclusion, one month 11 months after inclusion).
  intervention type: Device
  intervention name: ActiMyo
  description: The two "watches" can be worn as wristwatch or placed near the ankle and on the wheelchair. Patients will wear the ActiMyo° during one year in order to collect natural history data in DMD and FSHD. Control subjects will wear the ActiMyo° during one month after inclusion and during one other month 11 months after inclusion.
  arm group label: Patients with DMD/FSHD or control subjects
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Manon Duclos
  phone: 003243215586
  email: manon.duclos@chrcitadelle.be
  last name: Charline Dubois
  phone: 003243215695
  email: charline.dubois@chrcitadelle.be
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Belgium
  responsible party type: Sponsor-Investigator
  investigator affiliation: Centre Hospitalier Régional de la Citadelle
  investigator full name: Laurent Servais
  investigator title: Professor Laurent Servais
  mesh term: Muscular Dystrophies
  mesh term: Muscular Dystrophy, Duchenne
  mesh term: Muscular Dystrophy, Facioscapulohumeral
  sharing ipd: No