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/NCT05998265</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00150-45</org_study_id>
      <nct_id>NCT05998265</nct_id>
    </id_info>
    <brief_title>A Randomised, Controlled, Open-Label, Multi-Centre Study to Evaluate the Efficacy of FeetMe® Home-Bases Rehabilitation Program in Comparison to Conventional Physiotherapy in Patients With Parkinson's Disease Using Connected Insoles</brief_title>
    <acronym>Re-Connect</acronym>
    <official_title>A Randomised, Controlled, Open-Label, Multi-Centre Study to Evaluate the Efficacy of FeetMe® Home-Bases Rehabilitation Program in Comparison to Conventional Physiotherapy in Patients With Parkinson's Disease Using Connected Insoles</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>FeetMe</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University Hospital, Lille</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>FeetMe</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare home based rehalitation program with real time&#xD;
        biofeeback versus conventional physiotherapy on the gait velocity in Parkinson disease. The&#xD;
        main question[s] it aims to answer are:&#xD;
  &#xD;
        • How do the interventions afftect the gait velocity of the participants at week 12 ?&#xD;
        Participants will be randomized to either follow prescribtional physiotherapy or FeetMe&#xD;
        rehabilitation programs during the first 12 weeks.&#xD;
  &#xD;
        At the end of 12 weeks, participants will choose in which arm they want to pursue for 12&#xD;
        aditionnal weeks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gait velocity</measure>
      <time_frame>Week 12</time_frame>
      <description>Change from baseline to Week 12 (Visit 3) in gait velocity (cm/s) assessed during the 6 Minutes Walk-Test (6MWT).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Stance time variability</measure>
      <time_frame>Week 12</time_frame>
      <description>Change from baseline to Week 12 (Visit 3) in Stance Time Variability assessed during the 6MWT.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Parkinson Disease</condition>
    <condition>Gait Disorders, Neurologic</condition>
    <arm_group>
      <arm_group_label>FeetMe Rehabilitation arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional physiotherapy arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>FeetMe rehabilitation</intervention_name>
      <description>Home based rehabilitation program with real time biofeedback using a connected device</description>
      <arm_group_label>FeetMe Rehabilitation arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physiotherapy</intervention_name>
      <description>Conventional physiotherapy as prescribed by the neurologists</description>
      <arm_group_label>Conventional physiotherapy arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Written informed consent to participate in the study.&#xD;
  &#xD;
            -  Male or female patients between 40 to 70 years of age, inclusive.&#xD;
  &#xD;
            -  Body weight range of 40 kg to120 kg and a body mass index (BMI) of 18 to 34 kg/m2.&#xD;
  &#xD;
            -  Diagnosis of Idiopathic Parkinson's disease (PD) according to UK Brain Bank Criteria&#xD;
               (2/3 symptoms), with Hoehn and Yahr (H&amp;Y) staging level 2, 2.5 or 3.&#xD;
  &#xD;
            -  Disease onset of at least 3 years prior to enrolment.&#xD;
  &#xD;
            -  Patients with a history of 50% of levodopa responsiveness based on motor signs.&#xD;
  &#xD;
            -  On stable treatment of PD medication for at least 30 days before screening and with no&#xD;
               expected major changes during the first 3 months of the study.&#xD;
  &#xD;
            -  Prescription for physiotherapy available.&#xD;
  &#xD;
            -  Ability to walk without aid for at least 6 minutes.&#xD;
  &#xD;
            -  Shoe size between 35 - 46 (European Standard).&#xD;
  &#xD;
            -  Intact skin on feet.&#xD;
  &#xD;
            -  Adequate visual and auditory acuity to perform the rehabilitation program and the&#xD;
               assessments in the Investigator's judgement.&#xD;
  &#xD;
            -  Comfortable with the use of a smartphone. If assistance is required for the use of&#xD;
               FeetMe technology, a caregiver or volunteer is fully available to assist the patient.&#xD;
  &#xD;
            -  Willingness to be regularly contacted via phone-calls.&#xD;
  &#xD;
            -  Willingness to suspend conventional physiotherapy treatment and start the FeetMe&#xD;
               rehabilitation program, if applicable.&#xD;
  &#xD;
            -  French speaker.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Medical history indicating a Parkinsonian syndrome other than idiopathic PD.&#xD;
  &#xD;
            -  Unable to walk without walking aid or presence of an injury preventing the patient to&#xD;
               walk.&#xD;
  &#xD;
            -  Any relevant comorbidity or vestibular/visual dysfunctions limiting locomotion or&#xD;
               balance.&#xD;
  &#xD;
            -  Clinically significant comorbidities which in the judgement of the investigator may&#xD;
               preclude the reliable gait assessment of the patient.&#xD;
  &#xD;
            -  Patients with poor wound healing or broken skin on the feet.&#xD;
  &#xD;
            -  Patients with foot implants.&#xD;
  &#xD;
            -  Montreal Cognitive Assessment (MoCA) score ≤ 24/30.&#xD;
  &#xD;
            -  Patients with dementia.&#xD;
  &#xD;
            -  Patients with apathy.&#xD;
  &#xD;
            -  Participation in another clinical trial with an investigational drug/ therapeutic&#xD;
               within the three months before screening and during the study, unless agreed by the&#xD;
               Sponsor.&#xD;
  &#xD;
            -  Patients who had Lee Silverman Voice Treatment (LSVT) Big therapy within the past 12&#xD;
               months or have it planned during the course of the study.&#xD;
  &#xD;
            -  Patients with Deep Brain Stimulation planned during the first 12 weeks of the study.&#xD;
  &#xD;
            -  Patients with pacemakers.&#xD;
  &#xD;
            -  Patients performing vigorous exercise &gt; three times a week, 30 mins or more per&#xD;
               session.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Caroline Moreau, MD, PhD</last_name>
      <phone>0320446752</phone>
      <email>caroline.moreau@chru-lille.fr</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 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 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Rehabilitation</keyword>
    <keyword>Remote monitoring</keyword>
    <keyword>Physical therapy</keyword>
    <keyword>Connected insoles</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Nervous System Diseases</mesh_term>
      <mesh_term>Gait Disorders, Neurologic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>May 9, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT05998265/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>February 27, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT05998265/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05998265
  org study id: 2023-A00150-45
  nct id: NCT05998265
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The goal of this clinical trial is to compare home based rehalitation program with real time
        biofeeback versus conventional physiotherapy on the gait velocity in Parkinson disease. The
        main question[s] it aims to answer are:
  
        • How do the interventions afftect the gait velocity of the participants at week 12 ?
        Participants will be randomized to either follow prescribtional physiotherapy or FeetMe
        rehabilitation programs during the first 12 weeks.
  
        At the end of 12 weeks, participants will choose in which arm they want to pursue for 12
        aditionnal weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Gait velocity
  time frame: Week 12
  description: Change from baseline to Week 12 (Visit 3) in gait velocity (cm/s) assessed during the 6 Minutes Walk-Test (6MWT).
  measure: Stance time variability
  time frame: Week 12
  description: Change from baseline to Week 12 (Visit 3) in Stance Time Variability assessed during the 6MWT.
  arm group label: FeetMe Rehabilitation arm
  arm group type: Experimental
  arm group label: Conventional physiotherapy arm
  arm group type: Active Comparator
  intervention type: Device
  intervention name: FeetMe rehabilitation
  description: Home based rehabilitation program with real time biofeedback using a connected device
  arm group label: FeetMe Rehabilitation arm
  intervention type: Other
  intervention name: Physiotherapy
  description: Conventional physiotherapy as prescribed by the neurologists
  arm group label: Conventional physiotherapy arm
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Caroline Moreau, MD, PhD
  phone: 0320446752
  email: caroline.moreau@chru-lille.fr
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  mesh term: Nervous System Diseases
  mesh term: Gait Disorders, Neurologic
  sharing ipd: No
  provided document: 
  provided document: 