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/NCT06032468</url>
    </required_header>
    <id_info>
      <org_study_id>5135</org_study_id>
      <nct_id>NCT06032468</nct_id>
    </id_info>
    <brief_title>ARC Intellicare for Telerehabilitation</brief_title>
    <acronym>ARCTRAN</acronym>
    <official_title>ARC Intellicare for Telerehabilitation in Neurological Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</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>
        In the last 5 years, the available literature evidence has indicated that, in terms of&#xD;
        clinical efficacy, telerehabilitation can give comparable results compared to face-to-face&#xD;
        rehabilitation. Studies of post-stroke patients have revealed some benefits of&#xD;
        telerehabilitation, such as the ability for patients to self-record pain, mood and activity.&#xD;
        Telerehabilitation has comparable efficacy to face-to-face rehabilitation for the recovery of&#xD;
        some abilities, such as motor function, Activities of Daily Living (ADL), and independence;&#xD;
        it is less effective, however, for the recovery of balance control. Published reviews&#xD;
        concerning, in particular, neurological/neurodegenerative diseases show that&#xD;
        telerehabilitation systems are effective in maintaining and/or improving some motor aspects,&#xD;
        such as balance and gait, and non-motor aspects, such as mood and quality of life; they also&#xD;
        increase patient satisfaction, so in the long term they appear to be beneficial, convenient&#xD;
        and satisfying for patients and operators.&#xD;
  &#xD;
        ARC Intellicare is a device undergoing certification as a Class I Medical Device (DM),&#xD;
        already clinically tested during two uncontrolled clinical feasibility studies: ARCANGEL&#xD;
        study (post-stroke, ClinicalTrials.gov Identifier: NCT03787433) and RICOMINCIARE study&#xD;
        (post-COVID19 and Parkinson's disease, ClinicalTrials.gov Identifier: NCT05074771).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 9, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>
      <intervention_model_description>Early feasibility study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Efficacy outcome: Six minutes walking test (6MWT)</measure>
      <time_frame>8 weeks</time_frame>
      <description>number of meters walked in brisk 6 minutes walk</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Efficacy outcome: Borg scale</measure>
      <time_frame>8 weeks</time_frame>
      <description>score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>safety outcome: adverse event frequency</measure>
      <time_frame>8 weeks</time_frame>
      <description>number of adverse events reported</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Usability outcome: adherence to prescription</measure>
      <time_frame>8 weeks</time_frame>
      <description>percent of rehabilitation sessions completed</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Parkinson Disease</condition>
    <condition>Multiple Sclerosis</condition>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>Rehabilitation with ARC Intellicare Device</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>rehabilitation exercise for 8 weeks using wearable devices</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Rehabilitation with exercise sheet</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>rehabilitation exercise for 8 weeks using rehabilitation exercise sheets</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ARC Intellicare</intervention_name>
      <description>wearable devices to guide rehabilitation exercise</description>
      <arm_group_label>Rehabilitation with ARC Intellicare Device</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rehabilitation sheets</intervention_name>
      <description>rehabilitation exercise sheets to guide rehabilitation exercise</description>
      <arm_group_label>Rehabilitation with exercise sheet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with diagnosis of Parkinson's disease with Hoehn&amp;Yahr staging 1-3&#xD;
  &#xD;
            -  diagnosis of multiple sclerosis with extended disability scale score 3.5-6&#xD;
  &#xD;
            -  diagnosis of ischemic stroke in the past 12 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  history of falls&#xD;
  &#xD;
            -  dementia&#xD;
  &#xD;
            -  epilepsy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Flavia Torlizzi</last_name>
      <phone>0630155633</phone>
      <email>flavia.torlizzi@policlinicogemelli.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>policlinico Universitario A Gemelli</name>
        <address>
          <city>Roma</city>
          <state>Rome</state>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Flavia Torlizzi</last_name>
        <phone>0630155633</phone>
        <email>flavia.torlizzi@policlinicogemelli.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>May 12, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Multiple Sclerosis</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/NCT06032468
  org study id: 5135
  nct id: NCT06032468
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In the last 5 years, the available literature evidence has indicated that, in terms of
        clinical efficacy, telerehabilitation can give comparable results compared to face-to-face
        rehabilitation. Studies of post-stroke patients have revealed some benefits of
        telerehabilitation, such as the ability for patients to self-record pain, mood and activity.
        Telerehabilitation has comparable efficacy to face-to-face rehabilitation for the recovery of
        some abilities, such as motor function, Activities of Daily Living (ADL), and independence;
        it is less effective, however, for the recovery of balance control. Published reviews
        concerning, in particular, neurological/neurodegenerative diseases show that
        telerehabilitation systems are effective in maintaining and/or improving some motor aspects,
        such as balance and gait, and non-motor aspects, such as mood and quality of life; they also
        increase patient satisfaction, so in the long term they appear to be beneficial, convenient
        and satisfying for patients and operators.
  
        ARC Intellicare is a device undergoing certification as a Class I Medical Device (DM),
        already clinically tested during two uncontrolled clinical feasibility studies: ARCANGEL
        study (post-stroke, ClinicalTrials.gov Identifier: NCT03787433) and RICOMINCIARE study
        (post-COVID19 and Parkinson's disease, ClinicalTrials.gov Identifier: NCT05074771).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Early feasibility study
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Efficacy outcome: Six minutes walking test (6MWT)
  time frame: 8 weeks
  description: number of meters walked in brisk 6 minutes walk
  measure: Efficacy outcome: Borg scale
  time frame: 8 weeks
  description: score 0-20 of perceived effort during a motor task (higher scores mean a better or worse outcome)
  measure: safety outcome: adverse event frequency
  time frame: 8 weeks
  description: number of adverse events reported
  measure: Usability outcome: adherence to prescription
  time frame: 8 weeks
  description: percent of rehabilitation sessions completed
  arm group label: Rehabilitation with ARC Intellicare Device
  arm group type: Experimental
  description: rehabilitation exercise for 8 weeks using wearable devices
  arm group label: Rehabilitation with exercise sheet
  arm group type: Active Comparator
  description: rehabilitation exercise for 8 weeks using rehabilitation exercise sheets
  intervention type: Device
  intervention name: ARC Intellicare
  description: wearable devices to guide rehabilitation exercise
  arm group label: Rehabilitation with ARC Intellicare Device
  intervention type: Other
  intervention name: Rehabilitation sheets
  description: rehabilitation exercise sheets to guide rehabilitation exercise
  arm group label: Rehabilitation with exercise sheet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Flavia Torlizzi
  phone: 0630155633
  email: flavia.torlizzi@policlinicogemelli.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  mesh term: Multiple Sclerosis
  sharing ipd: No