<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/NCT03025126</url>
  </required_header>
  <id_info>
    <org_study_id>FdG_HEAD_01</org_study_id>
    <nct_id>NCT03025126</nct_id>
  </id_info>
  <brief_title>Human Empowerment Aging and Disability (HEAD): New Technologies for Neurorehabilitation</brief_title>
  <acronym>HEAD</acronym>
  <official_title>Human Empowerment Aging and Disability (HEAD): New Technologies for Neurorehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Don Carlo Gnocchi Onlus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro Riabilitativo Villa Beretta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondazione Opera S Camillo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione Don Carlo Gnocchi Onlus</source>
  <brief_summary>
    <textblock>
      Congenital or acquired neurological disorders could lead to consistent motor and cognitive&#xD;
      disabilities. The continuity and persistency of a tailored home rehabilitation protocol after&#xD;
      recovery is crucial to prevent disease aggravation or relapses. The integration of a&#xD;
      web-based new technology in home rehabilitation programme can constitute a functional low&#xD;
      cost resource by offering patients off-line (and on-line) monitoring and by proposing new&#xD;
      motivating ways of rehabilitation through high tech tools such as serious games.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health-related quality of life assessed on the short-form 12-item Health Survey (SF-12) questionnaire</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Endurance assessed on two-minute walking test (2MWT)</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and negative affective state assessed on Positive and Negative Affect Scale (PANAS)</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Static balance and fall risk assessed on Berg Balance Scale (BBS)</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Finger dexterity assessed on 9-Hole Peg Test (9HPT)</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking speed assessed on 10-Meter Walking Test (10MWT)</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength in upper and lower extremities assessed on Motricity Index (MI)</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention and concentration assessed on Attention and Concentration test</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory abilities assessed on Rivermead Behavioural Memory Test - 3 (RBMT3)</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire</measure>
    <time_frame>change from baseline after 4 months and after 7 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Rehabilitation</condition>
  <condition>Technology</condition>
  <condition>Telerehabilitation</condition>
  <condition>Nervous System Diseases</condition>
  <arm_group>
    <arm_group_label>HEAD Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rehabilitation with IT multimedial devices</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>usual care program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multimedial Rehabilitation</intervention_name>
    <arm_group_label>HEAD Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care program</intervention_name>
    <description>Usual care at home program according to healthcare professional's advice</description>
    <arm_group_label>Usual care program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age range 18-85&#xD;
&#xD;
          -  Parkinson Disease (PD - mild to moderate) in stable treatment for at least 3 months&#xD;
&#xD;
          -  Multiple Sclerosis (MS) without relapses in the last 3 months (EDSS ≤ 6)&#xD;
&#xD;
          -  post stroke ( ≥ 6 months after the acute event)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mini Mental State Examination &lt; 20&#xD;
&#xD;
          -  limited range of motion&#xD;
&#xD;
          -  severe pain&#xD;
&#xD;
          -  severe deficit of visual acuity or auditory perception or communication and severe&#xD;
             dysmetry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franco Molteni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Valduce Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ospedale Valduce</name>
      <address>
        <city>Lecco</city>
        <state>LC</state>
        <zip>23845</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidio Sanitario S Camillo</name>
      <address>
        <city>Torino</city>
        <state>TO</state>
        <zip>10131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Don Carlo Gnocchi ONLUS</name>
      <address>
        <city>Milano</city>
        <zip>20148</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>February 16, 2018</last_update_submitted>
  <last_update_submitted_qc>February 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2018</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>Nervous System Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03025126
org study id: FdG_HEAD_01
nct id: NCT03025126
lead sponsor: 
collaborator: 
collaborator: 
Congenital or acquired neurological disorders could lead to consistent motor and cognitive
      disabilities. The continuity and persistency of a tailored home rehabilitation protocol after
      recovery is crucial to prevent disease aggravation or relapses. The integration of a
      web-based new technology in home rehabilitation programme can constitute a functional low
      cost resource by offering patients off-line (and on-line) monitoring and by proposing new
      motivating ways of rehabilitation through high tech tools such as serious games.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Health-related quality of life assessed on the short-form 12-item Health Survey (SF-12) questionnaire
time frame: change from baseline after 4 months and after 7 months
measure: Global cognitive state assessed on MONTREAL COGNITIVE ASSESSMENT (MOCA)
time frame: change from baseline after 4 months and after 7 months
measure: Endurance assessed on two-minute walking test (2MWT)
time frame: change from baseline after 4 months and after 7 months
measure: Positive and negative affective state assessed on Positive and Negative Affect Scale (PANAS)
time frame: change from baseline after 4 months and after 7 months
measure: Static balance and fall risk assessed on Berg Balance Scale (BBS)
time frame: change from baseline after 4 months and after 7 months
measure: Finger dexterity assessed on 9-Hole Peg Test (9HPT)
time frame: change from baseline after 4 months and after 7 months
measure: Unilateral gross manual dexterity assessed on Box and Blocks Test (BBT)
time frame: change from baseline after 4 months and after 7 months
measure: Walking speed assessed on 10-Meter Walking Test (10MWT)
time frame: change from baseline after 4 months and after 7 months
measure: Strength in upper and lower extremities assessed on Motricity Index (MI)
time frame: change from baseline after 4 months and after 7 months
measure: Attention and concentration assessed on Attention and Concentration test
time frame: change from baseline after 4 months and after 7 months
measure: Memory abilities assessed on Rivermead Behavioural Memory Test - 3 (RBMT3)
time frame: change from baseline after 4 months and after 7 months
measure: Caregiver Need assessed on Caregiver Need Assessment (CNA) questionnaire
time frame: change from baseline after 4 months and after 7 months
arm group label: HEAD Rehabilitation
arm group type: Experimental
description: rehabilitation with IT multimedial devices
arm group label: Usual care program
arm group type: Active Comparator
description: usual care program
intervention type: Other
intervention name: Multimedial Rehabilitation
arm group label: HEAD Rehabilitation
intervention type: Other
intervention name: Usual care program
description: Usual care at home program according to healthcare professional's advice
arm group label: Usual care program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Franco Molteni, MD
role: Principal Investigator
affiliation: Valduce Hospital
facility: 
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Nervous System Diseases