<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/NCT01668979</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-12-NG-0363-CTIL</org_study_id>
    <nct_id>NCT01668979</nct_id>
  </id_info>
  <brief_title>Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults</brief_title>
  <official_title>Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is aimed to assess a new system for the automatic detection, quantification and&#xD;
      treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The&#xD;
      system is comprized of a treadmill and a virtual reality simulation which provides a&#xD;
      motor-cognitive challenge to provoke NF. The challenges provided by the system are&#xD;
      individualized and using machine learning algorithms will enable the identification and&#xD;
      detection of NF under different conditions and allow for the most suitable treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">September 2013</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>usability of the system to detect Near Falls</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Near Fall severity</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Idiopathic Fallers</condition>
  <arm_group>
    <arm_group_label>new system to detect Near Falls</arm_group_label>
    <description>the new system comprises of a treadmill and a virtual reality simulation that will be used to induce Near Falls in healthy older adults with a history of falls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>new system to detect Near Falls</intervention_name>
    <description>We will invite healthy older adults with a history of falls to try the new system and assess whether the new system can induce, detect and quantify Near Fall episodes</description>
    <arm_group_label>new system to detect Near Falls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy older adults with a history of falls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy older adults with a history of falls or complaints of gait instability&#xD;
&#xD;
          2. Able to walk independently for at least 10 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Systemic chronic or acute pathologies:&#xD;
&#xD;
               1. Ischemic heart disease&#xD;
&#xD;
               2. Orthopedic or Rheumatic diseases&#xD;
&#xD;
               3. Severe vision problems&#xD;
&#xD;
               4. Neurological disease: PD, AD, CVA&#xD;
&#xD;
          2. Patients who underwent brain surgery in the last 6 months prior to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nir Giladi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel-Aviv Sourasky Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nir Giladi, MD</last_name>
    <phone>+972 3 6974958</phone>
    <email>nirg@tasmc.health.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anat Mirelman, PhD</last_name>
    <phone>+972 3 6973960</phone>
    <email>anatmi@tasmc.health.gov.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Nir Giladi, MD</last_name>
      <phone>+972 3 6974958</phone>
      <email>nirg@tasmc.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>Anat Mirelman, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel-Aviv Sourasky Medical Center</investigator_affiliation>
    <investigator_full_name>Michal Roll PhD,MBA</investigator_full_name>
    <investigator_title>Director of Research and Development</investigator_title>
  </responsible_party>
  <!-- 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/NCT01668979
org study id: TASMC-12-NG-0363-CTIL
nct id: NCT01668979
lead sponsor: 
has dmc: No
The study is aimed to assess a new system for the automatic detection, quantification and
      treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The
      system is comprized of a treadmill and a virtual reality simulation which provides a
      motor-cognitive challenge to provoke NF. The challenges provided by the system are
      individualized and using machine learning algorithms will enable the identification and
      detection of NF under different conditions and allow for the most suitable treatment.
observational model: Cohort
time perspective: Cross-Sectional
measure: usability of the system to detect Near Falls
time frame: one year
measure: Near Fall severity
time frame: one year
arm group label: new system to detect Near Falls
description: the new system comprises of a treadmill and a virtual reality simulation that will be used to induce Near Falls in healthy older adults with a history of falls.
intervention type: Device
intervention name: new system to detect Near Falls
description: We will invite healthy older adults with a history of falls to try the new system and assess whether the new system can induce, detect and quantify Near Fall episodes
arm group label: new system to detect Near Falls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nir Giladi, MD
role: Principal Investigator
affiliation: Tel-Aviv Sourasky Medical Center
last name: Nir Giladi, MD
phone: +972 3 6974958
email: nirg@tasmc.health.gov.il
last name: Anat Mirelman, PhD
phone: +972 3 6973960
email: anatmi@tasmc.health.gov.il
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Tel-Aviv Sourasky Medical Center
investigator full name: Michal Roll PhD,MBA
investigator title: Director of Research and Development