<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/NCT02983955</url>
  </required_header>
  <id_info>
    <org_study_id>UPNRIDE-UR-SF-01</org_study_id>
    <nct_id>NCT02983955</nct_id>
  </id_info>
  <brief_title>UPNRIDE Powered Wheelchair for Individuals With Walking Impairment: Evaluation of Safety and Usability</brief_title>
  <acronym>UPNRIDE_SAFE</acronym>
  <official_title>UPNRIDE Powered Wheelchair for Individuals With Walking Impairment: Evaluation of Safety and Usability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UPnRIDE Robotics Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UPnRIDE Robotics Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting&#xD;
      to standing and standing to sitting. The product provides indoor and outdoor mobility.&#xD;
&#xD;
      The main purpose of this study is to evaluate the safety of the UPnRIDE powered wheelchair as&#xD;
      an outdoor and indoor mobility device by individuals with walking impairment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A new powered wheelchair has recently been developed to address the ability of the user to be&#xD;
      able to position them in an upright, standing position. This new device is called the UPnRIDE&#xD;
      powered wheelchair and is different from other upright wheelchairs because current standing&#xD;
      wheelchair models have limited mobility in the standing position. The UPnRIDE is an upright&#xD;
      or seated mobility device that is intended to provide full upright standing posture in a&#xD;
      mobile powered wheelchair. The UPnRIDE powered wheelchair provides wheelchair and scooter&#xD;
      users the ability to engage in society in either a standing (upright mobility) or seated&#xD;
      position (seated mobility). Additionally, the option to have upright posture throughout the&#xD;
      day may have the potential to improve some of the secondary medical conditions associated&#xD;
      with the extreme sedentary lifestyle that paralysis from SCI imposes. This wheeled, motorized&#xD;
      device can provide mobility to most urban environment situations by being able to be&#xD;
      navigated indoors and outdoors and over different surfaces in both the standing or seated&#xD;
      positions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">January 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Through study completion, an average of 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Successes rate of task performance</measure>
    <time_frame>Through study completion, an average of 3 months</time_frame>
    <description>Study success is defined if 70% of study subjects are defined success</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Spinal Cord Injury Cervical</condition>
  <arm_group>
    <arm_group_label>SCI with Tetraplegia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UPnRIDE Powered Wheelchair</intervention_name>
    <description>The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting to standing and standing to sitting. The product provides indoor and outdoor mobility.</description>
    <arm_group_label>SCI with Tetraplegia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Males and non-pregnant, non-lactating females&#xD;
&#xD;
          2. Ages 18-70&#xD;
&#xD;
          3. Suffered from a SCI which caused Tetraplegia, ASIA A-B-C&#xD;
&#xD;
          4. At least 1 year after SCI&#xD;
&#xD;
          5. Height of 155 to 190 cm;&#xD;
&#xD;
          6. Weight less than 100 kg&#xD;
&#xD;
          7. Able to sign informed consent.&#xD;
&#xD;
          8. Power or manual wheelchair user as a primary means of mobility&#xD;
&#xD;
          9. Regular user of a standing frame or tilt table for at least 30 minutes a week&#xD;
             Exclusion Criteria&#xD;
&#xD;
        1. History of severe neurological disorder other than SCI (multiple sclerosis, cerebral&#xD;
        palsy, amyotrophic lateral sclerosis, traumatic brain injury, stroke, etc.) 2. Concurrent&#xD;
        severe medical disease 3. Pressure sores 4. Unstable spine 5. Unhealed limb or pelvic&#xD;
        fractures 6. Psychiatric or cognitive status that may interfere with the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabi Zeilig, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurological Rehabilitation The Chaim Sheba Medical Center, Tel Hashomer and Sackler Faculty of Medicine,</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shany Kheifets-Zohar, Bsc.</last_name>
    <phone>972-4-6110061</phone>
    <email>shany@upnride.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amihai Gottlieb</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</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>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02983955
org study id: UPNRIDE-UR-SF-01
nct id: NCT02983955
lead sponsor: 
collaborator: 
has dmc: Yes
The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting
      to standing and standing to sitting. The product provides indoor and outdoor mobility.

      The main purpose of this study is to evaluate the safety of the UPnRIDE powered wheelchair as
      an outdoor and indoor mobility device by individuals with walking impairment.
A new powered wheelchair has recently been developed to address the ability of the user to be
      able to position them in an upright, standing position. This new device is called the UPnRIDE
      powered wheelchair and is different from other upright wheelchairs because current standing
      wheelchair models have limited mobility in the standing position. The UPnRIDE is an upright
      or seated mobility device that is intended to provide full upright standing posture in a
      mobile powered wheelchair. The UPnRIDE powered wheelchair provides wheelchair and scooter
      users the ability to engage in society in either a standing (upright mobility) or seated
      position (seated mobility). Additionally, the option to have upright posture throughout the
      day may have the potential to improve some of the secondary medical conditions associated
      with the extreme sedentary lifestyle that paralysis from SCI imposes. This wheeled, motorized
      device can provide mobility to most urban environment situations by being able to be
      navigated indoors and outdoors and over different surfaces in both the standing or seated
      positions.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Adverse events
time frame: Through study completion, an average of 3 months
measure: Successes rate of task performance
time frame: Through study completion, an average of 3 months
description: Study success is defined if 70% of study subjects are defined success
arm group label: SCI with Tetraplegia
arm group type: Other
intervention type: Device
intervention name: UPnRIDE Powered Wheelchair
description: The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting to standing and standing to sitting. The product provides indoor and outdoor mobility.
arm group label: SCI with Tetraplegia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Gabi Zeilig, MD
role: Principal Investigator
affiliation: Department of Neurological Rehabilitation The Chaim Sheba Medical Center, Tel Hashomer and Sackler Faculty of Medicine,
last name: Shany Kheifets-Zohar, Bsc.
phone: 972-4-6110061
email: shany@upnride.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
sharing ipd: No