<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/NCT03004144</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01093</org_study_id>
    <nct_id>NCT03004144</nct_id>
  </id_info>
  <brief_title>Impact of Assistive Forces on Activities of Daily Living</brief_title>
  <acronym>FLOAT-ADL</acronym>
  <official_title>Impact of Robotic Assistive Forces on the Performance of Activities of Daily Living</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <brief_summary>
    <textblock>
      This study is a cross-sectional study investigating the impact of assistive forces applied by&#xD;
      the body-weight support system &quot;the FLOAT&quot; on the study participants. The study is conducted&#xD;
      at the University Hospital Balgrist in Zurich over a period of around 3 years. During this&#xD;
      time measurements on approximately 140 able bodied subjects and 60 patients with an&#xD;
      incomplete spinal cord injury will take place. The study participants are invited for a&#xD;
      single visit of around 140 min duration to the University Hospital Balgrist. During this&#xD;
      visit the study participants will repeatedly perform various activities of daily living (free&#xD;
      walking, standing up and sitting down, stair climbing and balancing) with and without&#xD;
      assistive forces from the body-weight support system. While performing the tasks, the study&#xD;
      participants' motions and muscle activities will be measured to evaluate the naturalness of&#xD;
      their movements. In addition, the collected data permits us to compare different movement&#xD;
      patterns and make conclusions about effective and optimal movement support. Obtaining this&#xD;
      knowledge will help us to shape the therapy of these activities to be tailored to the&#xD;
      patients and to train these movements with the help of the FLOAT under optimal conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">May 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2025</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-dimensional kinematic analyses resulting in a detailed movement profile for each of the performed tasks</measure>
    <time_frame>Once (single visit) around 140 minutes duration</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>FLOAT-Support</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FLOAT</intervention_name>
    <arm_group_label>FLOAT-Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with incomplete spinal cord injury (AIS C-D) or able bodied persons&#xD;
&#xD;
          -  informed consent as documented by signature&#xD;
&#xD;
          -  bodyweight &lt; 120 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a significant psychiatric or orthopedic diagnose&#xD;
&#xD;
          -  any secondary neurological complications that may impact the outcome variables&#xD;
&#xD;
          -  dermatological conditions (pressure ulcers, etc.)&#xD;
&#xD;
          -  pacemaker or other implanted, electronic devices&#xD;
&#xD;
          -  contraindications for FLOAT training&#xD;
&#xD;
          -  inability or unwillingness to provide written informed consent or follow study&#xD;
             procedures e.g. due to language problems&#xD;
&#xD;
          -  psychological disorders, dementia, etc.&#xD;
&#xD;
          -  known or suspected non-compliance, drug or alcohol abuse&#xD;
&#xD;
          -  enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universitätsklinik Balgrist</name>
      <address>
        <city>Zürich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 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>Spinal Cord Injuries</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/NCT03004144
org study id: 2016-01093
nct id: NCT03004144
lead sponsor: 
This study is a cross-sectional study investigating the impact of assistive forces applied by
      the body-weight support system "the FLOAT" on the study participants. The study is conducted
      at the University Hospital Balgrist in Zurich over a period of around 3 years. During this
      time measurements on approximately 140 able bodied subjects and 60 patients with an
      incomplete spinal cord injury will take place. The study participants are invited for a
      single visit of around 140 min duration to the University Hospital Balgrist. During this
      visit the study participants will repeatedly perform various activities of daily living (free
      walking, standing up and sitting down, stair climbing and balancing) with and without
      assistive forces from the body-weight support system. While performing the tasks, the study
      participants' motions and muscle activities will be measured to evaluate the naturalness of
      their movements. In addition, the collected data permits us to compare different movement
      patterns and make conclusions about effective and optimal movement support. Obtaining this
      knowledge will help us to shape the therapy of these activities to be tailored to the
      patients and to train these movements with the help of the FLOAT under optimal conditions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: 3-dimensional kinematic analyses resulting in a detailed movement profile for each of the performed tasks
time frame: Once (single visit) around 140 minutes duration
arm group label: FLOAT-Support
arm group type: Other
intervention type: Other
intervention name: FLOAT
arm group label: FLOAT-Support
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Spinal Cord Injuries