<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/NCT03758040</url>
  </required_header>
  <id_info>
    <org_study_id>861-18</org_study_id>
    <nct_id>NCT03758040</nct_id>
  </id_info>
  <brief_title>Mechanisms of Fall Resistance to Diverse Slipping Conditions</brief_title>
  <official_title>Mechanisms of Fall Resistance to Diverse Slipping Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</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>
      Using movement analysis, the investigators will determine the relationships between diverse&#xD;
      slip conditions, reactive responses to slips from those conditions, and slip vulnerability&#xD;
      across the gait cycle to generate new data that may guide future interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent evidence suggests most slip-related falls in daily life happen in diverse slipping&#xD;
      conditions where the ground is not level, or the person is turning or changing direction.&#xD;
      While slips that occur during straight walking on level ground and the responses to those&#xD;
      slips are relatively well understood, very little is known about slips that occur while&#xD;
      walking on slopes or curved paths and which reactive responses are effective to prevent falls&#xD;
      in such conditions. This limits the ability of clinicians to incorporate a diverse range of&#xD;
      slipping experiences into fall prevention interventions. Understanding how reactive responses&#xD;
      and slip vulnerability depend on diverse slip conditions may guide future interventions that&#xD;
      promote a more general fall resistance to the broader range of slips we encounter in the real&#xD;
      environment. Thus, the objective of this research project is to determine the impact of turns&#xD;
      and slopes on reactive movements and fall vulnerability. The aims of this study are (1) to&#xD;
      determine the effects of path curvature on reactive movements and slip vulnerability at&#xD;
      different times in the gait cycle, and (2) to determine the effects of ground slope on&#xD;
      reactive movements and slip vulnerability at difference times in the gait cycle. The&#xD;
      investigators hypothesize that diverse slipping conditions will change the reactive responses&#xD;
      involving protective stepping and arm swing. In addition, the investigators hypothesize that&#xD;
      the distinct dynamics of turns and slopes produce maximum vulnerability to slips at different&#xD;
      times in the gait cycle compared to slips during straight walking on level ground. To&#xD;
      evaluate these aims, the investigators will administer slip perturbations on slopes that vary&#xD;
      in both magnitude and direction, on curved paths that vary in curvature, and with slip onset&#xD;
      that varies across early, middle, and late stance. Understanding the relationships between&#xD;
      diverse slipping conditions, reactive responses, slip severity and fall vulnerability may&#xD;
      guide future research and training interventions towards more comprehensive fall resistance&#xD;
      ability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2019</start_date>
  <completion_date type="Actual">November 16, 2021</completion_date>
  <primary_completion_date type="Actual">November 16, 2021</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fall Rate</measure>
    <time_frame>Up to 4 hours</time_frame>
    <description>Percentage of trials which result in a fall. Falls are classified when a load cell embedded in the harness system measures support forces exceeding 30% body weight.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Slipping foot distance</measure>
    <time_frame>Up to 4 hours</time_frame>
    <description>The distance travelled by the slipping foot relative to the center of mass following the administered slip perturbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slipping foot maximum velocity</measure>
    <time_frame>Up to 4 hours</time_frame>
    <description>The maximum velocity of the slipping foot relative to the center of mass following the administered slip perturbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trunk maximum angular momentum</measure>
    <time_frame>Up to 4 hours</time_frame>
    <description>The maximum angular momentum of the trunk following the administered slip perturbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactive stepping response placement</measure>
    <time_frame>Up to 4 hours</time_frame>
    <description>Position of the placement of the reactive stepping response relative to the center of mass following the administered slip perturbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactive stepping response time</measure>
    <time_frame>Up to 4 hours</time_frame>
    <description>Duration of time between the onset of the administered slip perturbation and the placement of the reactive stepping response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactive arm swing momentum change</measure>
    <time_frame>Up to 4 hours</time_frame>
    <description>The change in arm momentum between the onset of the administered slip perturbation and the end of the slip</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Slipping and Falls</condition>
  <arm_group>
    <arm_group_label>Slips on Turns</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Slips administered during walking on a curved paths of radii 1.0, or 2.0 meters in early, middle or late stance to the inside or outside foot.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Slips on Slopes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Slips administered during walking on sloped ground of 5.0 or 10.0 degrees mediolaterally or anteroposteriorly, or flat ground, in early middle or late stance. For mediolateral slopes, slips will be administered to the uphill or downhill foot.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Slips on Turns</intervention_name>
    <description>Subjects will be administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips will be delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters.</description>
    <arm_group_label>Slips on Turns</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Slips on Slopes</intervention_name>
    <description>Slips will be administered at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the CAREN system treadmill.</description>
    <arm_group_label>Slips on Slopes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 19-35&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Peripheral arterial disease&#xD;
&#xD;
          -  Knee osteoarthritis&#xD;
&#xD;
          -  Vertigo&#xD;
&#xD;
          -  Meniere's disease&#xD;
&#xD;
          -  Chronic dizziness&#xD;
&#xD;
          -  History of back or lower extremity injury&#xD;
&#xD;
          -  Surgery that affects mobility&#xD;
&#xD;
          -  Neurological disease that limits the ability to walk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Biomechanics Research Building</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68182</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nebraska</investigator_affiliation>
    <investigator_full_name>Nathaniel Hunt</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be made available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months of study completion.</ipd_time_frame>
    <ipd_access_criteria>Data access requests should be emailed to the PI.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>March 20, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03758040
org study id: 861-18
nct id: NCT03758040
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Using movement analysis, the investigators will determine the relationships between diverse
      slip conditions, reactive responses to slips from those conditions, and slip vulnerability
      across the gait cycle to generate new data that may guide future interventions.
Recent evidence suggests most slip-related falls in daily life happen in diverse slipping
      conditions where the ground is not level, or the person is turning or changing direction.
      While slips that occur during straight walking on level ground and the responses to those
      slips are relatively well understood, very little is known about slips that occur while
      walking on slopes or curved paths and which reactive responses are effective to prevent falls
      in such conditions. This limits the ability of clinicians to incorporate a diverse range of
      slipping experiences into fall prevention interventions. Understanding how reactive responses
      and slip vulnerability depend on diverse slip conditions may guide future interventions that
      promote a more general fall resistance to the broader range of slips we encounter in the real
      environment. Thus, the objective of this research project is to determine the impact of turns
      and slopes on reactive movements and fall vulnerability. The aims of this study are (1) to
      determine the effects of path curvature on reactive movements and slip vulnerability at
      different times in the gait cycle, and (2) to determine the effects of ground slope on
      reactive movements and slip vulnerability at difference times in the gait cycle. The
      investigators hypothesize that diverse slipping conditions will change the reactive responses
      involving protective stepping and arm swing. In addition, the investigators hypothesize that
      the distinct dynamics of turns and slopes produce maximum vulnerability to slips at different
      times in the gait cycle compared to slips during straight walking on level ground. To
      evaluate these aims, the investigators will administer slip perturbations on slopes that vary
      in both magnitude and direction, on curved paths that vary in curvature, and with slip onset
      that varies across early, middle, and late stance. Understanding the relationships between
      diverse slipping conditions, reactive responses, slip severity and fall vulnerability may
      guide future research and training interventions towards more comprehensive fall resistance
      ability.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Fall Rate
time frame: Up to 4 hours
description: Percentage of trials which result in a fall. Falls are classified when a load cell embedded in the harness system measures support forces exceeding 30% body weight.
measure: Slipping foot distance
time frame: Up to 4 hours
description: The distance travelled by the slipping foot relative to the center of mass following the administered slip perturbation
measure: Slipping foot maximum velocity
time frame: Up to 4 hours
description: The maximum velocity of the slipping foot relative to the center of mass following the administered slip perturbation
measure: Trunk maximum angular momentum
time frame: Up to 4 hours
description: The maximum angular momentum of the trunk following the administered slip perturbation
measure: Reactive stepping response placement
time frame: Up to 4 hours
description: Position of the placement of the reactive stepping response relative to the center of mass following the administered slip perturbation
measure: Reactive stepping response time
time frame: Up to 4 hours
description: Duration of time between the onset of the administered slip perturbation and the placement of the reactive stepping response
measure: Reactive arm swing momentum change
time frame: Up to 4 hours
description: The change in arm momentum between the onset of the administered slip perturbation and the end of the slip
arm group label: Slips on Turns
arm group type: Experimental
description: Slips administered during walking on a curved paths of radii 1.0, or 2.0 meters in early, middle or late stance to the inside or outside foot.
arm group label: Slips on Slopes
arm group type: Experimental
description: Slips administered during walking on sloped ground of 5.0 or 10.0 degrees mediolaterally or anteroposteriorly, or flat ground, in early middle or late stance. For mediolateral slopes, slips will be administered to the uphill or downhill foot.
intervention type: Other
intervention name: Slips on Turns
description: Subjects will be administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips will be delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters.
arm group label: Slips on Turns
intervention type: Other
intervention name: Slips on Slopes
description: Slips will be administered at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the CAREN system treadmill.
arm group label: Slips on Slopes
criteria: 
gender: All
minimum age: 19 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nebraska
investigator full name: Nathaniel Hunt
investigator title: Assistant Professor
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Data will be available within 6 months of study completion.
ipd access criteria: Data access requests should be emailed to the PI.
submitted: March 20, 2023