<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/NCT03813004</url>
  </required_header>
  <id_info>
    <org_study_id>DS-311</org_study_id>
    <nct_id>NCT03813004</nct_id>
  </id_info>
  <brief_title>Kinematics and Kinetics of Gait Perturbations in Young Healthy Adults</brief_title>
  <official_title>Kinematics and Kinetics of Gait Perturbations in Young Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barbara Łysoń</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Józef Piłsudski University of Physical Education</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators would like to examine, what are strategies for balance recovery in gait&#xD;
      perturbations. Different perturbation types where used in the current study. The study&#xD;
      involves the analysis of kinematic and kinetic parameters. Researchers hypothesize that&#xD;
      research including young healthy adults would help to elaborate fall prevention program for&#xD;
      seniors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2018</start_date>
  <completion_date type="Actual">June 20, 2018</completion_date>
  <primary_completion_date type="Actual">June 20, 2018</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>Motek Grail output (joint angles)</measure>
    <time_frame>40 minutes</time_frame>
    <description>Joint angles calculated using HBM Gait model [degrees]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motek Grail output (joint moments)</measure>
    <time_frame>40 minutes</time_frame>
    <description>Joint moments calculated using HBM Gait model [Newton*meter/kilogram]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motek Grail output (ground reaction forces)</measure>
    <time_frame>40 minutes</time_frame>
    <description>Ground reaction forces calculated using treadmill with built-in dual 6 DoF force plates and independent belts for each foot [Newtons]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motek Grail output (centre of pressure)</measure>
    <time_frame>40 minutes</time_frame>
    <description>Center of pressure calculated using treadmill with built-in dual 6 DoF force plates and independent belts for each foot [meters]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>10 minutes</time_frame>
    <description>Body composition using Tanita Body Composition Monitor (fat tissue percentage, muscle mass percentage, water percentage)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of movement</measure>
    <time_frame>20 minutes</time_frame>
    <description>Range of movement in hip, knee and ankle joint, measured using SFTR system [degrees]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height</measure>
    <time_frame>2 minutes</time_frame>
    <description>Height measured in meters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>2 minutes</time_frame>
    <description>Weight measured in kilograms</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Balance Disorders</condition>
  <arm_group>
    <arm_group_label>Young healthy adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Reaction for gait perturbation</intervention_name>
    <description>Participants were subjected to four different perturbation types while walking on the treadmill:&#xD;
left treadmill belt deceleration for right leg toe off&#xD;
right treadmill belt deceleration for left leg toe off&#xD;
left treadmill belt acceleration for right leg heel strike&#xD;
right treadmill belt acceleration for left leg heel strike&#xD;
Motion analysis was conducted to analyze effect of the intervention on gait.</description>
    <arm_group_label>Young healthy adults</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-35&#xD;
&#xD;
          -  female or male&#xD;
&#xD;
          -  good health condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lower limb injuries (last 6 months)&#xD;
&#xD;
          -  head injuries (last 6 months)&#xD;
&#xD;
          -  diseases of the vestibular system&#xD;
&#xD;
          -  serious eye defects&#xD;
&#xD;
          -  extreme sports athletes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Józef Piłsudski University of Physical Education in Warsaw</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowsze</state>
        <zip>00-968</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Józef Piłsudski University of Physical Education</investigator_affiliation>
    <investigator_full_name>Barbara Łysoń</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>motek grail</keyword>
  <keyword>balance</keyword>
  <keyword>gait perturbation</keyword>
  <!-- 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/NCT03813004
org study id: DS-311
nct id: NCT03813004
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Investigators would like to examine, what are strategies for balance recovery in gait
      perturbations. Different perturbation types where used in the current study. The study
      involves the analysis of kinematic and kinetic parameters. Researchers hypothesize that
      research including young healthy adults would help to elaborate fall prevention program for
      seniors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Motek Grail output (joint angles)
time frame: 40 minutes
description: Joint angles calculated using HBM Gait model [degrees]
measure: Motek Grail output (joint moments)
time frame: 40 minutes
description: Joint moments calculated using HBM Gait model [Newton*meter/kilogram]
measure: Motek Grail output (ground reaction forces)
time frame: 40 minutes
description: Ground reaction forces calculated using treadmill with built-in dual 6 DoF force plates and independent belts for each foot [Newtons]
measure: Motek Grail output (centre of pressure)
time frame: 40 minutes
description: Center of pressure calculated using treadmill with built-in dual 6 DoF force plates and independent belts for each foot [meters]
measure: Body composition
time frame: 10 minutes
description: Body composition using Tanita Body Composition Monitor (fat tissue percentage, muscle mass percentage, water percentage)
measure: Range of movement
time frame: 20 minutes
description: Range of movement in hip, knee and ankle joint, measured using SFTR system [degrees]
measure: Height
time frame: 2 minutes
description: Height measured in meters
measure: Weight
time frame: 2 minutes
description: Weight measured in kilograms
arm group label: Young healthy adults
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Reaction for gait perturbation
description: Participants were subjected to four different perturbation types while walking on the treadmill:
left treadmill belt deceleration for right leg toe off
right treadmill belt deceleration for left leg toe off
left treadmill belt acceleration for right leg heel strike
right treadmill belt acceleration for left leg heel strike
Motion analysis was conducted to analyze effect of the intervention on gait.
arm group label: Young healthy adults
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Poland
responsible party type: Sponsor-Investigator
investigator affiliation: Józef Piłsudski University of Physical Education
investigator full name: Barbara Łysoń
investigator title: Principal Investigator