<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/NCT03011164</url>
  </required_header>
  <id_info>
    <org_study_id>GuangzhouGH005</org_study_id>
    <nct_id>NCT03011164</nct_id>
  </id_info>
  <brief_title>The Influence of Running and Velocity to Kinematic Parameters</brief_title>
  <official_title>The Influence of Running and Velocity to Kinematic Parameters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou General Hospital of Guangzhou Military Command</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Center of Assessment, Prevention and Treatment of Bone &amp; Joint Diseases, Guangdong, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangzhou General Hospital of Guangzhou Military Command</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Some researches have found that gait posture velocity have influence on kinematic parameters.&#xD;
      However, how the gait velocity and posture will influence kinematic parameters remain&#xD;
      unclear. In addition to walking, running is one of the most daily activities of people. The&#xD;
      purpose of this research is to find out the influence of gait velocity and running to&#xD;
      kinematic parameters . To do this, it will provide a reference for future prospective studies&#xD;
      or investigations and make us fully understand the impact of gait velocity and running to&#xD;
      kinematic parameters of gait.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at initial contact.</measure>
    <time_frame>1 Day</time_frame>
    <description>The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at loading response.</measure>
    <time_frame>1 Day</time_frame>
    <description>The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at mid-stance.</measure>
    <time_frame>1 Day</time_frame>
    <description>The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at terminal stance.</measure>
    <time_frame>1 Day</time_frame>
    <description>The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at initial swing.</measure>
    <time_frame>1 Day</time_frame>
    <description>The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at mid-swing.</measure>
    <time_frame>1 Day</time_frame>
    <description>The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at terminal swing.</measure>
    <time_frame>1 Day</time_frame>
    <description>The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The ranges of motion in the the six-degree-of-motion (6DOF) of the gait.</measure>
    <time_frame>1 Day</time_frame>
    <description>The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Running</condition>
  <condition>Gait Velocity</condition>
  <arm_group>
    <arm_group_label>WV 1</arm_group_label>
    <description>The condition of this group will be set as participants walking at 3.5km/h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WV 2</arm_group_label>
    <description>The condition of this group will be set as participants walking at 4.0km/h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RV 1</arm_group_label>
    <description>The condition of this group will be set as participants running at 3.5km/h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RV 2</arm_group_label>
    <description>The condition of this group will be set as participants running at 4.0km/h</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Walk and Run</intervention_name>
    <description>Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk or run on a treadmill in barefoot for ten minutes to adapt the condition. The a gait analysis system will collect the data while they walk or run on the treadmill in barefoot at selected gait speed.</description>
    <arm_group_label>RV 1</arm_group_label>
    <arm_group_label>RV 2</arm_group_label>
    <arm_group_label>WV 1</arm_group_label>
    <arm_group_label>WV 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All the participants will be recruited via university advertisement.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        i) 20&lt; age &lt; 30. ii) Body mass index &lt; 30. iii) No history of major injury or surgery in&#xD;
        lower limbs. iv) No symptoms of lower limbs. v) Physical examination to test the lower&#xD;
        limbs to be normal. vi) The habit of moderate exercise (e.g. Jogging )at least once a week&#xD;
        for at least 30 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i)Body mass index &gt;30. ii) Injury or surgery in hip/knee/ankle. iii) History trauma in the&#xD;
        lower limbs (e.g. fracture). iv) Neuropathic disease . v) Muscular disease. vi) Lack&#xD;
        ability to finish the procedure physically or mentally. vii) Easy to fall. viii) Any other&#xD;
        conditions that can influence gait parameters of the lower limbs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu Zhang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yu Zhang, PhD</last_name>
    <phone>+86-20-88654440</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Limin Ma, PhD</last_name>
  </overall_contact_backup>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou General Hospital of Guangzhou Military Command</investigator_affiliation>
    <investigator_full_name>Yu Zhang</investigator_full_name>
    <investigator_title>chief surgeon, associate professor</investigator_title>
  </responsible_party>
  <keyword>Running</keyword>
  <keyword>Gait velocity</keyword>
  <keyword>Kinematics</keyword>
  <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/NCT03011164
org study id: GuangzhouGH005
nct id: NCT03011164
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Some researches have found that gait posture velocity have influence on kinematic parameters.
      However, how the gait velocity and posture will influence kinematic parameters remain
      unclear. In addition to walking, running is one of the most daily activities of people. The
      purpose of this research is to find out the influence of gait velocity and running to
      kinematic parameters . To do this, it will provide a reference for future prospective studies
      or investigations and make us fully understand the impact of gait velocity and running to
      kinematic parameters of gait.
observational model: Cohort
time perspective: Prospective
measure: Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at initial contact.
time frame: 1 Day
description: The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.
measure: Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at loading response.
time frame: 1 Day
description: The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.
measure: Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at mid-stance.
time frame: 1 Day
description: The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.
measure: Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at terminal stance.
time frame: 1 Day
description: The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.
measure: Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at initial swing.
time frame: 1 Day
description: The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.
measure: Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at mid-swing.
time frame: 1 Day
description: The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.
measure: Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at terminal swing.
time frame: 1 Day
description: The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.
measure: The ranges of motion in the the six-degree-of-motion (6DOF) of the gait.
time frame: 1 Day
description: The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/ lateral translation, proximal/distal translation.
arm group label: WV 1
description: The condition of this group will be set as participants walking at 3.5km/h
arm group label: WV 2
description: The condition of this group will be set as participants walking at 4.0km/h
arm group label: RV 1
description: The condition of this group will be set as participants running at 3.5km/h
arm group label: RV 2
description: The condition of this group will be set as participants running at 4.0km/h
intervention type: Procedure
intervention name: Walk and Run
description: Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk or run on a treadmill in barefoot for ten minutes to adapt the condition. The a gait analysis system will collect the data while they walk or run on the treadmill in barefoot at selected gait speed.
arm group label: RV 1
arm group label: RV 2
arm group label: WV 1
arm group label: WV 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yu Zhang, PhD
role: Principal Investigator
affiliation: Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China
last name: Yu Zhang, PhD
phone: +86-20-88654440
last name: Limin Ma, PhD
responsible party type: Principal Investigator
investigator affiliation: Guangzhou General Hospital of Guangzhou Military Command
investigator full name: Yu Zhang
investigator title: chief surgeon, associate professor
sharing ipd: No