<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/NCT03285464</url>
  </required_header>
  <id_info>
    <org_study_id>201508-387</org_study_id>
    <nct_id>NCT03285464</nct_id>
  </id_info>
  <brief_title>Utilizing the Trunk as a Proximal Lever to Strengthen the Hip Musculature and Alter Lower Extremity Function</brief_title>
  <official_title>Investigating the Effects of a Triplanar Rotary Based Hip Focused Therapeutic Exercise Program on Dynamic Lower Extremity Alignment and Functional Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>High Point University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>High Point University</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>
      Does a rotary based triplanar exercise intervention that utilizes the trunk as a proximal&#xD;
      lever, strengthen the hip and alter dynamic LE alignment in running females?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current hip-focused programs fail to alter hip adduction angles in females while performing&#xD;
      higher speed and more complex maneuvers such as running.&#xD;
&#xD;
      (Willy, et al., 2011) - 10 female runners, underwent 6 wk. hip focused intervention, change&#xD;
      in SLS but NO change in hip adduction angle while running.&#xD;
&#xD;
      A different intervention strategy that includes utilizing the trunk as the proximal lever to&#xD;
      strengthen the hip, could potentially alter biomechanical outcomes such as hip adduction&#xD;
      angles in female runners.&#xD;
&#xD;
      This study will apply a new intervention model and then measure running, single leg squat and&#xD;
      hip strength to determine if a newly informed intervention can alter LE kinematics in females&#xD;
      while running and make improvements in hip strength following the intervention Inclusion&#xD;
      Criteria&#xD;
&#xD;
        -  18 years old or greater&#xD;
&#xD;
        -  Female Exclusion Criteria&#xD;
&#xD;
        -  Injury of the lumbar spine, hips, knees or foot/ankle in the last 6mos that required&#xD;
           medical attention&#xD;
&#xD;
        -  any surgery of the lower back or the pelvis or lower extremities any time in the&#xD;
           subjects life&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>One group will do current hip focused intervention published previously second group will receive a new hip intervention and then pre/post testing will take place for static and dynamic kinematics and hip strength</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Only the subjects will not know which group they are being assigned to</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Hip Strength after a 12 week hip focused intervention</measure>
    <time_frame>Baseline measures at initial data collection; repeat post intervention measures at 6wks</time_frame>
    <description>Isometric hand held dynamometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomechanical assessment of single leg squat</measure>
    <time_frame>Baseline measures at initial data collection; repeat post intervention measures at 6wks</time_frame>
    <description>Subject squats on single leg and qualitative scoring is administered to determine the subjective amount of contralateral pelvic drop and femoral adduction to be described as dynamic knee valgus. The qualitative values will be binary in nature, whereas DKV is present or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomechanical Running Assessment</measure>
    <time_frame>Baseline measures at initial data collection; repeat post intervention measures at 6wks</time_frame>
    <description>2/3D analysis of running gait following intervention; Utilizing both 3D/2D methods the measure of contralateral pelvic drop and the bisection of the patella will determine the amount of femoral adduction noted during running. The change in the femoral adduction angle after a 6 week intervention is the specific outcome measure to be obtained.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Patellofemoral Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Hip</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will perform a known hip strengthening program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trunk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will use the trunk as a lever to strengthen the hip</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Triplanar Rotary Resistance</intervention_name>
    <description>Trunk group will strengthen the hip using the trunk as a lever to access the hip. The hip group will use femur as the lever to strengthen the hip.</description>
    <arm_group_label>Hip</arm_group_label>
    <arm_group_label>Trunk</arm_group_label>
    <other_name>Convention Hip Focused</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18&gt; year old female; must be able to run on the treadmill for 5-7 min and perform a&#xD;
             single leg squat&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  surgery to the LB or lower extremities Significant injury (seeking medical attention)&#xD;
             to the LB or LEs in the last 6mos.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Include only females</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexis Wright, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>HPU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric Hegedus, DPT</last_name>
    <role>Study Chair</role>
    <affiliation>HPU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kevin Ford, PhD</last_name>
    <role>Study Director</role>
    <affiliation>HPU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>High Point University</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27268</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>February 23, 2018</last_update_submitted>
  <last_update_submitted_qc>February 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>knee</keyword>
  <keyword>hip</keyword>
  <keyword>exercise</keyword>
  <keyword>proximal control</keyword>
  <keyword>PFPS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The data collected will only be shared amongst the research team named in this protocol.</ipd_description>
  </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/NCT03285464
org study id: 201508-387
nct id: NCT03285464
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Does a rotary based triplanar exercise intervention that utilizes the trunk as a proximal
      lever, strengthen the hip and alter dynamic LE alignment in running females?
Current hip-focused programs fail to alter hip adduction angles in females while performing
      higher speed and more complex maneuvers such as running.

      (Willy, et al., 2011) - 10 female runners, underwent 6 wk. hip focused intervention, change
      in SLS but NO change in hip adduction angle while running.

      A different intervention strategy that includes utilizing the trunk as the proximal lever to
      strengthen the hip, could potentially alter biomechanical outcomes such as hip adduction
      angles in female runners.

      This study will apply a new intervention model and then measure running, single leg squat and
      hip strength to determine if a newly informed intervention can alter LE kinematics in females
      while running and make improvements in hip strength following the intervention Inclusion
      Criteria

        -  18 years old or greater

        -  Female Exclusion Criteria

        -  Injury of the lumbar spine, hips, knees or foot/ankle in the last 6mos that required
           medical attention

        -  any surgery of the lower back or the pelvis or lower extremities any time in the
           subjects life
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One group will do current hip focused intervention published previously second group will receive a new hip intervention and then pre/post testing will take place for static and dynamic kinematics and hip strength
primary purpose: Treatment
masking: Single (Participant)
masking description: Only the subjects will not know which group they are being assigned to
measure: Change in Hip Strength after a 12 week hip focused intervention
time frame: Baseline measures at initial data collection; repeat post intervention measures at 6wks
description: Isometric hand held dynamometer
measure: Biomechanical assessment of single leg squat
time frame: Baseline measures at initial data collection; repeat post intervention measures at 6wks
description: Subject squats on single leg and qualitative scoring is administered to determine the subjective amount of contralateral pelvic drop and femoral adduction to be described as dynamic knee valgus. The qualitative values will be binary in nature, whereas DKV is present or not.
measure: Biomechanical Running Assessment
time frame: Baseline measures at initial data collection; repeat post intervention measures at 6wks
description: 2/3D analysis of running gait following intervention; Utilizing both 3D/2D methods the measure of contralateral pelvic drop and the bisection of the patella will determine the amount of femoral adduction noted during running. The change in the femoral adduction angle after a 6 week intervention is the specific outcome measure to be obtained.
arm group label: Hip
arm group type: Active Comparator
description: This group will perform a known hip strengthening program
arm group label: Trunk
arm group type: Experimental
description: This group will use the trunk as a lever to strengthen the hip
intervention type: Other
intervention name: Triplanar Rotary Resistance
description: Trunk group will strengthen the hip using the trunk as a lever to access the hip. The hip group will use femur as the lever to strengthen the hip.
arm group label: Hip
arm group label: Trunk
other name: Convention Hip Focused
criteria: 
gender: Female
gender based: Yes
gender description: Include only females
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alexis Wright, DPT
role: Principal Investigator
affiliation: HPU
last name: Eric Hegedus, DPT
role: Study Chair
affiliation: HPU
last name: Kevin Ford, PhD
role: Study Director
affiliation: HPU
facility: 
country: United States
responsible party type: Sponsor
mesh term: Patellofemoral Pain Syndrome
sharing ipd: Undecided
ipd description: The data collected will only be shared amongst the research team named in this protocol.