<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/NCT03027882</url>
  </required_header>
  <id_info>
    <org_study_id>ShenandoahU(3)</org_study_id>
    <nct_id>NCT03027882</nct_id>
  </id_info>
  <brief_title>Determining the Reliability and Validity of the Swing Test</brief_title>
  <official_title>Determining the Reliability and Validity of the Swing Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenandoah University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenandoah University</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the inter/intra rater reliability as well as the&#xD;
      validity of the Swing Test in asymptomatic adults . In addition, this study will examine if&#xD;
      there are musculoskeletal predictors to the movement quality of the swing test.&#xD;
&#xD;
      The Swing Test is a movement test used by physical therapists to identify movement problems&#xD;
      during a simulated running stride&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Upon arrival the subject will be given a questionnaire that will collect demographic&#xD;
      information and determine whether they meet the inclusion/exclusion criteria for the study.&#xD;
      If the subjects meet the inclusion/exclusion criteria for the study, they will be given an&#xD;
      informed consent form for participation and photography.&#xD;
&#xD;
      Prior to performing the swing test reflective markers will be placed on specific anatomical&#xD;
      landmarks of the subject.&#xD;
&#xD;
      An investigator will demonstrate how to perform the Swing test. The subject will then be&#xD;
      instructed to step onto a six inch box and asked to swing one leg forwards and backwards&#xD;
      mimicking their running stride. After ten practice repetitions, ten repetitions will be&#xD;
      recorded by the Vicon Motion Analysis System and 2 video cameras capturing different views.&#xD;
      The subject will then step off the box and the reflective markers will be removed.&#xD;
&#xD;
      After the swing test, the subject will undergo a series of common musculoskeletal examination&#xD;
      tests. The following examination tests will be performed in a random order.&#xD;
&#xD;
      The first musculoskeletal examination test is hip extension range of motion (ROM) that will&#xD;
      be measured using a goniometer. The subject will lie on their stomach and the investigator&#xD;
      will take the subjects hip into extension and measure their full motion.&#xD;
&#xD;
      The second examination tests is the Thomas test to determine the muscle length for rectus&#xD;
      femoris muscle and iliotibial band. The subject will be instructed to sit on the edge of the&#xD;
      bed and lower to supine while bringing one knee to chest. The investigator will assess the&#xD;
      subject's lower extremity position to determine the length of the rectus femoris muscle and&#xD;
      the iliotibial band.&#xD;
&#xD;
      The third examination test is hip strength measurements of internal rotation, external&#xD;
      rotation, and abduction which will be measured using a handheld dynamometer. The subject will&#xD;
      be placed on their back and their hip strength will be measured using the dynamometer. The&#xD;
      subject will then be placed on their side where further hip strength will be assessed.&#xD;
&#xD;
      The fourth examination tests is the navicular drop test. In a seated position, a mark will be&#xD;
      placed on the patient's navicular tubercle, which is a landmark on the inside of the foot. An&#xD;
      index card will be placed next to the middle of the subjects foot and the height of the&#xD;
      navicular will be marked on that index card. The subject will be instructed to stand up and&#xD;
      the navicular height will be marked again on the index card. The difference in height between&#xD;
      sitting and standing will be calculated.&#xD;
&#xD;
      The fifth examination test is the sorensen test to determine the endurance of the back&#xD;
      muscles. The subject will be instructed to lie prone with their trunk off the treatment&#xD;
      table. The subject will have arms crossed at chest, and will be instructed to maintain upper&#xD;
      body horizontal the floor. Time will be recorded during the test and the tests will stop when&#xD;
      the subject cannot maintain horizontal or 240 seconds is reached.&#xD;
&#xD;
      Three to five licensed physical therapists of varying levels of experience will be asked to&#xD;
      watch the video recordings of the subject performing the swing test and rate their&#xD;
      performance using a scoring system. Therapists who will be rating the Swing test will not&#xD;
      have access to any data other than the videos.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Swing Test</measure>
    <time_frame>10-15 minutes</time_frame>
    <description>The subject will then be instructed to step onto a six inch box and asked to swing one leg forwards and backwards mimicking their running stride. After ten practice repetitions, ten repetitions will be recorded by the Vicon Motion Analysis System and 2 video cameras capturing different views. Three to five licensed physical therapists of varying levels of experience will be asked to watch the video recordings of the subject performing the swing test and rate their performance using a newly developed scoring system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hip extension ROM</measure>
    <time_frame>5 minutes</time_frame>
    <description>The subject will lie on their stomach and the investigator will take the subjects hip into extension and measure their full motion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thomas Test</measure>
    <time_frame>5 minutes</time_frame>
    <description>To determine the muscle length for rectus femoris muscle and iliotibial band., the subject will be instructed to sit on the edge of the bed and lower to supine while bringing one knee to chest. The investigator will assess the subject's lower extremity position to determine the length of the rectus femoris muscle and the iliotibial band.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip strength</measure>
    <time_frame>5 minutes</time_frame>
    <description>Hip internal rotation, external rotation, and abduction will be measured using a handheld dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Navicular drop</measure>
    <time_frame>5 minutes</time_frame>
    <description>In a seated position, a mark will be placed on the subjects navicular tubercle. An index card will be placed next to the middle of the subjects foot and the height of the navicular will be marked on that index card. The subject will be instructed to stand up and the navicular height will be marked again on the index card. The difference in height between sitting and standing will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sorensen Test</measure>
    <time_frame>5 minutes</time_frame>
    <description>To determine the endurance of the back muscles, the subject will be instructed to lie prone with their trunk off the treatment table. The subject will have arms crossed at chest, and will be instructed to maintain upper body horizontal the floor. Time will be recorded during the test and the tests will stop when the subject cannot maintain horizontal or 240 seconds is reached.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Clinical Assessment</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>This is a reliability/validity study of a functional clinical test. There is no intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Asymptomatic adults over 18 who run at least 5 miles a week&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years or older who run at least five (5) miles a week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will be pain-free with no history of lower extremity, lumbar spine or pelvis&#xD;
             musculoskeletal or neurological injuries in the last 6 months. Subjects will also not&#xD;
             have a history of lumbar or lower extremity surgery in the last 6 months. Lastly,&#xD;
             subjects will not have a history of balance impairments due to a vestibular or&#xD;
             neurological disorder in the last 6 months.&#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>
  <overall_contact>
    <last_name>AJ Lievre</last_name>
    <phone>5403273170</phone>
    <email>alievre@su.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shenandoah University</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aaron J Hartstein, PT, MPT</last_name>
      <phone>540-327-7454</phone>
      <email>ahartste@su.edu</email>
    </contact>
    <contact_backup>
      <last_name>Arthur J Lievre, PT, DPT</last_name>
      <phone>5403273170</phone>
      <email>alievre@su.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Aaron J Hartstein, PT, MPT</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Arthur J Lievre, PT, DPT</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Taylor Blattenberger, SPT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brooke Perdue, SPT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cassie Ringstaff, SPT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Meredith Jackson, SPT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katie Dennis, SPT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>April 24, 2017</last_update_submitted>
  <last_update_submitted_qc>April 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shenandoah University</investigator_affiliation>
    <investigator_full_name>AJ Lievre</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Reliability</keyword>
  <keyword>Validity</keyword>
  <keyword>Functional Testing</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/NCT03027882
org study id: ShenandoahU(3)
nct id: NCT03027882
lead sponsor: 
The purpose of this study is to examine the inter/intra rater reliability as well as the
      validity of the Swing Test in asymptomatic adults . In addition, this study will examine if
      there are musculoskeletal predictors to the movement quality of the swing test.

      The Swing Test is a movement test used by physical therapists to identify movement problems
      during a simulated running stride
Upon arrival the subject will be given a questionnaire that will collect demographic
      information and determine whether they meet the inclusion/exclusion criteria for the study.
      If the subjects meet the inclusion/exclusion criteria for the study, they will be given an
      informed consent form for participation and photography.

      Prior to performing the swing test reflective markers will be placed on specific anatomical
      landmarks of the subject.

      An investigator will demonstrate how to perform the Swing test. The subject will then be
      instructed to step onto a six inch box and asked to swing one leg forwards and backwards
      mimicking their running stride. After ten practice repetitions, ten repetitions will be
      recorded by the Vicon Motion Analysis System and 2 video cameras capturing different views.
      The subject will then step off the box and the reflective markers will be removed.

      After the swing test, the subject will undergo a series of common musculoskeletal examination
      tests. The following examination tests will be performed in a random order.

      The first musculoskeletal examination test is hip extension range of motion (ROM) that will
      be measured using a goniometer. The subject will lie on their stomach and the investigator
      will take the subjects hip into extension and measure their full motion.

      The second examination tests is the Thomas test to determine the muscle length for rectus
      femoris muscle and iliotibial band. The subject will be instructed to sit on the edge of the
      bed and lower to supine while bringing one knee to chest. The investigator will assess the
      subject's lower extremity position to determine the length of the rectus femoris muscle and
      the iliotibial band.

      The third examination test is hip strength measurements of internal rotation, external
      rotation, and abduction which will be measured using a handheld dynamometer. The subject will
      be placed on their back and their hip strength will be measured using the dynamometer. The
      subject will then be placed on their side where further hip strength will be assessed.

      The fourth examination tests is the navicular drop test. In a seated position, a mark will be
      placed on the patient's navicular tubercle, which is a landmark on the inside of the foot. An
      index card will be placed next to the middle of the subjects foot and the height of the
      navicular will be marked on that index card. The subject will be instructed to stand up and
      the navicular height will be marked again on the index card. The difference in height between
      sitting and standing will be calculated.

      The fifth examination test is the sorensen test to determine the endurance of the back
      muscles. The subject will be instructed to lie prone with their trunk off the treatment
      table. The subject will have arms crossed at chest, and will be instructed to maintain upper
      body horizontal the floor. Time will be recorded during the test and the tests will stop when
      the subject cannot maintain horizontal or 240 seconds is reached.

      Three to five licensed physical therapists of varying levels of experience will be asked to
      watch the video recordings of the subject performing the swing test and rate their
      performance using a scoring system. Therapists who will be rating the Swing test will not
      have access to any data other than the videos.
observational model: Other
time perspective: Other
measure: Swing Test
time frame: 10-15 minutes
description: The subject will then be instructed to step onto a six inch box and asked to swing one leg forwards and backwards mimicking their running stride. After ten practice repetitions, ten repetitions will be recorded by the Vicon Motion Analysis System and 2 video cameras capturing different views. Three to five licensed physical therapists of varying levels of experience will be asked to watch the video recordings of the subject performing the swing test and rate their performance using a newly developed scoring system.
measure: Hip extension ROM
time frame: 5 minutes
description: The subject will lie on their stomach and the investigator will take the subjects hip into extension and measure their full motion.
measure: Thomas Test
time frame: 5 minutes
description: To determine the muscle length for rectus femoris muscle and iliotibial band., the subject will be instructed to sit on the edge of the bed and lower to supine while bringing one knee to chest. The investigator will assess the subject's lower extremity position to determine the length of the rectus femoris muscle and the iliotibial band.
measure: Hip strength
time frame: 5 minutes
description: Hip internal rotation, external rotation, and abduction will be measured using a handheld dynamometer.
measure: Navicular drop
time frame: 5 minutes
description: In a seated position, a mark will be placed on the subjects navicular tubercle. An index card will be placed next to the middle of the subjects foot and the height of the navicular will be marked on that index card. The subject will be instructed to stand up and the navicular height will be marked again on the index card. The difference in height between sitting and standing will be calculated.
measure: Sorensen Test
time frame: 5 minutes
description: To determine the endurance of the back muscles, the subject will be instructed to lie prone with their trunk off the treatment table. The subject will have arms crossed at chest, and will be instructed to maintain upper body horizontal the floor. Time will be recorded during the test and the tests will stop when the subject cannot maintain horizontal or 240 seconds is reached.
intervention type: Other
intervention name: No Intervention
description: This is a reliability/validity study of a functional clinical test. There is no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: AJ Lievre
phone: 5403273170
email: alievre@su.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shenandoah University
investigator full name: AJ Lievre
investigator title: Assistant Professor