<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/NCT03023943</url>
  </required_header>
  <id_info>
    <org_study_id>072-2017</org_study_id>
    <nct_id>NCT03023943</nct_id>
  </id_info>
  <brief_title>The Effects of IASTM and Proprioception</brief_title>
  <official_title>The Effects of Instrument Assisted Soft Tissue Mobilization on Proprioception</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Youngstown State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Youngstown State University</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>
      The research design will be single group pretest-posttest design. The subject will be&#xD;
      instructed to position the knee joint to a position previously set by the experimenter.&#xD;
      Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep&#xD;
      technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proprioception determined using the reposition error</measure>
    <time_frame>5 minutes</time_frame>
    <description>Proprioception will be determined by measuring the reposition error of the knee joint. The subject will be instructed to position the knee joint to a position (flexion) previously set by the experimenter at 30 degree flexion. The difference will be calculated as the reposition error. The position of the knee joint will be measure using a goniometer. An alternative is to use an App (e.g. Angle Meter) on a smart phone or an iPad for accuracy.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>IASTM group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Instrument Assisted Soft Tissue Mobilization</intervention_name>
    <description>Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.</description>
    <arm_group_label>IASTM group</arm_group_label>
    <other_name>IASTM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female, age 18 to 65.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sensory impairments or a present contraindications to IASTM which include cancer, burn&#xD;
             scars, kidney dysfunction, pregnancy, varicose veins, osteoporosis, body art, chronic&#xD;
             regional pain syndrome, polyneuropathies, fractures, autoimmune disorders, diabetes,&#xD;
             vitamin C &amp; D/Calcium deficiencies, rheumatoid arthritis, ankylosing spondylitis,&#xD;
             congestive heart failure, acute inflammation, lymphedema, flu or illness with flu-like&#xD;
             symptoms, and medications (anticoagulant, steroids, hormone replacements, NSAIDS,&#xD;
             fluoroquinolone antibiotics, herbal supplements).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Hripko</last_name>
    <role>Study Director</role>
    <affiliation>Youngstown State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Youngstown State University</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Youngstown State University</investigator_affiliation>
    <investigator_full_name>Weiqing Ge</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03023943
org study id: 072-2017
nct id: NCT03023943
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The research design will be single group pretest-posttest design. The subject will be
      instructed to position the knee joint to a position previously set by the experimenter.
      Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep
      technique.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proprioception determined using the reposition error
time frame: 5 minutes
description: Proprioception will be determined by measuring the reposition error of the knee joint. The subject will be instructed to position the knee joint to a position (flexion) previously set by the experimenter at 30 degree flexion. The difference will be calculated as the reposition error. The position of the knee joint will be measure using a goniometer. An alternative is to use an App (e.g. Angle Meter) on a smart phone or an iPad for accuracy.
arm group label: IASTM group
arm group type: Experimental
description: Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.
intervention type: Other
intervention name: Instrument Assisted Soft Tissue Mobilization
description: Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.
arm group label: IASTM group
other name: IASTM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Hripko
role: Study Director
affiliation: Youngstown State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Youngstown State University
investigator full name: Weiqing Ge
investigator title: Associate Professor