<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/NCT03032393</url>
  </required_header>
  <id_info>
    <org_study_id>071-2017</org_study_id>
    <nct_id>NCT03032393</nct_id>
  </id_info>
  <brief_title>The Effect of Power Posing on Timed Up and Go Test Score</brief_title>
  <official_title>The Effects of Posture on Timed up and go</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>
    <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>
      This study determines the effects of posture on time up and go test. Half of the subjects&#xD;
      will assume a high-power posture, while the other half will assume a low-power posture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects in the experimental group were instructed to stand with hands on their hips, elbows&#xD;
      pointing out and feet approximately one foot apart for 20 seconds. Subjects in the control&#xD;
      group were instructed to stand with hands and arms wrapping around the torso and feet&#xD;
      together for 20 seconds. Timed Up and Go test was administered using an OmniVR™ Virtual&#xD;
      Rehabilitation System before and after the postural intervention&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Timed up and go Test</measure>
    <time_frame>Up to 3 minutes during each Timed up and go Test. Twice (pre and post the postural intention) at the same session (day).</time_frame>
    <description>Patients wear their regular footwear and can use a walking aid if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters or 10 feet away on the floor. The timed up and go test measures the amount of time, in seconds, that it takes to stand from a chair, walk 3 meters, turn around and walk back to the chair, and sit down again.&#xD;
A change between pre and post postural intervention is reported. The time point for pre intervention is at baseline. The time point for post intervention is immediately after the intervention.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Dominant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the experimental group were instructed to stand with hands on their hips, elbows pointing out and feet approximately one foot apart for 20 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Submissive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in the control group were instructed to stand with hands and arms wrapping around the torso and feet together for 20 seconds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high-power</intervention_name>
    <description>Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.</description>
    <arm_group_label>Dominant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>low-power</intervention_name>
    <description>Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.</description>
    <arm_group_label>Submissive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female, age 18 to 65, with all 4 extremities intact, and ability to stand&#xD;
             still for 20 seconds.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to stand with their feet together or one foot apart for at least 20 seconds,&#xD;
             unable to wrap their arms around their torso or keep their hands on their hips for 20&#xD;
             seconds, unable to perform sit to stand transfer and ambulation independently, and&#xD;
             cognitive impairments that interfere with the experimental procedures.&#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>August 2020</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <results_first_submitted>January 9, 2019</results_first_submitted>
  <results_first_submitted_qc>August 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 10, 2020</results_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 13, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT03032393/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT03032393/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dominant</title>
          <description>high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.</description>
        </group>
        <group group_id="P2">
          <title>Submissive</title>
          <description>low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dominant</title>
          <description>high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.</description>
        </group>
        <group group_id="B2">
          <title>Submissive</title>
          <description>low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Timed up and go Test</title>
        <description>Patients wear their regular footwear and can use a walking aid if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters or 10 feet away on the floor. The timed up and go test measures the amount of time, in seconds, that it takes to stand from a chair, walk 3 meters, turn around and walk back to the chair, and sit down again.&#xD;
A change between pre and post postural intervention is reported. The time point for pre intervention is at baseline. The time point for post intervention is immediately after the intervention.</description>
        <time_frame>Up to 3 minutes during each Timed up and go Test. Twice (pre and post the postural intention) at the same session (day).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dominant</title>
            <description>high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Submissive</title>
            <description>low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Timed up and go Test</title>
          <description>Patients wear their regular footwear and can use a walking aid if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters or 10 feet away on the floor. The timed up and go test measures the amount of time, in seconds, that it takes to stand from a chair, walk 3 meters, turn around and walk back to the chair, and sit down again.&#xD;
A change between pre and post postural intervention is reported. The time point for pre intervention is at baseline. The time point for post intervention is immediately after the intervention.</description>
          <units>second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="0.65"/>
                    <measurement group_id="O2" value="0.20" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data will be collected for 11 months and 3 days during period of the data collection. For each participant, adverse event will be assessed for 1 day when the data collection is taken.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dominant</title>
          <description>high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.</description>
        </group>
        <group group_id="E2">
          <title>Submissive</title>
          <description>low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations of the study included convenience sampling and the small sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Associate Professor</name_or_title>
      <organization>Youngstown State University</organization>
      <phone>330941-2702</phone>
      <email>wge@ysu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03032393
org study id: 071-2017
nct id: NCT03032393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study determines the effects of posture on time up and go test. Half of the subjects
      will assume a high-power posture, while the other half will assume a low-power posture.
Subjects in the experimental group were instructed to stand with hands on their hips, elbows
      pointing out and feet approximately one foot apart for 20 seconds. Subjects in the control
      group were instructed to stand with hands and arms wrapping around the torso and feet
      together for 20 seconds. Timed Up and Go test was administered using an OmniVR™ Virtual
      Rehabilitation System before and after the postural intervention
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Timed up and go Test
time frame: Up to 3 minutes during each Timed up and go Test. Twice (pre and post the postural intention) at the same session (day).
description: Patients wear their regular footwear and can use a walking aid if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters or 10 feet away on the floor. The timed up and go test measures the amount of time, in seconds, that it takes to stand from a chair, walk 3 meters, turn around and walk back to the chair, and sit down again.
A change between pre and post postural intervention is reported. The time point for pre intervention is at baseline. The time point for post intervention is immediately after the intervention.
arm group label: Dominant
arm group type: Experimental
description: Subjects in the experimental group were instructed to stand with hands on their hips, elbows pointing out and feet approximately one foot apart for 20 seconds.
arm group label: Submissive
arm group type: Active Comparator
description: Subjects in the control group were instructed to stand with hands and arms wrapping around the torso and feet together for 20 seconds.
intervention type: Other
intervention name: high-power
description: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.
arm group label: Dominant
intervention type: Other
intervention name: low-power
description: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.
arm group label: Submissive
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
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations of the study included convenience sampling and the small sample size.
point of contact: 