<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/NCT04467827</url>
  </required_header>
  <id_info>
    <org_study_id>BW- 2020- SUM</org_study_id>
    <nct_id>NCT04467827</nct_id>
  </id_info>
  <brief_title>Connection of Body Posture From the Level and Form of Physical Activity in a Group of Young People</brief_title>
  <official_title>Assessment of Body Posture Connection From the Level and Form of Physical Activity in a Group of Young People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Silesia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Silesia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The assumption of the research is to assess the change in body posture depending on the given&#xD;
      level of physical activity in young people. The aim of the study is to assess body posture in&#xD;
      young healthy people depending on their level of physical activity. The research will allow&#xD;
      the analysis of the correlation between the level of energy expenditure and the occurrence of&#xD;
      changes in body posture. The obtained results will allow the development of diagnostic and&#xD;
      therapeutic programs for the prevention of overload changes in the spine in young people.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in a group of 200 people aged 19-25. Posture assessment will&#xD;
      concern the measurement of curvatures in the sagittal plane of the spine using a&#xD;
      gravitational Rippstein plurimeter and performing a three-dimensional analysis of the spine&#xD;
      using the DIERS 3D device. In addition, a modified Matthias test will be performed using the&#xD;
      DIERS 3D device, where kyphosis and lordosis parameters in the sagittal plane of the spine at&#xD;
      isometric tension of the spinal muscles will be assessed. The spinal motion in the sagittal&#xD;
      and frontal planes will also be measured using a digital inclinometer. In the second stage of&#xD;
      the study, the participants will participate in the activity in the form of endurance&#xD;
      training &quot;Nordic Walking&quot; (NW) for a period of 8 weeks 3 times a week. The recording of&#xD;
      energy expenditure during a normal day of activity will be done using an Actigraph GT3X&#xD;
      accelerometer. After a period of 8 weeks, all measurements will be repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 16, 2022</start_date>
  <completion_date type="Anticipated">February 24, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 27, 2023</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>Body posture parameters assessed:</measure>
    <time_frame>9 weeks</time_frame>
    <description>Rippstein plurimeter - measurement of curvature of the spine - kyphosis, lordosis and measurement of the range of spinal mobility in the frontal and transverse planes (ROM)&#xD;
formetric measurement using the DIERS 3D three-dimensional analysis system-tilt of the torso, pelvic lift, pelvic rotation ,pelvic tilt, kyphosis angle, lordosis angle, spine rotation ,side deviation&#xD;
assessment of spinal flexibility (measuring device - digital inclinometer) - range of spinal mobility in the frontal and sagittal plane (ROM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity parameters assessed:</measure>
    <time_frame>9 weeks</time_frame>
    <description>accelerometer ActiGraph GT3X - assessment of MET energy expenditure and the number of steps performed during one day</description>
  </primary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Body Posture</condition>
  <arm_group>
    <arm_group_label>Group A1 male</arm_group_label>
    <description>back shape neutral - a vertical line applied to the back of the body meets at the level of the thoracic segment and buttocks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group A2 female</arm_group_label>
    <description>back shape neutral - a vertical line applied to the back of the body meets at the level of the thoracic segment and buttocks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B1 male</arm_group_label>
    <description>round back shape - a vertical line applied to the back of the body contacts only at the level of the thoracic segment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B2 female</arm_group_label>
    <description>round back shape - a vertical line applied to the back of the body contacts only at the level of the thoracic segment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C1 male</arm_group_label>
    <description>round back shape - a vertical line applied to the back of the body only touches the level of the buttock section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C2 female</arm_group_label>
    <description>round back shape - a vertical line applied to the back of the body only touches the level of the buttock section</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>examining group</intervention_name>
    <description>Posture assessment in young healthy people depending on their level of physical activity</description>
    <arm_group_label>Group A1 male</arm_group_label>
    <arm_group_label>Group A2 female</arm_group_label>
    <arm_group_label>Group B1 male</arm_group_label>
    <arm_group_label>Group B2 female</arm_group_label>
    <arm_group_label>Group C1 male</arm_group_label>
    <arm_group_label>Group C2 female</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Students of Medical University of Silesia in Katowice, Poland&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age from 19 to 25 years old&#xD;
&#xD;
          -  good health enabling the exercise of various forms of physical effort -cardiologically&#xD;
             stable persons, without significant respiratory, nervous and musculoskeletal disorders&#xD;
             / no other diseases&#xD;
&#xD;
          -  written consent of the examined person&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age below 19 and above 25,&#xD;
&#xD;
          -  health condition preventing the exercise of various forms of physical effort&#xD;
             (cardiologically unstable persons with significant respiratory, nervous and&#xD;
             musculoskeletal disorders / other diseases that prevent physical activity,&#xD;
&#xD;
          -  lack of written consent of the examined person,&#xD;
&#xD;
          -  lack of cooperation of the examined person during the test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jacek Durmała, PhD MD</last_name>
    <phone>+48 32 252 43 70</phone>
    <email>jdurmala@sum.edu.pl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bartosz Wnuk, PhD PT</last_name>
    <phone>+48 32 252 43 70</phone>
    <email>bwnuk@sum.edu.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Department of Rehabilitation, Faculty of Health Sciences in Katowice, Medical University of Silesia, Katowice,</name>
      <address>
        <city>Katowice,</city>
        <state>Katowice Ochojec</state>
        <zip>40-635</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacek Durmała, M.D.</last_name>
      <email>jdurmala@sum.edu.pl</email>
    </contact>
    <investigator>
      <last_name>Bartosz Wnuk, Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>body posture, physical activity , young people</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04467827
org study id: BW- 2020- SUM
nct id: NCT04467827
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The assumption of the research is to assess the change in body posture depending on the given
      level of physical activity in young people. The aim of the study is to assess body posture in
      young healthy people depending on their level of physical activity. The research will allow
      the analysis of the correlation between the level of energy expenditure and the occurrence of
      changes in body posture. The obtained results will allow the development of diagnostic and
      therapeutic programs for the prevention of overload changes in the spine in young people.
The study will be conducted in a group of 200 people aged 19-25. Posture assessment will
      concern the measurement of curvatures in the sagittal plane of the spine using a
      gravitational Rippstein plurimeter and performing a three-dimensional analysis of the spine
      using the DIERS 3D device. In addition, a modified Matthias test will be performed using the
      DIERS 3D device, where kyphosis and lordosis parameters in the sagittal plane of the spine at
      isometric tension of the spinal muscles will be assessed. The spinal motion in the sagittal
      and frontal planes will also be measured using a digital inclinometer. In the second stage of
      the study, the participants will participate in the activity in the form of endurance
      training "Nordic Walking" (NW) for a period of 8 weeks 3 times a week. The recording of
      energy expenditure during a normal day of activity will be done using an Actigraph GT3X
      accelerometer. After a period of 8 weeks, all measurements will be repeated.
observational model: Cohort
time perspective: Prospective
measure: Body posture parameters assessed:
time frame: 9 weeks
description: Rippstein plurimeter - measurement of curvature of the spine - kyphosis, lordosis and measurement of the range of spinal mobility in the frontal and transverse planes (ROM)
formetric measurement using the DIERS 3D three-dimensional analysis system-tilt of the torso, pelvic lift, pelvic rotation ,pelvic tilt, kyphosis angle, lordosis angle, spine rotation ,side deviation
assessment of spinal flexibility (measuring device - digital inclinometer) - range of spinal mobility in the frontal and sagittal plane (ROM)
measure: Physical activity parameters assessed:
time frame: 9 weeks
description: accelerometer ActiGraph GT3X - assessment of MET energy expenditure and the number of steps performed during one day
arm group label: Group A1 male
description: back shape neutral - a vertical line applied to the back of the body meets at the level of the thoracic segment and buttocks
arm group label: Group A2 female
description: back shape neutral - a vertical line applied to the back of the body meets at the level of the thoracic segment and buttocks
arm group label: Group B1 male
description: round back shape - a vertical line applied to the back of the body contacts only at the level of the thoracic segment
arm group label: Group B2 female
description: round back shape - a vertical line applied to the back of the body contacts only at the level of the thoracic segment
arm group label: Group C1 male
description: round back shape - a vertical line applied to the back of the body only touches the level of the buttock section
arm group label: Group C2 female
description: round back shape - a vertical line applied to the back of the body only touches the level of the buttock section
intervention type: Diagnostic Test
intervention name: examining group
description: Posture assessment in young healthy people depending on their level of physical activity
arm group label: Group A1 male
arm group label: Group A2 female
arm group label: Group B1 male
arm group label: Group B2 female
arm group label: Group C1 male
arm group label: Group C2 female
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: 19 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jacek Durmała, PhD MD
phone: +48 32 252 43 70
email: jdurmala@sum.edu.pl
last name: Bartosz Wnuk, PhD PT
phone: +48 32 252 43 70
email: bwnuk@sum.edu.pl
facility: 
status: Recruiting
contact: 
investigator: 
country: Poland
responsible party type: Sponsor
sharing ipd: Undecided