xml: <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/NCT06010420</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar52</org_study_id>
      <nct_id>NCT06010420</nct_id>
    </id_info>
    <brief_title>The Effect of Using Medial Longitudinal Arch Supported Insoles on Jumping in Young Football Players</brief_title>
    <official_title>The Effect of Using Medial Longitudinal Arch Supported Insoles on Jumping in Young Football Players</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar 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>
        In this study, it was aimed to determine the effect of pressing styles and insoles on jumping&#xD;
        performances.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this clinical study, 30 healthy male football players between the ages of 16-20 will be&#xD;
        carried out at Kasımpaşa Sports Club Academy. In the study, the effect of medial longitudinal&#xD;
        arch height and the use of insoles on jumping using vertical jump, countermovement jump and&#xD;
        drop jump tests will be investigated. Football players; Medial longitudinal arch heights will&#xD;
        be measured by applying Foot Posture Index-6 and Navicular Position Test. As a result of&#xD;
        these measurements; flat sole, normal sole and high sole will be divided into three groups.&#xD;
        These three groups; Vertical jumping, countermovement jumping and drop jumping tests will be&#xD;
        applied with the help of portable jumping apparatus and the results will be recorded. These&#xD;
        tests will be re-applied to all three groups with a non-personalized, prefabricated insole&#xD;
        that supports the medial arch. According to these tests, it will be investigated whether&#xD;
        jumping performance depends on medial arch height. It will be evaluated whether there is a&#xD;
        change in jumps after the insoles used. The obtained data will be analyzed statistically.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>use of insoles</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Vertical jump test</measure>
      <time_frame>1 day</time_frame>
      <description>It is a test used to determine the jump height in athletes. In our study; The jump starting position for this test will be with the knees flexed at 90 degrees, the head facing forward, the arms positioned freely at the side of the body. While jumping; Upward jumping will be required with a sudden thrust. During this jump, the ankle will be plantar flexed, the knees and hips extended, and the arms will be lifted upwards. During landing, the ankle will contact the ground with dorsiflexion, knees and hips extended, and return to the starting position. 3 repetitions will be done and the highest will be accepted.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Countermovement Jump Test</measure>
      <time_frame>1 day</time_frame>
      <description>It is a frequently used method to evaluate the capacity of the musculoskeletal system in athletes. It is generally used to monitor the training capacity of athletes through parameters such as jump height, strength, power and speed. The jump start position for this test will be positioned with the knees flexed at 90 degrees, the head facing forward, with the hands on the waist from the sides to restrict the movement of the arms. While jumping; Upward jumping will be required with a sudden thrust. During this jump, the ankle will be plantar flexed, the knees and hips will be extended, and the hands will be at the waist. During landing, the ankle will contact the ground with dorsiflexion, knees and hips extended, and return to the starting position. 3 repetitions will be done and the highest will be accepted.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Drop Jump Test</measure>
      <time_frame>1 day</time_frame>
      <description>In our study, the starting position for this test will be on a high jump box with the hands at the sides on the waist and in a standing upright position. To initiate the fall movement, participants will be instructed: &quot;step out of the box with one foot and try to make the highest jump immediately after contact with the ground&quot;. The player will be instructed not to leave the jumping platform and jump out of the box for landing and jumping. The jump box will be 30 cm high. 3 repetitions will be done and the highest will be accepted. Reliability tests were conducted for jumping tests.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Navicular position test</measure>
      <time_frame>1 day</time_frame>
      <description>The test is done standing up. For whichever foot it will be applied, that foot will be in the back, the other foot will be in front, and the calcaneus of the front foot and the tip of the toe of the back foot will be on the same horizontal plane. In the extremity to be applied, the knee will be kept in a bent position so that it is vertically aligned with the 1st and 2nd finger. In this position, mark the head of the 1st metatarsal bone, the navicular bone, the apex of the medial malleolus, and the dorsal of the Achilles tendon horizontally aligned. First, a line is drawn and extended between the head of the 1st metatarsal bone and the navicular bone. Second, a line is drawn and lengthened between the navicular bone and the Achilles tendon. The angle between these two lines is measured.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Pes Planus</condition>
    <condition>Sports Physical Therapy</condition>
    <arm_group>
      <arm_group_label>flat sole</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Weighted-unweighted in navicular drop test 10 mm or more pronation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>normal base</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Weighted-unweighted in navicular drop test difference between measurement 5-9 mm is normal</description>
    </arm_group>
    <arm_group>
      <arm_group_label>high sole</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Weighted-unweighted in navicular drop test 4 mm or less is considered supination. are being</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>insoles</intervention_name>
      <description>Insoles are support devices that take the shape of the foot structure and enable the foot to press in a correct form.</description>
      <arm_group_label>flat sole</arm_group_label>
      <arm_group_label>high sole</arm_group_label>
      <arm_group_label>normal base</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Football players between the ages of 16-20 will be included in the study.&#xD;
  &#xD;
            -  Football players who were not injured at the time of the study were included in the&#xD;
               study will be.&#xD;
  &#xD;
            -  Football players who allow and want to participate in the study will be included in&#xD;
               the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Football players who had an injury at the time of the study were included in the study&#xD;
          will not be.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>20 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmet Can GÜNGÖRDÜ</last_name>
      <role>Study Chair</role>
      <affiliation>Kasimpasa Sports Club</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kasimpasa Sports Club</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ahmet Can GÜNGÖRDÜ</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Brocherie F, Millet GP, Girard O. Neuro-mechanical and metabolic adjustments to the repeated anaerobic sprint test in professional football players. Eur J Appl Physiol. 2015 May;115(5):891-903. doi: 10.1007/s00421-014-3070-z. Epub 2014 Dec 7.</citation>
      <PMID>25481506</PMID>
    </reference>
    <reference>
      <citation>Madeleine P, Hoej BP, Fernandez-de-Las-Penas C, Rathleff MS, Kaalund S. Pressure pain sensitivity changes after use of shock-absorbing insoles among young soccer players training on artificial turf: a randomized controlled trial. J Orthop Sports Phys Ther. 2014 Aug;44(8):587-94. doi: 10.2519/jospt.2014.5117. Epub 2014 Jul 16.</citation>
      <PMID>25029914</PMID>
    </reference>
    <reference>
      <citation>Girard O, Millet GP, Thomson A, Brocherie F. Is Plantar Loading Altered During Repeated Sprints on Artificial Turf in International Football Players? J Sports Sci Med. 2018 Aug 14;17(3):359-365. eCollection 2018 Sep.</citation>
      <PMID>30116108</PMID>
    </reference>
    <reference>
      <citation>Arundale AJH, Kvist J, Hagglund M, Faltstrom A. Jump performance in male and female football players. Knee Surg Sports Traumatol Arthrosc. 2020 Feb;28(2):606-613. doi: 10.1007/s00167-019-05747-1. Epub 2019 Oct 30.</citation>
      <PMID>31667569</PMID>
    </reference>
    <reference>
      <citation>Loturco I, Jeffreys I, Abad CCC, Kobal R, Zanetti V, Pereira LA, Nimphius S. Change-of-direction, speed and jump performance in soccer players: a comparison across different age-categories. J Sports Sci. 2020 Jun-Jun;38(11-12):1279-1285. doi: 10.1080/02640414.2019.1574276. Epub 2019 Feb 6.</citation>
      <PMID>30724662</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>Asst. Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>jumping</keyword>
    <keyword>insoles</keyword>
    <keyword>footballer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Flatfoot</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06010420
  org study id: Uskudar52
  nct id: NCT06010420
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, it was aimed to determine the effect of pressing styles and insoles on jumping
        performances.
  In this clinical study, 30 healthy male football players between the ages of 16-20 will be
        carried out at Kasımpaşa Sports Club Academy. In the study, the effect of medial longitudinal
        arch height and the use of insoles on jumping using vertical jump, countermovement jump and
        drop jump tests will be investigated. Football players; Medial longitudinal arch heights will
        be measured by applying Foot Posture Index-6 and Navicular Position Test. As a result of
        these measurements; flat sole, normal sole and high sole will be divided into three groups.
        These three groups; Vertical jumping, countermovement jumping and drop jumping tests will be
        applied with the help of portable jumping apparatus and the results will be recorded. These
        tests will be re-applied to all three groups with a non-personalized, prefabricated insole
        that supports the medial arch. According to these tests, it will be investigated whether
        jumping performance depends on medial arch height. It will be evaluated whether there is a
        change in jumps after the insoles used. The obtained data will be analyzed statistically.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: use of insoles
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Vertical jump test
  time frame: 1 day
  description: It is a test used to determine the jump height in athletes. In our study; The jump starting position for this test will be with the knees flexed at 90 degrees, the head facing forward, the arms positioned freely at the side of the body. While jumping; Upward jumping will be required with a sudden thrust. During this jump, the ankle will be plantar flexed, the knees and hips extended, and the arms will be lifted upwards. During landing, the ankle will contact the ground with dorsiflexion, knees and hips extended, and return to the starting position. 3 repetitions will be done and the highest will be accepted.
  measure: Countermovement Jump Test
  time frame: 1 day
  description: It is a frequently used method to evaluate the capacity of the musculoskeletal system in athletes. It is generally used to monitor the training capacity of athletes through parameters such as jump height, strength, power and speed. The jump start position for this test will be positioned with the knees flexed at 90 degrees, the head facing forward, with the hands on the waist from the sides to restrict the movement of the arms. While jumping; Upward jumping will be required with a sudden thrust. During this jump, the ankle will be plantar flexed, the knees and hips will be extended, and the hands will be at the waist. During landing, the ankle will contact the ground with dorsiflexion, knees and hips extended, and return to the starting position. 3 repetitions will be done and the highest will be accepted.
  measure: Drop Jump Test
  time frame: 1 day
  description: In our study, the starting position for this test will be on a high jump box with the hands at the sides on the waist and in a standing upright position. To initiate the fall movement, participants will be instructed: "step out of the box with one foot and try to make the highest jump immediately after contact with the ground". The player will be instructed not to leave the jumping platform and jump out of the box for landing and jumping. The jump box will be 30 cm high. 3 repetitions will be done and the highest will be accepted. Reliability tests were conducted for jumping tests.
  measure: Navicular position test
  time frame: 1 day
  description: The test is done standing up. For whichever foot it will be applied, that foot will be in the back, the other foot will be in front, and the calcaneus of the front foot and the tip of the toe of the back foot will be on the same horizontal plane. In the extremity to be applied, the knee will be kept in a bent position so that it is vertically aligned with the 1st and 2nd finger. In this position, mark the head of the 1st metatarsal bone, the navicular bone, the apex of the medial malleolus, and the dorsal of the Achilles tendon horizontally aligned. First, a line is drawn and extended between the head of the 1st metatarsal bone and the navicular bone. Second, a line is drawn and lengthened between the navicular bone and the Achilles tendon. The angle between these two lines is measured.
  arm group label: flat sole
  arm group type: Experimental
  description: Weighted-unweighted in navicular drop test 10 mm or more pronation
  arm group label: normal base
  arm group type: Experimental
  description: Weighted-unweighted in navicular drop test difference between measurement 5-9 mm is normal
  arm group label: high sole
  arm group type: Experimental
  description: Weighted-unweighted in navicular drop test 4 mm or less is considered supination. are being
  intervention type: Device
  intervention name: insoles
  description: Insoles are support devices that take the shape of the foot structure and enable the foot to press in a correct form.
  arm group label: flat sole
  arm group label: high sole
  arm group label: normal base
  criteria: 
  gender: Male
  minimum age: 16 Years
  maximum age: 20 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmet Can GÜNGÖRDÜ
  role: Study Chair
  affiliation: Kasimpasa Sports Club
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Brocherie F, Millet GP, Girard O. Neuro-mechanical and metabolic adjustments to the repeated anaerobic sprint test in professional football players. Eur J Appl Physiol. 2015 May;115(5):891-903. doi: 10.1007/s00421-014-3070-z. Epub 2014 Dec 7.
  PMID: 25481506
  citation: Madeleine P, Hoej BP, Fernandez-de-Las-Penas C, Rathleff MS, Kaalund S. Pressure pain sensitivity changes after use of shock-absorbing insoles among young soccer players training on artificial turf: a randomized controlled trial. J Orthop Sports Phys Ther. 2014 Aug;44(8):587-94. doi: 10.2519/jospt.2014.5117. Epub 2014 Jul 16.
  PMID: 25029914
  citation: Girard O, Millet GP, Thomson A, Brocherie F. Is Plantar Loading Altered During Repeated Sprints on Artificial Turf in International Football Players? J Sports Sci Med. 2018 Aug 14;17(3):359-365. eCollection 2018 Sep.
  PMID: 30116108
  citation: Arundale AJH, Kvist J, Hagglund M, Faltstrom A. Jump performance in male and female football players. Knee Surg Sports Traumatol Arthrosc. 2020 Feb;28(2):606-613. doi: 10.1007/s00167-019-05747-1. Epub 2019 Oct 30.
  PMID: 31667569
  citation: Loturco I, Jeffreys I, Abad CCC, Kobal R, Zanetti V, Pereira LA, Nimphius S. Change-of-direction, speed and jump performance in soccer players: a comparison across different age-categories. J Sports Sci. 2020 Jun-Jun;38(11-12):1279-1285. doi: 10.1080/02640414.2019.1574276. Epub 2019 Feb 6.
  PMID: 30724662
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst. Prof. Dr.
  mesh term: Flatfoot
  sharing ipd: No