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/NCT06034600</url>
    </required_header>
    <id_info>
      <org_study_id>2022/4027</org_study_id>
      <secondary_id>0000-0002-5941-1619</secondary_id>
      <nct_id>NCT06034600</nct_id>
    </id_info>
    <brief_title>Effect of Augmented Low-dye* Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus</brief_title>
    <acronym>Ald</acronym>
    <official_title>Effect of Augmented Low-dye Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inonu University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Inonu 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>
        Introduction: Pes planus is a deformity that affects the foot-ankle muscle complex as well as&#xD;
        passive components of the foot such as bones and ligaments. Various approaches such as taping&#xD;
        methods and exercise training are being investigated in the treatment of pes planus. The&#xD;
        effect of the applied methods and their superiority over each other are still unclear. The&#xD;
        effect of banding methods varies according to the band type and technique. Exercise methods&#xD;
        currently focus on the intrinsic and extrinsic muscles of the foot. Pedobarographic&#xD;
        evaluations are also performed in addition to clinical evaluations to evaluate the&#xD;
        effectiveness of treatments.&#xD;
  &#xD;
        Objective: It is planned to compare the effects of reinforced low-dye taping method, which is&#xD;
        one of the rigid taping techniques used in the treatment of pes planus, and exercise training&#xD;
        on foot plantar pressure, navicular drop and foot posture.&#xD;
  &#xD;
        Material and method: 34 individuals with pes planus between the ages of 18-25 will be&#xD;
        included in the study, which was designed as a single-blind randomized study. The universe of&#xD;
        our study will be Lokman Hekim University Faculty of Health Sciences and Institute of Health&#xD;
        Sciences. The whole universe will be tried to be reached and individuals who meet the&#xD;
        inclusion criteria will be selected from the relevant universe. Consent form will be obtained&#xD;
        from individuals who are deemed eligible to participate in the study. Pes planus evaluation;&#xD;
        It will be done using the navicular drop test and the foot posture index. In order for the&#xD;
        physical activity levels of the groups to be homogeneous, after stratified sampling,&#xD;
        individuals will be randomly assigned to the exercise groups by taping and exercise with the&#xD;
        closed envelope method. Evaluations will be made to each group at the beginning, at the&#xD;
        eighth and twelfth week. Static evaluation of the foot will be made using navicular drop and&#xD;
        foot posture index, and pedobarographic analysis will be done using a foot analyzer.&#xD;
  &#xD;
        Conclusion: The effects of taping and exercise training on foot static and plantar pressure&#xD;
        measurements will be interpreted.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        For taping application, intermittent taping will be done by the same researcher on the foot&#xD;
        with pes planus three times a week. The applied hard taping technique will be applied&#xD;
        continuously for eight weeks. The group that will perform exercises together with the taping&#xD;
        treatment will perform the exercises with the resistance band without taping and then do the&#xD;
        other exercises after the taping application. The applied taping will remain on the skin as&#xD;
        long as it can until the next taping day. Individuals will be asked to note the length of&#xD;
        stay of the tape on the skin. The exercises will be done three days a week for eight weeks.&#xD;
        After verbal information about the research protocol to be applied, practical training will&#xD;
        be given for the exercises. In the banding application, reinforced low-dye (ALD) technique,&#xD;
        one of the hard banding techniques, will be applied. A hard tape will be used on the&#xD;
        individuals by the same researcher throughout the study. With the tape application, to the&#xD;
        participants; Information will be given about physical activity, shoes and issues that should&#xD;
        be considered in daily life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 6, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 15, 2024</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>
      <intervention_model_description>Experimental, single-blind randomized controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>foot plantar pressure</measure>
      <time_frame>baseline, at 8 and 12 weeks</time_frame>
      <description>A foot analyzer will be used in the pedobarographic evaluation of the foot.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>navicular drop</measure>
      <time_frame>baseline, at 8 and 12 weeks</time_frame>
      <description>The distance measurement from the ground with the navicular will be measured using the caliper. Three measurements will be taken and the average recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>foot posture index</measure>
      <time_frame>baseline, at 8 and 12 weeks</time_frame>
      <description>Each criterion is scored on a scale ranging from -2 to +2, when the score is between 0 and 5, the foot will be considered neutral and between 6 and +12 as pronation.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Pes Planus</condition>
    <arm_group>
      <arm_group_label>exercise and taping</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individuals in this group are planned to practice exercise together with taping therapy for eight weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individuals in this group are planned to receive only exercise practice for eight weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>taping</intervention_name>
      <description>Taping will be applied to the exercise and taping group after the exercises with theraband. Other exercises that are not performed will be performed with the tape on the skin.The application will be repeated three days a week for eight weeks.</description>
      <arm_group_label>exercise and taping</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise</intervention_name>
      <description>Stretching and strengthening exercises will be applied to both groups three days a week for 8 weeks.The exercises performed with theraband will be performed in the same way in both groups. While the other exercises will be done after taping in the &quot;taping and exercise group&quot;, the &quot;exercise group&quot; will be done without taping.</description>
      <arm_group_label>exercise</arm_group_label>
      <arm_group_label>exercise and taping</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be between the ages of 18-25&#xD;
  &#xD;
            -  Navicular drop (ND) test &gt;10 mm&#xD;
  &#xD;
            -  Foot posture index ≥6&#xD;
  &#xD;
            -  Individuals in the 1st and 2nd category according to the international physical&#xD;
               activity survey&#xD;
  &#xD;
            -  Individuals who volunteered to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of systemic, neurological, rheumatological or orthopedic problems that may&#xD;
               affect the lower extremity&#xD;
  &#xD;
            -  Individuals who are allergic to the tape to be used&#xD;
  &#xD;
            -  Individuals who cannot adapt to exercise or taping practices&#xD;
  &#xD;
            -  Individuals who have received treatment for pes planus in the last 6 months&#xD;
  &#xD;
            -  Individuals with a BMI ≥ 30&#xD;
  &#xD;
            -  Presence of pregnancy&#xD;
  &#xD;
            -  Cases not wanting to take part in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Burcu Talu, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Inonu University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>asli oren, Msc</last_name>
      <phone>05065321333</phone>
      <email>fztaslioren@hotmail.com</email>
    </overall_contact>
    <results_reference>
      <citation>Tang M, Wang L, You Y, Li J, Hu X. Effects of taping techniques on arch deformation in adults with pes planus: A meta-analysis. PLoS One. 2021 Jul 2;16(7):e0253567. doi: 10.1371/journal.pone.0253567. eCollection 2021.</citation>
      <PMID>34214104</PMID>
    </results_reference>
    <results_reference>
      <citation>Hoang NT, Chen S, Chou LW. The Impact of Foot Orthoses and Exercises on Pain and Navicular Drop for Adult Flatfoot: A Network Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 29;18(15):8063. doi: 10.3390/ijerph18158063.</citation>
      <PMID>34360354</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Inonu University</investigator_affiliation>
      <investigator_full_name>Asli Oren</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>exercise</keyword>
    <keyword>flat foot</keyword>
    <keyword>Augmented Low-dye</keyword>
    <keyword>navicular drop</keyword>
    <keyword>plantar pressure</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/NCT06034600
  org study id: 2022/4027
  secondary id: 0000-0002-5941-1619
  nct id: NCT06034600
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Introduction: Pes planus is a deformity that affects the foot-ankle muscle complex as well as
        passive components of the foot such as bones and ligaments. Various approaches such as taping
        methods and exercise training are being investigated in the treatment of pes planus. The
        effect of the applied methods and their superiority over each other are still unclear. The
        effect of banding methods varies according to the band type and technique. Exercise methods
        currently focus on the intrinsic and extrinsic muscles of the foot. Pedobarographic
        evaluations are also performed in addition to clinical evaluations to evaluate the
        effectiveness of treatments.
  
        Objective: It is planned to compare the effects of reinforced low-dye taping method, which is
        one of the rigid taping techniques used in the treatment of pes planus, and exercise training
        on foot plantar pressure, navicular drop and foot posture.
  
        Material and method: 34 individuals with pes planus between the ages of 18-25 will be
        included in the study, which was designed as a single-blind randomized study. The universe of
        our study will be Lokman Hekim University Faculty of Health Sciences and Institute of Health
        Sciences. The whole universe will be tried to be reached and individuals who meet the
        inclusion criteria will be selected from the relevant universe. Consent form will be obtained
        from individuals who are deemed eligible to participate in the study. Pes planus evaluation;
        It will be done using the navicular drop test and the foot posture index. In order for the
        physical activity levels of the groups to be homogeneous, after stratified sampling,
        individuals will be randomly assigned to the exercise groups by taping and exercise with the
        closed envelope method. Evaluations will be made to each group at the beginning, at the
        eighth and twelfth week. Static evaluation of the foot will be made using navicular drop and
        foot posture index, and pedobarographic analysis will be done using a foot analyzer.
  
        Conclusion: The effects of taping and exercise training on foot static and plantar pressure
        measurements will be interpreted.
  For taping application, intermittent taping will be done by the same researcher on the foot
        with pes planus three times a week. The applied hard taping technique will be applied
        continuously for eight weeks. The group that will perform exercises together with the taping
        treatment will perform the exercises with the resistance band without taping and then do the
        other exercises after the taping application. The applied taping will remain on the skin as
        long as it can until the next taping day. Individuals will be asked to note the length of
        stay of the tape on the skin. The exercises will be done three days a week for eight weeks.
        After verbal information about the research protocol to be applied, practical training will
        be given for the exercises. In the banding application, reinforced low-dye (ALD) technique,
        one of the hard banding techniques, will be applied. A hard tape will be used on the
        individuals by the same researcher throughout the study. With the tape application, to the
        participants; Information will be given about physical activity, shoes and issues that should
        be considered in daily life.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Experimental, single-blind randomized controlled trial
  primary purpose: Treatment
  masking: Single (Participant)
  measure: foot plantar pressure
  time frame: baseline, at 8 and 12 weeks
  description: A foot analyzer will be used in the pedobarographic evaluation of the foot.
  measure: navicular drop
  time frame: baseline, at 8 and 12 weeks
  description: The distance measurement from the ground with the navicular will be measured using the caliper. Three measurements will be taken and the average recorded.
  measure: foot posture index
  time frame: baseline, at 8 and 12 weeks
  description: Each criterion is scored on a scale ranging from -2 to +2, when the score is between 0 and 5, the foot will be considered neutral and between 6 and +12 as pronation.
  arm group label: exercise and taping
  arm group type: Experimental
  description: Individuals in this group are planned to practice exercise together with taping therapy for eight weeks.
  arm group label: exercise
  arm group type: Experimental
  description: Individuals in this group are planned to receive only exercise practice for eight weeks.
  intervention type: Other
  intervention name: taping
  description: Taping will be applied to the exercise and taping group after the exercises with theraband. Other exercises that are not performed will be performed with the tape on the skin.The application will be repeated three days a week for eight weeks.
  arm group label: exercise and taping
  intervention type: Other
  intervention name: exercise
  description: Stretching and strengthening exercises will be applied to both groups three days a week for 8 weeks.The exercises performed with theraband will be performed in the same way in both groups. While the other exercises will be done after taping in the "taping and exercise group", the "exercise group" will be done without taping.
  arm group label: exercise
  arm group label: exercise and taping
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Burcu Talu, PhD
  role: Study Director
  affiliation: Inonu University
  last name: asli oren, Msc
  phone: 05065321333
  email: fztaslioren@hotmail.com
  citation: Tang M, Wang L, You Y, Li J, Hu X. Effects of taping techniques on arch deformation in adults with pes planus: A meta-analysis. PLoS One. 2021 Jul 2;16(7):e0253567. doi: 10.1371/journal.pone.0253567. eCollection 2021.
  PMID: 34214104
  citation: Hoang NT, Chen S, Chou LW. The Impact of Foot Orthoses and Exercises on Pain and Navicular Drop for Adult Flatfoot: A Network Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 29;18(15):8063. doi: 10.3390/ijerph18158063.
  PMID: 34360354
  responsible party type: Principal Investigator
  investigator affiliation: Inonu University
  investigator full name: Asli Oren
  investigator title: Principal Investigator
  mesh term: Flatfoot
  sharing ipd: No