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/NCT06022718</url>
    </required_header>
    <id_info>
      <org_study_id>EKK21-22/016/006</org_study_id>
      <nct_id>NCT06022718</nct_id>
    </id_info>
    <brief_title>Comparison of Kinesio-Taping and Rigid-Taping on Vertical Jump in Individuals With Pes Planus</brief_title>
    <official_title>A Randomised Crossover Comparison of Kinesio-Taping and Rigid-Taping on Vertical Jump in Individuals With Pes Planus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cyprus International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cyprus International 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>
        The effects of Kinesio-taping and rigid-taping on vertical jump performance have been&#xD;
        investigated; however, results remain unclear.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The effect of Kinesio-taping and rigid-taping on controlling foot pronation remains unclear&#xD;
        due to contradicted results. Moreover, to our knowledge, there is not any study to elucidate&#xD;
        the effect of rigid-taping on vertical jump performance. Therefore, the investigators&#xD;
        hypothesised that rigid-taping would be more effective on vertical jump performance because&#xD;
        of its direct mechanical correction in pes planus, and the study was aimed to compare the&#xD;
        effects of Kinesio-taping and RT on vertical jump performance in sedentary adults with pes&#xD;
        planus.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 9, 2023</start_date>
    <completion_date type="Actual">May 26, 2023</completion_date>
    <primary_completion_date type="Actual">April 28, 2023</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Low dye bandage technique was used with a 3.8 cm wide rigid band (Leuko® Sportstape Premium, Germany) for rigid taping. RT was performed on both feet in the subtalar neutral position while participants in the prone position with their heels and feet out of the bed. The taping protocol described elsewhere was followed. To optimise rigid tape adhesion, feet were washed and dried before taping. To increase consistency, the same researcher (MU) applied all taping.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Vertical Jump</measure>
      <time_frame>2 minutes</time_frame>
      <description>The jumping performance of each participant was evaluated using the VertiMetric (Lafayette Instrument Company, Lafayette, IN) device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Foot Posture</measure>
      <time_frame>10 minutes</time_frame>
      <description>Foot Posture Index is used for clinical diagnostic purposes that evaluate whether a foot is in pronation, supination, or normal posture. The sum of six-item scores between 0-5 are interpreted as normal foot, scores of 6-12 as pes planus, and scores &lt;0 as pes cavus.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical Activity</measure>
      <time_frame>3 minutes</time_frame>
      <description>The physical activity levels of the participants were evaluated with the International Physical Activity Questionnaire.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">74</enrollment>
    <condition>Pes Planus</condition>
    <arm_group>
      <arm_group_label>Kinesio-taping Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Kinesio® Tex GoldFP (USA) was applied on both feet in the prone position with the knee extended, and the feet in a slightly plantar flexed position and hanging off the bed. The first Kinesio-taping was cut as an I shape and prepared for the transverse arch ligament correction technique. The non-stretched starting anchor was attached to the dorsum of the 5th metatars on the lateral side of the foot, passed from the plantar surface to the medial side with 75-100% tension. The non-stretched end was attached to the medial side of the ankle over the navicular region. The non-stretched initial anchor of the second Kinesio-taping strip starting from the proximal dorsal of the 5th. metatarsal on the lateral side of the foot.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Rigid-taping Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Low dye bandage technique was used with a 3.8 cm wide rigid band (Leuko® Sportstape Premium, Germany) for rigid taping. Rigid taping was performed on both feet in the subtalar neutral position while participants in the prone position with their heels and feet out of the bed. The taping protocol described elsewhere was followed. 21 To optimise rigid tape adhesion, feet were washed and dried before taping. To increase consistency, the same researcher (MU) applied all taping.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Taping</intervention_name>
      <description>Kinesio taping and Rigid taping was applied.</description>
      <arm_group_label>Kinesio-taping Group</arm_group_label>
      <arm_group_label>Rigid-taping Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female individuals between the ages of 18-35,&#xD;
  &#xD;
            -  Individuals without any chronic disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those with lower extremity injuries in the last 1 year,&#xD;
  &#xD;
            -  Those with a history of lower extremity surgery and visual or vestibular disorders,&#xD;
  &#xD;
            -  Those with other foot deformities accompanying pes planus,&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Salih Angın, PhD.</last_name>
      <role>Study Chair</role>
      <affiliation>Cyprus International University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mehmet Miçooğulları</name>
        <address>
          <city>Mersin</city>
          <zip>99258</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Ledoux WR, Hillstrom HJ. The distributed plantar vertical force of neutrally aligned and pes planus feet. Gait Posture. 2002 Feb;15(1):1-9. doi: 10.1016/s0966-6362(01)00165-5.</citation>
      <PMID>11809575</PMID>
    </reference>
    <reference>
      <citation>Razeghi M, Batt ME. Foot type classification: a critical review of current methods. Gait Posture. 2002 Jun;15(3):282-91. doi: 10.1016/s0966-6362(01)00151-5.</citation>
      <PMID>11983503</PMID>
    </reference>
    <reference>
      <citation>Aguilar MB, Abian-Vicen J, Halstead J, Gijon-Nogueron G. Effectiveness of neuromuscular taping on pronated foot posture and walking plantar pressures in amateur runners. J Sci Med Sport. 2016 Apr;19(4):348-53. doi: 10.1016/j.jsams.2015.04.004. Epub 2015 Apr 24.</citation>
      <PMID>25956688</PMID>
    </reference>
    <reference>
      <citation>Arastoo AA, Aghdam EM, Habibi AH, Zahednejad S. Kinetic factors of vertical jumping for heading a ball in flexible flatfooted amateur soccer players with and without insole adoption. Prosthet Orthot Int. 2014 Jun;38(3):204-10. doi: 10.1177/0309364613492790. Epub 2013 Jul 4.</citation>
      <PMID>23828877</PMID>
    </reference>
    <reference>
      <citation>Vanezis A, Lees A. A biomechanical analysis of good and poor performers of the vertical jump. Ergonomics. 2005 Sep 15-Nov 15;48(11-14):1594-603. doi: 10.1080/00140130500101262.</citation>
      <PMID>16338725</PMID>
    </reference>
    <reference>
      <citation>Nakajima MA, Baldridge C. The effect of kinesio(R) tape on vertical jump and dynamic postural control. Int J Sports Phys Ther. 2013 Aug;8(4):393-406.</citation>
      <PMID>24175126</PMID>
    </reference>
    <reference>
      <citation>Franettovich MM, Murley GS, David BS, Bird AR. A comparison of augmented low-Dye taping and ankle bracing on lower limb muscle activity during walking in adults with flat-arched foot posture. J Sci Med Sport. 2012 Jan;15(1):8-13. doi: 10.1016/j.jsams.2011.05.009. Epub 2011 Aug 30.</citation>
      <PMID>21880545</PMID>
    </reference>
    <reference>
      <citation>Angin S, Crofts G, Mickle KJ, Nester CJ. Ultrasound evaluation of foot muscles and plantar fascia in pes planus. Gait Posture. 2014;40(1):48-52. doi: 10.1016/j.gaitpost.2014.02.008. Epub 2014 Feb 26.</citation>
      <PMID>24630465</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT06022718
  org study id: EKK21-22/016/006
  nct id: NCT06022718
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The effects of Kinesio-taping and rigid-taping on vertical jump performance have been
        investigated; however, results remain unclear.
  The effect of Kinesio-taping and rigid-taping on controlling foot pronation remains unclear
        due to contradicted results. Moreover, to our knowledge, there is not any study to elucidate
        the effect of rigid-taping on vertical jump performance. Therefore, the investigators
        hypothesised that rigid-taping would be more effective on vertical jump performance because
        of its direct mechanical correction in pes planus, and the study was aimed to compare the
        effects of Kinesio-taping and RT on vertical jump performance in sedentary adults with pes
        planus.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Low dye bandage technique was used with a 3.8 cm wide rigid band (Leuko® Sportstape Premium, Germany) for rigid taping. RT was performed on both feet in the subtalar neutral position while participants in the prone position with their heels and feet out of the bed. The taping protocol described elsewhere was followed. To optimise rigid tape adhesion, feet were washed and dried before taping. To increase consistency, the same researcher (MU) applied all taping.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Vertical Jump
  time frame: 2 minutes
  description: The jumping performance of each participant was evaluated using the VertiMetric (Lafayette Instrument Company, Lafayette, IN) device.
  measure: Foot Posture
  time frame: 10 minutes
  description: Foot Posture Index is used for clinical diagnostic purposes that evaluate whether a foot is in pronation, supination, or normal posture. The sum of six-item scores between 0-5 are interpreted as normal foot, scores of 6-12 as pes planus, and scores <0 as pes cavus.
  measure: Physical Activity
  time frame: 3 minutes
  description: The physical activity levels of the participants were evaluated with the International Physical Activity Questionnaire.
  arm group label: Kinesio-taping Group
  arm group type: Experimental
  description: Kinesio® Tex GoldFP (USA) was applied on both feet in the prone position with the knee extended, and the feet in a slightly plantar flexed position and hanging off the bed. The first Kinesio-taping was cut as an I shape and prepared for the transverse arch ligament correction technique. The non-stretched starting anchor was attached to the dorsum of the 5th metatars on the lateral side of the foot, passed from the plantar surface to the medial side with 75-100% tension. The non-stretched end was attached to the medial side of the ankle over the navicular region. The non-stretched initial anchor of the second Kinesio-taping strip starting from the proximal dorsal of the 5th. metatarsal on the lateral side of the foot.
  arm group label: Rigid-taping Group
  arm group type: Experimental
  description: Low dye bandage technique was used with a 3.8 cm wide rigid band (Leuko® Sportstape Premium, Germany) for rigid taping. Rigid taping was performed on both feet in the subtalar neutral position while participants in the prone position with their heels and feet out of the bed. The taping protocol described elsewhere was followed. 21 To optimise rigid tape adhesion, feet were washed and dried before taping. To increase consistency, the same researcher (MU) applied all taping.
  intervention type: Other
  intervention name: Taping
  description: Kinesio taping and Rigid taping was applied.
  arm group label: Kinesio-taping Group
  arm group label: Rigid-taping Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Salih Angın, PhD.
  role: Study Chair
  affiliation: Cyprus International University
  facility: 
  country: Turkey
  citation: Ledoux WR, Hillstrom HJ. The distributed plantar vertical force of neutrally aligned and pes planus feet. Gait Posture. 2002 Feb;15(1):1-9. doi: 10.1016/s0966-6362(01)00165-5.
  PMID: 11809575
  citation: Razeghi M, Batt ME. Foot type classification: a critical review of current methods. Gait Posture. 2002 Jun;15(3):282-91. doi: 10.1016/s0966-6362(01)00151-5.
  PMID: 11983503
  citation: Aguilar MB, Abian-Vicen J, Halstead J, Gijon-Nogueron G. Effectiveness of neuromuscular taping on pronated foot posture and walking plantar pressures in amateur runners. J Sci Med Sport. 2016 Apr;19(4):348-53. doi: 10.1016/j.jsams.2015.04.004. Epub 2015 Apr 24.
  PMID: 25956688
  citation: Arastoo AA, Aghdam EM, Habibi AH, Zahednejad S. Kinetic factors of vertical jumping for heading a ball in flexible flatfooted amateur soccer players with and without insole adoption. Prosthet Orthot Int. 2014 Jun;38(3):204-10. doi: 10.1177/0309364613492790. Epub 2013 Jul 4.
  PMID: 23828877
  citation: Vanezis A, Lees A. A biomechanical analysis of good and poor performers of the vertical jump. Ergonomics. 2005 Sep 15-Nov 15;48(11-14):1594-603. doi: 10.1080/00140130500101262.
  PMID: 16338725
  citation: Nakajima MA, Baldridge C. The effect of kinesio(R) tape on vertical jump and dynamic postural control. Int J Sports Phys Ther. 2013 Aug;8(4):393-406.
  PMID: 24175126
  citation: Franettovich MM, Murley GS, David BS, Bird AR. A comparison of augmented low-Dye taping and ankle bracing on lower limb muscle activity during walking in adults with flat-arched foot posture. J Sci Med Sport. 2012 Jan;15(1):8-13. doi: 10.1016/j.jsams.2011.05.009. Epub 2011 Aug 30.
  PMID: 21880545
  citation: Angin S, Crofts G, Mickle KJ, Nester CJ. Ultrasound evaluation of foot muscles and plantar fascia in pes planus. Gait Posture. 2014;40(1):48-52. doi: 10.1016/j.gaitpost.2014.02.008. Epub 2014 Feb 26.
  PMID: 24630465
  responsible party type: Sponsor
  mesh term: Flatfoot
  sharing ipd: No