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/NCT06004271</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar68</org_study_id>
      <nct_id>NCT06004271</nct_id>
    </id_info>
    <brief_title>The Effect of Kinesio Taping on q Angle and Pes Planus in Children With Cerebral Palsy</brief_title>
    <official_title>The Effect of Kinesio Taping on q Angle and Pes Planus in Children With Cerebral Palsy</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>
        The aim of our study is to examine the effect of using kinesiology tape and using it for 8&#xD;
        weeks on Q angle and pes planus on children with cerebral palsy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        At the beginning of the study, the pes planus level of the children will be determined. Then&#xD;
        randomization will be made and divided into 3 groups with equal number of participants. The&#xD;
        groups will be called control, experiment, and placebo. Only physiotherapy will be applied to&#xD;
        the control group, kinesio taping and physiotherapy to the experimental group, and damask&#xD;
        taping and physiotherapy to the placebo group. The study will be followed for 8 weeks, and&#xD;
        pre- and post-intervention data were statistically analyzed and compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 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>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomization will be made and divided into 3 groups with equal number of participants. The groups will be called control, experiment, and placebo. Only physiotherapy will be applied to the control group, kinesio taping and physiotherapy to the experimental group, and damask taping and physiotherapy to the placebo group.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Calcaneo-tibial angle measurement</measure>
      <time_frame>10 weeks</time_frame>
      <description>The calcaneo-tibial angle measurement is a method used in the general evaluation of the foot. By measuring this angle, it is checked whether the problems in the foot are related to the rear foot. Normal values in this measurement are eversion angles between 4° and 8°. During the evaluation, the angle between the axis passing through the middle of the calcaneus and the place where the Achilles tendon attaches to the calcaneus will be measured, while the patient is in the prone position, not putting weight on his foot. Measurements will be made again while standing on the ground. Each measurement will be repeated 3 times. The differences between the results obtained during standing and prone lying will be calculated. The measurements will be averaged and recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Navicular bone drop test</measure>
      <time_frame>10 weeks</time_frame>
      <description>This assessment method evaluates midfoot mobility and medial longitudinal arch depression. In this method, the measurements should be between 5-9 mm. Before the evaluation, the height of the tubercle of the navicular bone will be measured in meters in millimeters, while the patient is in a sitting position, not putting weight on his feet. Then, the patient will be lifted up, and the patient will be asked to give equal weight to both feet in an upright position, and the measurement will be repeated 3 times. The average of the measurements will be recorded after they are taken. After the measurement, the difference between standing and in bed will be found.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Cerebral Palsy</condition>
    <condition>Pes Planus</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the control group, only the exercise program was applied and the first and last measurements will be compared.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the experimental group, kinesiology taping will be applied twice a week for 8 weeks together with exercise. Kinesiology taping was first applied by closing the malleoli from the upper part of the foot, and stretching it to the anterior capsule of the foot using the ligament technique. For the second tape, it covered the plantar area under the malleolus and was attached in the form of stirrups. During the application, the tape will be applied with full tension on the malleolus and 50-75% tension will be applied on the other parts.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Tape application will be applied in the placebo group as it was in the experimental group. Kinesiology taping will be attached horizontally without tension along the Tensor Facie Late line. The application to the ankle will be attached horizontally without tension slightly above the lateral malleolus.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise</intervention_name>
      <description>Exercise protocol:&#xD;
  Progressive Resistance Exercise Training Bridge exercise sit-up exercise functional walking exercise Stretching</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_label>placebo group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise and taping</intervention_name>
      <description>When applying kinesiology taping to the gluteus medius, first of all, for its anterior fiber, the tape portion will be attached lateral to the Spina iliaca anterior superior by giving a slight slope downwards from the crista iliaca with 50-75% tension. For the posterior fiber; Starting from the trochanter major, 50-75% tension will be applied along the muscle fiber.</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>placebo</intervention_name>
      <description>In the placebo tape application, the kinesiological tappings will be adhered horizontally without tension along the long line of the Tensor facie late muscle. The application to the ankle will be attached horizontally, without tension, slightly above the lateral malleolus.</description>
      <arm_group_label>placebo group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being diagnosed with cerebral palsy&#xD;
  &#xD;
            -  Gross Motor Function Classification System level 1,2 and 3&#xD;
  &#xD;
            -  2-18 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having Gross Motor Function Classification System levels 4 and 5&#xD;
  &#xD;
            -  Those with genetic and metabolic diagnosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Burhan SANCAKDAR</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</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>Üsküdar Unıversıty</name>
        <address>
          <city>Üsküdar</city>
          <state>İstanbul</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Armstrong RW. Definition and classification of cerebral palsy. Dev Med Child Neurol. 2007 Mar;49(3):166. doi: 10.1111/j.1469-8749.2007.00166.x. No abstract available.</citation>
      <PMID>17355470</PMID>
    </reference>
    <reference>
      <citation>Shakeri H, Keshavarz R, Arab AM, Ebrahimi I. Clinical effectiveness of kinesiological taping on pain and pain-free shoulder range of motion in patients with shoulder impingement syndrome: a randomized, double blinded, placebo-controlled trial. Int J Sports Phys Ther. 2013 Dec;8(6):800-10.</citation>
      <PMID>24377066</PMID>
    </reference>
    <reference>
      <citation>Shultz SJ, Nguyen AD, Windley TC, Kulas AS, Botic TL, Beynnon BD. Intratester and intertester reliability of clinical measures of lower extremity anatomic characteristics: implications for multicenter studies. Clin J Sport Med. 2006 Mar;16(2):155-61. doi: 10.1097/00042752-200603000-00012.</citation>
      <PMID>16603886</PMID>
    </reference>
    <reference>
      <citation>Park EY, Kim WH. Structural equation modeling of motor impairment, gross motor function, and the functional outcome in children with cerebral palsy. Res Dev Disabil. 2013 May;34(5):1731-9. doi: 10.1016/j.ridd.2013.02.003. Epub 2013 Mar 15.</citation>
      <PMID>23500167</PMID>
    </reference>
    <reference>
      <citation>Merino-Andres J, Garcia de Mateos-Lopez A, Damiano DL, Sanchez-Sierra A. Effect of muscle strength training in children and adolescents with spastic cerebral palsy: A systematic review and meta-analysis. Clin Rehabil. 2022 Jan;36(1):4-14. doi: 10.1177/02692155211040199. Epub 2021 Aug 18.</citation>
      <PMID>34407619</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 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>assistant professor</investigator_title>
    </responsible_party>
    <keyword>Cerebral palsy</keyword>
    <keyword>Kinesio tape</keyword>
    <keyword>Pes Planus</keyword>
    <keyword>Q angle</keyword>
    <keyword>Exercise</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Flatfoot</mesh_term>
      <mesh_term>Paralysis</mesh_term>
      <mesh_term>Cerebral Palsy</mesh_term>
    </condition_browse>
    <!-- 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/NCT06004271
  org study id: Uskudar68
  nct id: NCT06004271
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of our study is to examine the effect of using kinesiology tape and using it for 8
        weeks on Q angle and pes planus on children with cerebral palsy.
  At the beginning of the study, the pes planus level of the children will be determined. Then
        randomization will be made and divided into 3 groups with equal number of participants. The
        groups will be called control, experiment, and placebo. Only physiotherapy will be applied to
        the control group, kinesio taping and physiotherapy to the experimental group, and damask
        taping and physiotherapy to the placebo group. The study will be followed for 8 weeks, and
        pre- and post-intervention data were statistically analyzed and compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomization will be made and divided into 3 groups with equal number of participants. The groups will be called control, experiment, and placebo. Only physiotherapy will be applied to the control group, kinesio taping and physiotherapy to the experimental group, and damask taping and physiotherapy to the placebo group.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Calcaneo-tibial angle measurement
  time frame: 10 weeks
  description: The calcaneo-tibial angle measurement is a method used in the general evaluation of the foot. By measuring this angle, it is checked whether the problems in the foot are related to the rear foot. Normal values in this measurement are eversion angles between 4° and 8°. During the evaluation, the angle between the axis passing through the middle of the calcaneus and the place where the Achilles tendon attaches to the calcaneus will be measured, while the patient is in the prone position, not putting weight on his foot. Measurements will be made again while standing on the ground. Each measurement will be repeated 3 times. The differences between the results obtained during standing and prone lying will be calculated. The measurements will be averaged and recorded.
  measure: Navicular bone drop test
  time frame: 10 weeks
  description: This assessment method evaluates midfoot mobility and medial longitudinal arch depression. In this method, the measurements should be between 5-9 mm. Before the evaluation, the height of the tubercle of the navicular bone will be measured in meters in millimeters, while the patient is in a sitting position, not putting weight on his feet. Then, the patient will be lifted up, and the patient will be asked to give equal weight to both feet in an upright position, and the measurement will be repeated 3 times. The average of the measurements will be recorded after they are taken. After the measurement, the difference between standing and in bed will be found.
  arm group label: control group
  arm group type: Active Comparator
  description: In the control group, only the exercise program was applied and the first and last measurements will be compared.
  arm group label: experimental group
  arm group type: Experimental
  description: In the experimental group, kinesiology taping will be applied twice a week for 8 weeks together with exercise. Kinesiology taping was first applied by closing the malleoli from the upper part of the foot, and stretching it to the anterior capsule of the foot using the ligament technique. For the second tape, it covered the plantar area under the malleolus and was attached in the form of stirrups. During the application, the tape will be applied with full tension on the malleolus and 50-75% tension will be applied on the other parts.
  arm group label: placebo group
  arm group type: Placebo Comparator
  description: Tape application will be applied in the placebo group as it was in the experimental group. Kinesiology taping will be attached horizontally without tension along the Tensor Facie Late line. The application to the ankle will be attached horizontally without tension slightly above the lateral malleolus.
  intervention type: Other
  intervention name: exercise
  description: Exercise protocol:
  Progressive Resistance Exercise Training Bridge exercise sit-up exercise functional walking exercise Stretching
  arm group label: control group
  arm group label: experimental group
  arm group label: placebo group
  intervention type: Other
  intervention name: exercise and taping
  description: When applying kinesiology taping to the gluteus medius, first of all, for its anterior fiber, the tape portion will be attached lateral to the Spina iliaca anterior superior by giving a slight slope downwards from the crista iliaca with 50-75% tension. For the posterior fiber; Starting from the trochanter major, 50-75% tension will be applied along the muscle fiber.
  arm group label: experimental group
  intervention type: Other
  intervention name: placebo
  description: In the placebo tape application, the kinesiological tappings will be adhered horizontally without tension along the long line of the Tensor facie late muscle. The application to the ankle will be attached horizontally, without tension, slightly above the lateral malleolus.
  arm group label: placebo group
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Burhan SANCAKDAR
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  country: Turkey
  citation: Armstrong RW. Definition and classification of cerebral palsy. Dev Med Child Neurol. 2007 Mar;49(3):166. doi: 10.1111/j.1469-8749.2007.00166.x. No abstract available.
  PMID: 17355470
  citation: Shakeri H, Keshavarz R, Arab AM, Ebrahimi I. Clinical effectiveness of kinesiological taping on pain and pain-free shoulder range of motion in patients with shoulder impingement syndrome: a randomized, double blinded, placebo-controlled trial. Int J Sports Phys Ther. 2013 Dec;8(6):800-10.
  PMID: 24377066
  citation: Shultz SJ, Nguyen AD, Windley TC, Kulas AS, Botic TL, Beynnon BD. Intratester and intertester reliability of clinical measures of lower extremity anatomic characteristics: implications for multicenter studies. Clin J Sport Med. 2006 Mar;16(2):155-61. doi: 10.1097/00042752-200603000-00012.
  PMID: 16603886
  citation: Park EY, Kim WH. Structural equation modeling of motor impairment, gross motor function, and the functional outcome in children with cerebral palsy. Res Dev Disabil. 2013 May;34(5):1731-9. doi: 10.1016/j.ridd.2013.02.003. Epub 2013 Mar 15.
  PMID: 23500167
  citation: Merino-Andres J, Garcia de Mateos-Lopez A, Damiano DL, Sanchez-Sierra A. Effect of muscle strength training in children and adolescents with spastic cerebral palsy: A systematic review and meta-analysis. Clin Rehabil. 2022 Jan;36(1):4-14. doi: 10.1177/02692155211040199. Epub 2021 Aug 18.
  PMID: 34407619
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: assistant professor
  mesh term: Flatfoot
  mesh term: Paralysis
  mesh term: Cerebral Palsy