<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/NCT03819205</url>
  </required_header>
  <id_info>
    <org_study_id>DorkuzEUZTOKEL</org_study_id>
    <nct_id>NCT03819205</nct_id>
  </id_info>
  <brief_title>Is Kinesio Taping Treatment Effective in Children With Cerebral Palsy?</brief_title>
  <official_title>Investıgatıng the Effect of Kinesiotaping on Hand Functions in Children With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dokuz Eylul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dokuz Eylul University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cerebral palsy (CP) is defined as a non-progressive lesion of the immature brain. Children&#xD;
      with CP may present with a variety of motor impairments.&#xD;
&#xD;
      The impaired upper limb function of children with cerebral palsy (CP) limits and restricts&#xD;
      participation in activities of daily living.&#xD;
&#xD;
      Kinesio Taping (KT) is commonly used in sport injuries, in neurology and oncology patients&#xD;
      following the surgical protocols, and for pediatric rehabilitation to reduce pain, facilitate&#xD;
      or inhibit muscle activity, prevent injuries, reposition joints, aid the lymphatic system,&#xD;
      support postural alignment, and improve proprioception. Kinesiotaping is a treatment that has&#xD;
      not been studied much and can be applied in cerebral palsy. The tapes were grouped as elastic&#xD;
      and rigid. In fact, there has been a few studies that investigates the effect of upper&#xD;
      extremity elastic kinesiotaping. High methodological studies about its efficacy in this&#xD;
      population are rare.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      34 Children with cerebral palsy aged between 6-18 applied to Dokuz Eylül Üniversity Medical&#xD;
      School Hospital Physical Medicine ve Rehabilitation Department will be included the study.&#xD;
      Patients have diagnosed as CP with the subgroup of diplegic, hemiplegic, tetraplegic and&#xD;
      mixt. The upper extremity side will be chosen as the affected side for the hemiplegic CP's&#xD;
      and for diplegic, tetraplegic CP's the side of upper extremity which children have been used&#xD;
      to but have obstacles in daily life. The chosen upper extremity side will be taped with the&#xD;
      functional correction technique on the dorsum of the hand and forearm by clinician. Patients&#xD;
      will be taped at least 2-3 hours a day every day and they will be also recomended dealing&#xD;
      with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way&#xD;
      that every patient has to be the control of themselves, 1 week before kinesiotaping,&#xD;
      immediately after kinesiotaping and 1 week after the period of kinesiotaping patients will be&#xD;
      evaluated with box and block test, nine hole peg test, modified house clasification score and&#xD;
      the active/passive wrist dorsiflexion range of motion. The investigator will also note the&#xD;
      gross motor function clasification system level, dominant hand side and affected side, for&#xD;
      chosen upper extremity side's zancolli clasification, modified aschwort scale of wrist and&#xD;
      hand fingers, manual ability clasification system level for every patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 15, 2018</start_date>
  <completion_date type="Anticipated">March 10, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>self-controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Box and block test</measure>
    <time_frame>1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)</time_frame>
    <description>With the stopwatch, it is recorded how many small cubes are transferred to the other side of the box within 60 seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nine hole peg test</measure>
    <time_frame>1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)</time_frame>
    <description>A wooden box with nine holes is placed in front of the patient and held in seconds with the stopwatch. Insersion and extraction time of pegs in second are noted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified house clasification score</measure>
    <time_frame>1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)</time_frame>
    <description>The score obtained from the Modified House Classification is calculated by recording the patient's capabilities among the listed 32 activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Active/passive wrist dorsiflexion range of motion</measure>
    <time_frame>1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)</time_frame>
    <description>With goniometer active/passive wrist dorsiflexion range of motion will be measured.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>kinesiotaping group(before/after)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hemiplegic CP:Kinesiotaping on the affected side&#xD;
Diplegic, tetraplegic CP: side of upper extremity which children have been used to but have obstacles in daily life&#xD;
intervention Duration: For 1 week at least 2-3 hours a day, renewing if it's necessary.&#xD;
Note:Patients will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day.&#xD;
Evaluation: In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>kinesiotaping</intervention_name>
    <description>The participants will receive kinesiotaping treatment on the affected side for the hemiplegic CP's and for diplegic, tetraplegic CP's the side of upper extremity which children have been used to but have obstacles in daily life for 1 week at least 2-3 hours a day, renewing if it's necessary. The participants will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion</description>
    <arm_group_label>kinesiotaping group(before/after)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 6-18&#xD;
&#xD;
          2. Following up with diagnose of hemiplegic/diplegic/tetraplegic CP patients with current&#xD;
             imaginig findings&#xD;
&#xD;
          3. Patient with stable clinical status&#xD;
&#xD;
          4. Stage ≤2 patients depended on the modified ascwort scale&#xD;
&#xD;
          5. Patients who are eligible to participate the study tests with suitable cognitive state&#xD;
&#xD;
          6. Patients who agreed to participate the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Stage &gt;2 patients depended on the modified ascwort scale&#xD;
&#xD;
          2. Botilinum toxin intervention to the upper extremity in the last 6 months.&#xD;
&#xD;
          3. Patients who undergo upper extremity surgery.&#xD;
&#xD;
          4. Patients who have contraindication for kinesiotaping (Wide and severe skin injury,&#xD;
             open wounds at risk of infection , allergic reactions)&#xD;
&#xD;
          5. Patients with intense sensory and motor loss in the banding area&#xD;
&#xD;
          6. Patients classified in stage IIB and above according to Zancolli stage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zeynep Tokel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dokuz Eylul University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zeynep Tokel</last_name>
    <phone>+905068535386</phone>
    <email>zeyneptkl343@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dokuz Eylul University</name>
      <address>
        <city>İ̇zmi̇r</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zeynep Tokel, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
    <investigator_full_name>ZEYNEP TOKEL</investigator_full_name>
    <investigator_title>: Principal investigator</investigator_title>
  </responsible_party>
  <keyword>cerebral palsy</keyword>
  <keyword>upper extremity kinesiotaping</keyword>
  <keyword>modified house</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03819205
org study id: DorkuzEUZTOKEL
nct id: NCT03819205
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cerebral palsy (CP) is defined as a non-progressive lesion of the immature brain. Children
      with CP may present with a variety of motor impairments.

      The impaired upper limb function of children with cerebral palsy (CP) limits and restricts
      participation in activities of daily living.

      Kinesio Taping (KT) is commonly used in sport injuries, in neurology and oncology patients
      following the surgical protocols, and for pediatric rehabilitation to reduce pain, facilitate
      or inhibit muscle activity, prevent injuries, reposition joints, aid the lymphatic system,
      support postural alignment, and improve proprioception. Kinesiotaping is a treatment that has
      not been studied much and can be applied in cerebral palsy. The tapes were grouped as elastic
      and rigid. In fact, there has been a few studies that investigates the effect of upper
      extremity elastic kinesiotaping. High methodological studies about its efficacy in this
      population are rare.
34 Children with cerebral palsy aged between 6-18 applied to Dokuz Eylül Üniversity Medical
      School Hospital Physical Medicine ve Rehabilitation Department will be included the study.
      Patients have diagnosed as CP with the subgroup of diplegic, hemiplegic, tetraplegic and
      mixt. The upper extremity side will be chosen as the affected side for the hemiplegic CP's
      and for diplegic, tetraplegic CP's the side of upper extremity which children have been used
      to but have obstacles in daily life. The chosen upper extremity side will be taped with the
      functional correction technique on the dorsum of the hand and forearm by clinician. Patients
      will be taped at least 2-3 hours a day every day and they will be also recomended dealing
      with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way
      that every patient has to be the control of themselves, 1 week before kinesiotaping,
      immediately after kinesiotaping and 1 week after the period of kinesiotaping patients will be
      evaluated with box and block test, nine hole peg test, modified house clasification score and
      the active/passive wrist dorsiflexion range of motion. The investigator will also note the
      gross motor function clasification system level, dominant hand side and affected side, for
      chosen upper extremity side's zancolli clasification, modified aschwort scale of wrist and
      hand fingers, manual ability clasification system level for every patient.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: self-controlled study
primary purpose: Treatment
masking: None (Open Label)
measure: Box and block test
time frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
description: With the stopwatch, it is recorded how many small cubes are transferred to the other side of the box within 60 seconds.
measure: Nine hole peg test
time frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
description: A wooden box with nine holes is placed in front of the patient and held in seconds with the stopwatch. Insersion and extraction time of pegs in second are noted.
measure: Modified house clasification score
time frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
description: The score obtained from the Modified House Classification is calculated by recording the patient's capabilities among the listed 32 activities
measure: Active/passive wrist dorsiflexion range of motion
time frame: 1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)
description: With goniometer active/passive wrist dorsiflexion range of motion will be measured.
arm group label: kinesiotaping group(before/after)
arm group type: Experimental
description: Hemiplegic CP:Kinesiotaping on the affected side
Diplegic, tetraplegic CP: side of upper extremity which children have been used to but have obstacles in daily life
intervention Duration: For 1 week at least 2-3 hours a day, renewing if it's necessary.
Note:Patients will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day.
Evaluation: In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion
intervention type: Other
intervention name: kinesiotaping
description: The participants will receive kinesiotaping treatment on the affected side for the hemiplegic CP's and for diplegic, tetraplegic CP's the side of upper extremity which children have been used to but have obstacles in daily life for 1 week at least 2-3 hours a day, renewing if it's necessary. The participants will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion
arm group label: kinesiotaping group(before/after)
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Zeynep Tokel, MD
role: Principal Investigator
affiliation: Dokuz Eylul University
last name: Zeynep Tokel
phone: +905068535386
email: zeyneptkl343@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dokuz Eylul University
investigator full name: ZEYNEP TOKEL
investigator title: : Principal investigator
mesh term: Paralysis
mesh term: Cerebral Palsy
sharing ipd: No