<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20231108059995N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the Efficacy of Kinesio Tape and Massage Therapy on Balance and Ankle Rang of Motion in Cerebral Palsy Children</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Efficacy of Kinesio Tape and Massage Therapy on Balance and Ankle Rang of Motion in Dipelgia Cerebral Palsy Children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74566</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Spastic diplegic cerebral palsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The first intervention group: massage therapy group The calf muscles are massaged three days a week for two months using special massage oil. The deep tissue massage technique is applied with prolonged deep pressure for 30 minutes. Plus, occupational therapy is conducted two days a week for two months. Intervention 2: Intervention group: The second intervention group: the kinesio tape groupThe Kinesio tape is placed on the leg muscles one day a week; plus, an inhibitory technique is employed to relieve muscle spasms and increase the ankle's range of motion. The tape is kept on the leg muscles for four days and then removed so the muscle rests for three days. It is repeated once a week for 2 months. In addition, occupational therapy is conducted two days a week for two months. Intervention 3: Control group:Only occupational therapy sessions are conducted two days a week for eight weeks.They understand the intention of the intervening person and can make an active move.Children with cerebral palsy without acute mental and physical problems.Participants aged 18 or younger who are diagnosed with Cerebral palsy.Caregivers who do not bring their children to the rehabilitation clinic regularly.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Data collection has not been done yet, we will make a decision later</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahla Hasheminezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1st Floor, No. 8, Second Mehr Alley ,16 meter Ave, Shahid Najafi town, Elahia, Kermanshah, Iran</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719687169</zip>
        <telephone>+98 930 918 1219</telephone>
        <email>shahlahasheminezhad1993@gamil.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahla Hasheminezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1st Floor, No. 8, Second Mehr Alley ,16 meter Ave, Shahid Najafi town, Elahia, Kermanshah, Iran</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719687169</zip>
        <telephone>+98 930 918 1219</telephone>
        <email>shahlahasheminezhad1993@gamil.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants 18 years of age or younger who have been diagnosed with cerebral palsy.
Children with cerebral palsy without acute mental and physical problems.
They understand the intention of the intervening person and can make an active move.
All the people must be spastic diplegia because the balance of hemiplegia is different from diplegia.
The age of the participants should not be less than 4 years, because, for the initial measurements, it is necessary for the person to actively participate and understand the interventionist's intention.</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Caregivers who do not bring their children to the rehabilitation clinic regularly.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spastic diplegic cerebral palsy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The first intervention group: massage therapy group The calf muscles are massaged three days a week for two months using special massage oil. The deep tissue massage technique is applied with prolonged deep pressure for 30 minutes. Plus, occupational therapy is conducted two days a week for two months.</i_keyword>
      <i_keyword>Intervention group: The second intervention group: the kinesio tape groupThe Kinesio tape is placed on the leg muscles one day a week; plus, an inhibitory technique is employed to relieve muscle spasms and increase the ankle's range of motion. The tape is kept on the leg muscles for four days and then removed so the muscle rests for three days. It is repeated once a week for 2 months. In addition, occupational therapy is conducted two days a week for two months.</i_keyword>
      <i_keyword>Control group:Only occupational therapy sessions are conducted two days a week for eight weeks.They understand the intention of the intervening person and can make an active move.Children with cerebral palsy without acute mental and physical problems.Participants aged 18 or younger who are diagnosed with Cerebral palsy.Caregivers who do not bring their children to the rehabilitation clinic regularly.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The balance score in berg test. Timepoint: before the start of the intervention and 8 weeks after the intervention (completion). Method of measurement: Berg Balance Scale.</prim_outcome>
      <prim_outcome>Degree of range of motion of the ankle with a goniometer. Timepoint: before the start of the intervention and 8 weeks after the intervention (completion). Method of measurement: Goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-02</approval_date>
        <contact_name>Islamic Azad University Kermanshah Branch</contact_name>
        <contact_address>Imam Khomeini Campus, Islamic Azad University, Farhikhtegan Bld., Shahid J'afari St., Kermanshah, Iran. kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
