<?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>IRCT20180627040262N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-11</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of mirror therapy in cerebral palsy</public_title>
      <acronym></acronym>
      <scientific_title>study of the effect of mirror therapy on upper limb function in the children with hemiplegic cerebral palsy aged 9_14 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32261</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: In this clinical trial study, a list of spastic hemiplegia children and adolescents in public, private and extraordinary schools in Tabriz, which were in the age range of 14 to 9 years old, were selected and entered randomly. (Lottery) were divided into two groups of control and intervention, Blinding description: The initial evaluation and final evaluation will be done by another therapist who is not aware of the grouping of the groups. . Individuals' referrals for implementing the therapeutic interventions of the two control and intervention groups are adjusted so that the two groups do not have contact during the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemiplegic Cerebral Palsy.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: In addition to the routine rehabilitation program, the subjects in the intervention group receive  mirror therapy for 6 weeks ( three days a week) and each session for 30 minutes.  In the routine rehabilitation program,   Bobath exercises, such as RIP, active and passive exercises( flexion, and extension of the shoulder, elbow, and wrists) are used. In addition to these exercises, several functional  exercises, such as bring a cup up into the mouth, drawing a circle and, squeeze a towel will done. Intervention 2: Control group:subjects in this group receive a routine rehabilitation for six weeks. In the routine rehabilitation program,   Bobath exercises, such as RIP, active and passive exercises( flexion, and extension of the shoulder, elbow, and wrists) are used. In addition to these exercises, several functional  exercises, such as bring a cup up into the mouth, drawing a circle and, squeeze a towel will done.program.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is According to the request of the participants, the information remains confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akbar Narimani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>6th Floor, Next to Sahel Pool, Azarbaijan Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5186836453</zip>
        <telephone>+98 41 3288 0817</telephone>
        <email>narimani.ofogh@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoo Kalantari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>at the Bu'ali Hospital,  Damavand Avenue (Tehran-Nou),  Imam Hossein Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7756 1721</telephone>
        <email>mn_kalantari@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of spastic hemiplegic cerebral palsy by pediatric neurologist
Children aged 9 to 14 years old
Lack of cognitive impairment and half-body forgetfulness and lack of orthopedic defects based on expert examination and diagnosis
Non-verbal and visual impairment based on a doctor's examination
no surgical procedures including tendon transfer
Having attention and concentration to the mirror and the ability to perform the relevant exercises within a specified time (at least 10 minutes) based on the interventionist view
Acquire level1 - 3 of the Manual Ability classification System (MACS)
Tone of the affected upper limb less than or equal to 2, was corrected based on the modified Ashworth scale.
Not having Botox injections over the last 6 months</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who for any reason have more than four alternate sessions or two consecutive sessions unable to participate in the program are excluded
If the child or his family are reluctant to continue treatment at each stage of the treatment
If the child fails to focus on the duration of the treatment
If he or she participates in another program at the same time</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spastic hemiplegic cerebral palsy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: In addition to the routine rehabilitation program, the subjects in the intervention group receive  mirror therapy for 6 weeks ( three days a week) and each session for 30 minutes.  In the routine rehabilitation program,   Bobath exercises, such as RIP, active and passive exercises( flexion, and extension of the shoulder, elbow, and wrists) are used. In addition to these exercises, several functional  exercises, such as bring a cup up into the mouth, drawing a circle and, squeeze a towel will done.</i_keyword>
      <i_keyword>Control group:subjects in this group receive a routine rehabilitation for six weeks. In the routine rehabilitation program,   Bobath exercises, such as RIP, active and passive exercises( flexion, and extension of the shoulder, elbow, and wrists) are used. In addition to these exercises, several functional  exercises, such as bring a cup up into the mouth, drawing a circle and, squeeze a towel will done.program</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dexterity. Timepoint: Measurement of dexterity before intervention and after intervention. Method of measurement: Dexterity is measured using box and block.</prim_outcome>
      <prim_outcome>Active ROM of wrist extention and Supination. Timepoint: Measurement of ROM before intervention and after intervention. Method of measurement: ROM is measured using Guniameter.</prim_outcome>
      <prim_outcome>Grasp. Timepoint: Measurement of Grasp before intervention and after intervention. Method of measurement: Grasp is measured using Dynamometer.</prim_outcome>
      <prim_outcome>Upper limb function. Timepoint: Measurement of Upper limb function before intervention and after intervention. Method of measurement: Upper limb function is measured using Fugle meyer test.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-07</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Ayatollah Taleghani Hospital, Shahid Araghi Shaheed Ave,  Yemeni Ave, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
