<?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>IRCT20200224046604N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-15</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of mirror therapy on hand of children with cerebral oalsy</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of motor learning based mirror therapy on the hand function of 7 to 12-year-old children with hemiplegic cerebral palsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46128</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sealed envelopes. Participants will choose one envelope between two separate envelopes. It is noteworthy that in each envelope there is a sheet in which the name of one of the groups is written, Blinding description: Participants, data analyzer, and outcome elevator will not know which of the participants belonged to the intervention group and which one was in the comparison group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cerebral palsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Motor learning based mirror therapy that is designed based on the principles of motor learning including behavior shaping, types and grading of the tasks and types of practice. Intervention protocol will consist of twenty 30-45 minute sessions for 7 weeks and 3 sessions per week. Intervention 2: Control group: Common mirror therapy intervention consists of 3 repetitions of 10 sets of 7 symmetrical motor tasks and simultaneously upper limb and hand. Exercises include fine motor exercises, full range of motion exercises, and finger and forearm strength exercises.Intervention protocol will consist of twenty 30-45 minute sessions for 7 weeks and 3 sessions per week.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Statistical indicators related to the total data

When:
Start of access period from 2022

To whom:
Researchers working in academic and scientific institutions

Conditions:
If data is needed for systematic review (meta-analysis) studies.

Where to obtain:
Hossein Sourtiji
Occupational therapy department, Rehabilitation sciences faculty, Isfahan University of medical sconces 
00983137925049

How to obtain:
Request from the applicant's person or organization
Approved by the President of the University,
Approved by the head of the faculty

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Sourtiji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Science Faculty Isfahan University of Medical  sciences Hezar Jarib Ave, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5049</telephone>
        <email>sourtiji@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Sourtiji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Science Faculty Isfahan University of Medical  sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5049</telephone>
        <email>sourtiji@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of partial cerebral palsy
Based on the MACS grading scale, participants have the hand function  ability to rank 1 to 3.
Having at least intelligence 70 based on the  Raven's Colored Progressive Matrices</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Health problems unrelated to cerebral palsy
Treatment-resistant seizures
Visual problems that interfere with the intervention or test.
Muscle tone above 3.5 (mean for elbow and wrist joint movements) based on modified Ashworth Scale</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hemiplegia and hemiparesis</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: Motor learning based mirror therapy that is designed based on the principles of motor learning including behavior shaping, types and grading of the tasks and types of practice. Intervention protocol will consist of twenty 30-45 minute sessions for 7 weeks and 3 sessions per week.</i_keyword>
      <i_keyword>Control group: Common mirror therapy intervention consists of 3 repetitions of 10 sets of 7 symmetrical motor tasks and simultaneously upper limb and hand. Exercises include fine motor exercises, full range of motion exercises, and finger and forearm strength exercises.Intervention protocol will consist of twenty 30-45 minute sessions for 7 weeks and 3 sessions per week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hand function. Timepoint: Before the intervention, after the intervention, one month after the post-test. Method of measurement: Bruininks-Oseretsky test of motor proficiency, Jebsen–Taylor Hand Function Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Grasp strength. Timepoint: Before the intervention, after the intervention, one month after the post-test. Method of measurement: Vigorimeter.</sec_outcome>
      <sec_outcome>Two-point discrimination. Timepoint: Before the intervention, after the intervention, one month after the post-test. Method of measurement: Two-point discrimination scale.</sec_outcome>
      <sec_outcome>Active and passive range of motion. Timepoint: Before the intervention, after the intervention, one month after the post-test. Method of measurement: Goniometry.</sec_outcome>
      <sec_outcome>Parent perception. Timepoint: Before the intervention, after the intervention, one month after the post-test. Method of measurement: Caregiver Functional Use Survey (CFUS).</sec_outcome>
      <sec_outcome>Visual motor coordination. Timepoint: Caregiver Functional Use Survey (CFUS). Method of measurement: Bruininks-Oseretsky test of motor proficiency.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-05</approval_date>
        <contact_name>The institutional research ethics committee of vice-chancellor of Isfahan University of medical scie</contact_name>
        <contact_address>Hezar Jarib Ave Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
