<?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>IRCT20220725055552N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-27</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of electrical stimulation in the treatment of upper limbs of cerebral palsy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Transcranial Directed Current Stimulation on upper limb function in children with unilateral cerebral palsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64932</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To select the sample, we refer to Tanin and Nikan Karaj clinics, and fifty people will be sampled according to the conditions of inclusion in the study, but the samples will be divided into two intervention and control groups in a simple randomization using the coin toss method. In this way, we consider one of the groups to be the lion and the other group to be the line, and based on the desired sample size, the same number of coins are tossed, Blinding description: The evaluator, the participants and the statistician are unaware of the grouping, and also to blind the participants, devices and electrodes are placed for both groups, but stimulation is not done for the control group.</study_design>
      <phase>3</phase>
      <hc_freetext>Hemiplegia  cerebral palsy.</hc_freetext>
      <i_freetext>Intervention 1: his group performed routine occupational therapy exercises for 45 minutes along with transcranial direct electrical stimulation technique, in which a low direct electric current with an intensity of 1.5-2 mV is injected into the primary motor area of the healthy hemisphere with a tDCS device. They receive for twenty minutes in each session and for twenty sessions in a period of one month. Intervention 2: Control group: This group receives routine occupational therapy exercises for forty-five minutes in each session and twenty sessions in a one-month period, and also to blind the participant, an electrical stimulation device is placed on the primary motor area of the healthy hemisphere for twenty minutes in each session. It can be done, but the stimulation does not take place.</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 To make a decision, I need to consult with the client and the professor.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behnam Ghaderian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Seventh Floor, Haft Tir Crossroad, the beginning of Student Blvd., in front of the police station clinic, Ghasemi Alley, Arad Doctors Building, 7th floor</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3133654689</zip>
        <telephone>+98 26 3271 5709</telephone>
        <email>behnamgh7491@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behnam Ghaderian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West taleghany,balance Blvd,ghasemy Town</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3133654689</zip>
        <telephone>+98 26 3224 7828</telephone>
        <email>behnamgh7491@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The person must be a hemiplegic cerebral palsy
The person must be 5-10 years old
The person without unstable medical conditions such as seizures</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to attend more than one meeting.
Non-cooperation of children and their families until the end of the regular study period</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>his group performed routine occupational therapy exercises for 45 minutes along with transcranial direct electrical stimulation technique, in which a low direct electric current with an intensity of 1.5-2 mV is injected into the primary motor area of the healthy hemisphere with a tDCS device. They receive for twenty minutes in each session and for twenty sessions in a period of one month.</i_keyword>
      <i_keyword>Control group: This group receives routine occupational therapy exercises for forty-five minutes in each session and twenty sessions in a one-month period, and also to blind the participant, an electrical stimulation device is placed on the primary motor area of the healthy hemisphere for twenty minutes in each session. It can be done, but the stimulation does not take place.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motor function of the upper limb. Timepoint: At the beginning of the intervention and after the end of the intervention. Method of measurement: Fugl-Meyer test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Upper limb coordination. Timepoint: The beginning and end of the intervention. Method of measurement: Bruininks-Oseretsky test.</sec_outcome>
      <sec_outcome>Upper limb Integration. Timepoint: The beginning and end of the intervention. Method of measurement: Bruininks-Oseretsky test.</sec_outcome>
      <sec_outcome>Precision of fine movement. Timepoint: The beginning and end of the intervention. Method of measurement: Bruininks-Oseretsky test.</sec_outcome>
      <sec_outcome>Upper extremity speed. Timepoint: The beginning and end of the intervention. Method of measurement: Box and block test.</sec_outcome>
      <sec_outcome>Dexterity of Upper extremity. Timepoint: The beginning and end of the intervention. Method of measurement: Bruininks-Oseretsky test.</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>no</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-15</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Damavand street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
