<?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>IRCT20180724040579N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-16</date_registration>
      <primary_sponsor>The University of Mohaghegh Ardabili</primary_sponsor>
      <public_title>The role of the premotor cortex and cerebellum in physiological and performance parameters of gymnastic athletes</public_title>
      <acronym>tDCS</acronym>
      <scientific_title>The role of the premotor cortex and cerebellum in physiological and performance parameters of gymnastic athletes: A randomized, sham control study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>17</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54989</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: In order to randomize, simple randomization method with random number Table method was used . This table contains a bunch of numbers that are randomly drawn in the form of a table without a specific pattern and order. The numbers directions(Left, right, up, down) were first determined by the researcher to read the numbers and then the numbers were considered for different research groups. In the next step, the researcher randomly placed on one of the numbers and moved in the preset direction and recorded the numbers for that direction in the target group, Blinding description: In order to eliminate the bias caused by the knowledge of the subject and the evaluator, the results of the muscle electromyography device and the research result of the study on the effect of electrical stimulation of the pre-motor areas and the cerebellum are performed in Double blind. Considering that the recorded frequencies of the muscle electromyography device are interpreted after the measurement and it is not possible to observe the variable during the test, the subject and the evaluator are not aware of the effect of the interfering factor on the muscle electromyography. Normally, Subject only performs his muscle contraction according to the plan and the information is stored in his body by installing the device, and it is in the analysis stage that the researcher himself will have access to the recorded information.</study_design>
      <phase>N/A</phase>
      <hc_freetext>nervous system.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Sham stimulation of the cerebellum and motor areas of the brain. In Sham stimulation of the premotor and cerebellum, there will be anodic stimulation in the left and right prefrontal cortex and left and right cerebellar cortex and cathodic stimulation in FP1 and FP2. For electrical stimulation, pads with dimensions of 5 × 7 will be used. Also, the stimulation intensity will be set 2 mA for 20 minutes, But it will turn off automatically after 10 seconds. Intervention 2: Intervention group: Real stimulation of the cerebellum areas of the brain.In real cerebellar stimulation, the anodic stimulation in the cortical region is left and right cerebellum and the cathodic stimulation will be in FP1 and FP2. For electrical stimulation, pads with dimensions of 5 × 7 will be used. Also, the stimulation intensity will be 2 mA for 20 minutes. Intervention 3: Intervention group: Real stimulation of the pre motor areas of the brain. In real stimulation of the pre motor areas , anodic stimulation will be located in the left and right pre motor cortex and cathodic stimulation will be located in FP1 and FP2. For electrical stimulation, pads with dimensions of 5 × 7 will be used. Also, the stimulation intensity will be 2 mA for 20 minutes.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sajjad Anoshirvani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street, The University of Mohaghegh Ardabili, Ardabil</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5619911367</zip>
        <telephone>+98 45 3351 3920</telephone>
        <email>s.anoushirvani@uma.ac.ir</email>
        <affiliation>The University of Mohaghegh Ardabili</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sajjad Anoshirvani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street, The University of Mohaghegh Ardabili, Ardabil</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5619911367</zip>
        <telephone>+98 45 3351 3920</telephone>
        <email>s.anoushirvani@uma.ac.ir</email>
        <affiliation>The University of Mohaghegh Ardabili</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being in the age range of 18 to 25 years
10 years of experience in gymnastics
No cardiovascular disease
No injuries</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Being a smoker
Have a competitive schedule in the next few months
Having a travel plan to other provinces during the measurement period</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G90.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of autonomic nervous system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Sham stimulation of the cerebellum and motor areas of the brain. In Sham stimulation of the premotor and cerebellum, there will be anodic stimulation in the left and right prefrontal cortex and left and right cerebellar cortex and cathodic stimulation in FP1 and FP2. For electrical stimulation, pads with dimensions of 5 × 7 will be used. Also, the stimulation intensity will be set 2 mA for 20 minutes, But it will turn off automatically after 10 seconds.</i_keyword>
      <i_keyword>Intervention group: Real stimulation of the cerebellum areas of the brain.In real cerebellar stimulation, the anodic stimulation in the cortical region is left and right cerebellum and the cathodic stimulation will be in FP1 and FP2. For electrical stimulation, pads with dimensions of 5 × 7 will be used. Also, the stimulation intensity will be 2 mA for 20 minutes.</i_keyword>
      <i_keyword>Intervention group: Real stimulation of the pre motor areas of the brain. In real stimulation of the pre motor areas , anodic stimulation will be located in the left and right pre motor cortex and cathodic stimulation will be located in FP1 and FP2. For electrical stimulation, pads with dimensions of 5 × 7 will be used. Also, the stimulation intensity will be 2 mA for 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency recorded in a muscle electromyography device. Timepoint: During stimulate the cerebellum and move forward. Method of measurement: Using a muscle electromyography device.</prim_outcome>
      <prim_outcome>Measuring the performance of gymnasts. Timepoint: After electrical stimulation of cerebellar and pre-motor areas. Method of measurement: Measuring the performance of gymnasts athletes using tests of Broad Jump, Straddle lift to handstand, Double Legs circle, Back Hang Scale, Dips on Parallel Bars, Active Shoulder Felexibility and Sit and Reach tests.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Ardabil General Directorate of Sports and Youth</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The University of Mohaghegh Ardabili</source_name>
      <source_name>Ardabil General Directorate of Sports and Youth</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-08</approval_date>
        <contact_name>Ethics Committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>North Side of Ardabil University of Medical Sciences Administrative Complex, Daneshgah Square, Daneshgah St, Ardabil Town Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
