<?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>IRCT20220819055745N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of transcranial direct current stimulation of different brain areas on postural adaptation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of transcranial electrical stimulation of the cerebellum, parietal, anterior cingulate and primary motor cortex on adaptation to postural perturbations in healthy adults: Linear and nonlinear approaches</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65369</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted Block Randomization method from the website randomization.com will be used for allocating participants to different groups. The size of each block will be 10. A secretary will announce the participant group via a sealed envelope for allocation concealment, Blinding description: To blind participants, there will be a sham control group. To blind the assessor, the therapist that will set the device for stimulation will be different from the therapist who will assess and collect data.</study_design>
      <phase>3</phase>
      <hc_freetext>Postural adaptation.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: This group will receive Transcranial Direct Current Stimulation on posterior parietal cortex by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes. Intervention 2: Second intervention group: This group will receive Transcranial Direct Current Stimulation on cerebellum by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes. Intervention 3: Third intervention group: This group will receive Transcranial Direct Current Stimulation on primary motor cortex by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes. Intervention 4: Forth intervention group: This group will receive Transcranial Direct Current Stimulation on anterior cingulate cortex by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes. Intervention 5: Sham control group: Second intervention group: This group will receive Transcranial Direct Current Stimulation on any random cite from the intervention groups by Star Stim device. The amplitude will be 1 milliampere and will stop after ramp-up. The ramp-up time is 10 seconds.</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 No decision has been made regarding it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nastaran Bahadorani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran university of medical science school of rehabilitation, Enghelab street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6511111489</zip>
        <telephone>+98 21 6694 5185</telephone>
        <email>nbahadorani@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roya Khanmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran university of medical science school of rehabilitation, Enghelab street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6511111489</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>rkhanmohammadi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy people
Age 18-40
No history of sever neurologic or musculoskeletal disorders based on the participant's clam
Not having cognitive disorder (Mini-Mental State Exam (MMSE) ≥24)
No wound or scratch on the scalp
No sensory disorder
No metal or implant in head
No skin infection
No pacemaker
No history of epilepsy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking any medication that influence balance, neural system or brain.
Heavy bodily exertion before experiment
Not willing to continue the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: This group will receive Transcranial Direct Current Stimulation on posterior parietal cortex by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes.</i_keyword>
      <i_keyword>Second intervention group: This group will receive Transcranial Direct Current Stimulation on cerebellum by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes.</i_keyword>
      <i_keyword>Third intervention group: This group will receive Transcranial Direct Current Stimulation on primary motor cortex by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes.</i_keyword>
      <i_keyword>Forth intervention group: This group will receive Transcranial Direct Current Stimulation on anterior cingulate cortex by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes.</i_keyword>
      <i_keyword>Sham control group: Second intervention group: This group will receive Transcranial Direct Current Stimulation on any random cite from the intervention groups by Star Stim device. The amplitude will be 1 milliampere and will stop after ramp-up. The ramp-up time is 10 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Standard Deviation of Center of Pressure Displacement: This parameter comes from the second root of the sum of the square of the distance of each center of pressure from the average center of pressure divided by the number of the center of pressure in the anterior-posterior and lateral axis. The scale is in millimeter. Timepoint: Before and after the intervention. Method of measurement: Force Plate.</prim_outcome>
      <prim_outcome>Range of Center of Pressure Displacement: The difference between the maximum and minimum center of pressure displacement in the anterior-posterior and lateral axis. The scale is in millimeters. Timepoint: Before and after the intervention. Method of measurement: Force Plate.</prim_outcome>
      <prim_outcome>Path Length of Center of Pressure Displacement: This parameter comes from the summation of the distance of every center of pressure point from the consecutive point in the anterior-posterior and lateral axis. The scale is in millimeters. Timepoint: Before and after the intervention. Method of measurement: Force Plate.</prim_outcome>
      <prim_outcome>Lyapunov Exponent: Lyapunov Exponent is used to define the system chaos. When consecutive points diverge (divergence) the system will become chaotic, which can be quantified by Lyapunov Exponent. Timepoint: Before and after the intervention. Method of measurement: To calculate, the Rosenstein algorithm will be used in Chaos Data Analyzer Software.</prim_outcome>
      <prim_outcome>Approximate Entropy: Approximate Entropy is a scale for showing the complexity, regularity, and predictability of the center of pressure time series. In another word, Entropy gives a probability of the existence of a repeatable pattern with the length of m, the similarity of r, and delay of T. Timepoint: Before and after the intervention. Method of measurement: To calculate, the Pincus algorithm will be used in Matlab Software.</prim_outcome>
      <prim_outcome>Correlation Dimension: Correlation Dimension is a scale that shows degrees of freedom or the dimensions of the time series of the center of pressure. Timepoint: Before and after the intervention. Method of measurement: To calculate, the Grassberger and Procaccia algorithm will be used in Chaos Data Analyzer Software.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-17</approval_date>
        <contact_name>Research ethics committees of school of nursing and midwifery and rehabilitation of Tehran universit</contact_name>
        <contact_address>Tehran university of medical science school of rehabilitation, Enghelab street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
