<?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>IRCT20220216054035N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-24</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of unihemispheric concurrent  dual-Site transcranial direct Current stimulation of primary motor and dorsolateral prefrontal cortices  with stimulation of  primary motor cortex  on  postural control of older  adult with and without  cognitive task</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of unihemispheric concurrent  dual-Site transcranial direct Current stimulation of primary motor and dorsolateral prefrontal cortices  with stimulation of  primary motor cortex  on  postural control of older  adult with and without  cognitive task</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>27</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65636</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: Assessment of static balance is simple randomization. First chose from two sealed envelopes that decide their standing that will be with or without cognitive activity then intervention is on simple randomization  thus choosing 
 their intervention method than chose from three envelopes that contain one of three interventions  include sham, primary motor cortex (M1) stimulation and, M1-dorsolateral prefrontal cortex (DLPFC) stimulation.After intervention assessment of static balance is simple randomization, Blinding description: We will explain about intervention to participants but they will not aware what type of intervention they will receive in each session.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Elderly stability.</hc_freetext>
      <i_freetext>Intervention 1: Control group: electrode will be like  M1 stimulation but device would be off after 60 seconds. 60 second is a reliable stimulation for sham due to the fact that transcranial direct current stimulation( tDCS) effect will be forgotten after one minute. Intervention 2: Intervention group: M1 stimulation , using one tDCS device anode electrode would be placed at M1 and cathode would be placed at supraorbital region. Intervention 3: Intervention group: concurrent dual-Site of M1-DLPFC, 2 tDCS devices will be used. in left hemisphere anode electrode of one device would be placed at M1 and on the other side anode electrode would be placed at DLPFC and cathode electrode for both devices would be placed at opposite side supraorbital region.</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:
All of this study data could be shared after making it unrecognizable.

When:
Data would be shared one month after publication.

To whom:
This data only assessable for academic researchers.

Conditions:
There is no specific qualification for using this study data.

Where to obtain:
To receive this study data please contact Dr.Minoo KhalkhaliZavieh. phone:+98 21 2057 7754 email:minoo_kh@yahoo.comaddress: Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences.

How to obtain:
Only a request letter would be enough for receiving data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Minoo KhalkhaliZavieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 2057 7754</telephone>
        <email>minoo_kh@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoo KhalkhaliZavieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 2057 7754</telephone>
        <email>minoo_kh@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy elderly with age between 65-74 years old
Ability to stand without assistive device
Right handed ( according to edinburgh Handeness,old field 1917)
Educated enough because our study contain cognitive components</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>74 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any cardiovascular , neurological ( like Parkinson, Alzheimer) , musculoskeletal diseases, surgery history , brain tumor, peripheral neuropathy, any visual or auditory defects that isn't managed, vertigo, any vestibular problems, any metal implant in brain
Hospital stay in recent 6 month
Using any drug that effect central nervous system
Inability to stand or walk without help
Any condition that cause abnormality in physical activity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R54</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Age-related physical debility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: electrode will be like  M1 stimulation but device would be off after 60 seconds. 60 second is a reliable stimulation for sham due to the fact that transcranial direct current stimulation( tDCS) effect will be forgotten after one minute.</i_keyword>
      <i_keyword>Intervention group: M1 stimulation , using one tDCS device anode electrode would be placed at M1 and cathode would be placed at supraorbital region.</i_keyword>
      <i_keyword>Intervention group: concurrent dual-Site of M1-DLPFC, 2 tDCS devices will be used. in left hemisphere anode electrode of one device would be placed at M1 and on the other side anode electrode would be placed at DLPFC and cathode electrode for both devices would be placed at opposite side supraorbital region.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anteroposterior displacement  of center of pressure in stance without cognitive task. Timepoint: Every session  before and after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Mediolateral displacement of center of pressure in stance without cognitive task. Timepoint: Every session before and after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Total displacement of center of pressure in stance without cognitive task. Timepoint: Every session before and after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Total velocity of displacement of center of pressure in stance without cognitive task. Timepoint: Every session before and after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Mediolateral velocity of displacement of center of pressure in stance without cognitive task. Timepoint: Every session before and after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Anteroposterior velocity of displacement of center of pressure in stance without cognitive task. Timepoint: Every session before and after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Anteroposterior velocity of displacement of center of pressure in stance with cognitive task. Timepoint: Every session before and after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Mediolateral velocity of displacement of center of pressure in stance with cognitive task. Timepoint: Every session before and after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Total velocity of displacement of center of pressure in stance with cognitive task. Timepoint: Every session before and after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Total displacement of center of pressure in stance with cognitive task. Timepoint: Every session before and after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Mediolateral displacement of center of pressure in stance with cognitive task. Timepoint: Every session before and after intervention. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Anteroposterior displacement of center of pressure in stance with cognitive task. Timepoint: Every session before and after intervention. Method of measurement: Force plate.</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>2021-11-07</approval_date>
        <contact_name>Ethics committee of shahid beheshti university of medical university</contact_name>
        <contact_address>7th Floor, Bldg No.2 SBUM, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
