<?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>IRCT20220718055490N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-01</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of transcranial electrical stimulation  on the dual-task cost of parameters of gait in older adults</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of transcranial electrical stimulation of the prefrontal, primary motor cortex and cerebellum on the dual-task cost of parameters of gait in older adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65148</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: All people participating in the study will receive three types of real stimulation and one non-real stimulation alternately with different sequences, and the aim is to compare the interventions, Blinding description: Based on the three locations of real stimulation and one sham stimulation that is planned in this study, we assign one of the letters of the alphabet (A, B, C, D) to each stimulation, and people are randomly assigned in 4 sequences (BDC, BCAD , CDBA and DACB) are divided according to the brain stimulation area and it is determined what type of stimulation should be done in each session. Before the start of the first session, a sealed and numbered envelope is used in which the type of stimulation sequence is placed. It is provided by the secretary to the participants. As a result, the participants are blinded to the type of stimulation that is applied. However, according to the study design and the type of stimulation that is applied by the therapist, it is not possible for the therapists and the evaluator to be blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dual task cost in older adults.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: a session of transcranial electrical stimulation of the prefrontal area using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and for 20 minutes. Intervention 2: 205 / 5,000Translation resultsThe second intervention group: a session of transcranial electrical stimulation of the primary motor cortex using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and for 20 minutes. Intervention 3: The third intervention group: a session of transcranial electrical stimulation of the cerebellum using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and for 20 minutes. Intervention 4: Control group: a non-real transcranial electrical stimulation session in one of the prefrontal areas, primary motor cortex or cerebellum using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
after making volunteers unknowable, all data will be shareable.

When:
beginning of availability period from 2023

To whom:
data will be available for all researchers

Conditions:
no other conditions needed

Where to obtain:
Vahid Rafiei Manesh 0098 9123147196

How to obtain:
after receiving sms he can get data in one week

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Rafiei Manesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>2th Floor,No 31,Mohammadi St., Ghayoori St., Ray,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1857814959</zip>
        <telephone>+98 21 3375 9083</telephone>
        <email>vahidrafieemanesh@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Rafiei Manesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>2th Floor. No.31, Mohammadi St., Ghayoori St., Ray, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1857814959</zip>
        <telephone>+98 21 3375 9083</telephone>
        <email>vahidrafieemanesh@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age more than 65
Berg Balance Scale (BBS) &gt;40
Mini-Mental State Exam (MMSE) ≥24
Hospital Anxiety and Depression Scale (HADS- Depression      subscale) ≤7
Ability of reading and writing
ability of walking without aids in 10 meters
No history of CNS and PNS problems
No history of orthopedic problem in recent 6 months
No history of falling in recent 6 months
No scalp scratch
No sensory impairment
no history of epilepsy
no metal implant in cranium
No skin infection
No pacemaker or electronic implants</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use narcotics or pain killers 24 hours before
Severe activity 24 hours before
Unusual physical or mental exhaustion
Unwilling to do or continue</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: a session of transcranial electrical stimulation of the prefrontal area using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and for 20 minutes.</i_keyword>
      <i_keyword>205 / 5,000Translation resultsThe second intervention group: a session of transcranial electrical stimulation of the primary motor cortex using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and for 20 minutes.</i_keyword>
      <i_keyword>The third intervention group: a session of transcranial electrical stimulation of the cerebellum using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and for 20 minutes.</i_keyword>
      <i_keyword>Control group: a non-real transcranial electrical stimulation session in one of the prefrontal areas, primary motor cortex or cerebellum using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and for 20 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dual task cost. Timepoint: Assessment of Dual task cost before and after TDCS in every session. Method of measurement: Inertial sensor.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Assessment of balance and fall risk. Timepoint: After completing the study. Method of measurement: Berg Balance Scale Questionnaire.</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>2022-08-07</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>2th Floor,No. 31,mohammadi St,  Ghayoori St ,Ray, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
