<?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>IRCT20240513061781N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-18</date_registration>
      <primary_sponsor>Razi University</primary_sponsor>
      <public_title>Investigating the effect of TDCS on knee proprioception, balance, muscle EMG, movement function and reaction time speed, after neuromuscular fatigue.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of transcranial direct current stimulation (M1 and DLPFC) on knee joint proprioception, balance, muscles activity, movement function and reaction time speed, after neuromuscular fatigue in female amateur athletes.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79016</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Subjects will be randomly assigned to one of the experimental or control groups based on the output of the random number generator software by a person not involved in the research. The sequentially numbered opaque sealed envelope (SNOSE) method will hide the allocation, Blinding description: Subjects and outcome assessors will not be aware of the assigned group. The random assignment of subjects to groups is done by a person not involved in the research, and the assigned group for each subject is placed in a sealed envelope and will be available to the laboratory expert. After evaluating the results of the study before the test, each subject will be provided with the envelope related to the person applying the stimuli, in this way, neither the subject nor the evaluator will be informed of the type of intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Controlling the effect of fatigue on factors such as balance, proprioception, electrical activity of the muscles acting on the knee and movement performance.</hc_freetext>
      <i_freetext>Intervention 1: The first Intervention group: receiving tDCS stimulation of the M1 point, with a current intensity of 2 mA for 20 minutes in each session with a number of 5 sessions. Intervention 2: The second Intervention group: Intervention group: receiving tDCS stimulation of the DLPFC point, with a current intensity of 2 mA for 20 minutes in each session with a number of 5 sessions. Intervention 3: Control group: Sham (inactive) tDCS stimulation, after 30 seconds of active stimulation, the electric current is cut off until the end of 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:
Information about study outcomes will be shared.

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic institutions

Conditions:
Research in the relevant work area

Where to obtain:
Samaneh Valadbeigi - s.valadbeigi.99@gmail.com

How to obtain:
Sending the request from the applicant, checking it from the researcher and responding immediately

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh Valadbeigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madreseh Ave, Fathoalmobin Blvd, Amirabad</address>
        <city>Eslamabad Gharb</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6761111478</zip>
        <telephone>+98 83 4522 6988</telephone>
        <email>s.valadbaigi@stu.razi.ac.ir</email>
        <affiliation>Razi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samaneh Valadbeigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madreseh Ave, Fathoalmobin Blvd, Amirabad</address>
        <city>Eslamabad Gharb</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6761111478</zip>
        <telephone>+98 83 4522 6988</telephone>
        <email>s.valadbaigi@stu.razi.ac.ir</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having regular sports activity.
Sports fields with jumping-landing skills or changing direction.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a history of injury in the trunk and lower limbs in the last six months.
Skeletal-muscular diseases.
visual, vestibular (such as vertigo) or sensory (such as diabetes) disorders.
People with mental problems and epilepsy.
Use of neuroleptics.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Injury to</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>S83.7</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first Intervention group: receiving tDCS stimulation of the M1 point, with a current intensity of 2 mA for 20 minutes in each session with a number of 5 sessions.</i_keyword>
      <i_keyword>The second Intervention group: Intervention group: receiving tDCS stimulation of the DLPFC point, with a current intensity of 2 mA for 20 minutes in each session with a number of 5 sessions.</i_keyword>
      <i_keyword>Control group: Sham (inactive) tDCS stimulation, after 30 seconds of active stimulation, the electric current is cut off until the end of 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Degree of knee joint proprioception. Timepoint: Proprioceptive measurement at the beginning of the study and 7 days after the tDCS stimulation intervention. Method of measurement: goniometer.</prim_outcome>
      <prim_outcome>Balance check. Timepoint: Balance measurement at the beginning of the study and 7 days after the tDCS stimulation intervention. Method of measurement: Y-Balance test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Electrical activity of knee muscles. Timepoint: Examining the electrical activity of the knee muscles at the beginning of the study and 7 days after applying tDCS stimulation intervention. Method of measurement: Noraxon electromyography device.</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>Razi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-17</approval_date>
        <contact_name>Research Ethics Committee of Kermanshah Razi University</contact_name>
        <contact_address>Zakariya Razi Blvd, Kermanshah, Kermanshah Province Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
