<?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>IRCT20230619058535N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-26</date_registration>
      <primary_sponsor>The University of Bu Ali Sina</primary_sponsor>
      <public_title>The effect of neuromuscular training with and without cognitive intervention on ankle sprain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of neuromuscular training with and without cognitive intervention on proprioception‚ balance‚ strength and center of pressure displacement in active females at risk of ankle sprain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70872</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is done based on the Random Number Generator software, and they will be assigned to double groups based on the allocation concealment using the SNOSE method. The randomization of subjects is done in two steps. First, each subject chooses a number between 1-30 using a lottery, then fifteen random numbers are selected between 1-30 numbers using the Random  Number Generator software and according to the generated numbers and the selected numbers, subjects are divided into two groups, Blinding description: In this study, outcome assessors (laboratory technicians) are asked to take the desired tests from the clients. These people will be unaware of the  purpose of the research, the allocation of study groups and the reason for  their presence in the laboratory, and they will only evaluate the variables and record their observations.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ankle sprain.</hc_freetext>
      <i_freetext>Intervention 1: The neuromuscular training with cognitive intervention, exercises for 8 weeks and three 1-hour sessions each week. Neuromuscular training will include balance, strength, plyometric and agility exercises. Cognitive  exercises will be used as an effective strategy for this group to examine  the amount of attention needs of pastural control. Intervention 2: Intervention group: the neuromuscular training without cognitive intervention, exercises for 8 weeks and three 1-hour sessions each we ek. Neuromuscular training will include balance, strength, plyometric and agility exercises.</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>Mina Mansouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu Ali Sina University, Abu Taleb ST, Modares Quarter, Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3869565178</zip>
        <telephone>+98 81 3838 1423</telephone>
        <email>m.mansouribidekani@phe.basu.ac.ir</email>
        <affiliation>The University of  Bu Ali Sina</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mina Mansouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu Ali Sina University, Abu Taleb ST, Modares Quarter, Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3869565178</zip>
        <telephone>+98 81 3838 1423</telephone>
        <email>m.mansouribidekani@ph.basu.ac.ir</email>
        <affiliation>The University of Bu Ali Sina</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Normal body mass index is 20-25
Age range 16-30 years
Obtaining a dynamic balance score
Obtaining a score of 13-15 from Beck's questionnaire</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of ankle sprain injury
History of fracture, injury or surgery of the lower limb
Abnormalities of the lower limbs include Foot Flat, Genu Varum, Genu Valgum, Genu Recurvatom
History of Vestibular System disorders
The presence of diseases such as diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S93.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of ankle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The neuromuscular training with cognitive intervention, exercises for 8 weeks and three 1-hour sessions each week. Neuromuscular training will include balance, strength, plyometric and agility exercises. Cognitive  exercises will be used as an effective strategy for this group to examine  the amount of attention needs of pastural control.</i_keyword>
      <i_keyword>Intervention group: the neuromuscular training without cognitive intervention, exercises for 8 weeks and three 1-hour sessions each we ek. Neuromuscular training will include balance, strength, plyometric and agility exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Before the intervention begins, one day after the end of the intervention. Method of measurement: Y balance test, Foot lift test.</prim_outcome>
      <prim_outcome>Strength. Timepoint: Before the intervention begins, one day after the end of the intervention. Method of measurement: Dynamometer.</prim_outcome>
      <prim_outcome>Proprioception. Timepoint: Before the intervention begins, one day after the end of the intervention. Method of measurement: Electrogoniometer.</prim_outcome>
      <prim_outcome>Center of pressure displacement. Timepoint: Before the intervention begins, one day after the end of the intervention. Method of measurement: RS-Scan device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Chronic ankle instability (CAI). Timepoint: Before and after the intervention. Method of measurement: Electrogoniometer, Dynamometer, RS-Scan device, Y balance test, Foot lift test.</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>The University of Bu Ali Sina</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-11</approval_date>
        <contact_name>Ethics Committee of Bu Ali Sina Hamadan University</contact_name>
        <contact_address>Bu Ali Sina University, Abu Taleb ST, Modares Quarter, Hamedan Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
