<?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>IRCT20211113053053N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-10</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>The effect of neurocognitive training on rehabilitation of male athletes with anterior cruciate ligament reconstruction</public_title>
      <acronym></acronym>
      <scientific_title>The effect of neuromuscular training with neurocognitive training on selected psychological, functional and biomechanical factors in male athletes with anterior cruciate ligament reconstruction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60049</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to 1 of 3 groups, the samples will be determined in a simple random method using a random number table of Random Allocation software. Randomization and allocation sequence for concealment will be done by the person not involved in the research. The ratio of sample allocation will be 1: 1 and will be divided into 2 experimental groups and 1 control group, Blinding description: Outcome assessor is kept blind. The assessor was blinded to the group allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anterior cruciate ligament reconstruction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Performing neuromuscular training including single-legged exercises (single-legged hop and anterior progressions), posterior chain activation exercises (Romanian dead lift and lunge progressions), bilateral jumping exercises (double-legged jump progression), and core stability and trunk strengthening exercises (prone trunk stability and lateral trunk flexion progressions) with the use of tools such as Traband, Busobal, balance board during eight weeks, each week for two sessions (each session approximately 60 minutes). Intervention 2: Intervention group B: Performing neuromuscular training with cognitive and visual challenges such as counting numbers backwards, looking back and forth while performing neuromuscular training (single-legged exercises (single-legged hop and anterior progressions), posterior chain activation exercises (Romanian dead lift and lunge progressions), bilateral jumping exercises (double-legged jump progression), and core stability and trunk strengthening exercises (prone trunk stability and lateral trunk flexion progressions) with the use of tools such as Traband, Busobal, balance board) during eight weeks, each week for two sessions (each session approximately 60 minutes). The base movement is first done alone  and then becomes more difficult by the addition of a single visual or cognitive task. Intervention 3: Control group: The control group is without any training intervention and they will just do their usual exercise program.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Tajdini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center for Human Movement Sciences Kharazmi University, Keshvari Sport complex, South Razan Street, Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>158754398</zip>
        <telephone>+98 21 8832 9220</telephone>
        <email>h.tajdini@khu.acc.ir</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Tajdini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center for Human Movement Sciences Kharazmi University, Keshvari Sport complex, South Razan Street, Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>158754398</zip>
        <telephone>+98 21 8832 9220</telephone>
        <email>h.tajdini@khu.ac.ir</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 18-30
All patients who have first performed anterior cruciate ligament restoration using hamstring auto grafting method
Passing 6 to 9 months after the surgery
Having completed physiotherapy course
Having at least 2 years of experience in the fields of Handball, Basketball, Football and Volleyball in the provincial level
No swelling and pain in the knee
Lack of lower limb abnormalities</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Hearing and vision problems
Balance problems
Participation in any rehabilitation program for anterior cruciate ligament</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of cruciate ligament of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Performing neuromuscular training including single-legged exercises (single-legged hop and anterior progressions), posterior chain activation exercises (Romanian dead lift and lunge progressions), bilateral jumping exercises (double-legged jump progression), and core stability and trunk strengthening exercises (prone trunk stability and lateral trunk flexion progressions) with the use of tools such as Traband, Busobal, balance board during eight weeks, each week for two sessions (each session approximately 60 minutes).</i_keyword>
      <i_keyword>Intervention group B: Performing neuromuscular training with cognitive and visual challenges such as counting numbers backwards, looking back and forth while performing neuromuscular training (single-legged exercises (single-legged hop and anterior progressions), posterior chain activation exercises (Romanian dead lift and lunge progressions), bilateral jumping exercises (double-legged jump progression), and core stability and trunk strengthening exercises (prone trunk stability and lateral trunk flexion progressions) with the use of tools such as Traband, Busobal, balance board) during eight weeks, each week for two sessions (each session approximately 60 minutes). The base movement is first done alone  and then becomes more difficult by the addition of a single visual or cognitive task.</i_keyword>
      <i_keyword>Control group: The control group is without any training intervention and they will just do their usual exercise program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamic knee valgus angle during landing. Timepoint: Before the intervention and the end of the intervention. Method of measurement: Motion analysis system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Psychological readiness. Timepoint: Before the intervention and the end of the intervention. Method of measurement: Anterior Cruciate Ligament Return - To - Sport after Injury.</sec_outcome>
      <sec_outcome>Torque of the lower limb joints during landing. Timepoint: Before the intervention and the end of the intervention. Method of measurement: Motion analysis system and force plate.</sec_outcome>
      <sec_outcome>Coordination and Coordination Variability. Timepoint: Before the intervention and the end of the intervention. Method of measurement: Motion analysis system.</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>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-21</approval_date>
        <contact_name>Ethics Committee of Sports Science Research Institute</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
