<?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>IRCT20231006059636N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-17</date_registration>
      <primary_sponsor>ُShahid Beheshti University</primary_sponsor>
      <public_title>The effect of four weeks of selected rehabilitation exercises before surgery with the emphasis on core stability exercises on knee functional indexes after surgery in athletes with anterior cruciate ligament rupture: clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of four weeks of selected rehabilitation exercises before surgery with the emphasis on core stability exercises on knee functional indexes after surgery in athletes with anterior cruciate ligament rupture: clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73091</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random - lottery (in this method, the researcher gives a code or a special number to each member of the society. Then he writes down the number of each of them on a piece of paper, then he pours them into a container and shakes them. Then the papers are separated one by one. take them out, write down their numbers and divide them into experimental and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Rupture of anterior cruciate ligament.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The experimental group, after reviewing the records and meeting the entry criteria, all of whom have torn the anterior cruciate ligament and are athletes, 20 people will be selected by the surgeon to implement an exercise program to strengthen the muscles of the central region before the operation, and then with written consent will be obtained from these people, then for 4 weeks and 3 sessions a week, all these athletes will receive their exercises under the direct supervision of a physiotherapist, finally, immediately before the operation, in order to assess the level of pain ,The range of motion, terminal knee extension, function of the knee joint and fear of movement of these people will be examined and post-tested, then the experimental group will undergo anterior cruciate ligament reconstruction, and 4 weeks after the reconstruction of the anterior cruciate ligament they will be tested again. The test will be taken and will be compared with the control group. Intervention 2: Control group: after examining the records and evaluating the patients with anterior cruciate ligament injury, 20 patients were invited by the surgeon to obtain informed written consent from the subjects, and in these 4 weeks, the control group continued their routine activities. given and before the surgery under the direct supervision of the physiotherapist immediately before the operation, the amount of pain, the range of motion, terminal knee extension, the function of the knee joint and the fear of movement of these people will be examined and pre-tested, then the control group will undergo ligament reconstruction. Anterior cruciate ligaments will be placed and 4 weeks after the reconstruction of the anterior cruciate ligament, they will be tested again and will be compared with the experimental group.</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 The Information about the subjects is personal and will not be shared with others</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirhosein Barati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University,Shahid Shahriari Square,Evin,Tehran,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 5821</telephone>
        <email>ahbarati20@gmail.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirhosein Barati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University,Shahid Shahriari Square,Evin,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 5836</telephone>
        <email>ahbarati20@gmail.com</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Fear of movement between 18 and above 27 according to the Tampa fear of movement questionnaire
The time from injury to surgery is a maximum of 3 months
Age range between 18 and 35 years
One-sided anterior cruciate ligament rupture
Not participating in any sports activity after tearing the anterior cruciate ligament</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not using the same graft for each of the studied subjects
Intensification of injury, pain and swelling during each of the stages of research
Lack of regular participation in any of the training sessions during any of the stages of the research
Dissatisfaction of any of the subjects during the research process</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain and strain involving (anterior)(posterior) cruciate ligament of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The experimental group, after reviewing the records and meeting the entry criteria, all of whom have torn the anterior cruciate ligament and are athletes, 20 people will be selected by the surgeon to implement an exercise program to strengthen the muscles of the central region before the operation, and then with written consent will be obtained from these people, then for 4 weeks and 3 sessions a week, all these athletes will receive their exercises under the direct supervision of a physiotherapist, finally, immediately before the operation, in order to assess the level of pain ,The range of motion, terminal knee extension, function of the knee joint and fear of movement of these people will be examined and post-tested, then the experimental group will undergo anterior cruciate ligament reconstruction, and 4 weeks after the reconstruction of the anterior cruciate ligament they will be tested again. The test will be taken and will be compared with the control group.</i_keyword>
      <i_keyword>Control group: after examining the records and evaluating the patients with anterior cruciate ligament injury, 20 patients were invited by the surgeon to obtain informed written consent from the subjects, and in these 4 weeks, the control group continued their routine activities. given and before the surgery under the direct supervision of the physiotherapist immediately before the operation, the amount of pain, the range of motion, terminal knee extension, the function of the knee joint and the fear of movement of these people will be examined and pre-tested, then the control group will undergo ligament reconstruction. Anterior cruciate ligaments will be placed and 4 weeks after the reconstruction of the anterior cruciate ligament, they will be tested again and will be compared with the experimental group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Range of motion. Timepoint: 4 weeks before ACL reconstruction and 4 weeks after surgery. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Terminal knee extension. Timepoint: 4 weeks before ACL reconstruction and 4 weeks after surgery. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Fear of movement. Timepoint: 4 weeks before ACL reconstruction and 4 weeks after surgery. Method of measurement: Tampa questionnaire.</prim_outcome>
      <prim_outcome>Pain. Timepoint: 4 weeks before ACL reconstruction and 4 weeks after surgery. Method of measurement: Visual Analouge scale.</prim_outcome>
      <prim_outcome>Knee joint function. Timepoint: 4 weeks before ACL reconstruction and 4 weeks after surgery. Method of measurement: International Knee Documentation Committee questionnaire.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-13</approval_date>
        <contact_name>The Ethics Committee of the Research Institute of Physical Education and Sports Sciences</contact_name>
        <contact_address>No.3, 5th Alley, Miremad St., Ostad Motahari St., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
