<?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>IRCT20200507047331N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-15</date_registration>
      <primary_sponsor>University of Isfahan</primary_sponsor>
      <public_title>Effect of exercise on motor function and micro-structure of injured meniscus</public_title>
      <acronym></acronym>
      <scientific_title>Effect of 8-weeks selected physical rehabilitation exercises on motor function and micro-structure of meniscus in injured athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47972</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Meniscus Injury (Musculoskeletal Injury).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: one hour daily of selective rehabilitation exercises for eight weeks composed of stretch, strengthening, and balance exercises applied by the researcher based on FITT principles. These exercises were   modified by the associated orthopedic surgeon. Intervention 2: Control group: did not receive any intervention.</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 Publication of participants files is due to supervisor's and faculty's decision</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyede Mona Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, Apt. 4, Yas Ct., Shahid Soori St., Evin, Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1997657557</zip>
        <telephone>+98 21 2234 5000</telephone>
        <email>mona_s1379@yahoo.com</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyede Mona Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, Apt. 4, Yas Ct., Shahid Soori St., Evin, Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1997657557</zip>
        <telephone>+98 21 2234 5000</telephone>
        <email>mona_s1379@yahoo.com</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be a volunteer for meniscectomy
Not more than six months is passed from the time of his/her meniscus injury
Having surgery up to three month after acquaintance with the study
Having specific severity in injury which is diagnosed by the surgeon
Be a volunteer for participating in the exercise protocol</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: one hour daily of selective rehabilitation exercises for eight weeks composed of stretch, strengthening, and balance exercises applied by the researcher based on FITT principles. These exercises were   modified by the associated orthopedic surgeon.</i_keyword>
      <i_keyword>Control group: did not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maximum torque of knee flexor muscles. Timepoint: Before and after eight weeks of exercise. Method of measurement: Biodex Isokinetic Dynamometer.</prim_outcome>
      <prim_outcome>Maximum torque of knee extensor muscles. Timepoint: Before and after eight weeks of exercise. Method of measurement: Biodex Isokinetic Dynamometer.</prim_outcome>
      <prim_outcome>Overall static balance index. Timepoint: Before and after eight weeks of exercise. Method of measurement: Biodex Balance System SD.</prim_outcome>
      <prim_outcome>Anteroposterior static balance index. Timepoint: Before and after eight weeks of exercise. Method of measurement: Biodex Balance System SD.</prim_outcome>
      <prim_outcome>Mediolateral static balance index. Timepoint: Before and after eight weeks of exercise. Method of measurement: Biodex Balance System SD.</prim_outcome>
      <prim_outcome>Overall dynamic balance index. Timepoint: Before and after eight weeks of exercise. Method of measurement: Biodex Balance System SD.</prim_outcome>
      <prim_outcome>Anteroposterior dynamic balance index. Timepoint: Before and after eight weeks of exercise. Method of measurement: Biodex Balance System SD.</prim_outcome>
      <prim_outcome>Mediolateral dynamic balance index. Timepoint: Before and after eight weeks of exercise. Method of measurement: Biodex Balance System SD.</prim_outcome>
      <prim_outcome>Absolute repositioning active angle error. Timepoint: Before and after eight weeks of exercise. Method of measurement: Biodex Isokinetic Dynamometer.</prim_outcome>
      <prim_outcome>Knee extension range of motion. Timepoint: Before and after eight weeks of exercise. Method of measurement: Biodex Isokinetic Dynamometer.</prim_outcome>
      <prim_outcome>Roughness of meniscus surface. Timepoint: Post surgery. Method of measurement: Atomic Force Microscope.</prim_outcome>
      <prim_outcome>Number of meniscus fibrocartilages. Timepoint: Post surgery. Method of measurement: Atomic Force Microscope.</prim_outcome>
      <prim_outcome>Diameter of meniscus fibrocartilages. Timepoint: Post surgery. Method of measurement: Atomic Force Microscope.</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>University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-23</approval_date>
        <contact_name>Ethics Committee of the Isfahan University</contact_name>
        <contact_address>Isfahan University, Azadi Sq. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
