<?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>IRCT20220420054598N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-21</date_registration>
      <primary_sponsor>Shahid Beheshti University</primary_sponsor>
      <public_title>Effect of eight weeks of rehabilitation exercises on rotator cuff's architecture and function after remplissage procedure on hill-sachs defect</public_title>
      <acronym></acronym>
      <scientific_title>Effect of eight weeks of rehabilitation exercises on rotator cuff's architecture and function after remplissage procedure on hill-sachs defect</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63152</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization,In this method, we should use simple randomization models such as tap or line, using a table of random numbers, or using computer randomization methods, and assign each client to the intervention group, for example, by tossing a coin, tapping and drawing a line, or We control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hill Sachs lesion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the experimental group, after reviewing the records and evaluation of patients with Hill-Sachs injuries, 15 patients will be selected by the surgeon to implement the post-operative rehabilitation exercise program, and then by obtaining written informed consent and registering the data collection form of the subjects. including age, sports history, etc., these people will be invited to do the pre-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) and follow the exercise program (for 8 week) and finally the post-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) will be taken. Intervention 2: Control group: The control group, after examining the records and evaluating the patients with heel-sachs injury, 15 patients by obtaining written informed consent and registering the form to collect the subjects' information, including age, sports history, etc., by surgeon, from These people will be invited to participate in this research. At first, the people did the pre-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) and in these 8 weeks, they just continued with their routine activities. and finally, after 8 weeks, the post-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) will be taken.</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>Fariborz Hovanloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Sports and Health Sciences, Shahid Beheshti University, Shahid Dr. Shahriari Square (University Square), Rashiduddin Fazlullah St., Yaman St., Velanjak,Chamran Highway,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 5821</telephone>
        <email>f_hovanloo@sbu.ac.ir</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariborz Hovanloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Sports and Health Sciences, Shahid Beheshti University, Shahid Dr. Shahriari Square (University Square), Rashiduddin Fazlullah St., Yaman St., Velanjak,Chamran Highway,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 5821</telephone>
        <email>f_hovanloo@sbu.ac.ir</email>
        <affiliation>Shahid Beheshti University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of the patients should be between 23 to 33 years old
Body mass index (BMI) should be less than 25
No previous history of shoulder surgery</inclusion_criteria>
      <agemin>23 years</agemin>
      <agemax>33 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Must not have musculoskeletal and metabolic diseases
Inability to perform pre-test sections</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dislocation and sprain of joints and ligaments of shoulder girdle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the experimental group, after reviewing the records and evaluation of patients with Hill-Sachs injuries, 15 patients will be selected by the surgeon to implement the post-operative rehabilitation exercise program, and then by obtaining written informed consent and registering the data collection form of the subjects. including age, sports history, etc., these people will be invited to do the pre-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) and follow the exercise program (for 8 week) and finally the post-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) will be taken.</i_keyword>
      <i_keyword>Control group: The control group, after examining the records and evaluating the patients with heel-sachs injury, 15 patients by obtaining written informed consent and registering the form to collect the subjects' information, including age, sports history, etc., by surgeon, from These people will be invited to participate in this research. At first, the people did the pre-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) and in these 8 weeks, they just continued with their routine activities. and finally, after 8 weeks, the post-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) will be taken.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Muscle architecture changes. Timepoint: eight weeks. Method of measurement: Ultrasonography &amp; MRI.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: eight weeks. Method of measurement: Mobee Med (for measuring range of motion).</prim_outcome>
      <prim_outcome>Strength. Timepoint: eight weeks. Method of measurement: Biodex System model pro 4 (for measuring strength).</prim_outcome>
      <prim_outcome>Proprioception. Timepoint: eight weeks. Method of measurement: Biodex System model pro 4 (for measuring proprioception).</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>2022-04-30</approval_date>
        <contact_name>Ethics committee of Shahid beheshti University</contact_name>
        <contact_address>Ethics committee, Shahid Beheshti University, Shahid Dr. Shahriari Square (University Square), Rashiduddin Fazlullah St., Yaman St., Velanjak,Chamran Highway,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
