<?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>IRCT20211004052666N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-23</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effects of balance training with and without cognitive task and external focus of attention on postural control in individuals with anterior cruciate ligament reconstruction</public_title>
      <acronym>کنترل پاسچر ،بازسازی رباط صلیبی قدامی زانو، تکلیف شناختی ، تمرکز توجه ، تمرینات تعادلی</acronym>
      <scientific_title>The effects of balance training with and without cognitive task and external focus of attention on postural control in individuals with anterior cruciate ligament reconstruction-A duoble blinded randomized control trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59124</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: They will be selected from the available population by simple non-probability sampling method and then randomly divided into three groups. And after obtaining informed consent, people enter the study. The advantage of this method is that while keeping the number of people in the three groups equal, the balance of groups in terms of the distribution of influential variables (gender in this study) is also maintained. For this purpose, first by Random allocation computer software (version 1.1 of Isfahan University of Medical Sciences, Iran) a random order of three letters A (first group) and B (second group) and C (third group) with random numbers 4 and 5 And 6 will be built. The blocks are then hidden by an opaque envelope. In order to minimize bias, select, and ensure that the allocation of individuals in groups is concealed, the randomization process will be performed by a person who will not participate in any of the other stages of the research, Blinding description: This study is a double-blind randomized trial in which patients are evaluated by a physiotherapist who is unaware of the assignments of individuals in groups. The data analyst is also unaware of the specifics of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>individuals with (knee) anterior cruciate ligament reconstruction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1: People with anterior cruciate ligament reconstruction who perform regular balance exercises. Intervention 2: Group 2: People with anterior cruciate ligament reconstruction who perform routine balance exercises with external attention focus exercises. Intervention 3: Intervention group: Group 3: People with ligament reconstruction Anterior cruciate ligament that combines common balance exercises with cognitive 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Informed consent forms, koos questionnaire, tegner, and personal information collection form are given. And only information about the main outcome is shared.

When:
Access period starts 6 months after the results are published

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
The applicant must be a researcher working in an academic institution

Where to obtain:
To receive information, you need to contact Dr. Kouhzad Mohammadi, in charge of the project, by email:
Correspondence should be sent to www.kouhzad@yahoo.com.

How to obtain:
Request an email from the developer and receive a response within one to two months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>HOSSAIN KOHZAD MOHAMMADI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Highway, Farvardin Boulevard, Ahvaz University of Medical Sciences, School of Rehabilitation</address>
        <city>AHWAZ</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1579461357</zip>
        <telephone>+98 61 3333 3477</telephone>
        <email>WWW.kouhzad@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>HASSAIN KOHZAD MAHAMMADI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Highway, Farvardin Boulevard, Ahvaz Jundishapur University of Medical Sciences, School of Rehabilitation</address>
        <city>AHWAZ</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3333 3477</telephone>
        <email>WWW.kouhzad@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1) At least 6 months after the anterior cruciate ligament reconstraction of the knee
2) Age between 17 and 45 years old
3)The subjects in the study did not participate in another treatment exercise during the last six weeks.</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Existence of untreated meniscus tear in the operated leg
Have a history of lateral ligament injury or surgery
Have a history of surgery or traumatic injury to the opposite knee
Have a history of surgery or traumatic injury to either of the ankle and hip joints
Complain about instability
Have a history of neurological diseases, vestibular disorders and vision
Have a history of posterior cruciate ligament rupture
Have a history of diabetes, taking medication that affects balance and confusion
Existence of musculoskeletal problems in the back and neck</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M23.61</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other spontaneous disruption of anterior cruciate ligament of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group 1: People with anterior cruciate ligament reconstruction who perform regular balance exercises</i_keyword>
      <i_keyword>Group 2: People with anterior cruciate ligament reconstruction who perform routine balance exercises with external attention focus exercises</i_keyword>
      <i_keyword>Intervention group: Group 3: People with ligament reconstruction Anterior cruciate ligament that combines common balance exercises with cognitive exercises</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sway of center of pressure. Timepoint: Measurement of pressure center sway before intervention, after 8 weeks of intervention and 4 weeks after the end of the study. Method of measurement: Force plate apparatus.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-04</approval_date>
        <contact_name>Ethics Committee of Ahwaz Jundishapur University of Medical Sciences and Health Services</contact_name>
        <contact_address>University City, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences and Health Services, Ground Floor Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
