<?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>IRCT20180925041138N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-31</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Affect of Dual_Task Balance Training on Balance of People with Anterior Cruciate Ligament Reconstruction</public_title>
      <acronym>Anterior Cruciate Ligament Reconstruction (ACL_R)</acronym>
      <scientific_title>Comparison of the Effects of Cognitive_Balance  Dual-Task Training and Single Task Balance Training on Static Balance of People with Anterior Cruciate Ligament Reconstruction (ACL_R)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34138</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study people with inclusion criteria will be divided into control and Intervention groups according to simple randomization way by Random Software Allocation, Blinding description: In this study all of the participants will be unaware of group of study they  belong to. Also researcher, outcomes assessors and data analyzer will be unaware the group each participants belong to. Inevitably, the trainer physiotherapist base on intervention type will not be blind. However, he will not be allowed to outcome assessment and data analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anterior Cruciate Ligament Reconstruction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Anterior cruciate reconstructed patients during rehabilitation in balance training phase will do progressive balance training including single leg standing on reconstructed limb, standing on bi-direction balance board in med-lat direction, standing on bi-direction balance board in ant-post direction, standing on bi-direction balance board with foam surface(10 cm thickness), standing on multi-direction balance board, standing on multi-direction balance board with foam surface(10 cm thickness) simultaneously with cognitive tasks including backward counting of numbers at a specified interval, saying the days of the week in reverse and alternative ways, saying the names started with special letters, reverse words spelling (Dual Task) for 20 minutes, 3 sessions a week for 6 weeks. Intervention 2: Control group: Anterior cruciate reconstructed patients during rehabilitation in balance training phase will do progressive balance training including single leg standing on reconstructed limb, standing on bi-direction balance board in med-lat direction, standing on bi-direction balance board in ant-post direction, standing on bi-direction balance board with foam surface(10 cm thickness), standing on multi-direction balance board, standing on multi-direction balance board with foam surface(10 cm thickness) without any cognitive tasks (Single Task) for 20 minutes, 3 sessions a week for 6 weeks.</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>Jalal Ahadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy department, Rehabilitation Sciences Faculty, Tabriz University of Medical Sciences, Golgasht street, Azadi street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166615669</zip>
        <telephone>+98 41 3337 5359</telephone>
        <email>Ahadij@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jalal Ahadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy department, Rehabilitation Sciences Faculty, Tabriz University of Medical Sciences, Golgasht street, Azadi street, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166615669</zip>
        <telephone>+98 41 3337 5359</telephone>
        <email>Ahadij@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Unilateral ACL Reconstruction Surgery by Hamstring Tendon Allograft
Full Weight Bearing Ability on Reconstructed limb
At Least 120 Degree Reconstructed Knee Range of Motion</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The History of Neurological, Vestibular and Visual Disorder
The History of Injury or Surgery of the Spine
The History of Injury or Surgery of the Other Segments of Reconstructed Limb
The History of Injury or Surgery of the Other Ligaments of Reconstructed Knee</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of anterior cruciate ligament of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Anterior cruciate reconstructed patients during rehabilitation in balance training phase will do progressive balance training including single leg standing on reconstructed limb, standing on bi-direction balance board in med-lat direction, standing on bi-direction balance board in ant-post direction, standing on bi-direction balance board with foam surface(10 cm thickness), standing on multi-direction balance board, standing on multi-direction balance board with foam surface(10 cm thickness) simultaneously with cognitive tasks including backward counting of numbers at a specified interval, saying the days of the week in reverse and alternative ways, saying the names started with special letters, reverse words spelling (Dual Task) for 20 minutes, 3 sessions a week for 6 weeks.</i_keyword>
      <i_keyword>Control group: Anterior cruciate reconstructed patients during rehabilitation in balance training phase will do progressive balance training including single leg standing on reconstructed limb, standing on bi-direction balance board in med-lat direction, standing on bi-direction balance board in ant-post direction, standing on bi-direction balance board with foam surface(10 cm thickness), standing on multi-direction balance board, standing on multi-direction balance board with foam surface(10 cm thickness) without any cognitive tasks (Single Task) for 20 minutes, 3 sessions a week for 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean Anterior - Posterior Sway amplitude of Center of Pressure. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
      <prim_outcome>Mean Medial - Lateral Sway amplitude of Center of Pressure. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
      <prim_outcome>Total path length of Center of Pressure. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
      <prim_outcome>Root-mean-square amplitude of center of pressure in anterior - posterior direction. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
      <prim_outcome>Root-mean-square amplitude of center of pressure in medial - lateral direction. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
      <prim_outcome>Root-mean-square velocity of center of pressure in anterior - posterior direction. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
      <prim_outcome>Root-mean-square velocity of center of pressure in medial - lateral direction. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
      <prim_outcome>ٍEllipse sway area. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
      <prim_outcome>Center of pressure velocity in anterior - posterior direction. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
      <prim_outcome>Center of pressure velocity in medial - lateral direction. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
      <prim_outcome>Path length of center of pressure in anterior - posterior direction. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
      <prim_outcome>Path length of center of pressure in medial - lateral direction. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire. Timepoint: Before starting balance training and at the end of treatment (18 session later). Method of measurement: Force Plate Instrument.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-21</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
