<?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>IRCT20191013045090N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-03</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>Developing a machine-based training program in rehabilitation after reconstruction of the anterior cruciate ligament</public_title>
      <acronym></acronym>
      <scientific_title>Developing a machine-based training program for using Wii Fit to evaluate patient's balance and physical function after anterior cruciate ligament reconstruction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43088</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study samples will be divided into study groups (Interfering with Wii Fit, treatment with conventional therapy) by a quadruple-block random sampling among eligible patients undergoing ACL reconstruction, Blinding description: In this study, the evaluator of research outcomes will be blinded to treatment groups.
The person who does the statistical analysis of the data will also be blind to the treatment modalities and treatment groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anterior cruciate ligament tear.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: ]It is a game-based rehabilitation program based on expert opinions and with the Wii Fit system to improve the balance for patients after reconstruction of the anterior cruciate ligament and Includes seven Ski Slalom, Ski Jump, Table Tilt, Balance Bubble, Perfect 10, Penguin Slide, Skateboard Adena on Wii system. Intervention 2: Control group: The common rehabilitation program treatments used in physiotherapy clinics for patients after reconstruction of the anterior cruciate ligament.Patients' exercise therapy programs in the control group will include:• Static exercises for quadriceps, hamstring, gluteal muscles and SLR. .•Closed chain exercises to increase knee mobility.• Proprioseptive exercises on the balance board.• Functional exercises such as using a stationary bike or treadmill.• Stretching exercises for the lower extremities .• Lower extremity muscle strengthening 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to ethical standards, The participants have been ‎promised that the information of this research will remain ‎confidential in their written consent form.‎</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arezoo Abasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University -Jalal Al ahmad Street - Tehran - Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3875</telephone>
        <email>arezoo_abasi@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezoo Abasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University -Jalal Al ahmad Street - Tehran - Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3875</telephone>
        <email>arezoo_abasi@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Unilateral ACL injury with specialist physician diagnosis and MRI approval
At least 3 months after ACL reconstruction surgery (With Bone-Patellar-Tendon-Bone Surgery Type)
Male
Full consent to participate in the research
Having a referral from an orthopedic specialist
Complete cardiovascular health of patients with physician approval
Balanced state of mind</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Unfinished treatment programs and assessment
The occurrence of any sudden systemic disorder during rehabilitation according to the patient
The patient's willingness to withdraw from the study and unfinished treatment
Performing exercises outside the prescribed schedule according to the patient
Receive any treatment other than the treatment plans prescribed in this research plan
Injury to other ligaments and knee joint structures with orthopedic specialist approval
Previous surgery or injury in the knee of the opposite side and other joints of the lower extremities with orthopedic specialist approval
Taking painkillers, anti-inflammatory drugs, etc
Chronic illness or other known condition that may affect research research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></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: ]It is a game-based rehabilitation program based on expert opinions and with the Wii Fit system to improve the balance for patients after reconstruction of the anterior cruciate ligament and Includes seven Ski Slalom, Ski Jump, Table Tilt, Balance Bubble, Perfect 10, Penguin Slide, Skateboard Adena on Wii system.</i_keyword>
      <i_keyword>Control group: The common rehabilitation program treatments used in physiotherapy clinics for patients after reconstruction of the anterior cruciate ligament.Patients' exercise therapy programs in the control group will include:• Static exercises for quadriceps, hamstring, gluteal muscles and SLR. .•Closed chain exercises to increase knee mobility.• Proprioseptive exercises on the balance board.• Functional exercises such as using a stationary bike or treadmill.• Stretching exercises for the lower extremities .• Lower extremity muscle strengthening exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Static Balance. Timepoint: Pre and Post Intervention. Method of measurement: Balance Error Scoring System ‎Test.</prim_outcome>
      <prim_outcome>Dynamic Balance. Timepoint: Pre and Post Intervention. Method of measurement: Modified Star Excursion Balance Test.</prim_outcome>
      <prim_outcome>Physical Function. Timepoint: Pre and Post Intervention. Method of measurement: Single leg  hop for time &amp;   One leg  hop for distance.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain Intensity. Timepoint: Pre and Post Intervention. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Knee range of motion. Timepoint: Pre and Post Intervention. Method of measurement: Goniometery.</sec_outcome>
      <sec_outcome>Thigh Atrophy. Timepoint: Pre and Post Intervention. Method of measurement: Measurement of thigh circumference with Cm tape measure.</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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-07</approval_date>
        <contact_name>Tarbiat Modares University</contact_name>
        <contact_address>Tarbiat Modares University, Jalal Al ahmad Street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
