<?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>IRCT20220226054122N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-01</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of Whole Body Vibration Effect on Stability during Jump Landing</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Whole Body Vibration (WBV) on Dynamic Postural Stability during Jump Landing in Athletes Following Anterior Cruciate Ligament Reconstruction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62172</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random َAllocation will be done through Randomization.com and Balanced Block Randomization Method. The Size of the Blocks is 4. Also, for Allocation Concealment, sealed and numbered Envelopes are used, which are provided to the Participants by the Secretary, Blinding description: Assessor and Analyser.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Poor Dynamic Postural Stability. Condition 2: Anterior Cruciate Ligament Reconstruction Surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Whole Body Vibration and exercise training 3 sessions a week and for 4 week.  9 positions are defined for the person, each of which from sessions 1 to 12 with different repetitions on the Whole Body Vibration device with a frequency between 30 to 50 Hz, amplitude 2.5 to 5 mm, number of sets between 8 to 16, rest Between sets of 60 seconds and duration of vibration 4 to 16 minutes, are performed from the first session to 12th session. Position 1: legs in the middle of the plate and slightly apart, knees slightly bent and back straight , Position 2: Standing on one leg, middle leg Plate, knees also slightly bent and waist straight, Position 3: Mini-squat / Position 4: Mini-squat on one leg / Position 5: Squat / Position 6: Squat on one leg / Position 7: Squat with the legs apart ./ Position 8: One foot in the middle of the plate and the other foot outside the plate, knees at 90 degrees flexion and back straight / Position 9: Standing on toes. Intervention 2: Control group: exercise training. 10 RM. exercise training include strength training and perturbation training. 12 sessions: 3 sessions per week for 4 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>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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Rostampour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Farahani Alley, Kamali Ave, Abouzar Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1363945641</zip>
        <telephone>+98 21 5514 2480</telephone>
        <email>z.rostampur@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roya Khanmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Piche Shemiran Ave, Rehabilitation Faculty</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1363945641</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>rkhanmohammadi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of Anterior Cruciate Ligament Surgery (Hamstrings) without Surgery for Other Ligament and Meniscus Injuries
More than 6 Months have passed since the Surgery
The operated Leg should be One-Sided
Having Mild to Moderate Physical Activity (at least 3 Times a Week and more than 30 Minutes each Time) in Jumping Sports such as Volleyball, Basketball, Football, Handball, etc.
No Pain, Inflammation and Limited Range of Motion in the Knee Joint
The Person has returned to Exercise with the Advice of a Doctor and has received some Rehabilitation Programs after Surgery and before entering the Study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not having Items that prohibit Whole Body Vibration (Pregnancy, Acute Thrombosis, Severe Cardiovascular Problems, Pacemaker, Discopathy, Spondylosis, Severe Diabetes, Epilepsy, Acute Infection, Severe Migraine, Tumor, Kidney Stones)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></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: Whole Body Vibration and exercise training 3 sessions a week and for 4 week.  9 positions are defined for the person, each of which from sessions 1 to 12 with different repetitions on the Whole Body Vibration device with a frequency between 30 to 50 Hz, amplitude 2.5 to 5 mm, number of sets between 8 to 16, rest Between sets of 60 seconds and duration of vibration 4 to 16 minutes, are performed from the first session to 12th session. Position 1: legs in the middle of the plate and slightly apart, knees slightly bent and back straight , Position 2: Standing on one leg, middle leg Plate, knees also slightly bent and waist straight, Position 3: Mini-squat / Position 4: Mini-squat on one leg / Position 5: Squat / Position 6: Squat on one leg / Position 7: Squat with the legs apart ./ Position 8: One foot in the middle of the plate and the other foot outside the plate, knees at 90 degrees flexion and back straight / Position 9: Standing on toes</i_keyword>
      <i_keyword>Control group: exercise training. 10 RM. exercise training include strength training and perturbation training. 12 sessions: 3 sessions per week for 4 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>AnteroPosterior/MedioLateral/ vertical and resultant time to stabilization during forward and diagonal jump landing. Timepoint: Before intervention and 48 hours after last treatment session. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>AnteroPosterior/Mediolateral/ vertical and resultant stability index during forward and diagonal jump landing. Timepoint: Before intervention and 48 hours after last treatment session. Method of measurement: Force plate.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Distance traveled in Y balance test in anterior/posteromedial and posterolateral. Timepoint: Before intervention and 48 hours after last treatment session. Method of measurement: Y balance test.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-23</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical sciences</contact_name>
        <contact_address>13th Floor, A block, Headquarters of the Ministry of Health, Simaye Iran Ave, between Zarafshan and South Falamak, Qods town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
