<?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>IRCT20220220054078N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-11</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>investigating the effect of Whole body vibration in athletes following anterior cruciate ligament reconstruction</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Whole body vibration on muscle inhibition, cortical excitability and topographic map of quadriceps muscle in the brain of athletes following anterior cruciate ligament reconstruction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62194</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: individuals are randomly divided into two groups, which will be done using randomization sequence through randomization.com and balanced blocked 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: patients are randomly divided into 2 groups of real treatment and control group who do not know the type of their group. the information obtained from the evaluation of patients is categorized by another person and analyst is not aware of the grouping of information.</study_design>
      <phase>N/A</phase>
      <hc_freetext>athletes following anterior cruciate ligament reconstruction.</hc_freetext>
      <i_freetext>Intervention 1: treatment group: Whole body vibration and exercise therapy including resistive exercises and perturbation exercises for 12 sessions in 4 weeks. Intervention 2: Control group: exercise therapy including resistive exercises and perturbation exercises for 12 sessions in 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>Roya Khanmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, corner of Safi Alishahi street, Pich E Shemi, Enghelab street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7753 5132</telephone>
        <email>rkhanmohammadi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roya Khanmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, corner of Safi Alishahi street, Pich E Shemi, Enghelab street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7753 5132</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>18-40 years old
both of gender
lll
More than 6 months have passed since the surgery
Edinburgh handedness inventory (EHI) questionnaire
Tegner Activity Level Scale &lt; 8
Have a history of anterior cruciate ligament surgery (all types of graft) without surgery for other ligament and meniscus injuries
had no pain, inflammation or limited range of motion in the knee joint
WBV contraindication: pregnancy, acute thrombosis, serious cardiovascular disease, pacemaker, acute hernia, discopathy, spondylolysis, severe diabetes, epilepsy, recent infections, severe migraine, tumors or kidney stones.
TMS contraindication: having a history of seizures, epilepsy (first-degree person or family), head injury or brain injury, having metal in the head (outside the mouth) such as a surgical clip, implantation Welded cochlear implants, history of a bad reaction to an MRI or TMS, history of stroke, brain-related diseases such as MS or brain tumor, history of fainting, severe headache, pregnancy Or planning for pregnancy in the past 3 months, taking medications known to lower the seizure threshold such as imipramine &amp; ….
Have a history of anterior cruciate ligament surgery (hamstring graft) without surgery for other ligament and meniscus injuries</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inability to understand and/or perform the required maneuvers.
Alcohol, caffeine and drug consumption on the day of the test.
Participant dissatisfaction with the continuation of the program.
Presence of pain at the time of the tests or any complication preventing the data collection.
Being absent for more than 2 sessions or for 3 times during the whole procedure</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>treatment group: Whole body vibration and exercise therapy including resistive exercises and perturbation exercises for 12 sessions in 4 weeks</i_keyword>
      <i_keyword>Control group: exercise therapy including resistive exercises and perturbation exercises for 12 sessions in 4 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Central Activation Ratio. Timepoint: At the start of the study and 48 hours after end of the treatment. Method of measurement: By using Biodex &amp; stimulator.</prim_outcome>
      <prim_outcome>Active Motor Threshold. Timepoint: At the start of the study and 48 hours after end of the treatment. Method of measurement: By using Transcranial magnetic stimulation (MagPro X100).</prim_outcome>
      <prim_outcome>Amplitude of Motor Evoked Potentials. Timepoint: At the start of the study and 48 hours after end of the treatment. Method of measurement: By using Transcranial magnetic stimulation (MagPro X100).</prim_outcome>
      <prim_outcome>Map Volume of quadriceps muscle in motor cortex. Timepoint: At the start of the study and 48 hours after end of the treatment. Method of measurement: By using Transcranial magnetic stimulation (MagPro X100).</prim_outcome>
      <prim_outcome>Center of Gravity of quadriceps muscle's map in motor cortex. Timepoint: At the start of the study and 48 hours after end of the treatment. Method of measurement: By using Transcranial magnetic stimulation (MagPro X100).</prim_outcome>
      <prim_outcome>6m-Timed Hop Test Limb Symmetry Index. Timepoint: At the start of the study and 48 hours after end of the treatment. Method of measurement: By using chronometer.</prim_outcome>
      <prim_outcome>Disability in Activities of Daily Living. Timepoint: At the start of the study and 48 hours after end of the treatment. Method of measurement: By using  Knee Outcome Survey Activities of Daily Living Questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-17</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Rehabilitation, corner of Safi Alishahi street, Pich E Shemi, Enghelab street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
