<?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>IRCT20090831002391N39</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-07</date_registration>
      <primary_sponsor>Vice chancellor for research, Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of whole body vibration on flexibility, vertical jump, agility and pain</public_title>
      <acronym></acronym>
      <scientific_title>The effects of whole body vibration with exercise therapy vs exercise therapy alone on flexibility, vertical jump, agility and pain in athletes with patellofemoral pain syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28325</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients in two groups of test and control was done by Block Balanced Randomization (BBR) method. The Randomization Sequence is generated with using the free web site at http://www.randomization.com, Blinding description: The examiner will not be aware of which intervention will be administered to which subject. The patients aware of the existence of two different groups, but do not know about their groups (treatment or control).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patellofemoral Pain Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, exercise therapy with whole body vibration training with frequency of 50 Hz and amplitude of 4 mm and for 2 sets 60 seconds with 30 second rest between sets are performed for 4 weeks and three times a week. Intervention 2: Control group: In the control group, exercise therapy  is performed for 4 weeks and three times per week.</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 The standard data will be prepared, but will be sent to the journal if needed.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Rasti Esmat Abad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Abiverdi1, Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194733669</zip>
        <telephone>+98 71 3627 2495</telephone>
        <email>e.rasti67@gmail.com</email>
        <affiliation>School of Rehabilitation Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Rojhani Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Abiverdi1, Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194733669</zip>
        <telephone>+98 71 3627 1552</telephone>
        <email>rojhaniz@sums.ac.ir</email>
        <affiliation>School of Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18-40 years male athletes
Antro or retropatellar pain
Physical activity at least 3 times a week for 2 hours
Unilateral involvement
Sports with leap and jump (soccer, volleyball, basketball, futsal and handball)
Report the pain at least in two of the activities of running, jumping, prolonged sitting, step up and down and squat
At least one of the tests being positive: step down eccentric test, patellar apprehension test, vastus medialis coordination test</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of dislocation or sublaxation of the patella
History of hip, knee or ankle surgery
Other lesion on the knee associated with this lesion
Kidney stone
Diabetes
Cardiovascular diseases
Epilepsy
Recent fracture
Gallstone
Acute disk herniation
Recent surgery
Acute arthritis
Pacemaker</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M22.2X9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Patellofemoral disorders, unspecified knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, exercise therapy with whole body vibration training with frequency of 50 Hz and amplitude of 4 mm and for 2 sets 60 seconds with 30 second rest between sets are performed for 4 weeks and three times a week.</i_keyword>
      <i_keyword>Control group: In the control group, exercise therapy  is performed for 4 weeks and three times per week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of the whole body vibration training on flexibility. Timepoint: Before and 1 month after intervention. Method of measurement: Flexibility with sit and reach test.</prim_outcome>
      <prim_outcome>The effect of the whole body vibration training on agility. Timepoint: Before and 1 month after intervention. Method of measurement: Agility with modified t-test.</prim_outcome>
      <prim_outcome>The effect of the whole body vibration training on vertical jump. Timepoint: Before and 1 month after intervention. Method of measurement: Vertical jump by vertical jump test.</prim_outcome>
      <prim_outcome>The effect of the whole body vibration training on pain. Timepoint: Before and 1 month after intervention. Method of measurement: Evaluation of pain by the visual analogue scale.</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>Vice chancellor for research, Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-10</approval_date>
        <contact_name>Ethics committee of research in Shiraz University of Medical Science</contact_name>
        <contact_address>Central building of Shiraz University of Medical Science, Zand Ave Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
