<?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>IRCT20151118025105N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-01</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effects of Sensorimotor Training versus Hip، Knee &amp; Trunk Strengthening Exercise on patellofemoral pain syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effects of Sensorimotor Training versus Hip، Knee &amp; Trunk Strengthening Exercise on Pain &amp; Function of Patients with Patellofemoral Pain Syndrome – A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36810</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: participants will be randomly allocated with random block method each block size is 4 to the 2 groups. A list of randomized 4-letter permutations of the letters A and B representing groups one and two Produced with Random Allocation Random Software and the criterion is the allocation of people in groups. For example, if the ABBA permutation is generated in the first block Shows the first person in group A, Second and third in group B and the fourth in the group A.  There are 10 blocks in total, Blinding description: In this study, the outcome assessor as well as data analyzer will be blinded to the group allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>patellofemoral pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  intervention group 1This group will receive the sensory motor exercise for 12 sessions during a period of 4 weeks(Three sessions per week) and each session will contain 3 exercises and duration of each exercise is 5 minutes. The exercises are performed in four situations, both using ball and balance board, and without using the device. Intervention 2: Intervention group 2: This group will receive the hip, knee and trunk strengthening exercise for 12 sessions during a period of 4 weeks(Three sessions per week). for progress strengthenin exercise Which are done with weightcuff We use the 70% 1 Repetitive Movement, which is re-evaluated weekly and For other exercises Which are done without weightcuff progress is By changing position and increase the number of 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>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 اطلاعات بیشتری وجود ندارد.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sobhan Sobhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Abiverdi 1 Street, Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71947-33669</zip>
        <telephone>+98 987136265108</telephone>
        <email>sobhan132@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sobhan Sobhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Abiverdi 1 Street, Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>+98 71 3627 1551</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>sobhan132@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Persons 18 to 40 years old with unilateral knee anterior pain
Starting spontaneous pain  without any reports of knee injury
Knee pain report at least previous three months
Pain reporting in two or more cases in activities such as climbing of stairs, scatt, kneeling, jumping and prolong sitting
Moderate pain report between 3 to 7 in Numerical Pain Rating Scale at least one week
Pain during pressure testing of the patella
grind positive test or tenderness of medial and lateral facets</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with other knee injuries such as knee ligament injury, patellar instability, meniscal injuries, tendinopathy  and osteoarthritis.
Any injury of hip, ankle and spine
Surgical history on the lower extremity
The difference in the length of the lower limbs
Peripheral and central nervous system disorders
People who take topical, oral and injectable drugs during the course of treatment
People who use medications that affect balance over the past 48 hours, as well as those who have any problems such as hearing impairments that affect balance
History of drug and alcohol abuse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M22.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Patellofemoral disorders</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:  intervention group 1This group will receive the sensory motor exercise for 12 sessions during a period of 4 weeks(Three sessions per week) and each session will contain 3 exercises and duration of each exercise is 5 minutes. The exercises are performed in four situations, both using ball and balance board, and without using the device.</i_keyword>
      <i_keyword>Intervention group 2: This group will receive the hip, knee and trunk strengthening exercise for 12 sessions during a period of 4 weeks(Three sessions per week). for progress strengthenin exercise Which are done with weightcuff We use the 70% 1 Repetitive Movement, which is re-evaluated weekly and For other exercises Which are done without weightcuff progress is By changing position and increase the number of exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pre and post intervention (after 4 weeks) and during follow up (after 4 weeks). Method of measurement: Anterior Knee Pain Scale.</prim_outcome>
      <prim_outcome>Function. Timepoint: Pre and post intervention (after 4 weeks). Method of measurement: Step Down Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hip and Knee muscle strength(knee extensor+ hip abductor and external rotator)-Trunk flexor- Trunk extensor. Timepoint: Pre and post intervention (after 4 weeks). Method of measurement: Hand Held Dynamometer.</sec_outcome>
      <sec_outcome>Balance. Timepoint: Pre and post intervention (after 4 weeks). Method of measurement: Modified Star Excursion 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-18</approval_date>
        <contact_name>Ethics Committee of Shiraz Rehabilitation Sciences School</contact_name>
        <contact_address>School of Rehabilitation Sciences, Abiverdi 1 Street, Chamran Blvd Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
