<?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>IRCT20230604058380N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-28</date_registration>
      <primary_sponsor>University of guilan</primary_sponsor>
      <public_title>Comparison of the effect of a course of corrective exercises with and without foot orthosis on people with patellofemoral pain syndrome.</public_title>
      <acronym></acronym>
      <scientific_title>comparison of the effect of a course of course of corrective exercises with and without foot orthosis on the improvement of pain and performance of patients with patellofemoral pain syndrome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>117</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71271</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: NO, Randomization description: To allocate participants to each study group by a third party who is not present in the study, sealed, numbered, and opaque envelopes will be prepared based on the number of patients. Notably, the envelope will contain a slip of paper on which the treatment will be written in coded letters (namely, ABC). Then, each participant will randomly select an envelope like a lottery and will be allocated to one of three groups (Group I: PSEFO, Group II: PSEs, or Group III: CG) according to the code in each envelope, Blinding description: In this study, the outcome evaluator is blind, so that he does not know how the subjects are assigned to the groups and what treatment intervention each group of subjects will receive. In this way, during the evaluation before and after the period of interventions, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patellofemoral pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: The first intervention group receives proximal hip and core strengthening exercises for eight weeks. Intervention 2: Intervention group: The second intervention group receives foot orthotics in addition toproximal strengthening hip and core exercises. Intervention 3: Control group: These people continue their way of life as usual.</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 No, there is no plan to publish</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mansoureh barati ashtiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometer 5 of Qazvin Highway - Rasht, Faculty of Physical Education and Sports, Pilan</address>
        <city>rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 903 499 0769</telephone>
        <email>manbarati1377@gmail.com</email>
        <affiliation>Gilan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hasan Daneshmandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometer 5, Bezgarah, Qazvin, Rasht, Faculty of Sports Sciences and Physical Education, Gilan</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>guilan.central.lab@g</zip>
        <telephone>0133369027</telephone>
        <email>daneshmandi_ph@yahoo.com</email>
        <affiliation>University of Gilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range between 18 and 40 years
Having knee pain for at least 6 weeks or more
Having anterior knee pain with non-traumatic origin
Not having a history of injury and surgery on the spine and lower limbs
Exacerbation of pain with at least 2 of the following activities including: running, jumping, walking on a hill or stairs, sitting for a long time, kneeling, squatting
Clark's test is positive
Navicular drop more than 9 mm
A score greater than 6 from the foot posture index
Pain score greater than 3 on the visual analog scale</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Knee meniscus and ligament or tendon injury
patellar dislocation (patellar instability)
Osgoodschlatter disease
Celica syndrome,
Larsen-Johnson syndrom
knee joint effusion</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: The first intervention group receives proximal hip and core strengthening exercises for eight weeks.</i_keyword>
      <i_keyword>Intervention group: The second intervention group receives foot orthotics in addition toproximal strengthening hip and core exercises.</i_keyword>
      <i_keyword>Control group: These people continue their way of life as usual.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pain measurement before and after exercises and intervention. Method of measurement: Visual Analog Scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability. Timepoint: Measurement of functional  before and after exercises and intervention. Method of measurement: Kujala questionnaire.</sec_outcome>
      <sec_outcome>Balance. Timepoint: Measurement of functional  before and after exercises and intervention. Method of measurement: Y balance test.</sec_outcome>
      <sec_outcome>Functional. Timepoint: Measurement of functional  before and after exercises and intervention. Method of measurement: step down test at 30 second.</sec_outcome>
      <sec_outcome>Functional. Timepoint: Measurement of functional  before and after exercises and intervention. Method of measurement: Single leg squat test.</sec_outcome>
      <sec_outcome>Functional. Timepoint: Measurement of functional  before and after exercises and intervention. Method of measurement: bilateral squat test.</sec_outcome>
      <sec_outcome>Q angle. Timepoint: Measurement of Q angle   before and after exercises and intervention. Method of measurement: Measuring the angle Q with a goniometer.</sec_outcome>
      <sec_outcome>Flat foot. Timepoint: Measurement  before and after exercises and intervention. Method of measurement: Navicular drop.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Measurement  before and after exercises and intervention. Method of measurement: Quality of life questionnaire (SF_36).</sec_outcome>
      <sec_outcome>Functional. Timepoint: Measurement of functional  before and after exercises and intervention. Method of measurement: anteromidial lunge test.</sec_outcome>
      <sec_outcome>Disability. Timepoint: Measurement disability of before and after exercises and intervention. Method of measurement: Kujala questionnaire.</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>University of guilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-28</approval_date>
        <contact_name>Ethics Committee of Gilan University of Medical Sciences</contact_name>
        <contact_address>1st block, 13th floor, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran St., between South Flank and Zarafshan, Quds town, Tehran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
