<?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>IRCT20131225015932N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-21</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of trunk training with hip and knee strength training on pain ,function and proprioception  in patients with patellofemoral pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of  unstable seated core postural control training with hip and knee strength training on pain, function and proprioception in patients with patellofemoral pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>57</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46098</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples via Block randomizer application and Block size=3  will be placed in one of the three control groups, the hip and knee strengthening exercises group, or the postural control training group, Blinding description: The physiotherapist who will measure the outcome measures will be blinded to the patient’s allocation group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patellofemoral pain.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group, hip and knee strengthening group: participants will do  3 treatment sessions per week for a period of 1 month stretching exercises for quadriceps, hamstring, illiotibial band and calf muscles (3 repetition, 30 second hold) and quadriceps setting, terminal knee extention, straight leg raise and hip abductor and external rotator strengthening exercise.Each session almost will take time 47 minutes. Intervention 2: Second intervention group; postural control training exercise group: this group participants will do stretching exercises same as hip and knee strengthening group then patients will be received postural control training exercise using unstable sitting 3 treatment sessions per week for a period of 1 month.Patients will be asked to control their balance on unstable sitting and hold it as long as possible. In order to progress the training, 3 unstable sitting with 3 different diameters (24, 30 and 50 cm) will be provided. Each session will take time 47 min, and 7 sets of 5 min each with a 2-min rest interval between sets will used. Intervention 3: Control group: This group will be received no intervention.</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 I haven't decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Ahmadi Ashan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۳۶۶۹-۷۱۹۴۷</zip>
        <telephone>00</telephone>
        <email>Ahmadiii.elham1994@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Alireza Motealleh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۳۶۶۹-۷۱۹۴۷</zip>
        <telephone>+98 71 1626 1081</telephone>
        <email>motealleh@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 18-40 years/old with unilateral patellofemoral pain
Anterior knee pain  provoked by at least 2 of the following activities:prolonged sitting, ascending or descending stairs, squatting,kneeling, jumping, running
Pain on palpation of the medial and lateral patellar facets, and positive patellar grinding test
An insidious onset of symptoms not related to trauma for the last 3 months
Kujula scores 50-80
Average pain level of at least 3 out of 10 on an NRS during the previous week
Active for at least 30 min daily, but not professional athletes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Other knee joint pathologies such as meniscus and ligament injuries, osteoarthritis and tendon impairments;Self-reported history of patellar subluxation or dislocations; plica syndrome and Osgood-Schlatter disease; trauma in hip; knee or ankle joint
Knee surgery within the previous year
Radicular pain from other joints including lumbar spine, hip and sacroiliac joints or any pain in sitting position
Spinal problems such as fractures; discopathies; spondylolysthesis and previous abdomen surgeries ; vertebral column trauma or surgeries and spinal tumors
Metabolic disorders such as Diabetes; neurological, and rheumatology diseases  such as Stroke;MS;RA and balance disorders and peripheral Neuropathies
Pregnancy
Athlete women who participates in a specific sport at least 2 h /day and 3 times a week regularly
Scoliosis</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>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group, hip and knee strengthening group: participants will do  3 treatment sessions per week for a period of 1 month stretching exercises for quadriceps, hamstring, illiotibial band and calf muscles (3 repetition, 30 second hold) and quadriceps setting, terminal knee extention, straight leg raise and hip abductor and external rotator strengthening exercise.Each session almost will take time 47 minutes.</i_keyword>
      <i_keyword>Second intervention group; postural control training exercise group: this group participants will do stretching exercises same as hip and knee strengthening group then patients will be received postural control training exercise using unstable sitting 3 treatment sessions per week for a period of 1 month.Patients will be asked to control their balance on unstable sitting and hold it as long as possible. In order to progress the training, 3 unstable sitting with 3 different diameters (24, 30 and 50 cm) will be provided. Each session will take time 47 min, and 7 sets of 5 min each with a 2-min rest interval between sets will used.</i_keyword>
      <i_keyword>Control group: This group will be received no intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: first ;6th ;12th  sessions and 1 month after intervention. Method of measurement: Numeric Rate Scale (NRS).</prim_outcome>
      <prim_outcome>Functional steping. Timepoint: First;6th and 12th sessions and 1 month after intervention. Method of measurement: Step down test.</prim_outcome>
      <prim_outcome>Function. Timepoint: First;6th;12th sessions and 1month after intervention. Method of measurement: Kujala questioner.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lumbar proproiception. Timepoint: First and 12th sessions. Method of measurement: Isokinetic.</sec_outcome>
      <sec_outcome>Knee proprioception. Timepoint: First and 12th sessions. Method of measurement: Isokinetic.</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>2020-02-19</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>Rehabilitation school of Shiraz University of Medical Sciences, Abivardi Ave., Chamran Boulevard Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
