<?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>IRCT20200825048523N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-13</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of strengthening exercises on anterior knee pain syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of of purposeful strengthening exercises based on biomechanical defects on ultrasonographic parameters and kinematic variables in people with Patellofemoral Pain Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67143</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized method: balanced randomized blocks. Random concealment: sealed envelope. Randomization method: code of the intervention group: A code of the control group: B. Due to having two groups, the determined blocks are of four, so that the total number of possible permutations of four is 6, including: ABAB, ABBA, BAAB, BABA, AABB, BBAA. To create a random sequence, we will number the possible blocks (6 blocks) from 1 to 6, we will select the block numbers from the random number table, and based on these numbers, we will determine the sequence of blocks in each group. According to the sample size of 40, 10 of these blocks are randomly placed together, each of these codes representing the treatment group of each patient is placed in a sealed envelope, then patients will be assigned to one of the envelopes in order of number. In this study, the unit of randomization is the individual, Blinding description: The main researcher is blinded to the selection and randomization of participants, and assigning groups will be done by another colleague. Treatment for the intervention group will be done on even days of the week and treatment for the control group will be done on odd days of the week, so the participants will be blinded to their treatment and group assignment. Data collection and analysis after the completion of the interventions will be done by another colleague who is blind to group assignment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patellofemoral pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: specific strengthening exercises of the vastus medialis oblique muscle with routine physiotherapy treatments (stretching exercises, gluteal and quadriceps isometric exercises, electrotherapy including conventional tens). The interventions will be conducted for eight weeks and three sessions per week. Intervention 2: Control group: Routine physiotherapy treatments (stretching exercises, gluteal and quadriceps isometric exercises, electrotherapy including conventional tens). The interventions will be conducted for eight weeks and three sessions 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All above will be published in the article.

When:
After the article publication

To whom:
Researchers and students in academic centers

Conditions:
Other researchers and therapists in the rehabilitation and medical field can use this use the data of this study after the article publication.

Where to obtain:
After the article publication, people can find the article by searching in internet and access the data.

How to obtain:
After the article publication, people can find the article by searching in internet and access the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Mikaili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 8863 1084</telephone>
        <email>saeed.mikaely@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khosro Khademi Kalantari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7756 1722</telephone>
        <email>khosro_khademi@yahoo.co.uk</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with patellofemoral pain syndrome with lateral gliding patella
Pain at least 3 on the visual analog scale
Knee pain when running, jumping, sitting and standing up</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of patella dislocation
History of knee surgery</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: specific strengthening exercises of the vastus medialis oblique muscle with routine physiotherapy treatments (stretching exercises, gluteal and quadriceps isometric exercises, electrotherapy including conventional tens). The interventions will be conducted for eight weeks and three sessions per week.</i_keyword>
      <i_keyword>Control group: Routine physiotherapy treatments (stretching exercises, gluteal and quadriceps isometric exercises, electrotherapy including conventional tens). The interventions will be conducted for eight weeks and three sessions per week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Measurement of pain intensity at the beginning of the study (before the intervention), at the end of the study (8 weeks after the intervention) and 3 months after the intervention In the follow-up period. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>Distance between patellar tip and trochlear groove. Timepoint: Measurement of distance between patellar tip and trochlear groove at the beginning of the study (before the intervention), at the end of the study (8 weeks after the intervention) and 3 months after the intervention In the follow-up period. Method of measurement: Ultrasonography.</prim_outcome>
      <prim_outcome>Femoral sulcus angle. Timepoint: Measurement of femoral sulcus angle at the beginning of the study (before the intervention), at the end of the study (8 weeks after the intervention) and 3 months after the intervention In the follow-up period. Method of measurement: Ultrasonography.</prim_outcome>
      <prim_outcome>Patella offset position. Timepoint: Measurement of patella offset position at the beginning of the study (before the intervention), at the end of the study (8 weeks after the intervention) and 3 months after the intervention In the follow-up period. Method of measurement: Ultrasonography.</prim_outcome>
      <prim_outcome>Patella condylar distance. Timepoint: Measurement of patella condylar distance at the beginning of the study (before the intervention), at the end of the study (8 weeks after the intervention) and 3 months after the intervention In the follow-up period. Method of measurement: Ultrasonography.</prim_outcome>
      <prim_outcome>Knee kinematic. Timepoint: Measurement of knee kinematic at the beginning of the study (before the intervention), at the end of the study (8 weeks after the intervention) and 3 months after the intervention In the follow-up period. Method of measurement: Motion analysis device.</prim_outcome>
      <prim_outcome>Hip kinematic. Timepoint: Measurement of hip kinematic at the beginning of the study (before the intervention), at the end of the study (8 weeks after the intervention) and 3 months after the intervention In the follow-up period. Method of measurement: Motion analysis device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of functional disability. Timepoint: Measurement of level of functional disability at the beginning of the study (before the intervention), at the end of the study (8 weeks after the intervention) and 3 months after the intervention In the follow-up period. Method of measurement: The knee injury and osteoarthritis outcome score.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-11</approval_date>
        <contact_name>Research Ethic Committees of Vice Chancellor in Research Affairs Shahid Beheshti University of Medic</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
