<?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>IRCT20200628047946N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-16</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>Comparison of the effect of Real-time Feedback and Electromyography Biofeedback compared with Exercise therapy on Fear of movement, Clinical prediction rules and Stair-descent Kinematics in Subjects with Patellofemoral Pain Syndrome</public_title>
      <acronym>PFPS</acronym>
      <scientific_title>Comparison of the effect of Real-time Feedback and Electromyography Biofeedback compared with Exercise therapy on Fear of movement, Clinical prediction rules and Stair-descent Kinematics in Subjects with Patellofemoral Pain Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>93</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49631</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: The samples will be randomly divided into three homogeneous groups including two intervention groups and a control group, Blinding description: Participants, Researchers, Outcome evaluators and data analyzer are kept blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>patellofemoral pain syndrom.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 45 minutes of therapeutic exercises including strengthening the central muscles of the trunk and thigh and knee muscles in each session. Intervention 2: Intervention group: 45 minutes of therapeutic exercises including strengthening the central muscles of the trunk and thigh and knee muscles with Real-time feedback in each session. Intervention 3: Intervention group: 45 minutes of therapeutic exercises including strength training of the central muscles of the trunk and muscles of the thighs and knees with biofeedback electromyography in each session.</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:
Only part of the data, such as dependent variables, the average of all samples, can be shared in scientific article.

When:
The date of access is November 2020.

To whom:
Personal information is confidential and general outcomes in paper form  available to everyone.

Conditions:
Information is not available to anyone. Only the results are presented as a scientific article.

Where to obtain:
Seyedeh Saeedeh Mousavi Moghadam Qaleh Zoo- Phone 09010965165- Email smusavi73@gmail.com

How to obtain:
-

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Saeedeh Mousavi Moghaddam Qaleh Zoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center for Human Movement Sciences Kharazmi university Mirdamad, Sout Razan Street, Hesari Street, Keshvarei Sport complex Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>smusavi73@gmail.com</email>
        <affiliation>Center for Human Movement Sciences Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh Saeedeh Mousavi Moghaddam Qaleh Zoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center for Human Movement Sciences Kharazmi university Mirdamad, Sout Razan Street, Hesari Street, Keshvarei Sport complex Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>smusavi73@gmail.com</email>
        <affiliation>Center for Human Movement Sciences Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Retropatellar knee pain present for at least 2 mo during at least 2 of the following activities : Ascending / descending stairs Hopping / jogging Prolonged sitting with flexed knees Kneeling Squatting
Pain on palpation of 1 of the following , medial or lateral patellar facets, Anterior portion of the medial or lateral femoral condyle Patellar tendon
Pain rated as at least 3 cm within the week before participation on the 10-cm visual analogue pain scale
Clark test is positive</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of knee surgery
Severe abnormalities in the lower limbs
Any neurologic injury or disease that would influence gait or balance
History of low back, hip, or ankle injury within the 6 mo before participation
Insidious onset of knee pain not related to trauma
Currently involved in physical therapy or has undergone physical therapy for a lower extremity injury within the 6 mo before participation
Anterior knee pain of secondary origin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M22.2X</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>Control group: 45 minutes of therapeutic exercises including strengthening the central muscles of the trunk and thigh and knee muscles in each session.</i_keyword>
      <i_keyword>Intervention group: 45 minutes of therapeutic exercises including strengthening the central muscles of the trunk and thigh and knee muscles with Real-time feedback in each session.</i_keyword>
      <i_keyword>Intervention group: 45 minutes of therapeutic exercises including strength training of the central muscles of the trunk and muscles of the thighs and knees with biofeedback electromyography in each session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of movement. Timepoint: Before and after the intervention. Method of measurement: Fear of movement questionnaire.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before and after the intervention. Method of measurement: VAS.</prim_outcome>
      <prim_outcome>Function. Timepoint: Before and after the intervention. Method of measurement: WOMAC Functional Questionnaire.</prim_outcome>
      <prim_outcome>Strength of Knee extensor muscles and Hip muscles. Timepoint: Before and after the intervention. Method of measurement: Manual dynamometer.</prim_outcome>
      <prim_outcome>Endurance of Trunk muscles. Timepoint: Before and after the intervention. Method of measurement: Planck test.</prim_outcome>
      <prim_outcome>Lower limb kinematics. Timepoint: Before and after the intervention. Method of measurement: 3D motion analysis system.</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>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-12</approval_date>
        <contact_name>Ethics Committee of Kharazmi University</contact_name>
        <contact_address>Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street, Keshvarei Sport complex Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
