<?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>IRCT20201112049361N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-29</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Telerehabilitation on Knee Pain</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of a blended care Tele-rehabilitation Versus face-to-face Physical Therapy on Pain, Physical Function and Quality of Life in individuals with Patellofemoral Pain Syndrome: A Single Blind Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64889</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After completing the outcome measurement tests before treatment intervention, people are divided into two groups of tele- rehabilitation treatment and face-to-face physical treatment group using the Permuted Block Stratified randomization method. In this method, the allocation of people into two groups is done with the same sample size - and also the balance of the groups is maintained in terms of the dispersion of the influential variables (age, gender, and activity level in this study). RandomAllocation computer software (version 1.1, Isfahan University of Medical Sciences, Iran) is used for randomization. First, a random order of two letters A (remote rehabilitation combined treatment group) and B (face-to-face physical therapy group) is made in blocks with random numbers of 4 and 6 (for example, ABBA and ABAABB). Then the blocks are hidden by the opaque envelope. The randomization process will be done by a person who is not involved in any of the other stages of the research, Blinding description: Due to the fact that the type of study is such that the participants and the physiotherapist are aware of the type of intervention that participants receive, it is not possible to blind the patients and the physiotherapist. All evaluations are done by a physiotherapist who is not aware of the type of intervention that the participants receive. The people participating in the study are told not to disclose the type of intervention to the physiotherapist.</study_design>
      <phase>3</phase>
      <hc_freetext>Patellofemoral Pain Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: exercise therapy which includes stretching exercises, strengthening exercises, balance exercises and functional exercises for 6 weeks, 3 sessions every week and 18 sessions totally with application and based on tele-rehabilitation. Intervention 2: Control group: face to face exercise therapy which includes stretching exercises, strengthening exercises, balance exercises and functional exercises for 6 weeks, 3 sessions every week and 18 sessions totally at physical therapy clinic.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Masumeh Hessam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physiotherapy. Ahvaz, Faculty of Rehabilitation Sciences, Jundishapur University of Medical Sciences, Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Postal code: 61357-1</zip>
        <telephone>+98 61 3743 1013</telephone>
        <email>hesam-m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Masumeh Hessam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physiotherapy. Faculty of Rehabilitation Sciences, Jundishapur University of Medical Sciences, Ahvaz. Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33133 -61357</zip>
        <telephone>+98 61 3743 1013</telephone>
        <email>hesam-m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having knee pain for at least 1 month
Access to internet and mobile phone
not attended in physical therapy  program or sport activity
Anterior or posterior knee pain following going up and down stairs, knee flexion and sitting for a long time</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>knee ligament instability
Knee meniscus pathologies
Patellar tendinopathy or Iliotibial Band tendinopathy
Knee joint effusion
Knee Subluxation or Dislocation or Fracture
Sinding-Larsen-Johansson syndrome
Plica syndrome
Osgood-Schlatter disease
Neuromuscular, rheumatologic or metabolic diseases
Having undergone conservative or surgical treatment of the affected knee less than 6 months previously</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M22.40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chondromalacia patellae, unspecified knee, Patellofemoral disorders, Disorders of patella</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: exercise therapy which includes stretching exercises, strengthening exercises, balance exercises and functional exercises for 6 weeks, 3 sessions every week and 18 sessions totally with application and based on tele-rehabilitation</i_keyword>
      <i_keyword>Control group: face to face exercise therapy which includes stretching exercises, strengthening exercises, balance exercises and functional exercises for 6 weeks, 3 sessions every week and 18 sessions totally at physical therapy clinic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain level. Timepoint: Before the start of treatment/ at the end of the sixth week of treatment intervention/ 1 month after the end of the treatment period. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Physical function. Timepoint: Before the start of treatment/ at the end of the sixth week of treatment intervention/ 1 month after the end of the treatment period. Method of measurement: Physical function section of kujala questionnaire,  Step down test, Bilateral squat test and Antero-medial lunge test.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the start of treatment/ at the end of the sixth week of treatment intervention/ 1 month after the end of the treatment period. Method of measurement: Quality of life section of knee injury and osteoarthritis outcome score questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adherence to the treatment plan. Timepoint: Before the start of the treatment/ at the end of the sixth week of treatment intervention/ 1 month after the end of the treatment period. Method of measurement: based on the number of treatment sessions that patients have participated in face-to-face physical therapy group; based on the application calendar in tele-rehabilitation group.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-01</approval_date>
        <contact_name>Ethics Committee of Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Faculty of Rehabilitation Sciences,  Jundishapur University of Medical Sciences, Golestan highway, Ahvaz, Iran. Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
