<?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>IRCT20161221031506N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-15</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparative effect of two hamstring strengthening methods in patients with knee osteoarthritis</public_title>
      <acronym>MOAS</acronym>
      <scientific_title>A comparative study of lateral hamstring strengthening versus overall hamstring strengthening on pain, disability, and quality of life, and foot loading pattern  in patients with primary osteoarthritis and varus deformity: randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54538</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method will be the block randomization method and based on that, the randomization unit will be individual.
Randomization will be done using a sealed envelope.
The grouping will be done by the secretary of the physiotherapy department. The secretary of the physiotherapy department will select a card from the envelope after referring the person to the physiotherapy department. The patients will be assigned to one of two groups, Blinding description: The assessor will be blinded from the patient’s grouping. The statistical analysis will be performed by one of authors who blinded about the label of grouping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: All hamstring therapy exercises in this group will be performed with external rotation of the tibia and the stretch will focus on medial hamstring muscle. Intervention 2: Control group: In this group, hamstring exercises will be applied on the muscle in general and the hamstring muscle will be stretched completely.</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>Hamed Mamipour Gharanjick</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 313, 2st Floor, Department of Physiotherapy, School of Paramedical Sciences, Mashhad University of Medical Sciences. Vakilabad Blvd, Bahonar Blvd, Pardis campus, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3869 8719</telephone>
        <email>hamed.mamipour72@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Mamipour Gharanjick</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 313, 2st Floor, Department of Physiotherapy, School of Paramedical Sciences, Mashhad University of Medical Sciences. Vakilabad Blvd, Bahonar Blvd, Pardis campus, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3869 8719</telephone>
        <email>hamed.mamipour72@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Knee pain on last six months.
Pain scale (VAS) should be higher than 4 out of 10.
OA patients will have Knee varrus deformity, knee crepitus, and significant limited ROM.
Graded 2, and 3 based on  Kellgren and Lawrence scale.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any knee alignment corrective surgery
Candidate for joint replacement surgery
Any severe change in patient's gait due to pain and limited ROM
ligament instability (Grade 3)
The involvement of the patellofemoral joint or the lateral femoral condyle is greater than the medial condyle (diagnosed by X-ray)
Any disorders that limit daily movements and activities
Corticosteroids usage for the knee pain in the last three months
Use assistive devices such as knee orthoses and walker
Patients with varrus deformity (grade 1, and 3)
Cognitive problems diagnosed using EMMSE questionnaire
Spinal stenosis, and lumbar disc herniation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unilateral primary osteoarthritis, unspecified knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: All hamstring therapy exercises in this group will be performed with external rotation of the tibia and the stretch will focus on medial hamstring muscle.</i_keyword>
      <i_keyword>Control group: In this group, hamstring exercises will be applied on the muscle in general and the hamstring muscle will be stretched completely.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: At the time of referral - after 12 sessions of treatment - one month after treatment. Method of measurement: visual analog scale.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Pre-treatment, Immediately after completion of treatment - one month after completion of treatment. Method of measurement: Based on the KOOS questionnaire.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Pre-treatment, Immediately after completion of treatment - one month after completion of treatment. Method of measurement: Tegner activity scale questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Pre-treatment, Immediately after completion of treatment - one month after completion of treatment. Method of measurement: OAKHQOL questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Foot loading pattern  (medial-to-lateral COP index(MLCOPi)). Timepoint: At the time of referral - after 12 sessions of treatment. Method of measurement: Using a foot scan device.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-13</approval_date>
        <contact_name>The Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Head Office of Mashhad University of Medical Science, Qoreishi Center, Daneshgah st., Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
