<?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>IRCT20150314021459N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-30</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of core stability and hip joint muscle strengthening on (KOA)</public_title>
      <acronym>نقش فیزیوتراپی در درمان آرتوز زانو</acronym>
      <scientific_title>The Effect of Hip and Core Stability Exercise on Pain and Disability of Patients with Knee Osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70514</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: ِDoes not have, Randomization description: Subjects will be distributed in control and test groups by simple lottery, in such a way that people with odd numbers will enter the control group and people with even numbers will enter the test group, Blinding description: Subjects will not be informed of the difference in treatment methods. In this way, the subjects of the control and test groups will be treated in a different treatment center with similar facilities.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee arthritis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: application, surface heat, electrical stimulation and knee muscle strengthening. Intervention 2: Intervention group: application of the program of the control group in addition to strengthening the hip joint muscles and core stability muscles in the back and hip areas.</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:
After the people cannot be identified, the results of the data will be published through statistical analysis through the publication of articles in reputable journals. For this purpose, the data of the first outcome and also other outcomes will be used.

When:
It is hoped that this work will be realized in about a year.

To whom:
Principal researcher and statistical consultant

Conditions:
If there is a significant difference between the control and test groups in the study variables. The results will be used to treat people with knee arthritis.

Where to obtain:
There is no need to visit in person. Items will be available by searching for articles.

How to obtain:
Searching for articles about knee arthritis in databases

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madadkaran Aly, Sahnazari Av. Madar Sq. Mirdamad High Way.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913187</zip>
        <telephone>00982122228051-02</telephone>
        <email>Akbari.mo@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madadkaran Aly, Sharnazari Av. Madar Sq. Mirdamad Blv.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913187</zip>
        <telephone>+98 21 2222 8052</telephone>
        <email>Akbari.mo@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 40 -70 years,
Both males and females,
Patients with grade 1 or 2 (KOA) according KL scale),
Chronic stages of knee pain,
Unilateral or bilateral (KOA),
Patients who scored 3 out of 10 knee pain or greater on the VAS with activity intervention at baseline,
WOMAC score above 10,</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute knee pain and inflammation
Recent fractures
Prolonged immobilization
Uncontrolled hypertension
Severe cardiopulmonary disease
Other grades of knee osteoporosis (grade I and IV)
Having active rheumatoid arthritis
Having any neurological disorders affecting lower limbs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Degenerative knee disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: application, surface heat, electrical stimulation and knee muscle strengthening</i_keyword>
      <i_keyword>Intervention group: application of the program of the control group in addition to strengthening the hip joint muscles and core stability muscles in the back and hip areas</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: At the beginning of the study and before the intervention and at the end of 10 treatment sessions. Method of measurement: Visual  analogue scale (VAS).</prim_outcome>
      <prim_outcome>McMaster Osteoarthritis Index (WOMAC). Timepoint: At the beginning of the study and before the intervention and at the end of 10 treatment sessions. Method of measurement: Summarizing the answers to key questions.</prim_outcome>
      <prim_outcome>Knee Flexion range of motion. Timepoint: At the beginning of the study and before the intervention and at the end of 10 treatment sessions. Method of measurement: By gonio meter.</prim_outcome>
      <prim_outcome>Knee Extension range of motion. Timepoint: At the beginning of the study and before the intervention and at the end of 10 treatment sessions. Method of measurement: By gonio meter.</prim_outcome>
      <prim_outcome>Thigh muscle trophy. Timepoint: At the beginning of the study and before the intervention and at the end of 10 treatment sessions. Method of measurement: Tape.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>WOMAC Scale. Timepoint: Knee flexion ROM. Method of measurement: Knee extension ROM.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-18</approval_date>
        <contact_name>Ethics Committee of the Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat High Way, Near the Milad Tower Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
