<?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>IRCT20220824055786N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-24</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the immediate effect of distractive “KIA-knee” knee brace on reduction of adduction moment and pain in patients with knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the immediate effect of distractive “KIA-knee” knee brace on reduction of adduction moment and pain in patients with knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65466</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention group: In this study, for 16 patients with knee osteoarthritis, distractive “KIA-knee” knee brace will be designed and manufactured in the appropriate size for each patient. This knee brace is a redesigned example of OA Knee Trac Brace and by the triangular leverage traction system used in the joint of the knee brace, the weight is removed from both compartments when the knee position is changed from flexion to extension. Evaluations are done in 2 stages with knee brace and without knee brace..</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:
Study information (other than individual information) will be shared with other researchers.

When:
Information will be shared after results or data summaries are published.

To whom:
Information will be shared for academic purposes only.

Conditions:
Information is shared for the teaching and research of applicants.

Where to obtain:
People can request information from the introduced responsible person.

How to obtain:
Requests must be sent via email (asiyaeimehr@gmail.com).

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ِِ ِDr. Hossein Asiyaeimehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation, Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5081</telephone>
        <email>asiyaeimehr@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hossein Asiyaeimehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation, Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5081</telephone>
        <email>asiyaeimehr@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having medial knee osteoarthritis
The severity of osteoarthritis is mild or moderate (Kelgren-Lawrence classification) based on the graph prepared in the last 6 months
Has an age range of 40 to 70 years
The amount of pain at rest (VAS index) is equal to or more than 4
Severity of knee varus deformity based on graph in anterior-posterior view is 2 to 11 degrees
BMI is equal to or less than 35
No injections of hyaluronic acid or corticosteroids in the last 6 months
No use of other orthoses</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Indications for knee joint surgery according to the opinion of an orthopedic specialist
Suffering from concurrent arthritis of hip or ankle joints or feet on the same or opposite side
Having heart or lung diseases, rheumatoid arthritis, skin disorders, infection, diabetes, acute knee inflammation, knee pain caused by other factors or deep vein thrombosis
History of stroke
History of fracture around the knee or total or partial knee arthroplasty surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, for 16 patients with knee osteoarthritis, distractive “KIA-knee” knee brace will be designed and manufactured in the appropriate size for each patient. This knee brace is a redesigned example of OA Knee Trac Brace and by the triangular leverage traction system used in the joint of the knee brace, the weight is removed from both compartments when the knee position is changed from flexion to extension. Evaluations are done in 2 stages with knee brace and without knee brace.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee adduction moment. Timepoint: Measurement of the knee adducton moment in gait before and after using distractive “KIA-knee” knee brace.The immediate effect is investigated. Method of measurement: Visual 3D motion analysis software.</prim_outcome>
      <prim_outcome>Knee flexion moment. Timepoint: Measurement of the knee flexion moment in gait before and after using distractive “KIA-knee” knee brace.The immediate effect is investigated. Method of measurement: Visual 3D motion analysis software.</prim_outcome>
      <prim_outcome>Ground reaction force. Timepoint: Measurement of the ground reaction force during gait before and after using distractive “KIA-knee” knee brace.The immediate effect is investigated. Method of measurement: Force plate.</prim_outcome>
      <prim_outcome>Knee angle in the frontal plane. Timepoint: Measurement of the knee angle in the frontal plane during gait before and after using distractive “KIA-knee” knee brace.The immediate effect is investigated. Method of measurement: Visual 3D motion analysis software.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Measuring the amount of pain before and after using distractive “KIA-knee” knee brace based on Visual Analogue Scale. Method of measurement: The pain questionnaire, which includes a 10 cm line, and the person participating in the study shows his pain level as a vertical line on this scale before and after using the knee brace.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-20</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Faculty of Rehabilitation, Isfahan University of Medical Sciences, Hezar Jarib St., Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
