<?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>IRCT20180414039299N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-04</date_registration>
      <primary_sponsor>Shahid Beheshti university</primary_sponsor>
      <public_title>The Effect of 12 week corrective exercises on radiological indices of lower limb alignment, Proprioception and Balance in Patients with Osteoarthritis with Varus Knee Deformity</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of 12 week corrective exercises on radiological indices of lower limb alignment, Proprioception and Balance in Patients with Osteoarthritis with Varus Knee Deformity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77389</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using randomized permuted block randomization (7 blocks of size 8), the two treatment combinations are independently assigned to participants in a 1:1 ratio (after the initial assessment). Randomized sequence listing is done by computer (Pocock SJ. Clinical Trials: A Practical Approach. Wiley; 1983) and also by website (https://www.randomizer.org). This step will be ensured by a blind evaluator, Blinding description: Outcome assessors will be blinded to group allocation. Participants will not be blinded to study and grouping, but will be blinded to the intervention they are receiving (there is an unavoidable risk of bias in this study that the intervention cannot be blinded to interventionists, patients). Before the evaluation, the necessary training will be given to the outcome evaluator in relation to how to evaluate the variables in order to prevent any questions and answers between the evaluator and the subjects.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Osteoarthritis of knee. Condition 2: Knee varus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, the combination of theraband and strength exercises was used for the training group. In this research, the use of the Theraband exercise protocol approved by the Medical College of Georgia, University of Nursing, Augusta, Georgia, USA for people with knee osteoarthritis, adapted to Joost Decker's 2014 recommendation and based on special recommendations The American College of Sports Medicine (ACSM) was implemented based on the principles of exercise science, each training session consisted of 10 minutes of warm-up, the main part of the exercises was 30-50 minutes, and 5 minutes of cooling down. There was a 2-minute rest between each exercise. The exercises were performed for 12 weeks and in the form of 3 sessions per week. Yellow, red, and green tapes were used to perform the theraband exercises, and the repetition of each exercise was 8 to 12 times per leg. Also, in the strength training program, attention was paid to the ability of the participants, and each session added repetitions or movement time. Intervention 2: The control group continued their daily activities during the implementation of the project.</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:
The information related to the variables of the radiological indicators of the lower limbs, proprioception and balance are recorded in the pre-test and after twelve weeks of training, the information of the mentioned variables are recorded in the post-test and the results of the changes are recorded.

When:
After publishing the article/articles extracted from the study

To whom:
The data can be displayed and shared upon the reasonable request of Iran's Clinical Trial Registration Center, journals and academic people/researchers who are conducting research and scientific activities in this field.

Conditions:
Data analysis and the use of documentation can only be done under the condition that their results are reported in scientific articles by academic researchers and authors. The necessary conditions for sending data and documents include: 1. Sending an email (preferably with valid university addresses) to one of the researchers of the study. 2. A brief and logical explanation related to the use of data or documents.

Where to obtain:
Through request from researcher Mohsen Moradi Mohsenmoradi90@gmail.com

How to obtain:
The applicant can request details from the researchers using the message sent by email within 7 to 10 days

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kharazmi University, Faculty of Physical Education and Sport Sciences, Mirdamad Boulevard, tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1544733111</zip>
        <telephone>+98 919 345 0353</telephone>
        <email>Mohsenmoradi90@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sports Sciences, Mirdamad Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4519174555</zip>
        <telephone>+98 919 345 0353</telephone>
        <email>Mohsenmoradi90@gmail.com</email>
        <affiliation>Kharazmi university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having knee pain for 6 months or more.
Having knee varus deformity (the distance between the knees is more than 2.5 cm).
Having limited Range of Motion.
Functional score II and III based on clinical and radiological signs.</inclusion_criteria>
      <agemin>55 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to participate in two consecutive and three non-consecutive training sessions.
Progression of symptoms and pain.
The patient's unwillingness to continue treatment.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
      <hc_code>M21.16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
      <hc_keyword>Varus deformity, not elsewhere classified, knee</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: In this study, the combination of theraband and strength exercises was used for the training group. In this research, the use of the Theraband exercise protocol approved by the Medical College of Georgia, University of Nursing, Augusta, Georgia, USA for people with knee osteoarthritis, adapted to Joost Decker's 2014 recommendation and based on special recommendations The American College of Sports Medicine (ACSM) was implemented based on the principles of exercise science, each training session consisted of 10 minutes of warm-up, the main part of the exercises was 30-50 minutes, and 5 minutes of cooling down. There was a 2-minute rest between each exercise. The exercises were performed for 12 weeks and in the form of 3 sessions per week. Yellow, red, and green tapes were used to perform the theraband exercises, and the repetition of each exercise was 8 to 12 times per leg. Also, in the strength training program, attention was paid to the ability of the participants, and each session added repetitions or movement time.</i_keyword>
      <i_keyword>The control group continued their daily activities during the implementation of the project.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Radiological indicators of lower limb alignment. Timepoint: The First of all,  Measuring the parameters of radiological indices of the lower limb in the post-test, and then after twelve weeks, measuring the parameter of radiological indices of the lower limb in the pre-test. Method of measurement: Radiographs were taken in the standard position and bearing weight of the entire length of the lower limb.</prim_outcome>
      <prim_outcome>Proprioception. Timepoint: First, Measuring the parameter proprioception in the post-test, and then after eight weeks, Measuring the parameter of proprioception in the pre-test. Method of measurement: Knee joint position sense was measured by goniometer.</prim_outcome>
      <prim_outcome>Balance. Timepoint: First, Measuring the parameter Balance in the post-test, and then after eight weeks, Measuring the parameter of balance in the pre-test. Method of measurement: Stork test was used to measure static balance and Y test was used to measure dynamic balance.</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>Shahid Beheshti university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-13</approval_date>
        <contact_name>Shahid Beheshti University</contact_name>
        <contact_address>Shahid Beheshti University, Daneshjo Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
