<?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>IRCT20200825048523N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-17</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Effect of rehabilitation treatment in dynamic valgus of lower limb</public_title>
      <acronym></acronym>
      <scientific_title>Effect of comprehensive rehabilitation treatment on pain, muscle force, physical function and quality of life in officer students with dynamic valgus of the lower limb</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66757</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation method in this study will be performed as block randomization method. This method is implemented considering blocks of 4, so that the total number of possible permutations of four is 6, including: ABAB, ABBA, BAAB, BABA AABB, BBAA. Eligible people are placed in one of the following groups based on quadruple blocks, A: intervention group, B: control group. To create a random sequence, we will number the possible blocks (6 blocks) from 1 to 6, we will select the block numbers from the random number table, and based on these numbers, we will determine the sequence of blocks in each group. We need 20 blocks to select 80 people. In this study, the unit of randomization is the individual. Allocation concealment will be done by using sequentially numbered, sealed opaque envelopes in a random sequence, Blinding description: The main researcher will be blinded to the selection and randomization of the participants. The treatment in the intervention and control groups will be done by the main researcher. Data collection before and after the intervention will be done by another colleague who is blinded like the main researcher. The outcomes evaluation and data statistical analysis will be done by the statistical consultant of the project and the main researcher will be also blinded in these fields.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Genu Valgum (Knock knee).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: knee strengthening exercises (specific strengthening of vastus medialis oblique muscle), hip strengthening exercises (specific strengthening of hip abductor and external rotator muscles), taping and biofeedback correction of wrong biomechanical patterns of lower limbs in daily functions. The interventions will be conducted for six weeks and three sessions per week. Intervention 2: Control group: knee strengthening exercises (general strengthening of the quadriceps muscle), hip strengthening exercises (general strengthening of the muscles around the hip). The interventions will be conducted for six weeks and three sessions per week.</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:
All above will be published in the article.

When:
After the article publication

To whom:
Researchers and students in academic centers

Conditions:
Other researchers and therapists in the rehabilitation and medical field can use this use the data of this study after the article publication.

Where to obtain:
After the article publication, people can find the article by searching in internet and access the data.

How to obtain:
After the article publication, people can find the article by searching in internet and access the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Mikaili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 8863 1084</telephone>
        <email>saeed.mikaely@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Mikaili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 8863 1084</telephone>
        <email>saeed.mikaely@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with knee rotation syndrome along with valgus
Pain at least 3 score based on the numerical pain scale
Knee pain when running, jumping sitting, and standing up</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Trauma to knee
Injury to anterior cruciate ligament</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M21.06</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Valgus 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: knee strengthening exercises (specific strengthening of vastus medialis oblique muscle), hip strengthening exercises (specific strengthening of hip abductor and external rotator muscles), taping and biofeedback correction of wrong biomechanical patterns of lower limbs in daily functions. The interventions will be conducted for six weeks and three sessions per week.</i_keyword>
      <i_keyword>Control group: knee strengthening exercises (general strengthening of the quadriceps muscle), hip strengthening exercises (general strengthening of the muscles around the hip). The interventions will be conducted for six weeks and three sessions per week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Measurement of pain intensity at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention). Method of measurement: Numerical pain rating scale.</prim_outcome>
      <prim_outcome>Maximum muscle isometric contraction force. Timepoint: Measurement of maximum muscle isometric contraction force at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention). Method of measurement: Hand dynamo-meter.</prim_outcome>
      <prim_outcome>Physical performance level. Timepoint: Measurement of physical performance level at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention). Method of measurement: Lower extremity functional scale.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Measurement of level of quality of life at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention). Method of measurement: 36-question quality of life questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Thickness and angle fibers of vastus medialis and leteralis oblique muscles. Timepoint: Measurement of thickness and angle of muscle fibers at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention). Method of measurement: Ultrasonography.</sec_outcome>
      <sec_outcome>Joint distance of knee. Timepoint: Measurement of joint distance at the beginning of the study (before the intervention) and at the end of the study (6 weeks after the intervention). Method of measurement: Ultrasonography.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-03</approval_date>
        <contact_name>Research Ethics Committees of Baqiyatallah Hospital</contact_name>
        <contact_address>Baqiyatallah University of Medical Sciences., South Sheikh Bahai., Mollasadea St., Vanak Sq Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
