<?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>IRCT20231002059590N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-14</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>design and construction of Postural Forward Head and Hyperkyphosis corrective Orthosis (FHKO) in youth people and evaluation of its 2-month effect with exercise training on craniovertberal angle of head and neck, thoracic kyphosis angle and electrical activity level of target muscles</public_title>
      <acronym></acronym>
      <scientific_title>design and construction of Postural Forward Head and Hyperkyphosis corrective Orthosis (FHKO) in youth people and evaluation of its 2-month effect with exercise training on craniovertberal angle of head and neck, thoracic kyphosis angle and electrical activity level of target muscles</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73004</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Sampling will be non-probability and available sampling. To randomize the samples, random block method with R software is used. For example, in the sequence event of ABBA, the character A represents the assignment of the individual to the group of exercises, and character B represents the assignment of the individual to the group of exercises with orthotics.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: thoracic hyper kyphosis. Condition 2: forward head posture.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group receive Designed kyphotic orthosis with corrective exercises for kyphosis and forward head posture (Three times a week) for two months. Intervention 2: The control group received only kyphotic postural correction exercises three times a week for two months.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Ethical issues</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>reza hamzeloei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Armenian Street</address>
        <city>arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3881917558</zip>
        <telephone>+98 86 4633 9228</telephone>
        <email>rezarh777@yahoo.com.sg</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>reza hamzeloei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Armenian Street</address>
        <city>arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3881917558</zip>
        <telephone>+98 86 4633 9228</telephone>
        <email>rezarh777@yahoo.com.sg</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 45 years Kyphosis angle greater than 42° Cranivertebral angle less than 48°</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of cervical vertebral surgery
A history of fracture, surgery or trauma in the spine and lower extremity within the past year according to the individual's report
Inflammatory diseases such as Ankylosing spondylitis and rheumatoid arthritis based on the individual's report
History of neurological diseases
Fracture in cervical vertebrae
Scoliosis above ten degrees.
Rheumatic diseases
Torticollis
Use of hearing aids.
Systemic diseases such as arthritis.
History of surgery or injury to the shoulder during the past year
BMI less than 18.5 and more than 25 kg/m2.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M40.04</hc_code>
      <hc_code>M40.03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postural kyphosis, thoracic region</hc_keyword>
      <hc_keyword>Postural kyphosis, cervicothoracic region</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 receive Designed kyphotic orthosis with corrective exercises for kyphosis and forward head posture (Three times a week) for two months.</i_keyword>
      <i_keyword>The control group received only kyphotic postural correction exercises three times a week for two months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Craniovertebral angle. Timepoint: At the beginning of the study, one month and then two months after the start of the study. Method of measurement: Digital imaging to measure angles.</prim_outcome>
      <prim_outcome>Thoracic kyphosis angle. Timepoint: At the beginning of the study, one month and then two months after the start of the study. Method of measurement: Digital imaging to measure angles.</prim_outcome>
      <prim_outcome>Intensity of the electrical activity of the muscles. Timepoint: At the beginning of the study, one month and then two months after the start of the study. Method of measurement: electromyography to check the intensity of electrical activity.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-02</approval_date>
        <contact_name>Ethics Committee of University of Rehabilitation Sciences and Social Health</contact_name>
        <contact_address>University of Rehabilitation Sciences and Social Health, Koodakyar St., Daneshjoo Blvd., Evin, Iran. arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
