<?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>IRCT20140811018762N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-22</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The comparison of Spinomed and Elderly Spinal Orthosis on Kyphosis Angle.</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of Spinomed and Elderly Spinal Orthosis on Kyphosis Angle, Back Pain and Quality of Life in Elderly with Thoracic Hyperkyphosis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43711</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After the first visit to the clinic, individuals choose their treatment envelope from the available envelopes for each treatment group without knowing the groups, Blinding description: After the first visit to the clinic, individuals choose their treatment envelope from the available envelopes for each treatment group without knowing the groups. The groups receive their treatment separately.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Thoracic hyperkyphosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first group received both Spinomed Orthosis and Back School exercise.The duration of use of orthosis and exercise is 3 months. The people of this group come to Hazrat Rasoul Hospital on a specific day of the week until the end of treatment and under the supervision of a sports medicine specialist they perform their group exercises and their orthoses are adjusted by the relevant expert. Everyone is given their own workout schedule to continue their workouts at home during the week. The duration of wearing the orthosis is 2 hours a day. Intervention 2: Intervention group: The second group received simultaneous elderly spinal orthosis and back school exercise.The duration of use of orthosis and exercise is 3 months. The people of this group come to Hazrat Rasoul Hospital on a specific day of the week until the end of treatment and under the supervision of a sports medicine specialist they perform their group exercises and their orthoses are adjusted by the relevant expert. Everyone is given their own workout schedule to continue their workouts at home during the week. The duration of wearing the orthosis is 2 hours a day. Intervention 3: Control group: The third group, which is the control group, will only do the back school exercise. Exercise time is 3 months. The control group is referred to Hazrat Rasoul Hospital on a specific day of the week until the end of treatment and under the supervision of a sports medicine specialist they perform group exercises.Everyone is given their own workout schedule to continue their workouts at home during the 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:
The outcomes of this study will be interpreted into a manuscript and will be submitted to a peer reviewed journal

When:
Starting data access period 6 months after the article is published.

To whom:
Researchers working in academic centers who plan to use these findings in a systematic review and meta analysis.

Conditions:
Due to the presence of the authors of this article in the academic center, there is a need for written permission from the university to submit data. Therefore, data will be sent no later than 6 months after applying for a written permission from the university.

Where to obtain:
School of Rehabilitation Sciences, Iran University of Medical Sciences, Dr Kamyab, Zahra Rahimi

How to obtain:
Upon requesting the documentation, the researcher must obtain written approval from the university and submit the documentation after obtaining permission. Therefore,wiht a time estimate of about 6 months after the request will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mojtaba Kamyab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Mirdamad Square, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913478</zip>
        <telephone>009822220947</telephone>
        <email>kamyab.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mojtaba Kamyab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Mirdamad Square, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913478</zip>
        <telephone>009822220947</telephone>
        <email>kamyab.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Kyphosis angle above 50 degrees.
Ability to sit and stand up and walk at least 10 meters independently.
60 years or older.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Physical abnormalities that are more important than kyphosis or impair the research process.
People who had a history of fracture or surgery in the lower extremity or spine 12 months before the start of the study.
Any illness or disorder that disables one's participation in sports and group activities.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M40.04</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postural kyphosis, thoracic region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first group received both Spinomed Orthosis and Back School exercise.The duration of use of orthosis and exercise is 3 months. The people of this group come to Hazrat Rasoul Hospital on a specific day of the week until the end of treatment and under the supervision of a sports medicine specialist they perform their group exercises and their orthoses are adjusted by the relevant expert. Everyone is given their own workout schedule to continue their workouts at home during the week. The duration of wearing the orthosis is 2 hours a day.</i_keyword>
      <i_keyword>Intervention group: The second group received simultaneous elderly spinal orthosis and back school exercise.The duration of use of orthosis and exercise is 3 months. The people of this group come to Hazrat Rasoul Hospital on a specific day of the week until the end of treatment and under the supervision of a sports medicine specialist they perform their group exercises and their orthoses are adjusted by the relevant expert. Everyone is given their own workout schedule to continue their workouts at home during the week. The duration of wearing the orthosis is 2 hours a day.</i_keyword>
      <i_keyword>Control group: The third group, which is the control group, will only do the back school exercise. Exercise time is 3 months. The control group is referred to Hazrat Rasoul Hospital on a specific day of the week until the end of treatment and under the supervision of a sports medicine specialist they perform group exercises.Everyone is given their own workout schedule to continue their workouts at home during the week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The kyphosis angle. Timepoint: At the beginning and end of the study (three months after the first evaluation). Method of measurement: Inclinometer and radiograph.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: At the beginning and end of the study (three months after the first evaluation). Method of measurement: SF36 questionnaire.</prim_outcome>
      <prim_outcome>Pain. Timepoint: At the beginning and end of the study (three months after the first evaluation). Method of measurement: Visual Analogue Scale.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-31</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
