<?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>IRCT20170803035480N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-21</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of orthosis and kinesiotaping on posture and balance of the elderly with hyperkyphosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of hyperkyphosis orthosis and postural kinesiotaping on spino-pelvic sagittal alignment and postural control strategy of the elderly with hyperkyphosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64231</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to divide participations into two intervention groups, will be prepared lists of random numbers and patients will be assigned to two groups based on random blocking that will be made by the software. In order to conceal the allocation, the codes determining the type of intervention will be kept in sealed envelopes, Blinding description: The data analyzer is kept blind to the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Thoracic kyphosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: orthosis. Intervention 2: Intervention group: kinesiotaping.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>Jalali.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>Jalali.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>Age≥60 years
Kyphosis angle ≥ 50
Capability of walking without assistive devices</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of cervical, spinal or lower limb fracture and/or trauma, severe spinal pathologies and deformities, cervical and spinal surgery
History of inflammatory diseases such as ankylosing spondylitis, and rheumatoid arthritis
History of disease of the central nervous system, neuromuscular disorder, and diabetic neuropathy
Bone mineral density with T-Score less than -1
History of vestibular disease, and dizziness
Foot deformities
History of cardiovascular disease
History of diseases of the lymphatic and kidneys system
Uncorrectable visual or vestibular impairments
History of joint replacement in the lower limb
History of falls more than twice in the last six months
History of grade 2 and 3 osteoarthritis of the knee based on the Kellgren-Lawrence scale in one or both legs
Cognitive impairment with AMTS≤6 score
Taking drugs known to affect the central nervous system or equilibrium
inability to put on orthosis
taping Sensitivity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other secondary kyphosis</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: orthosis</i_keyword>
      <i_keyword>Intervention group: kinesiotaping</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Thoracic Kyphosis. Timepoint: Before intervention, 3 months after intervention. Method of measurement: EOS radiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lumbar lordosis. Timepoint: Before intervention and 3 months after intervention. Method of measurement: EOS radiography.</sec_outcome>
      <sec_outcome>Pelvic Incidence. Timepoint: Before intervention and 3 months after intervention. Method of measurement: EOS radiography.</sec_outcome>
      <sec_outcome>Pelvic Tilt. Timepoint: Before intervention and 3 months after intervention. Method of measurement: EOS radiography.</sec_outcome>
      <sec_outcome>Sacral Slope. Timepoint: Before intervention and 3 months after intervention. Method of measurement: EOS radiography.</sec_outcome>
      <sec_outcome>Sagittal Vertical Axis. Timepoint: Before intervention and 3 months after intervention. Method of measurement: EOS radiography.</sec_outcome>
      <sec_outcome>Cervical Sagittal Vertical Axis. Timepoint: Before intervention and 3 months after intervention. Method of measurement: EOS radiography.</sec_outcome>
      <sec_outcome>T1 Slope. Timepoint: Before intervention and 3 months after intervention. Method of measurement: EOS radiography.</sec_outcome>
      <sec_outcome>Cervical Lordosis. Timepoint: Before intervention and 3 months after intervention. Method of measurement: EOS radiography.</sec_outcome>
      <sec_outcome>Open loop control. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Force plate.</sec_outcome>
      <sec_outcome>Close loop control. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Force plate.</sec_outcome>
      <sec_outcome>Critical displacement. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Force plate.</sec_outcome>
      <sec_outcome>Critical time. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Force plate.</sec_outcome>
      <sec_outcome>Anteroposterior mean velocity. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Force plate.</sec_outcome>
      <sec_outcome>Radial mean velocity. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Force plate.</sec_outcome>
      <sec_outcome>Sway area per unit time. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Force plate.</sec_outcome>
      <sec_outcome>Balance performance. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Mini balance evaluation systems test.</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>2022-05-31</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
