<?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>IRCT20240722062512N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-27</date_registration>
      <primary_sponsor>University of Oradea</primary_sponsor>
      <public_title>Rehabilitation in elderly fall risk assessment</public_title>
      <acronym></acronym>
      <scientific_title>A strength and balance exercise program combined with vestibular training could improve postural stability and reduce fall risk in elderly population - a follow-up study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78114</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Blinding description: The person designated for assessment will not be involved in the rehabilitation process nor know who will be enrolled in the study.</study_design>
      <phase>1</phase>
      <hc_freetext>Impaired balance and falls in elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group consists of elderly subjects, ages 65-85 years old, with a history of 1-3 falls in the last year. Intervention 2: Control group: The control group consists of subjects with a history of 1-3 falls within the last year. They did not receive the balance and vestibular treatment for various reasons but agreed to undergo the three assessments (baseline, final, and follow-up).</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Doriana Ioana Ciobanu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.41. str. Anatole France nr.41, Oradea</address>
        <city>Oradea</city>
        <country1>Romania</country1>
        <zip>410482</zip>
        <telephone>+40 259 408 419</telephone>
        <email>doriana.ciobanu@yahoo.com</email>
        <affiliation>University of Oradea</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dorina Ianc</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.1, str. Universitatii, Oradea</address>
        <city>Oradea</city>
        <country1>Romania</country1>
        <zip>410087</zip>
        <telephone>+40 259 408 419</telephone>
        <email>dorina.ianc@yahoo.com</email>
        <affiliation>University of Oradea</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Romania</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 65 - 85 years;
Subjects with a history of 1-3 fallings in the last year;
No medical or vestibular rehabilitation treatment  in the previous 6 month;
Subjects who completed the rehabilitation program;
Subjects who completed the three assessments;</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Subjects who did not meet the age requirements
Subejcts who did not want to participate in the study
Subjects with conditions requiring medication potentially generating the dizziness
Subjects who presented limitations for the tests
Subjects who did not attend one of the scheduled assessment sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R29.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Repeated falls</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group consists of elderly subjects, ages 65-85 years old, with a history of 1-3 falls in the last year.</i_keyword>
      <i_keyword>Control group: The control group consists of subjects with a history of 1-3 falls within the last year. They did not receive the balance and vestibular treatment for various reasons but agreed to undergo the three assessments (baseline, final, and follow-up).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Increase postural stability. Timepoint: Baseline assessment, 2 months after rehabiliation program, follow-up at 6 months. Method of measurement: Index of postural instability measured by Framiral Multitest Equilibre dynamic platform.</prim_outcome>
      <prim_outcome>Balance improvement. Timepoint: Baseline assessment, 2 months after rehabiliation program, follow-up at 6 months. Method of measurement: Balance Outcome Measure for Elder Rehabilitation (BOOMER) score.</prim_outcome>
      <prim_outcome>Fall risk prevention. Timepoint: baseline assessment, 2 months after rehabiliation program, follow-up at 6 months. Method of measurement: The Falls Efficacy Scale International (FES-I).</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 Oradea</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-13</approval_date>
        <contact_name>Committee of Scientific Research Conduct and Ethics, University of Oradea</contact_name>
        <contact_address>str. Universitatii, nr.1 Oradea Bihor Romania</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
