<?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>IRCT20210122050111N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-03</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Investigating and comparing the effect of brain training and balance training on the static and dynamic balance of the elderly individuals in nursing homes</public_title>
      <acronym></acronym>
      <scientific_title>Investigating and comparing the effect of brain training and balance training on the static and dynamic balance of the elderly individuals in nursing homes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70175</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Blinding description: The person who evaluates the outcome of the study and assesses the results obtained in both groups remains blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Elder. Condition 2: Static Balance. Condition 3: Dynamic Balance.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: balance exercises; 1. standing exercises 2. transitional exercises 3. walking exercises 4. functional strength exercises. twelve sessions of 30 minutes each. Intervention 2: The second intervention group: brain exercises; including; 1. lateralization: cross crawl, eight lazy, elephant, double duddle 2. focalization: owl, lively arm, gravity glider, rocker 3. centralization: brain button, earth button , balance button, space button, thinking cap. twelve sessions of 30 minutes each.</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>Akram Sadat Divandari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 5, Talghani Ave., Alame Tabatabei Ave., Alame Tababaei15 Blvd., Sabzevar Town</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617695788</zip>
        <telephone>+98 51 4464 1975</telephone>
        <email>akramdivandari858@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Sadat Divandari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 5, Talghani Ave., Alame Tabatabei Ave., Alame Tababaei15 Blvd., Sabzevar Town</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617695788</zip>
        <telephone>+98 51 4464 1975</telephone>
        <email>akramdivandari858@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 60 years
Ability to walk at least 9 meters without the assistance of another person or a cane
Not engagment in regular exercise during the past year
No physical disabilities of any kind (as per the World Health Organization's ICF definition of disability and based on medical opinions in the elderly file)
No history of neurological disease including Parkinson's, Stroke and Multiple Sclerosis
Absence of severe muscle and joint pain as per the doctor's opinion
No dizziness and ability to cooperate during the research according to the doctor
No history of surgery in the lower limbs and spine
The absence of severe vision problems and significant hearing problems
Informed consent to participate in the study</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Withdrawal and dissatisfaction of participants from the research for any reason
Physical injuries during the research
Performing surgery on the lower limbs and spine
Lack of informed consent to continue participating in any phase of the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F60.7</hc_code>
      <hc_code>W18</hc_code>
      <hc_code>W17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dependent personality disorder</hc_keyword>
      <hc_keyword>Other fall on same level</hc_keyword>
      <hc_keyword>Other fall from one level to another</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: balance exercises; 1. standing exercises 2. transitional exercises 3. walking exercises 4. functional strength exercises. twelve sessions of 30 minutes each.</i_keyword>
      <i_keyword>The second intervention group: brain exercises; including; 1. lateralization: cross crawl, eight lazy, elephant, double duddle 2. focalization: owl, lively arm, gravity glider, rocker 3. centralization: brain button, earth button , balance button, space button, thinking cap. twelve sessions of 30 minutes each.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Static balance. Timepoint: Static balance measurement is conducted at the beginning of the study (prior to the initiation of the intervention) and 30 days after the commencement of the exercise. Method of measurement: Single leg stance test.</prim_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Dynamic balance measurements at the beginning of the study (prior to the initiation of the intervention) and 30 days after the commencement of the exercise. Method of measurement: Time up and go test.</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>2023-05-09</approval_date>
        <contact_name>Ethics Committee in Research of University of Rehabilitation Sciences and Social Health</contact_name>
        <contact_address>No. 5, Talghani Ave., Alame Tabatabei Ave., Alame Tababaei15 Blvd., Sabzevar Town Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
