<?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>IRCT20190410043229N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-09</date_registration>
      <primary_sponsor>Faculty of Physical Education and Sport Science</primary_sponsor>
      <public_title>The impact of a balance board training program on posture control, balance, walking speed, fall risk, and quality of life in elderly individuals</public_title>
      <acronym></acronym>
      <scientific_title>Designing a 6-week training program with balance boards and examining its effects on posture control, balance, walking speed, fall risk, and quality of life in elderly individuals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40986</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The present study has two intervention and control groups (both male and female in each group) that has the intervention group with balance training using shuttle balance but the control group is considered without any intervention, Randomization description: In this study, subjects (female, male) are randomly  drawn and divided into two intervention and control groups. Randomization is designed to occur in a manner where group allocation takes place only after the initial stages are completed. Allocation concealment is achieved through the use of computerized coding software. Consequently, random codes are automatically assigned to each participant, and allocation information is encrypted in the system to ensure confidentiality until the final data analysis, Blinding description: In the present study, participants are divided into two research groups through random allocation. The evaluator is also blinded to the allocation of individuals to each intervention and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Posture control. Condition 2: Balance. Condition 3: Gait speed. Condition 4: Risk of falling. Condition 5: Quality of life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, a group consisting of (male, female) receive intervention, the intervention is applied to people using shuttle balance. The present study uses the shuttle balance in the Corrective Movement Laboratory of the Faculty of Physical Education, University of Tehran, manufactured by Pajouhesh Sport today company. People practice the exercises under the supervision of a researcher for 90 minutes per session, 3 times a week for 6 weeks. Subjects warm-up for 15 minutes before starting the exercise. The exercise program lasts 60 minutes. Then they cool down for 15 minutes. Intervention 2: Control group: The control group also includes (male, female). The people in this group do not receive any intervention.</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 The data file cannot be published to the article due to its illegal use without the author's permission.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zahra mohammadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Monirieh Makhsous Avenue, Greece Alley, No5, Unit 4th</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۷۴۱۴۴۱۸</zip>
        <telephone>+98 21 8831 3178</telephone>
        <email>zahra.md70@gmail.com</email>
        <affiliation>Faculty of Physical Education and Sports Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zahra mohammadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Monirieh Street 5 Greece Alley No. 4 Unit 4</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۷۴۱۴۴۱۸</zip>
        <telephone>+98 21 8131 3178</telephone>
        <email>zahra.md70@gmail.com</email>
        <affiliation>Faculty of Physical Education and Sports Sciences university of tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 60 years
Ability to move independently
The satisfaction of the patient and his/her family to participate in the research
Scoring 21 or higher on the Berg Balance Test.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have a history of cognitive problems, orthopedics, neurology, cardiovascular disease
Receive help from other persons or device to walk
Lower limb fracture in the last 3 months
BMI higher than 35</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, a group consisting of (male, female) receive intervention, the intervention is applied to people using shuttle balance. The present study uses the shuttle balance in the Corrective Movement Laboratory of the Faculty of Physical Education, University of Tehran, manufactured by Pajouhesh Sport today company. People practice the exercises under the supervision of a researcher for 90 minutes per session, 3 times a week for 6 weeks. Subjects warm-up for 15 minutes before starting the exercise. The exercise program lasts 60 minutes. Then they cool down for 15 minutes.</i_keyword>
      <i_keyword>Control group: The control group also includes (male, female). The people in this group do not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postural control. Timepoint: Before the intervention and 6 weeks after the intervention. Method of measurement: FDM-S pressure distribution device manufactured by ZBIS company.</prim_outcome>
      <prim_outcome>Balance. Timepoint: Before the intervention and 6 weeks after the intervention. Method of measurement: Berg scale.</prim_outcome>
      <prim_outcome>Gait speed. Timepoint: Before the intervention and 6 weeks after the intervention. Method of measurement: Timed Up and Go Test.</prim_outcome>
      <prim_outcome>Risk of fall. Timepoint: Before the intervention and 6 weeks after the intervention. Method of measurement: The falls effiacacy scale-international.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention and 6 weeks after the intervention. Method of measurement: The item short-form health survey (SF-36) questionnaire is used for measurement.</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>Faculty of Physical Education and Sport Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-11</approval_date>
        <contact_name>Sport Sciences Research Institute</contact_name>
        <contact_address>No. 3 Fifth Alley, Mir Emad St, Motahhari St., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
