<?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>IRCT20181113041645N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-23</date_registration>
      <primary_sponsor>University of Guilan</primary_sponsor>
      <public_title>Effects of virtual-reality training on balance</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison of the effects of virtual-reality training and traditional balance training on the balance of the elderly: a randomized trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35192</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>balance.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: As an alternative to traditional balance training, balance exercises based on virtual reality (VR); that simulates an activity technology, has been proposed to advancement motor learning and transfer to factual world tasks.  (Virtual Reality Training) performed training sessions using the Xbox Kinect, which includes Kinect and Console Sensors. The sensor was an infrared camera that diagnosed the position and movements of the player without the need for a specific controller and controlled the various games by the participant. Intervention 2: Intervention group: traditional balance training ), includes training with the reduced Supporting surface, Close eyes, increase speed of movement, and adding proper movements. Intervention 3: Control group: during this period of the control group were asked to perform routine daily activities and not participate in specific exercises. So from the control group, in order, the effect of exercises and daily activities probabilistic on the participants' balance was used.</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 only part of the information, such as information on the main outcomes or the like, can be shared.

When:
Start the access period 6 month after the publication of the research results in a scientific journal

To whom:
Data will be available to all scientific researchers

Conditions:
Only to help scientific research and with the written permission of the researcher can be used

Where to obtain:
To receive data/document via email and phone, contact the researcher

How to obtain:
Data/document is provided by email to other investigators

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saaed Yousefi Babadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht, Persian Gulf Highway (5 km on Qazvin Road)</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 38 3362 7153</telephone>
        <email>saeed.yoosefi@gmail.com</email>
        <affiliation>University of Guilan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Yousefi Babadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht, Persian Gulf Highway (5 km on Qazvin Road)</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 38 3362 7153</telephone>
        <email>saeed.yoosefi@gmail.com</email>
        <affiliation>Guilan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Receiving the consent of the elderly to participate in the study
The age range between 60-75 years
Able to stand independently for 90 seconds
Not having a history of lower extremity fractures in the past two years</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Impaired cognitive status (Mini-Mental State Examination score &lt;24)
Serious visual or hearing impairment
Neurological diseases were excluded from the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: As an alternative to traditional balance training, balance exercises based on virtual reality (VR); that simulates an activity technology, has been proposed to advancement motor learning and transfer to factual world tasks.  (Virtual Reality Training) performed training sessions using the Xbox Kinect, which includes Kinect and Console Sensors. The sensor was an infrared camera that diagnosed the position and movements of the player without the need for a specific controller and controlled the various games by the participant.</i_keyword>
      <i_keyword>Intervention group: traditional balance training ), includes training with the reduced Supporting surface, Close eyes, increase speed of movement, and adding proper movements.</i_keyword>
      <i_keyword>Control group: during this period of the control group were asked to perform routine daily activities and not participate in specific exercises. So from the control group, in order, the effect of exercises and daily activities probabilistic on the participants' balance was used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance is the ability to maintain the body’s center of mass over its base of support. Timepoint: One week before and after carrying out training interventions. Method of measurement: To assess the participants' balance, the balance tests were used on one leg stance (OLS) with open and closed eyes, Functional reach test (FRT), Timed up and go Test (TUG), and Fullerton Advance Balance Scale (FABS).</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 Guilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-16</approval_date>
        <contact_name>Ethic's committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Guilan_ Rasht _ Namjou Street _ Shahid Siyadati Street, opposite the 17th Shahrivar Hospital Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
