<?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>IRCT20231229060567N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-07</date_registration>
      <primary_sponsor>University of Esfahan</primary_sponsor>
      <public_title>Motor and Cognitive Empowerment of the Elderly Using Dual-Task Training</public_title>
      <acronym>VRS360</acronym>
      <scientific_title>Design, Implementation, and Validation of a Virtual Reality Package based on 360-Degree Videos with Dual-Task Training for Enhancing Motor-Cognitive Functions in the Elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74786</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, the block method is used for random allocation in such a way that a statistician designs blocks of four into four equal groups, using "sealedenvelope.com". A person not involved in the research, block and allocate sequence for concealment. The allocation ratio of the samples is 1:1. Finally, based on the obtained blocks and according to the sequence of allocation, dual-task rehabilitation training is presented to the participants, Blinding description: Participants are randomly divided into four groups. These groups are the control group, the treadmill rehabilitation, the virtual reality rehabilitation, and the dual rehabilitation of treadmill and virtual reality. They are unaware of the allocation of study groups and the type of rehabilitation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Empowering Healthy Elderly.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 15 Healthy Elderly People. Intervention 2: Intervention group: 15 Healthy Elderly People only Treadmill (Motor). Intervention 3: Intervention group: 15 Healthy Elderly People only Virtual Reality (Cognitive). Intervention 4: Intervention group: 15 Healthy Elderly People Treadmill and Virtual Reality (Motor and Cognitive).</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:
Total Results of Scores of Intervention Sessions, Pre-Intervention  and Post-Intervention Tests

When:
One Year after the Publishing of Results

To whom:
Researchers Working in Academic and Scientific Institutions

Conditions:
Data Analysis and Comparison

Where to obtain:
Email Address

How to obtain:
Sending Email and Authentication

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Mohammadvaliee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Isfahan, Hezar Jarib Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۴۱</zip>
        <telephone>+98 31 3793 2127</telephone>
        <email>momova@gmail.com</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Javad Rasti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Isfahan, Hezar Jarib Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۳۴۴۱۸۱۷۴۶</zip>
        <telephone>+98 31 3793 4034</telephone>
        <email>rasti@eng.ui.ac.ir</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having an old age of 60 Years Or Older According to the Definition of the World Health Organization
Normal Eyesight and Hearing
None Serious Psychiatric, Cognitive and Psychological Disorders
None Simultaneous Cognitive Interventions
Being able to Stand, Walk, and Do Usual Physical Activity
None Medical Prohibition for Physical Activities
Weight Less Than 110 Kg Due to Prevent Damage to the Treadmill Platform
Signing the Consent Form to Participate in the Research
None Bone Lesion (Decentralized Fractures, Unstable Spine or Severe Osteoporosis)</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Need Help During Intervention
Having Uncontrolled Blood Pressure Greater than 100/160 mmHg
Lack of Ability to Follow Orders
Several Falls During Intervention
Not Being Able to Carry out Interventions Independently
Physical Problems Occurrence During the Implementation of Interventions
Simultaneous Concurrent Cognitive or Psychiatric Interventions
Absence in more than One-Third of Intervention Sessions
Cardio-Pulmonary Disorders Affecting Movement or Having Bone Lesions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z76.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Healthy person accompanying sick person</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: 15 Healthy Elderly People</i_keyword>
      <i_keyword>Intervention group: 15 Healthy Elderly People only Treadmill (Motor)</i_keyword>
      <i_keyword>Intervention group: 15 Healthy Elderly People only Virtual Reality (Cognitive)</i_keyword>
      <i_keyword>Intervention group: 15 Healthy Elderly People Treadmill and Virtual Reality (Motor and Cognitive)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: One Day before the Start of the Intervention Sessions and One Day after the End of the Intervention Sessions. Method of measurement: Berg Balance Scale (BBS), Timed Up and Go Test (TUG), and Functional Reach Test (FRT).</prim_outcome>
      <prim_outcome>Attention. Timepoint: One Day before the Start of the Intervention Sessions and One Day after the End of the Intervention Sessions. Method of measurement: Mini–Mental State Examination (MMSE) and Continuous Performance Test (CPT).</prim_outcome>
      <prim_outcome>Memory. Timepoint: One Day before the Start of the Intervention Sessions and One Day after the End of the Intervention Sessions. Method of measurement: Mini–Mental State Examination (MMSE) and N-Back Working Memory Test.</prim_outcome>
      <prim_outcome>Visual-Spatial Perception. Timepoint: One Day before the Start of the Intervention Sessions and One Day after the End of the Intervention Sessions. Method of measurement: Mini–Mental State Examination (MMSE), Hooper Visual Organization Test (HVOT), and Judgment of Line Orientation (JLO).</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 Esfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-23</approval_date>
        <contact_name>Research Ethics committees of University of Isfahan</contact_name>
        <contact_address>Dept. 2, No.2, Sabzi Alley, Karimshahian St., Pirouzi Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
