<?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>IRCT20211224053509N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-16</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Effect of virtual reality on balance of elderly</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of virtual reality and therapeutic exercise on improving balance and fear of falling in Military retirees and elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60941</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the sealed envelope method is used for randomization. Participants are allocated based on a selection of randomly arranged sealed envelopes labeled "virtual reality group" or "exercise therapy group." This process is done by someone who has no role in the data analysis or intervention process, Blinding description: Evaluation of the outcomes is performed by experienced individuals who are blind to the patient's allocation to the groups .</study_design>
      <phase>N/A</phase>
      <hc_freetext>Older adult- fear of falling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (Virtual Reality):                                                                 The intervention in this group is based on the virtual reality system. The virtual reality system is designed based on force sensors and a motion detector system (Kinect). In performing interventions based on the force sensor, the person stands on the surface in dimensions of 50 x 30 in front of the monitor and performs the activities and games shown on the monitor by changing the center of mass of the body. The activities that a person performs can be leveled and its intensity increases as the person's performance changes. In performing interventions using the Kinect device, the person stands in front of the sensor and performs different motor activities in accordance with the designed activities and games that are displayed on the screen. These motor activities include a variety of activities, such as standing on one leg, jumping, and maintaining balance in a variety of body postures. Intervention 2: Control group: In the control group, conventional interventions to improve balance are performed according to the Otago Exercise Program (OEP). OEP exercises consist of two parts: strengthening exercises and balance exercises. Strengthening exercises are aimed at increasing the strength of the pelvic floor, knee, and ankle muscles, which will move from an assetive to a resistance one. Balance exercises also include bending the knee, walking backward, walking sideways, standing in a tandem position, random walking, standing on one foot, walking on the toe and heel, sitting and standing up going up and down the stairs.</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 plagiarism</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aliraza Shamsoddini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>BaqiatallahUniversity of Medical Sciences, Mullasadra Street, Vanak Square, Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8804 0060</telephone>
        <email>alirezaot@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aliraza Shamsoddini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>BaqiatallahUniversity of Medical Sciences, Mullasadra Street, Vanak Square, Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8804 0060</telephone>
        <email>alirezaot@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having an acceptable level of cognitive function, i.e. score equal to or greater than 21 on the Persian version of Mini Mental State Examination
Ability to walk at least 10 meters with or without assistive device
No severe orthopedic or psychological disorders, acute pain, or addictive disorder based on the report fromy the elderly, patient's family, physician, or medical record.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of neurological disorders such as stroke, traumatic brain injury, Parkinson, seizures.</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (Virtual Reality):                                                                 The intervention in this group is based on the virtual reality system. The virtual reality system is designed based on force sensors and a motion detector system (Kinect). In performing interventions based on the force sensor, the person stands on the surface in dimensions of 50 x 30 in front of the monitor and performs the activities and games shown on the monitor by changing the center of mass of the body. The activities that a person performs can be leveled and its intensity increases as the person's performance changes. In performing interventions using the Kinect device, the person stands in front of the sensor and performs different motor activities in accordance with the designed activities and games that are displayed on the screen. These motor activities include a variety of activities, such as standing on one leg, jumping, and maintaining balance in a variety of body postures.</i_keyword>
      <i_keyword>Control group: In the control group, conventional interventions to improve balance are performed according to the Otago Exercise Program (OEP). OEP exercises consist of two parts: strengthening exercises and balance exercises. Strengthening exercises are aimed at increasing the strength of the pelvic floor, knee, and ankle muscles, which will move from an assetive to a resistance one. Balance exercises also include bending the knee, walking backward, walking sideways, standing in a tandem position, random walking, standing on one foot, walking on the toe and heel, sitting and standing up going up and down the stairs</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of falling. Timepoint: Before intervention, after intervention and 4 weeks after intervention. Method of measurement: Activities-specific Balance Confidence questionnaire - Fall Efficiency Scale.</prim_outcome>
      <prim_outcome>Balance  ability. Timepoint: Before intervention, after intervention and 4 weeks after intervention. Method of measurement: Berg Balance scale - 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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-06</approval_date>
        <contact_name>Ethics Committee in Research of Baqiyatallah Al-Azam Medical Center</contact_name>
        <contact_address>Baqiatallah University of Medical Sciences, Mullasadra Street, Vanak Square,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
