<?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>IRCT20100505003871N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-20</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of proprioceptive exercises using virtual reality on postural stability and functional balance of military personnel with non-specific back pain</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of proprioceptive exercises using virtual reality on postural stability and functional balance of military personnel with non-specific back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77777</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random block allocation method will be used to select and group the samples. This allocation is done in several steps, first by using the Random Allocation Software 
A random sequence will be created with blocks of 6. Then, to hide the random allocation, non-transparent sealed envelopes will be used with the random sequence. Based on the sample size of the research, a number of envelopes with aluminum wrappers (in order not to make the content of the envelopes unclear) will be prepared and each of the random sequences created will be recorded on a card and the cards will be placed inside the envelope in order. Maintaining the random sequence, the numbering on the outer surface of the envelopes will be done in the same order.
Finally, the lids of the envelopes are glued and placed in a box. At the time of registration of the participants, one of the envelopes will be opened according to the order in which the eligible participants entered the study, and They will be placed in one of three groups (virtual reality group, proprioception group and control group).</study_design>
      <phase>3</phase>
      <hc_freetext>Non-specific back pain.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group is not based on virtual reality and will receive only 12 sessions and for a duration of 20-30 minutes in each session, common rehabilitation interventions that include strengthening the paravertebral and lumbar extensor muscles and stretching exercises for the paravertebral and lumbar extensor muscles. . Before the intervention of the patients, Biodex tools to measure postural stability, force plate and Y balance test (YBT) to measure dynamic balance and the stork test (Stroke) to measure static balance to check postural control and balance and also from the grading scale Pain will be used to measure patients' pain. Intervention 2: Before the intervention of the patients, Biodex tools to measure postural stability, force plate and Y balance test (YBT) to measure dynamic balance and the stork test (Stroke) to measure static balance to check postural control and balance and also from the grading scale Pain will be used to measure patients' pain. Intervention 3: Control group: The control group will only be shown the recorded videos of virtual reality and will be asked to imitate the exercises.</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:
A part of the data such as the information related to the main outcome or the like can be shared.

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions will be available

Conditions:
Researchers who intend to study in this area

Where to obtain:
To access this data, the responsible author must give an email

How to obtain:
After completing the research, they can email the responsible author to receive the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza shamsodini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Science ,Sheikh Fazlollah Nouri Expressway, Mollasadra Bridge,District 2 ,Tehran,1455915371,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 4551</telephone>
        <email>alirezaot@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alioreza shamsodini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah University of Medical Science ,Sheikh Fazlollah Nouri Expressway, Mollasadra Bridge,District 2 ,Tehran,1455915371,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 4551</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>Age range between 18-28 years
More than 12 weeks have passed since the onset of back pain.
The disability criterion of these patients based on the Quebec questionnaire scale (for the purpose of screening) should be above 25.
Taking public health
Body mass index between 20 and 26
Drug consumption is reported by the doctor and its dosage by the patient</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>28 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Physiotherapy treatment in the last six months
Having back pain of non-mechanical origin
Use of aids such as corsets, braces, and belly bands
Participation in regular sports activities during the past six months
Having any surgery, fracture, dislocation and twisting in the spine
Having diseases such as osteoporosis, arthritis, cancer, rheumatism, urinary tract infections and pelvic diseases, disc herniation, sciatica pains, inflammatory diseases, malignant tumors, nervous system diseases and spinal cord lesions, etc or Any skeletal abnormalities that affect the research process.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dorsalgia, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group is not based on virtual reality and will receive only 12 sessions and for a duration of 20-30 minutes in each session, common rehabilitation interventions that include strengthening the paravertebral and lumbar extensor muscles and stretching exercises for the paravertebral and lumbar extensor muscles. . Before the intervention of the patients, Biodex tools to measure postural stability, force plate and Y balance test (YBT) to measure dynamic balance and the stork test (Stroke) to measure static balance to check postural control and balance and also from the grading scale Pain will be used to measure patients' pain.</i_keyword>
      <i_keyword>Before the intervention of the patients, Biodex tools to measure postural stability, force plate and Y balance test (YBT) to measure dynamic balance and the stork test (Stroke) to measure static balance to check postural control and balance and also from the grading scale Pain will be used to measure patients' pain.</i_keyword>
      <i_keyword>Control group: The control group will only be shown the recorded videos of virtual reality and will be asked to imitate the exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Non-specific back pain score based on the Quebec questionnaire. Timepoint: قبل از شروع مداخله و بلافاصله بعد از اخرین جلسه درمانی. Method of measurement: Quebec questionnaire.</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>No financial resources</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-28</approval_date>
        <contact_name>Ethics Committee of Baqiyatullah University of Medical Sciences</contact_name>
        <contact_address>Baqiyatallah University of Medical Science ,Sheikh Fazlollah Nouri Expressway, Mollasadra Bridge,District 2 ,Tehran,1455915371,Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
