<?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>IRCT20230723058891N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-04</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>"Design and evaluation of the impact of active video games on joint range of motion, pain intensity, and motor function in children with burn injuries"</public_title>
      <acronym></acronym>
      <scientific_title>"Design and evaluation of the impact of active video games on joint range of motion, pain intensity, and motor function in children with burn injuries"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72575</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: This research has two stages. In the first stage, by using the guidelines and applying the opinions of relevant specialists, the upper body exercises are prepared and short films are made based on them. Then these films will be used to make active video games. The second phase is a randomized controlled clinical trial, to investigate the effect of active video games on joint range of motion, pain intensity and performance of children with burns, Randomization description: The researcher selected the eligible patients as available and after introducing himself and providing explanations regarding the purpose of the research and the working method to them and obtaining informed consent, assigning them to the intervention and control groups randomly using the software. Stata (stata) version will be done. Then, permuted blocks with sizes 4 and 2 will be produced by a statistician with the help of Stata software version 17. To hide the allocation of each block, it will be placed in an envelope. After completing each sampling with the envelope, the envelope is discarded and the next envelope will be opened.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Children with second degree burns on the upper limbs with total body burns less than 30%.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will perform exercises through Xbox Kinect games based on the burn site. Children in the intervention group will play the games designed by the research team using the Xbox Kinect game console twice a day at 11 am and 5 pm. The location of the game console and TV for playing designed games will be one of the rooms of the burn department. The distance of children from the TV screen will be 1.5 to 2 meters and the duration of their exposure to the screen will be 15 to 30 minutes. Intervention 2: Control group: The control group will receive standard exercises based on the location of the burn (equal to the number of sessions of the test group). Children in the control group will receive standard physical therapy that includes daily targeted therapy aimed at maintaining normal ROM and muscle strength, preventing contracture formation and facilitating normal activities of daily living (ADLs) and activity according to protocols set in It is the burn part. In the control group, after warming up for 15 minutes, children play games like the one designed in Xbox Kinect for 15 to 30 minutes in the playroom with game equipment.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Razie Frootan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>froutanr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razie Froutan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, East Gate of Ferdowsi University of Mashhad, University Campus, Shahid Dr. Kharazmi Educational Complex</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>froutanr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No visual impairment
Absence of medical contraindications for doing practices (for example, epilepsy and cognitive disorders, orthopedic, cardiovascular problems, infection, hand amputation), which will be examined by a pediatrician.
A child aged 5 to 15 years who has TBSA&lt;30% and has second degree burns on the hand, wrist, elbow and shoulder.
Informed consent
Stabilization of the patient's hemodynamic conditions after hospitalization</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Readmission of a child with burns for any reason
Failure to participate in practicing sessions
Leaving the child from the research project at the doctor's discretion
Symptoms of infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T29.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burns of multiple regions, no more than second-degree burns mentioned</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: The intervention group will perform exercises through Xbox Kinect games based on the burn site. Children in the intervention group will play the games designed by the research team using the Xbox Kinect game console twice a day at 11 am and 5 pm. The location of the game console and TV for playing designed games will be one of the rooms of the burn department. The distance of children from the TV screen will be 1.5 to 2 meters and the duration of their exposure to the screen will be 15 to 30 minutes.</i_keyword>
      <i_keyword>Control group: The control group will receive standard exercises based on the location of the burn (equal to the number of sessions of the test group). Children in the control group will receive standard physical therapy that includes daily targeted therapy aimed at maintaining normal ROM and muscle strength, preventing contracture formation and facilitating normal activities of daily living (ADLs) and activity according to protocols set in It is the burn part. In the control group, after warming up for 15 minutes, children play games like the one designed in Xbox Kinect for 15 to 30 minutes in the playroom with game equipment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>In the current study, motor performance is the score obtained by the subjects in the 30-question ASK (The Activities Scale for Kids) self-report questionnaire, which has 9 domains. Timepoint: upon discharge. Method of measurement: The Activities Scale for Kids (ASK) is a 30-question self-report questionnaire that has 9 domains.</prim_outcome>
      <prim_outcome>Pain intensity in the present study is the score obtained by the subjects in pain measurement. Pain intensity is measured using the Wong-Baker FACES® tool, which is in the form of 5 faces. Smiley number 5 has the most pain and smiley number 0 has no pain. Timepoint: Daily and upon discharge. Method of measurement: Pain intensity is measured using the Wong-Baker FACES® tool, which is in the form of 5 faces. Smiley number 5 has the most pain and smiley number 0 has no pain.</prim_outcome>
      <prim_outcome>The range of motion of the joints in the present study is the score obtained by the subjects in measuring the range of motion of the joints with goniometry. Timepoint: Daily and upon discharge. Method of measurement: Using goniometry.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-17</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Ave. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
