<?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>IRCT20241016063385N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-22</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Action Observation on upper extremity function</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Action Observation on upper extremity function of hemiplegic children from 3 to 5 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79610</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Considering that in this study the samples are entered gradually, each of the samples is assigned a number from one to the last, and to remove the bias of the researcher, it was initially decided that the samples with odd numbers entered the intervention group and Samples with even numbers enter the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cerebral palsy, hemiplegia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, the intervention group will undergo movement observation therapy in five sessions of 30 minutes per week for 4 weeks. Before starting, the parents of the intervention group will spend a training session in groups of three to four people to learn how to implement the treatment in the home environment, then they will enter a virtual group that will explain the framework of the activities and how to implement each one in this group. Activities (stacking colored cubes and building a tower, removing the stamp and pressing it on the paper in the horizontal and vertical plane to print the shape, turning over the colored cards and matching with the card of the same color, removing the magnet and putting it on the fridge, pouring water inside glass and drinking water, taking the pencil and drawing on the paper, pressing the water spray on the flowers, Folding a shirt, taking a coin and putting it in a wallet, opening a container and taking a chocolate out of it, putting cards in a clothespin, opening toothpaste and pouring it on a toothbrush) are divided into 4 sets of three according to the level of each child and her cooperation. The intervention program takes place in the home environment. The therapist defines the framework for each activity and the equipment needed for the parent. At the appropriate time, the parent should perform the activities that include targeted daily one-handed or two-handed activities from simple to complex within the said framework for 3 minutes for the child. Then, for 3 minutes, the child practices the activity with the help and guidance of the caregiver, and then we give the child 3 minutes to imitate the activity. The execution method for the other two activities is the same. Intervention 2: Control group: The control group does not receive any other intervention apart from the usual occupational therapy interventions (including botox injection along with upper limb training, forced therapeutic restriction, intensive bimanual training and neurodevelopmental therapy).</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 To comply with the trust</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Rahmanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Hossein Square, in front of Bu Ali Hospital, Faculty of Rehabilitation of Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7756 1721</telephone>
        <email>sararahmanian@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Rahmanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Hossein Square, in front of Bu Ali Hospital, Faculty of Rehabilitation of Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7756 1721</telephone>
        <email>sararahmanian@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children diagnosed with hemiplegic cerebral palsy by a pediatric neurologist
Age range from 3 to 5 years
Mother being a housewife
Absence of vision and hearing problems
IQ above 70 based on Sparkle questionnaire
Modified Ashworth score less than 3 in passive upper limb movements
mini-MACS score maximum 3 for children 3-4 years old and MACS score maximum 3 for children 4-5 years old
Ability to follow instructions
Lack of uncontrolled seizures
Children should not receive any intervention other than routine treatments during the 4 weeks of AO intervention.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>5 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Botox injection during intervention
Seizures while studying
Non-cooperation of parents or child</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Cerebral p</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>G80</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: In this study, the intervention group will undergo movement observation therapy in five sessions of 30 minutes per week for 4 weeks. Before starting, the parents of the intervention group will spend a training session in groups of three to four people to learn how to implement the treatment in the home environment, then they will enter a virtual group that will explain the framework of the activities and how to implement each one in this group. Activities (stacking colored cubes and building a tower, removing the stamp and pressing it on the paper in the horizontal and vertical plane to print the shape, turning over the colored cards and matching with the card of the same color, removing the magnet and putting it on the fridge, pouring water inside glass and drinking water, taking the pencil and drawing on the paper, pressing the water spray on the flowers, Folding a shirt, taking a coin and putting it in a wallet, opening a container and taking a chocolate out of it, putting cards in a clothespin, opening toothpaste and pouring it on a toothbrush) are divided into 4 sets of three according to the level of each child and her cooperation. The intervention program takes place in the home environment. The therapist defines the framework for each activity and the equipment needed for the parent. At the appropriate time, the parent should perform the activities that include targeted daily one-handed or two-handed activities from simple to complex within the said framework for 3 minutes for the child. Then, for 3 minutes, the child practices the activity with the help and guidance of the caregiver, and then we give the child 3 minutes to imitate the activity. The execution method for the other two activities is the same.</i_keyword>
      <i_keyword>Control group: The control group does not receive any other intervention apart from the usual occupational therapy interventions (including botox injection along with upper limb training, forced therapeutic restriction, intensive bimanual training and neurodevelopmental therapy).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of upper extremity. Timepoint: At the beginning of the study and 4 weeks after the start of the intervention and 2 weeks after the end of the intervention. Method of measurement: Quest.</prim_outcome>
      <prim_outcome>Bimanual function. Timepoint: At the beginning of the study and 4 weeks after the start of the intervention and 2 weeks after the end of the intervention. Method of measurement: ABILHAND-Kids.</prim_outcome>
      <prim_outcome>Dextrity. Timepoint: At the beginning of the study and 4 weeks after the start of the intervention and 2 weeks after the end of the intervention. Method of measurement: Nine hole peg 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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-31</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University Faculty of Rehabilitation Sciences, Imam Hossein Square, Damavand St., in front of Bo Ali Hospital, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
