<?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>IRCT20240221061073N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-13</date_registration>
      <primary_sponsor>Payam noor University</primary_sponsor>
      <public_title>The effect of dynamic neuromuscular stabilization exercises on some physical and motor fitness indicators in children with spastic hemiplegic cerebral palsy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 8 weeks of dynamic neuromuscular stabilization exercises on some physical and motor fitness indicators in children with spastic hemiplegia cerebral palsy aged 10 to 12 years in Qazvin</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80491</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The simple Randomization Method was used to Assign Individuals to two Groups that in this Method It was done by Flip the coin method. This method is usually used to create a random sequence in two-group experiments in such a way that one of the study groups considers the A and the other group the B and based on the sample size, coins were tossed and Individuals are assigned to two random groups. Then, in Order not to Determine Which Group the Individuals will be Assigned to before Dividing them into two Groups, or in other words, Allocation Concealment, the Sequentially numbered, sealed opaque envelopes was used. This method is one of the common methods in concealing random allocation, which is abbreviated to SNOSE method. In this method, after a random sequence, a number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Spastic hemiplegic cerebral palsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will perform dynamic neuromuscular stabilization exercises. These exercises will be performed for 8 weeks, 3 sessions of 2 hours each week. Intervention 2: Control group: Without any training and just doing normal daily activities.</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:
All potential data can be shared after people have not been identified

When:
Start the access period one year after printing the results

To whom:
Data will be available to academic and scientific researchers

Conditions:
Any kind of functional analysis on the submitted data is allowed

Where to obtain:
by Email: dr.momeni@pnu.ac.ir

How to obtain:
by Email: dr.momeni@pnu.ac.ir and the reason for using the documents

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Nejatollahi Street, Payam Noor University, South Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1584668611</zip>
        <telephone>+98 21 8894 0007</telephone>
        <email>dr.momeni@pnu.ac.ir</email>
        <affiliation>Payam noor University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Nejatollahi Street, Payam Noor University, South Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1584668611</zip>
        <telephone>+98 21 4492 7037</telephone>
        <email>dr.momeni@pnu.ac.ir</email>
        <affiliation>Payame Noor University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Hemiplegic cerebral palsy
Their degree of spasticity ranges from mild to severe (grade 1+ to grade 3)</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>12 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue cooperation
Creating a specific problem that prevents you from continuing to practice</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spastic hemiplegic cerebral palsy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will perform dynamic neuromuscular stabilization exercises. These exercises will be performed for 8 weeks, 3 sessions of 2 hours each week.</i_keyword>
      <i_keyword>Control group: Without any training and just doing normal daily activities</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spasticity. Timepoint: At the beginning of the study (before the start of the intervention) and after 8 weeks of intervention. Method of measurement: Ashworth's test.</prim_outcome>
      <prim_outcome>Balance. Timepoint: At the beginning of the study (before the start of the intervention) and after 8 weeks of intervention. Method of measurement: Berg balance test.</prim_outcome>
      <prim_outcome>Walking speed. Timepoint: At the beginning of the study (before the start of the intervention) and after 8 weeks of intervention. Method of measurement: 10 meter walk test.</prim_outcome>
      <prim_outcome>Range of Motion. Timepoint: At the beginning of the study (before the start of the intervention) and after 8 weeks of intervention. Method of measurement: Goniometer.</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>PAYAM NOOR UNIVERSITY</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-21</approval_date>
        <contact_name>Payam Noor University</contact_name>
        <contact_address>Mini City, Artesh Blvd., Nakhl St., Payam Noor University Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
