<?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>IRCT20260622069918N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Sensorimotor and Core Stability Exercises on Balance and Quality of Life in Children with Autism Spectrum Disorder</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Adding standard Core Stability Exercises to Standard Sensorimotor Training on Balance Indices and Quality of Life in Children with Autism Spectrum Disorder: A Clinical Trial”</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91096</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: To allocate participants to the study groups, block randomization will be employed. This method will be used to ensure a balanced distribution of participants between the study groups throughout the recruitment process and to minimize selection bias and the influence of potential confounding variables.

First, each eligible child with Autism Spectrum Disorder (ASD) who meets the inclusion criteria will be assigned a unique identification code. Subsequently, the randomization process will be performed using a web-based randomization program, and participants will be randomly allocated to one of the two study groups.

Given the total sample size of 30 participants, the participants will be organized into five blocks of six participants each. Within each block, three participants will be assigned to the intervention group and three participants to the control group according to a computer-generated random allocation sequence.

At the completion of the randomization process, two groups of 15 participants each will be formed. The intervention group will receive a combined core stability and sensorimotor training program, whereas the control group will receive sensorimotor training only. The use of block randomization will ensure balanced group sizes and minimize the risk of allocation bias throughout the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism Spectrum Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Control GroupChildren aged 8–12 years with Autism Spectrum Disorder (ASD) in the control group will participate in a standard sensorimotor exercise program. All training sessions will be conducted face-to-face under the direct supervision of the principal investigator or a corrective exercise specialist. The program consists of sensorimotor exercises designed to improve balance, postural control, motor coordination, and proprioception. The exercises will be performed using standard rehabilitation equipment, including balance pads, balance boards, therapy balls, obstacles, and training cones. The intervention will be delivered for 8 weeks, 3 sessions per week, with each session lasting 45–60 minutes. Exercise intensity and difficulty will be progressively increased according to each child’s functional abilities to ensure safety and optimize training effectiveness. Intervention 2: Intervention group: Intervention GroupChildren aged 8–12 years with Autism Spectrum Disorder (ASD) in the intervention group will participate in a play-based core stability exercise program in addition to the standard sensorimotor exercise program. All training sessions will be conducted face-to-face under the direct supervision of the principal investigator or a corrective exercise specialist. The intervention consists of play-based exercises designed to strengthen the trunk and pelvic stabilizing muscles and improve postural control, balance, motor coordination, and proprioception. The exercises will be performed using therapy balls, BOSU balls, and balance boards, with activities progressively adapted to each child’s functional abilities. The intervention will be delivered over 8 weeks, with three sessions per week, and each session lasting 45–60 minutes. Exercise intensity and difficulty will be progressively increased throughout the intervention to ensure safety, promote active participation, and maximize the effectiveness of the program.</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 information generated from this research will be made freely and openly available to researchers and interested individuals through university databases and reputable scientific publications, at no cost.

When:
months after the completion of the research project.

To whom:
All researchers, clinicians, and specialists.

Conditions:
To facilitate the advancement of academic research and improve patient care by clinicians, researchers, and specialists.

Where to obtain:
Faculty of Physical Education, University of Tehran
Islamic Azad University, Mashhad Branch
Faculty of Humanities Complex
Ostad Yousefi Street, Mashhad, Iran

How to obtain:
Upon publication of the scientific articles, all relevant findings and data that may contribute to the advancement of research and the improvement of therapeutic approaches will be made available to the scientific community

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shamim Fadakar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th Floor, No. 4, Kolahdooz 14, Ahmadabad St., Ahmadabad, Mashhad, Iran</address>
        <city>Mahshhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9183846898</zip>
        <telephone>+98 51 3843 1826</telephone>
        <email>Shamimefdakar@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arash Khaledi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Soleimani Educational Complex, Islamic Azad University of Mashhad, Ostad Yousefi Blvd., Ghasemabad, Mashhad, Razavi Khorasan Province, Iran.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187147578</zip>
        <telephone>+98 51 3666 1300</telephone>
        <email>arashkhaledi666@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>confirmed diagnosis of Autism Spectrum Disorder (ASD) by a child and adolescent psychiatrist or a pediatric neurologist based on DSM-5 diagnostic criteria.
Ability to understand simple instructions
Ability to participate in the exercise program
Ability to walk independently without the use of assistive devices.
No participation in a structured core stability exercise program during the previous 3 months
No participation in a structured sensorimotor exercise program during the previous 3 months.
Written informed consent provided by a parent or legal guardian.</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Age younger than 8 years or older than 12 years
No confirmed diagnosis of Autism Spectrum Disorder (ASD) based on DSM-5 criteria
Presence of neurological, musculoskeletal, cardiovascular, or other medical conditions that would preclude safe participation in the exercise program.
Inability to walk independently without assistive devices.
Inability to understand or follow simple instructions.
Failure to obtain written informed consent from a parent or legal guardian.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autistic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control GroupChildren aged 8–12 years with Autism Spectrum Disorder (ASD) in the control group will participate in a standard sensorimotor exercise program. All training sessions will be conducted face-to-face under the direct supervision of the principal investigator or a corrective exercise specialist. The program consists of sensorimotor exercises designed to improve balance, postural control, motor coordination, and proprioception. The exercises will be performed using standard rehabilitation equipment, including balance pads, balance boards, therapy balls, obstacles, and training cones. The intervention will be delivered for 8 weeks, 3 sessions per week, with each session lasting 45–60 minutes. Exercise intensity and difficulty will be progressively increased according to each child’s functional abilities to ensure safety and optimize training effectiveness.</i_keyword>
      <i_keyword>Intervention group: Intervention GroupChildren aged 8–12 years with Autism Spectrum Disorder (ASD) in the intervention group will participate in a play-based core stability exercise program in addition to the standard sensorimotor exercise program. All training sessions will be conducted face-to-face under the direct supervision of the principal investigator or a corrective exercise specialist. The intervention consists of play-based exercises designed to strengthen the trunk and pelvic stabilizing muscles and improve postural control, balance, motor coordination, and proprioception. The exercises will be performed using therapy balls, BOSU balls, and balance boards, with activities progressively adapted to each child’s functional abilities. The intervention will be delivered over 8 weeks, with three sessions per week, and each session lasting 45–60 minutes. Exercise intensity and difficulty will be progressively increased throughout the intervention to ensure safety, promote active participation, and maximize the effectiveness of the program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1. Static balance:Static balance was assessed using the Tandem Stance Test, measured as the duration of maintaining the tandem stance in seconds.2. Dynamic balance:Dynamic balance was assessed using the Tandem Walk Test, Measured based on performance during the tandem walking task.3. Quality of life:Quality of life was assessed using the Pediatric Quality of Life Inventory (PedsQL), Measured by the total questionnaire score. Timepoint: Measurements will be performed at baseline (prior to the intervention) and immediately after completion of the 8-week intervention. Method of measurement: Tendom walk,tendom stance,test quality of lif(peal).</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>Azad Islamic</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-01</approval_date>
        <contact_name>Faculty of Medicine, Islamic Azad University – Mashhad Medical Sciences Branch, Iran</contact_name>
        <contact_address>No. 4, 4th Floor, Kolahdooz 14, Kolahdooz Street, Ahmadabad District, Mashhad, Iran. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
