<?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>IRCT20250721066577N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-21</date_registration>
      <primary_sponsor>The University of Isfahan</primary_sponsor>
      <public_title>The Effect of eight Weeks of Dynamic Neuromuscular Stabilization (DNS) exercises on a Trampoline on Functional Performance and Respiratory Function in Individuals with Intellectual Disabilities</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of eight Weeks of Dynamic Neuromuscular Stabilization (DNS) exercises on a Trampoline on Functional Performance and Respiratory Function in Individuals with Intellectual Disabilities</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84961</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Other design features: After approving the proposal and selecting the subjects on a purposeful and voluntary basis, the participants will be placed into two groups by completing the consent form and based on the inclusion and exclusion criteria. One group will perform dynamic neuromuscular stability exercises on a trampoline and the other group will perform dynamic neuromuscular stability exercises on the ground. These exercises will be performed for 8 weeks, 3 sessions per week, each session lasting approximately 45 minutes. The participants' motor function and respiratory function will be measured before and after the intervention, Randomization description: The samples will be selected purposively and conveniently based on inclusion and exclusion criteria from among mentally retarded girls aged 20 to 30 years at the Pegah Omid Comprehensive Career Support Center and Production Workshop for the Disabled in Isfahan (Nemat Branch). These individuals will be randomly paired and divided into two groups of 15 people.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Intellectual Disabilities.</hc_freetext>
      <i_freetext>Intervention group: The present study will be conducted as a pre-test-post-test and semi-experimental study with the participation of two groups of dynamic neuromuscular stability exercises on a trampoline and on the ground..</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Valikhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 29,opposite Saadi Street, Golestan Boulevard</address>
        <city>Dehaghan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8641653351</zip>
        <telephone>+98 31 5333 5952</telephone>
        <email>maryamvalikhani801@gmail.com</email>
        <affiliation>The University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Valikhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 29,opposite Saadi Street, Golestan Boulevard</address>
        <city>Dehaghan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8641653351</zip>
        <telephone>+98 31 5333 5952</telephone>
        <email>maryamvalikhani801@gmail.com</email>
        <affiliation>The University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Girls with mild to moderate mental retardation with an IQ of 50 to 70 (educable)
Written consent from a parent or legal guardian to participate during the training and study period
Age range 20 to 30 years
Absence of any specific disease or any restriction that would prevent participation in the research process
No history of regular participation in exercises similar to the exercise protocol within the past 6 months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lack of cooperation and absence during the study for more than 3 consecutive sessions throughout the entire training period
The occurrence of a new injury or medical condition that prevents the individual from continuing to exercise as recommended by their doctor
Unwillingness of the participant or parent to continue participating in the study at any time
Having heart or respiratory diseases or behavioral problems and any acute or chronic illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The present study will be conducted as a pre-test-post-test and semi-experimental study with the participation of two groups of dynamic neuromuscular stability exercises on a trampoline and on the ground.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional Performance and Respiratory Function. Timepoint: Eight Weeks. Method of measurement: Motor Performance: 1) The Time up and go(TUG) test will be used to assess dynamic balance.2)The 4x10 meter back and forth test will be used to assess the lower body agility of these individuals. During this test, the participant moves back and forth along a 10 meter path 4 times as quickly as possible upon hearing the start command, and after reaching the line each time, crosses it and changes direction. 3)The Sargent Jump Test will be used to measure explosive power of the lower body muscles. The maximum distance the participant can jump upwards will be recorded as an indicator of explosive power of the lower body muscles. 4)To assess visual-motor coordination, a toss and catch test will be used. During this test, the participant throws and catches a ball against a wall. The number of successful catches will be recorded in a specified time. 5)The Ruler Drop Test will be used to assess reaction speed. The ruler is dropped from a specified height and the participant must catch it as quickly as possible. The distance traveled before catching the ruler will be recorded as an indicator of reaction time. Respiratory function: A spirometer will be used to assess respiratory function. This device is capable of measuring parameters such as forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC ratio. The spirometry test will be performed by a trained operator following standard guidelines.</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>The University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-10</approval_date>
        <contact_name>Ethics committee of Isfahan  University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib Street, Isfahan University of Medical Sciences and Health Services Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
