<?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>IRCT20251126068122N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-13</date_registration>
      <primary_sponsor>The University of Guilan</primary_sponsor>
      <public_title>The Effect of Exercise Training on the Sports Performance of Futsal Players with Down Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of multi component neuromuscular exercises on balance and sport performance of futsal players with down syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87809</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants are randomly assigned to one of the two study groups using a random number table, and they receive the corresponding intervention, Blinding description: Participants will not be informed about their allocation to the study groups and will be kept blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Individual with Down syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Multi-component neuromuscular exercises for eight weeks, three days per week, lasting 40 to 45 minutes. Intervention 2: Control group: During the eight week period, the control group performed their regular futsal training three days per week.</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 data from the measured variables will be shareable once individuals have been de-identified.

When:
The access period will begin in 1405 (2026).

To whom:
Only for researchers employed at academic and scientific institutions.

Conditions:
The scientific use of the data for improvement and comparison with other research is allowed.

Where to obtain:
Correspondence with researchers for obtaining necessary information can be directed to: masoomehek2000@gmail.com

How to obtain:
Requesters are required to submit the justification for using the documents to the following email address. The researcher will review the request and provide a response at the earliest opportunity: masoomehek2000@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoomeh Evazkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th Kilometer of Persian Gulf Highway، Rasht، Guilan Provience، Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>009842532837</telephone>
        <email>masoomehek2000@gmail.com</email>
        <affiliation>The University of Guilan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoomeh Evazkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th Kilometer of Persian Gulf Highway، Rasht، Guilan Provience، Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 13 4253 2834</telephone>
        <email>masoomehek2000@gmail.com</email>
        <affiliation>The University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gender: Male
Age range: 20 to 30 years
Diagnosis of Down syndrome
IQ between 50 and 70, or being trainable
Minimum of 3 years of sports experience
Regular training (at least three sessions per week)
No history of lower limb injury in the past six months that could cause functional or structural limitations, and no history of lower limb surgery that could alter the natural alignment of the body
No evident orthopedic, perceptual, or musculoskeletal disorders
No use of specific medications that could affect balance</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Failure to cooperate in performing the pre-test or post-test
Incomplete participation in the training program for any reason
Absence from more than three training sessions or two consecutive sessions
Experiencing pain or injury during training, or unwillingness to continue participation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Down syndrome</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: Multi-component neuromuscular exercises for eight weeks, three days per week, lasting 40 to 45 minutes.</i_keyword>
      <i_keyword>Control group: During the eight week period, the control group performed their regular futsal training three days per week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: The balance tests were assessed at baseline and after the eight week intervention. Method of measurement: Stork Test and Y Balance Test.</prim_outcome>
      <prim_outcome>Lower limb muscle strength. Timepoint: The Lower limb muscle strength tests were assessed at baseline and after the eight week intervention. Method of measurement: 30-Second Chair Stand Test.</prim_outcome>
      <prim_outcome>Sports perfomance. Timepoint: Sport performance tests were assessed at baseline and after the eight week intervention. Method of measurement: The assessments were selected from the futsal sports skill test battery for individuals with intellectual disabilities.</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 Guilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-10</approval_date>
        <contact_name>Ethics commitee in biomedical research of guilan university</contact_name>
        <contact_address>5th Kilometer of Persian Gulf Highway، Rasht، Guilan Provience، Iran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
