<?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>IRCT20190425043370N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-10</date_registration>
      <primary_sponsor>University of Guilan</primary_sponsor>
      <public_title>The effect of different physical training on the basic motor skills of the intellectual impairment</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness and Durability of three different approaches of physical training on fundamental movement skills and motor coordination in intellectual impairments with developmental coordination disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74657</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: subjects are randomly studied in one of the four groups with the help of a table of random numbers and receive the intervention related to the same group, Blinding description: The physical exercises of the intervention and control groups are kept blind without the participants knowing the allocation of the study groups. Also, the evaluators were blinded as to which group they were in the control or intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>intellectual impairment people.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Intervention group 1: playing mini basketball for eight weeks, 3 days a week and 45 minutes, with an increase in the training load in the third to fifth weeks and a greater increase in the load compared to the previous weeks in the sixth to eighth weeks. Intervention 2: Intervention group 2: Intervention group 2: Spark movement game for eight weeks, 3 days a week and 45 minutes, with variety in the type of movement games and also starting from easy to difficult levels from the beginning to the end of the training program. Intervention 3: Intervention group3 : Intervention group 3: functional exercises Dual task for eight weeks, 3 days a week and 45 minutes, with an increase in training load in the first to fourth weeks and a greater increase in load compared to the previous weeks in the fifth to eighth weeks. Intervention 4: control group: The control group did not receive an exercise program for eight weeks and did their daily activities and only did sports in the physical education class at school.</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 on measured variables can be shared after de-identifying individuals.

When:
Access period starting from 2024

To whom:
only available for people working in academic institutions or people working in businesses

Conditions:
scientific use in improving and comparing with other research is allowed.

Where to obtain:
E-mail address for correspondence with researchers to receive necessary information
94hamidzolghadr@gmail.com

How to obtain:
The applicant must send the reason for using the documents to the e-mail so that the answer will be given as soon as possible after the review by the researchers.
94hamidzolghadr@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Zolghadr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 13 3375 3395</telephone>
        <email>94hamidzolghadr@gmail.com</email>
        <affiliation>University of Guilan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Zolghadr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۹۹۶۱۳۷۷۶</zip>
        <telephone>+98 13 3375 3395</telephone>
        <email>94hamidzolghadr@gmail.com</email>
        <affiliation>University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>intellectual impairment with an IQ of 50 to 75
intellectual impairment with developmental coordination disorder
Gender of subjects (boy)
Age range between 7 and 12 years
Willingness and ability to participate in the study</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a history of lower limb injury and surgery during the last 1 year
The need for support or the use of aids to balance and walk
Having any disease in the vestibular system and not having a cochlear implant
suffering from other disabilities (such as cerebral palsy, autism, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F71</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Moderate intellectual disabilities</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Intervention group 1: playing mini basketball for eight weeks, 3 days a week and 45 minutes, with an increase in the training load in the third to fifth weeks and a greater increase in the load compared to the previous weeks in the sixth to eighth weeks.</i_keyword>
      <i_keyword>Intervention group 2: Intervention group 2: Spark movement game for eight weeks, 3 days a week and 45 minutes, with variety in the type of movement games and also starting from easy to difficult levels from the beginning to the end of the training program.</i_keyword>
      <i_keyword>Intervention group3 : Intervention group 3: functional exercises Dual task for eight weeks, 3 days a week and 45 minutes, with an increase in training load in the first to fourth weeks and a greater increase in load compared to the previous weeks in the fifth to eighth weeks.</i_keyword>
      <i_keyword>control group: The control group did not receive an exercise program for eight weeks and did their daily activities and only did sports in the physical education class at school.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fundamental Movement Skills. Timepoint: Measurement of Fundamental motor skill tests before and after 8 weeks of intervention and also after two month of intervention. Method of measurement: TGMD-3: Test of Gross Motor Development-Third Edition Ulrich.</prim_outcome>
      <prim_outcome>Motor coordination. Timepoint: Measurement of motor coordination tests before and after 8 weeks of intervention and also after two month of intervention. Method of measurement: Körperkoordinationstest Für Kinder  (KTK).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Developmental coordination disorder. Timepoint: Screening of intellectually disabled students with developmental coordination disorder before starting the intervention. Method of measurement: questionnaire for developmental coordination disorder (DCDQ).</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>University of Guilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-27</approval_date>
        <contact_name>Ethics committee in biomedical research of guilan University</contact_name>
        <contact_address>5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
