<?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>IRCT20210602051477N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-02</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>The effect of cognitive challenge and fatigue on the risk of anterior cruciate ligament injury</public_title>
      <acronym>ACL</acronym>
      <scientific_title>Comparison of the Effect of the Combination of Neurocognitive Challenges and Fatigue on the Biomechanical Pattern of Athletes with and without Anterior Cruciate Ligament (ACL) Reconstruction During Single-leg Landing</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81928</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Other design features: The current study includes two groups of healthy athletes with a history of anterior cruciate ligament (ACL) surgery, who have completed the rehabilitation period under the supervision of a physiotherapist, and 9 months have passed since their surgery. All participants will undergo 4 immediate interventions to evaluate their biomechanical functions, and this will provide a better understanding of injury risk factors in the design of ACL injury prevention programs.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Participants with a history of anterior cruciate ligament surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first intervention when the athlete performs a single-leg landing task, visual cognitive load is imposed on him. cognitive load includes using a color frame with blue, red, yellow, and green words to display to the subjects during the landing task. Participants will be asked to call out the color of the word aloud if the meaning of the word and the color of its font were similar, and to otherwise use the phrase " false.". Intervention 2: Intervention group: In the second intervention group, performance fatigue protocol will be used to impose physiological load on athletes during single-leg landing. first, the maximum vertical jump height of each subject will be measured. the protocol will consist of a combination of five consecutive vertical jumps at an altitude above 70 percent of the maximum jump height of each subject, followed by a series of back-and-forth speed races with maximum effort. subjects will be asked to perform the above method until their vertical jump height in five consecutive jumps reaches below 70 percent of the maximum height of each subject. Heart rate will be used to monitor the intensity of the fatigue protocol, so that the heart rate should be about 90 percent of each person's maximum heart rate. Intervention 3: Intervention group: The athletes will first perform the functional fatigue protocol followed by the single-leg landing task along with the cognitive challenge simultaneously. First, the maximum vertical jump height of each subject will be measured. the protocol will consist of a combination of five consecutive vertical jumps at an altitude above 70 percent of the maximum jump height of each subject, followed by a series of back-and-forth speed races with maximum effort. subjects will be asked to perform the above method until their vertical jump height in five consecutive jumps reaches below 70 percent of the maximum height of each subject. Heart rate will be used to monitor the intensity of the fatigue protocol, so that the heart rate should be about 90 percent of each person's maximum heart rate. Cognitive load includes using a color frame with blue, red, yellow, and green words to display to the subjects during the landing task. Participants will be asked to call out the color of the word aloud if the meaning of the word and the color of its font were similar, and to otherwise use the phrase " false.". Intervention 4: Control group: Participants in the control group will perform the single-leg landing task only. The subjects will be asked to jump down a 30 cm high box with one leg followed by a maximum vertical jump on the same leg. The subjects will be told to do as much as possible to achieve an overhead goal by raising both hands (similar to a sport-specific task) at 300 cm height. If the subjects jump over the box instead of landing, if the other foot touches the ground, or if it loses its balance and falls during the test, the test will be repeated. No cognitive challenges and fatigue conditions are imposed on athletes.</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:
The data file of the participants, the study protocol, the informed consent form and the study report after the completion of the research and the publication of the articles extracted from it will be published as attached files of the article as well as the results as an average of the entire population and anonymously.

When:
The period of access to protocols and results will begin about 6 months after the results are published.

To whom:
Researchers working in scientific institutions and universities, trainers working in sports clubs and physiotherapists, and health professionals.

Conditions:
The research results will be in the form of articles published in scientific journals, and researchers and experts can access and use the results in this way.

Where to obtain:
Applicants can email the responsible author of the article to receive the results of the study after its publication or submit their request through other scientific databases such as Research Gate.
Email address: majidhamoongard@gmail.com

How to obtain:
Applicants can email the corresponding author to receive the results of the study after it is published, and a response will be given as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Hamoongard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 26, Azar Ave., Qom Town</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3714945131</zip>
        <telephone>+98 25 3775 6424</telephone>
        <email>majidhamoongard@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Hamoongard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 26, Azar Ave., Qom Town</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3714945131</zip>
        <telephone>+98 25 3775 6424</telephone>
        <email>majidhamoongard@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male athletes in the age range of 18 to 30 years old, healthy and with a history of anterior cruciate ligament surgery (at least 9 months have passed since the surgery and the rehabilitation period has been completed)
Experience in participating in sports that require cutting, turning, jumping and landing movements (futsal, volleyball, handball and basketball)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>A history of anterior cruciate ligament injury and lower limb surgery in the past year (except for injury in the group with a history of anterior cruciate ligament surgery)
Neurocognitive and vision disorders in participants
Pain in the lower limbs
sleep disorders
The presence of cartilage, meniscal and other knee ligament injuries in the group with a history of anterior cruciate ligament surgery</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the first intervention when the athlete performs a single-leg landing task, visual cognitive load is imposed on him. cognitive load includes using a color frame with blue, red, yellow, and green words to display to the subjects during the landing task. Participants will be asked to call out the color of the word aloud if the meaning of the word and the color of its font were similar, and to otherwise use the phrase " false."</i_keyword>
      <i_keyword>Intervention group: In the second intervention group, performance fatigue protocol will be used to impose physiological load on athletes during single-leg landing. first, the maximum vertical jump height of each subject will be measured. the protocol will consist of a combination of five consecutive vertical jumps at an altitude above 70 percent of the maximum jump height of each subject, followed by a series of back-and-forth speed races with maximum effort. subjects will be asked to perform the above method until their vertical jump height in five consecutive jumps reaches below 70 percent of the maximum height of each subject. Heart rate will be used to monitor the intensity of the fatigue protocol, so that the heart rate should be about 90 percent of each person's maximum heart rate.</i_keyword>
      <i_keyword>Intervention group: The athletes will first perform the functional fatigue protocol followed by the single-leg landing task along with the cognitive challenge simultaneously. First, the maximum vertical jump height of each subject will be measured. the protocol will consist of a combination of five consecutive vertical jumps at an altitude above 70 percent of the maximum jump height of each subject, followed by a series of back-and-forth speed races with maximum effort. subjects will be asked to perform the above method until their vertical jump height in five consecutive jumps reaches below 70 percent of the maximum height of each subject. Heart rate will be used to monitor the intensity of the fatigue protocol, so that the heart rate should be about 90 percent of each person's maximum heart rate. Cognitive load includes using a color frame with blue, red, yellow, and green words to display to the subjects during the landing task. Participants will be asked to call out the color of the word aloud if the meaning of the word and the color of its font were similar, and to otherwise use the phrase " false."</i_keyword>
      <i_keyword>Control group: Participants in the control group will perform the single-leg landing task only. The subjects will be asked to jump down a 30 cm high box with one leg followed by a maximum vertical jump on the same leg. The subjects will be told to do as much as possible to achieve an overhead goal by raising both hands (similar to a sport-specific task) at 300 cm height. If the subjects jump over the box instead of landing, if the other foot touches the ground, or if it loses its balance and falls during the test, the test will be repeated. No cognitive challenges and fatigue conditions are imposed on athletes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee biomechanics (Kinematic and kinetics). Timepoint: Biomechanical factors will be measured simultaneously with the intervention's effect on a cross-sectional and one-time basis. Method of measurement: A motion capture system (Kestrel 8.0 motion analysis, US) 8 cameras and a force plate (Bertec corporation, Columbus, OH) 60x40 will simultaneously record data.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Coordination variability of lower extremity. Timepoint: Coordination variability will be done simultaneously with the effect of the intervention on a one-time basis. Method of measurement: A motion capture system (Kestrel 8.0 motion analysis, US) 8 cameras and a force plate (Bertec corporation, Columbus, OH) 60x40 will simultaneously record data.</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>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-15</approval_date>
        <contact_name>Research Ethics committees of kharazmi university</contact_name>
        <contact_address>No. 43, Shahid Moftah St., Enghelab Blvd., Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
