<?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>IRCT20230709058724N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-29</date_registration>
      <primary_sponsor>Department of Sports and Youth</primary_sponsor>
      <public_title>The effect of aquatic exercise on Athletes with Chronic Ankle Instability</public_title>
      <acronym>AQE-CAI</acronym>
      <scientific_title>The effect of aquatic exercise on Functional Movement Assessments and Elements of Sensorimotor Function in Athletes with Chronic Ankle Instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71221</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: two control and experimental groups. The experimental group performs the water sports protocol along with the sports exercises, and the control group performs their own sports exercises, Randomization description: Participants will randomly assign to either the aquatic exercise group or the control group using a computer-generated random sequence with a 1:1 allocation ratio.  This randomization sequence will be generated by an independent statistician not involved in participant recruitment or data collection. Allocation concealment was achieved using sequentially numbered, opaque envelopes.  These envelopes contained pre-printed group assignments and were opened only after obtaining informed consent and completing baseline assessments for each participant, Blinding description: This study will employ a single-blind randomized controlled trial design. Participants will be aware of their group assignment (aquatic exercise group or control group) throughout the study duration. However, all data collection procedures will be standardized to minimize potential bias from assessors. Data analysts will be blinded to group assignment until after all data collection complete and the primary analyses conduct. A single, un-blinded researcher not involve in data collection or participant interaction will maintain the randomization sequence and ensured proper allocation concealment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic ankle instability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Aquatic exercises that focus on the ankle joint start from the first week with the least resistance and gradually intensify until the eighth week and reach the maximum pressure. These exercises include the following: increasing the load (resistance exercises), improving agility and jumping (after reaching the necessary preparation). And tools such as: water noodle, swimming board, rope, ladder have been used. Intervention 2: Control group:Participants in the control group will continue their daily activities and routine work (team or individual exercises three times a 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:
Data can be shared.6

When:
The access period starts one year after the results are published

To whom:
Academic and scientific researchers

Conditions:
For use in future research

Where to obtain:
saeidzareei1999@gmail.com

How to obtain:
One year after the statistical analysis and summarization of all the results and all the mentioned documents will be provided to you.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>saeedzarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Leader Blvd</address>
        <city>Sharekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۳۴۷۵ – ۸۸۱۶۴</zip>
        <telephone>+98 38 1225 1000</telephone>
        <email>saeidzareei1999@gmail.com</email>
        <affiliation>Shahrekord University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>sajad bagherian dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Leader Blvd</address>
        <city>Sharekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۳۴۷۵ – ۸۸۱۶۴</zip>
        <telephone>+98 38 1220 1000</telephone>
        <email>sajjadbagherian@yahoo.com</email>
        <affiliation>Sharekord University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Athletes (basketball, handball, volleyball, futsal)
History of ankle sprains in the last two years
Twice feeling empty ankles in six months
Obtaining the determined score in four questionnaires
Male athletes (18-30) with chronic ankle instability
Three years of sports experience with three sessions a week
No history of spine or lower limb surgery
No hearing problems
Not having balance problems</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Acute Ankle Sprain (less than 6 weeks old)
Severe Lower Limb Injuries like fractures, ligament tears requiring surgery
uncontrolled medical conditions like heart disease, high blood pressure, or neurological disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.37</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other instability, ankle and foot</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: Aquatic exercises that focus on the ankle joint start from the first week with the least resistance and gradually intensify until the eighth week and reach the maximum pressure. These exercises include the following: increasing the load (resistance exercises), improving agility and jumping (after reaching the necessary preparation). And tools such as: water noodle, swimming board, rope, ladder have been used.</i_keyword>
      <i_keyword>Control group:Participants in the control group will continue their daily activities and routine work (team or individual exercises three times a week).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motor performance and sensory-motor performance elements. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: 8 specialized tests(1-Knee to wall dorsiflexion ankle test 2-Stroke balance test 3-Y balance test 4-Functional movement screen 5-Side–hop test  6-Figure-of-8-Hop Test 7-Triple hop for distance 8-Assessment of sensory-motor function.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>After the implementation of the water exercise protocol on chronic ankle instability in the study, the secondary outcome variable can be "quality score of ankle questionnaires and self-report" and "lower limb motor performance screening scores" and "static and dynamic balance test and range of motion" ankle dorsiflexion and elements of sensory-motor and functional function. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: پرسشنامه (1-پرسشنامه بی ثباتی مچ پای کامبرلند 2- پرسشنامه تشخیص بی ثباتی عملکردی مچ پا 3-مقایس سنجش توانایی پا و مچ پا 4- مقیاس سنجش توانایی پا و مچ پل در فعالیت ورزشی) 8 تست تخصصی(1-آزمون رساندن زانو به دیوار 2-آزمون تعادل ایستا لک لک 3-آزمون تعادل پویا 4-آزمون غربالگری حرکات عملکردی 5-آزمون جهش جانبی 6-آزمون جهش هشت لاین 7-آزمون سه لی برای مسافت 8-ارزیابی عملکرد حسی-حرکتی.</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>Department of Sports and Youth</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-11</approval_date>
        <contact_name>Ethics Committee of Shahrekord University</contact_name>
        <contact_address>Rahbar Boulevard, Shahrekord University Chaharmahal va Bakhtiari Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
