<?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>IRCT20231022059811N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-06</date_registration>
      <primary_sponsor>Shahrekord University</primary_sponsor>
      <public_title>The effect of gluteal muscle strengthening exercises on ankle instability</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of gluteal muscle strengthening exercises on Sensorimotor Function, balance and ankle instability in women with chronic ankle instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73379</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple randomization
Randomization Unit: Individual
Randomization tools: Lottery using cards and bowls
How to create a random sequence and concealment: First, the names of 30 students with ankle instability and weakness of the middle and large pelvis were written on a sheet as a statistical population, and the sheets were folded and thrown into a bowl. Then I separate two bowls and put one of the papers in one bowl and the other paper in the other bowl and continue doing this until the last paper and in the end there are 15 papers in each bowl, one of the bowls is the intervention group and the other is the intervention group. We will choose control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>ankle sprain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They will do gluteal strengthening exercises for 8 weeks, 3 sessions per week and 30 minutes each session. Each exercise has 8 repetitions, each movement is performed with a 2 second pause and 2 minutes of rest between each exercise. After 4 weeks, by adding weight to each of the exercises, the level of muscle activation can be increased, which causes more strengthening effects. Intervention 2: Control group: There was no intervention and they went about their daily lives.</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 People's information will remain confidential and I only have the right to publish the results as a group.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maedeh kafami ladani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Shahrekord, Rahbar Blvd</address>
        <city>Sahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8818634141</zip>
        <telephone>+98 31 3772 0619</telephone>
        <email>maedehkafami77@gmail.com</email>
        <affiliation>The University of Shahrekord</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maedeh kafami ladani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord University, Rahbar Blvd</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8818634141</zip>
        <telephone>+98 31 3772 0619</telephone>
        <email>maedehkafami77@gmail.com</email>
        <affiliation>Shahrekord University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of ankle sprain in the last 2 years
Having at least two ankle sprains in the last 6 months
Obtaining a score from the questionnaire (score zero to 24 of the Cumberland CAIT questionnaire)
non-athlete
Voluntary consent of the subjects
Weakness of the gluteus medius
Weakness of the gluteus maximus
Female students aged 18 to 40
No history of surgery
No history of fracture
No history of neurological diseases
Not using drugs that affect the nervous system, such as sedatives, on the day of the test
No balanced hearing problems
No pain in any part of the body</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>No history of ankle sprain in the last 2 years
Not having at least two ankle sprains in the last 6 months
Failure to obtain a grade from the transcript (CAIT more than 24)
athlete
Lack of voluntary consent of subjects
Absence of weakness of gluteus medius
Absence of weakness of gluteus maximus
Female or male students less than 18 or more than 40
History of surgery
History of fracture
History of neurological diseases
Using drugs that affect the nervous system, such as sedatives, on the day of the test
Pain in any part of the body</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>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: They will do gluteal strengthening exercises for 8 weeks, 3 sessions per week and 30 minutes each session. Each exercise has 8 repetitions, each movement is performed with a 2 second pause and 2 minutes of rest between each exercise. After 4 weeks, by adding weight to each of the exercises, the level of muscle activation can be increased, which causes more strengthening effects.</i_keyword>
      <i_keyword>Control group: There was no intervention and they went about their daily lives.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cumberland questionnaire and gluteal muscle weakness. Timepoint: Pre-test and post-test. Method of measurement: The method of measuring gluteal weakness is done by hand dynamometer, and subjects should score less than 24 in the Cumberland Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sensorimotor function, balance, ankle instability. Timepoint: Pre-test and post-test. Method of measurement: How to measure sensorimotor function with a goniometer, balance is measured by static and dynamic tests with a stopwatch, and ankle instability is measured with the dentification of function ankle instability questionnaire.</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>Shahrekord University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-12</approval_date>
        <contact_name>Ethics Committee of Shahrekord University</contact_name>
        <contact_address>University Shahrekord, Rahbar Blvd Sharekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
