<?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>IRCT20211113053047N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-27</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of hip muscle strengthening  on postural control in subjects with functional ankle instability</public_title>
      <acronym></acronym>
      <scientific_title>The effect of hip muscle strengthening  on postural control in subjects with functional ankle instability: a randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60012</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random assignment of patients to two groups is done by permutation block stratified randomization method. First, eligible patients are classified according to age, sex and BMI, respectively. Then, based on 4 blocks (Consisting of two groups A and B and two repetitions for each) which are randomly selected from all possible modes of permutations, They are assigned to the desired group. These blocks were ceated using statistical software R version 4.0.2, Blinding description: In this research, the one-blind method is used. So that the statistician will not be aware of the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Recurrent ankle sprain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Exercises of the control group included: Theraband strengthening exercises for dorsiflexor and plantarflexor muscles, Weight bearing on heels and toes, Maintain balance on the tilt board and leg reaches exercise. Three sets of ten exercises will be performed, with a 60-second break between each exercise. The load applied during the exercise was determined based on 70% of a maximum repetition. The maximum load is determined during the first evaluation session and re-examined every week to make changes if necessary based on the ability of each subject. Individuals will perform exercises three times a week for 4 weeks under the supervision of a physiotherapist at the physiotherapy clinic. Intervention 2: Intervention group: Exercises of the intervention group included: hip abduction with weights in the side position, hip abduction with theraband in standing position, hip extention in prone position, hip external rotation with theraband in sitting position, clam shell exercise in side position, lateral stepping with theraband and ankle routine exercises (control group exercises). Three sets of ten exercises will be performed, with a 60-second break between each exercise. The load applied during the exercise was determined based on 70% of a maximum repetition. The maximum load is determined during the first evaluation session and re-examined every week to make changes if necessary based on the ability of each subject. Individuals will perform exercises three times a week for 4 weeks under the supervision of a physiotherapist at the physiotherapy clinic.</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 of the data can be shared

When:
6 Months after printing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Researchers and experts in this field It must ensured that data will not be misused

Where to obtain:
soheilkhalili.aban@yahoo.com

How to obtain:
The Applicant must state himself / herself fully and clearly and state his / her Intention to apply. About 2 to 4 Weeks after the test, he will receive the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soheil Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 6, 15 sadra Ave, Zibashahr</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817917997</zip>
        <telephone>+98 54 3328 0777</telephone>
        <email>soheil.khalili@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheil Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 6, 15 sadra Ave, Zibashahr</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817917997</zip>
        <telephone>+98 54 3328 0777</telephone>
        <email>soheil.khalili@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 and 45 years
Unilateral functional instability of the ankle. At least one sprain in a recent year and a feeling of frequent giving way
Conscious and informed consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of mechanical functional instability in the affected ankle by performing anterior drawer test and talar displacement
History of fracture, dislocation and structural abnormality in the lower limb
Ankle injury in the last three months
History of severe low back pain in the last six months
History of dizziness and fainting
History of head trauma
History of numbness and tingling in the lower extremities
Take painkillers, sedatives and alcohol 48 hours before  the test</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>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Exercises of the control group included: Theraband strengthening exercises for dorsiflexor and plantarflexor muscles, Weight bearing on heels and toes, Maintain balance on the tilt board and leg reaches exercise. Three sets of ten exercises will be performed, with a 60-second break between each exercise. The load applied during the exercise was determined based on 70% of a maximum repetition. The maximum load is determined during the first evaluation session and re-examined every week to make changes if necessary based on the ability of each subject. Individuals will perform exercises three times a week for 4 weeks under the supervision of a physiotherapist at the physiotherapy clinic.</i_keyword>
      <i_keyword>Intervention group: Exercises of the intervention group included: hip abduction with weights in the side position, hip abduction with theraband in standing position, hip extention in prone position, hip external rotation with theraband in sitting position, clam shell exercise in side position, lateral stepping with theraband and ankle routine exercises (control group exercises). Three sets of ten exercises will be performed, with a 60-second break between each exercise. The load applied during the exercise was determined based on 70% of a maximum repetition. The maximum load is determined during the first evaluation session and re-examined every week to make changes if necessary based on the ability of each subject. Individuals will perform exercises three times a week for 4 weeks under the supervision of a physiotherapist at the physiotherapy clinic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Overall, anterior-posterior and medial-lateral dynamic instability index (two legs and one leg). Timepoint: Dynamic index measurement before the start of the study and 4 weeks after the start of training. Method of measurement: Biodex SD balance system (Balance System SD 950-304 Model SW45-30D-E6N, Biodex Medical System, Inc., New York, USA).</prim_outcome>
      <prim_outcome>Overall, anterior-posterior and medial-lateral static instability index (two legs and one leg). Timepoint: Static index measurement before the start of the study and 4 weeks after the start of training. Method of measurement: Biodex SD balance system (Balance System SD 950-304 Model SW45-30D-E6N, Biodex Medical System, Inc., New York, USA).</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-01</approval_date>
        <contact_name>Ethics committee of zahedan university of medical sciences</contact_name>
        <contact_address>no. 15, Sadra Ave., Zibashahr Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
