<?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>IRCT20180714040466N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-26</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of physiotherapy in functional ankle instability</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot intrinsic muscles strengthening  on postural control in subjects with functional ankle instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40717</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be selected by available sampling method. then by randomization permutation blocks method will enter the groups:
A: intrinsic exercises group B: routine exercises group C: control group
In this method, after determining the age and sex, patients will enter the research in the following order:
 CCCBBAA ABCABB ACCABCAA ACBCCAB BCACABA CCAABA CCABCBB BBCAABBCCBAB
According to this randomization, for example patient number 1 will enter group C and patient number 4 will enter group B and so on it will continue, Blinding description: Patients are considered blind regardless of the difference in treatment methods of the groups. In this research, patient will be blinded from other research groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>functional ankle instability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The patient will perform foot intrinsic muscles exercises for 12 sessions. Patients in intrinsic muscles exercise group will perform the following exercises: scrunching towel with toes: the patient sitting on a chair, then puts his foot on top a towel and with toes flexion scrunches the towel. By putting weight at the end of the towel will progress the exercise. Short foot exercise: While the patient sitting on a chair, increase and decrease medial longitudinal arch. By doing in standing position, the exercise is progressed. Toes abduction and adduction: while sitting on a chair, the patient abduct and adduct the toes. By using elastic band, exercise is progressed. Piano key exercise: while sitting on a chair, alternately extend toes and big toe. Stretching big toe: in sitting position, he stretches his big toe toward extension. Passive exercises include mobilization of sub talar, midfoot and forefoot joints. These techniques are performed according to Maitland method. Exercises are done 3 sets with 10 repetitions. There is 30-60 seconds rest between each set. Exercises are conducted in physiotherapy clinic 3 times per week for 4 weeks. Intervention 2: Intervention group 2:The patient will perform routine exercises in functional ankle instability for 12 sessions. Patients in routine group will perform the following exercises: strengthening exercises with theraband for dorsi and plantar flexor muscles: in sitting position with extended knee, the exercise will be perform in both dorsi and plantar directions. Plantar flexor muscles stretching: in sitting position with extended knee, stretching is applied in the dorsi flexion direction with theraband or rope. Weight bearing on the heel and toe exercise: in standing position, the patient alternately shifts the weight on the heel and toe. Tilt board balance exercise: the patient preserves his balance on the affected foot on the tilt board. Leg reaches exercise: the sun is designed on the ground and then the patient stands on one foot in the middle point and moves the other foot in the directions of the sun's rays. This exercise will perform for both feet. Jump: the patient will practice jumping on the ground. Exercises will done 3 sets with 10 repetitions. There is 30-60 seconds rest between each set. Exercises are conducted in physiotherapy clinic 3 times per week for 4 weeks. Intervention 3: Control group: There is no intervention in control group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Ghiasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam al anbia Hosp, Jame jam Blvd</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9815733169</zip>
        <telephone>+98 54 3322 0501</telephone>
        <email>f_ghiasi_p@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Ghiasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam al anbia Hosp, Jame jam Blvd</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9815733169</zip>
        <telephone>+98 54 3322 0501</telephone>
        <email>f_ghiasi_p@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Unilateral functional ankle instability with at least one sprain in recent year and recurrent giving way
Not being mechanical instability in unstable ankle with doing anterior drawer test and  talar tilt test
Not existing fracture, dislocation and structural disorders in lower limb
Not existing vertigo, faint and head trauma
No ankle injury in the last 3 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Receive other treatment
Unwillingness to enter research
Taking painkillers, sedatives and alcohol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S93.40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of unspecified ligament of ankle</hc_keyword>
    </health_condition_keyword>
    <intervention_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: The patient will perform foot intrinsic muscles exercises for 12 sessions. Patients in intrinsic muscles exercise group will perform the following exercises: scrunching towel with toes: the patient sitting on a chair, then puts his foot on top a towel and with toes flexion scrunches the towel. By putting weight at the end of the towel will progress the exercise. Short foot exercise: While the patient sitting on a chair, increase and decrease medial longitudinal arch. By doing in standing position, the exercise is progressed. Toes abduction and adduction: while sitting on a chair, the patient abduct and adduct the toes. By using elastic band, exercise is progressed. Piano key exercise: while sitting on a chair, alternately extend toes and big toe. Stretching big toe: in sitting position, he stretches his big toe toward extension. Passive exercises include mobilization of sub talar, midfoot and forefoot joints. These techniques are performed according to Maitland method. Exercises are done 3 sets with 10 repetitions. There is 30-60 seconds rest between each set. Exercises are conducted in physiotherapy clinic 3 times per week for 4 weeks.</i_keyword>
      <i_keyword>Intervention group 2:The patient will perform routine exercises in functional ankle instability for 12 sessions. Patients in routine group will perform the following exercises: strengthening exercises with theraband for dorsi and plantar flexor muscles: in sitting position with extended knee, the exercise will be perform in both dorsi and plantar directions. Plantar flexor muscles stretching: in sitting position with extended knee, stretching is applied in the dorsi flexion direction with theraband or rope. Weight bearing on the heel and toe exercise: in standing position, the patient alternately shifts the weight on the heel and toe. Tilt board balance exercise: the patient preserves his balance on the affected foot on the tilt board. Leg reaches exercise: the sun is designed on the ground and then the patient stands on one foot in the middle point and moves the other foot in the directions of the sun's rays. This exercise will perform for both feet. Jump: the patient will practice jumping on the ground. Exercises will done 3 sets with 10 repetitions. There is 30-60 seconds rest between each set. Exercises are conducted in physiotherapy clinic 3 times per week for 4 weeks.</i_keyword>
      <i_keyword>Control group: There is no intervention in control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamic balance indexes for single leg. Timepoint: The beginning of research and after of 4 week intervention. Method of measurement: Biodex system.</prim_outcome>
      <prim_outcome>Dynamic balance indexes for double legs. Timepoint: The beginning of research and after of 4 week intervention. Method of measurement: Biodex system.</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>2019-07-28</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Dr. Hesabi Street Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
