<?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>IRCT20220408054452N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-23</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dry needling on chronic ankle instability</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of progressive neuromuscular training alone and combined with trigger point dry needling of peroneal muscles on functional status, postural control, and muscular activity of the lower extremity during jump-landing task in athletes with chronic ankle Instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62932</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects will be randomly allocated to three experimental groups using blocked randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Ankle Instability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: (1st intervention) subjects will complete progressive neuromuscular exercise, 2 sessions per week for 6 sequential weeks. Each session will last about 30 minutes. The subjects will also receive dry needling of peroneus longus and peroneus brevis trigger points, 1 session per week for 6 weeks. Intervention 2: Intervention group: (2nd intervention) subjects will complete progressive neuromuscular exercise, 2 sessions per week for 6 sequential weeks. Each session will last about 30 minutes. The subjects will also receive placebo dry needling of peroneus longus and peroneus brevis trigger points, 1 session per week for 6 weeks, while all stages of intervention is similar to real dry needling sessions. Intervention 3: Control group: Subjects will complete progressive neuromuscular exercise, 2 sessions per week for 6 sequential weeks. Each session will last about 30 minutes.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation faculty of Shahid Beheshti university of medical sciences, Damavand St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 8496</telephone>
        <email>majid_hoseini@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation faculty of Shahid Beheshti university of medical sciences, Damavand St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 8496</telephone>
        <email>majid_hoseini@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Regular sport activity in soccer, volleyball or basketball, at least 3 sessions per week, each lasting at least 2 hours
A history of repeated ankle sprains along with inflammatory symptoms
Existing ankle instability according to Cumberland Ankle Instability Tools (CAIT)
Clinical presentation of trigger points in peroneal muscles</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A history of musculoskeletal injury in other lower extremity joints within last 3 months leading to at least on day loss of regular activity.
A history of the immune system or blood coagulation disorders, vestibular dysfunction, neurological or neurovascular conditions, or convulsion
Acute inflammatory symptoms in ankle region</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S93.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of ankle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: (1st intervention) subjects will complete progressive neuromuscular exercise, 2 sessions per week for 6 sequential weeks. Each session will last about 30 minutes. The subjects will also receive dry needling of peroneus longus and peroneus brevis trigger points, 1 session per week for 6 weeks.</i_keyword>
      <i_keyword>Intervention group: (2nd intervention) subjects will complete progressive neuromuscular exercise, 2 sessions per week for 6 sequential weeks. Each session will last about 30 minutes. The subjects will also receive placebo dry needling of peroneus longus and peroneus brevis trigger points, 1 session per week for 6 weeks, while all stages of intervention is similar to real dry needling sessions.</i_keyword>
      <i_keyword>Control group: Subjects will complete progressive neuromuscular exercise, 2 sessions per week for 6 sequential weeks. Each session will last about 30 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Onset time of peroneus longus, peroneus brevis, soleus, vastus medialis, gluteus medius, tibialis anterior. Timepoint: 1- Before intervention 2- Immediately after the 1st session of intervention 3- After the last session of intervention 4- Three months after the end of the last session of intervention. Method of measurement: Surface electromyography device (time difference between initial foot-ground contact and onset of electromyographic activity of each muscle).</prim_outcome>
      <prim_outcome>Amplitude of electromyographic activity of peroneus longus, peroneus brevis, soleus, vastus medialis, gluteus medius, tibialis anterior. Timepoint: 1- Before intervention 2- Immediately after the 1st session of intervention 3- After the last session of intervention 4- Three months after the end of the last session of intervention. Method of measurement: Surface electromyography device (average amplitude of muscular activity 200 milliseconds before - 200 milliseconds after initial foot-ground contact).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional status scores. Timepoint: 1- Before intervention, 2- After the last intervention session, 3- Three months after the last intervention session. Method of measurement: 1- Foot and Ankle Ability Measure (FAAM), 2- Cumberland's Ankle instability index.</sec_outcome>
      <sec_outcome>Dynamic postural stability. Timepoint: 1- Before intervention, 2- After the last intervention session, 3- Three months after the last intervention session. Method of measurement: Scores of the Star Excursion Balance Test (SEBT).</sec_outcome>
      <sec_outcome>Time of figure of 8 hop test. Timepoint: 1- Before intervention, 2- After the last intervention session, 3- Three months after the last intervention session. Method of measurement: Measurement of time for completing figure of 8 hop test.</sec_outcome>
      <sec_outcome>Distance in triple hop test. Timepoint: 1- Before intervention, 2- After the last intervention session, 3- Three months after the last intervention session. Method of measurement: Measuring distance in triple hop test.</sec_outcome>
      <sec_outcome>Static postural control. Timepoint: 1- Before intervention, 2- After the last intervention session, 3- Three months after the last intervention session. Method of measurement: Measuring stability indices in Biodex balance test.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-21</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid A'rabi St, Yaman St, Shahid Chamran highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
