<?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>IRCT20180627040251N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-08</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>Effect of balance training with and without stroboscopic vision on functional performance in athletes with chronic ankle instability</public_title>
      <acronym></acronym>
      <scientific_title>Effect of balance training with and without stroboscopic vision on kinesiophobia, proprioception and timing of muscle activity of selected muscles in people with chronic ankle instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77095</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using simple randomization individually and random sequence allocation through a computer program aided by a web-based program (randomizer.org). It will be determined by a non-involved research team member when selecting samples from opaque, sequentially numbered sealed envelopes for allocation concealment. Participants will be allocated to two intervention groups and one control group, Blinding description: In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Sprain of Ankle. Condition 2: Balance Exercise.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1 : Includes static and dynamic balance exercises for the injured ankle. The program consists of 6 exercises, which start from an easy level and gradually become more difficult according to the way of execution and the person's ability. It should be noted that the intensity, duration, type of movements and level of exercises in this protocol are controlled by the examiner and are changed according to the principle of overload. All participants do 18 training sessions for 6 weeks. Intervention 2: Intervention group 2: Includes balance exercises with stroboscopic vision. This exercise protocol includes static and dynamic balance for the injured ankle. The program consists of 6 exercises, which start from an easy level and gradually become more difficult according to the way of execution and the ability of the person. It should be noted that the intensity, duration, type of movements and level of exercises in this protocol are controlled by the examiner and are changed according to the principle of overload. The exercises are done in a circle for 20 minutes and all participants do 18 training sessions for 6 weeks. The participants perform the above-mentioned balance exercises by adding glasses in the form of alternating vision between opaque and transparent phases during the intervention. The glasses are on the eyes of the participants during the entire training, and the glasses are completely transparent during rest. Intervention 3: Control group: In the control group, there is no intervention and only pre-test and post-test are taken. They are asked not to exercise during this time.</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 It is not necessary to publish this information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hassan Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad - Shahid Hesari St. - Shahid Keshvari Complex - Faculty of Physical Education and Sports Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1544733111</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>hassan.sadeghi81@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad - Shahid Hesari St. - Shahid Keshvari Complex - Faculty of Physical Education and Sports Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1544733111</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>hassan.sadeghi81@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A score of less than 27 on the Cumberland Ankle Functional Instability Test
A history of at least two acute sprains in the last 6 months
Ability to bear weight on the affected limb
Not receiving exercise therapy and physiotherapy in the last year</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of any ankle fracture
History of ankle joint surgery
Acute ankle sprain in the last 6 weeks
Vestibular or balance dysfunction
Disability of the athlete during training due to severe pain, fatigue, muscle cramps, and limited movement in the ankle joint</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S93.4</hc_code>
      <hc_code>Y93.B9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of ankle</hc_keyword>
      <hc_keyword>Activity, other involving muscle strengthening exercises</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 group1 : Includes static and dynamic balance exercises for the injured ankle. The program consists of 6 exercises, which start from an easy level and gradually become more difficult according to the way of execution and the person's ability. It should be noted that the intensity, duration, type of movements and level of exercises in this protocol are controlled by the examiner and are changed according to the principle of overload. All participants do 18 training sessions for 6 weeks</i_keyword>
      <i_keyword>Intervention group 2: Includes balance exercises with stroboscopic vision. This exercise protocol includes static and dynamic balance for the injured ankle. The program consists of 6 exercises, which start from an easy level and gradually become more difficult according to the way of execution and the ability of the person. It should be noted that the intensity, duration, type of movements and level of exercises in this protocol are controlled by the examiner and are changed according to the principle of overload. The exercises are done in a circle for 20 minutes and all participants do 18 training sessions for 6 weeks. The participants perform the above-mentioned balance exercises by adding glasses in the form of alternating vision between opaque and transparent phases during the intervention. The glasses are on the eyes of the participants during the entire training, and the glasses are completely transparent during rest.</i_keyword>
      <i_keyword>Control group: In the control group, there is no intervention and only pre-test and post-test are taken. They are asked not to exercise during this time.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ankle Proprioception. Timepoint: immediately before intervention; immediately after intervention. Method of measurement: Biodex Isokinetic Dynamometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ankle Instability. Timepoint: immediately before intervention; immediately after intervention. Method of measurement: Cumberland ankle instability questionnaire.</sec_outcome>
      <sec_outcome>Electromyography of lower limb muscles. Timepoint: immediately before intervention; immediately after intervention. Method of measurement: Electromyography.</sec_outcome>
      <sec_outcome>Kinesiophobia. Timepoint: immediately before intervention; immediately after intervention. Method of measurement: kinesiophobia Questioner.</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>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-05</approval_date>
        <contact_name>Ethical Committee of Kharazmi University-Iran</contact_name>
        <contact_address>Enghlab- Mofateh St. Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
