<?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>IRCT20180728040618N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-01</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of agility ladder and hop training exercises on chronic ankle instability</public_title>
      <acronym></acronym>
      <scientific_title>The effect of agility ladder and hop training exercises on dynamic balance and functional tests in semi professional athletes with chronic ankle instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56327</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are randomly assigned to one of the two groups of agility ladder exercises and hop exercises equally by the restricted randomization and law of random allocation (drawing a card from the number of cards equal to the sample size and entering a group of two groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic ankle instability.</hc_freetext>
      <i_freetext>Intervention 1: Hop exercises are a modified version of plyometric exercises and have recently been used to reduce ankle instability. These exercises are relatively inexpensive, so it is easy to use in exercises. These exercises also improve dynamic balance .Hop exercises are a type of exercise that is similar to basic and dynamic movements in many sports. It also improves functional and postural control in people with chronic ankle instability. In hop exercises, the athlete exercises 3 days a week for 6 weeks. The athlete runs 5 minutes in each session to warm up at the beginning of the training session, 5 minutes of dynamic stretching, and 5 minutes of cooling at the end .The exercises get harder every week, the level of reliance changes and the number of repetitions and sets increases, the person first has his hands free and then puts his hands on his chest and finally behind his head. There is a 30 second break between sets and a 1 minute break between workouts .The exercises are done in front of a mirror and the person has both visual and auditory feedback (the person is told about his mistakes and is motivated).Hop exercises include the following exercises (the exercises are randomly in the text below) .  Forward hopping  Hopping in 4-square shape  Hopping side to side  Hopping forward and back ward Hopping in zigzag shape  Hopping in figure-8 shape. Intervention 2: Intervention group: Agility Ladder: An agility ladder is an inexpensive and accessible device that is placed on the ground like a ladder and the person moves one or two feet in and out of it. Depending on the purpose, it can be made of different lengths and widths. It can also be made using a tape or rope. The person also maintains his or her balance while moving rapidly, which is used in various sports to improve performance, improve acceleration, speed, coordination, dynamic balance, static, and body posture. Two of its most important goals are to improve coordination and speed, and the agility ladder is the best way to teach movement patterns. For best results, the exercises should progress from easy to difficult. Also, in the type of exercises, the type of sports activity of the person should be considered. The second group receives agility ladder exercises that they do 3 times a week for 6 weeks. Before training, they run for 5 minutes and do 5 minutes of dynamic stretching and warm up. The training lasts for 10 minutes and at the end, they cool down for 5 minutes. The exercises become more difficult as the progress progresses and the number of sets and repetitions varies, with 30 seconds between repetitions and 1 minute rest between sets. The exercises are as follows: Lateral two in two out Two in the hole Two in lateral One lateral Lateral ickey shuffle ickey shuffle backward ickey shuffle frontal two in two out forward zigzag cross over shuffle zigzag cross over shuffle backward frontal two in two out backward.</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:
Deidentified individual participant data collected for the primary and secondary outcome measures will be shared if necessary

When:
Starting 6 months after publication

To whom:
The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders

Conditions:
The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of ankle sprain and chronic ankle instability.

Where to obtain:
Applicants can contact the researcher of this study Elham Yazdani  by email. Email address: elhamyazdani992@gmail.com

How to obtain:
Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Holako Mohsenifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran St, Shah Nazari St, Madar Sq, Mirdamad Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>1545913487</telephone>
        <email>Mohsenifarpt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Holako Mohsenifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran St, Shah Nazari St, Madar Sq, Mirdamad Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>Mohsenifarpt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range of 18 to 35 years.                                                                                                    3 days a week and have 1 hour of regular exercise each time.                                                                    At least one ankle sprain that has caused pain, swelling, and dysfunction for more than a year.                                                                                                                                                            Have episodes of twisting and frequent giving way and have at least two episodes in the last 6 months.                                                                                                                                                       Unilateral ankle sprain .                                                                                                                        90% or less score in FAAM questionnaire.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Ankle sprains in the last 6 weeks.                                                                                                                       Ankle surgery.                                                                                                                                                 Vision problems.                                                                                                                            Neurological problems that cause imbalance, including: Parkinson's and multiple sclerosis and stroke.                                                                                                                                                                                                        Lower limb fractures.                                                                                                                                     Participants do not want to continue participating in the study due to pain or any unforeseen event.                                                                                                                                                     Acute musculoskeletal problems in the last 3 months (strains and tears of muscles and tendons, knee ligament injury and knee meniscus injury).                                                            Consumption of psychotropic drugs: benzodiazepines, antipsychotics, antidepressants.                                     Alcoholism.                                                                                                                                                                            genu recurvatum.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.37</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other instability, ankle and foot</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Hop exercises are a modified version of plyometric exercises and have recently been used to reduce ankle instability. These exercises are relatively inexpensive, so it is easy to use in exercises. These exercises also improve dynamic balance .Hop exercises are a type of exercise that is similar to basic and dynamic movements in many sports. It also improves functional and postural control in people with chronic ankle instability. In hop exercises, the athlete exercises 3 days a week for 6 weeks. The athlete runs 5 minutes in each session to warm up at the beginning of the training session, 5 minutes of dynamic stretching, and 5 minutes of cooling at the end .The exercises get harder every week, the level of reliance changes and the number of repetitions and sets increases, the person first has his hands free and then puts his hands on his chest and finally behind his head. There is a 30 second break between sets and a 1 minute break between workouts .The exercises are done in front of a mirror and the person has both visual and auditory feedback (the person is told about his mistakes and is motivated).Hop exercises include the following exercises (the exercises are randomly in the text below) .  Forward hopping  Hopping in 4-square shape  Hopping side to side  Hopping forward and back ward Hopping in zigzag shape  Hopping in figure-8 shape</i_keyword>
      <i_keyword>Intervention group: Agility Ladder: An agility ladder is an inexpensive and accessible device that is placed on the ground like a ladder and the person moves one or two feet in and out of it. Depending on the purpose, it can be made of different lengths and widths. It can also be made using a tape or rope. The person also maintains his or her balance while moving rapidly, which is used in various sports to improve performance, improve acceleration, speed, coordination, dynamic balance, static, and body posture. Two of its most important goals are to improve coordination and speed, and the agility ladder is the best way to teach movement patterns. For best results, the exercises should progress from easy to difficult. Also, in the type of exercises, the type of sports activity of the person should be considered. The second group receives agility ladder exercises that they do 3 times a week for 6 weeks. Before training, they run for 5 minutes and do 5 minutes of dynamic stretching and warm up. The training lasts for 10 minutes and at the end, they cool down for 5 minutes. The exercises become more difficult as the progress progresses and the number of sets and repetitions varies, with 30 seconds between repetitions and 1 minute rest between sets. The exercises are as follows: Lateral two in two out Two in the hole Two in lateral One lateral Lateral ickey shuffle ickey shuffle backward ickey shuffle frontal two in two out forward zigzag cross over shuffle zigzag cross over shuffle backward frontal two in two out backward</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Determining the reach distance in the star balance test before the intervention and after 6 weeks of hop exercises and agility ladder exercises. Method of measurement: In the star balance test, a person can reach a greater distance with a non-involved foot.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determining the number of hop to the side in 30 seconds at a distance of 40 cm. Timepoint: Determining the number of hop to the side in 30 seconds at a distance of 40 cm, before the intervention and after the 6-week intervention hop exercises and agility ladder exercises. Method of measurement: Chronometer for time of side hop test.</sec_outcome>
      <sec_outcome>Determining the time of multiple hop. Timepoint: Before the intervention and after the 6-week intervention hop and agility ladder exercises. Method of measurement: Chronometer for time of multiple hop test.</sec_outcome>
      <sec_outcome>Foot and ankle ability measurement. Timepoint: Before the intervention and after the intervention 6 weeks of  hop training and agility ladder training. Method of measurement: Foot and ankle ability measurement  questionaries.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-17</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
