<?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>IRCT20231103059941N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-15</date_registration>
      <primary_sponsor>Riphah International University, Lahore</primary_sponsor>
      <public_title>Effects of  Wobble board and CrossFit training in athletes with ankle instability</public_title>
      <acronym></acronym>
      <scientific_title>COMPARATIVE EFFECTS OF WOBBLE BOARD AND CROSSFIT TRAINING IN ATHLETES WITH CHRONIC ANKLE INSTABILITY</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73584</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization (Lottery Method).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Ankle Instability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1(WOBBLE BOARD TRAINING): The wobble board is a circular platform (30 inches) with different-sized domes that screw into the bottom of the board to make balance exercises more or less challenging. Participants will be placed near a wall and allowed to touch it with their fingertips only for any means of stability. 1-legged stance will be performed on the board, standing on board and moving forward, backward, and side to side and standing on one leg (affected side), and then clockwise and counterclockwise rotations of the rim will be completed. The participants will perform exercises for 6 weeks and pre and post-measurements will be recorded. Intervention 2: Intervention group 2 (CROSSFIT TRAINING): The session will be divided into 3 parts: a warm-up period, a principal training phase (which is known in CrossFit as the Workout of the Day), and a cool-down aimed at easing recovery after the effort. The warm-up period will consist of cardiovascular activity, dynamic stretching, and progressive-load strength exercises. The main portion of the training session will consist of exercises to address strength, endurance, agility, and functional mobility. The difficulty level of each exercise will be controlled by a certified instructor who monitors the participant's form. Some exercises are based on body weight, such as a squat or burpees, whereas others require specific equipment such as barbells, kettlebells, or medicine balls. The final part of each session will consist of slow cardiovascular activity and foam rolling. The participants will perform exercises for 6 weeks and pre and post-measurements will be recorded for both study groups.</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 I haven't decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nida Shabbir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ripha International University,25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54660</zip>
        <telephone>+92 301 4857099</telephone>
        <email>nidas2765@gmail.com</email>
        <affiliation>Riphah International University, Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nida Shabbir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University, 25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54660</zip>
        <telephone>+92 301 4857099</telephone>
        <email>nidas2765@gmail.com</email>
        <affiliation>Riphah International University, Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age ranging from 18 to 40 years.
Perform cardiovascular or resistance training for at least 1.5 hours per week.
A previous ankle sprain at least 6 months before the study.
Recurrent feeling of “giving way.”
A score of 25 or less on the CAIT(cumberland ankle instability tool) to confirm current ankle-joint instability.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Self-reported vestibular or balance-related dysfunction.
An acute ankle sprain in the previous 6 weeks.
Recent surgery(knee, hip, ankle).
Being a habitual CrossFit practitioner.</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1(WOBBLE BOARD TRAINING): The wobble board is a circular platform (30 inches) with different-sized domes that screw into the bottom of the board to make balance exercises more or less challenging. Participants will be placed near a wall and allowed to touch it with their fingertips only for any means of stability. 1-legged stance will be performed on the board, standing on board and moving forward, backward, and side to side and standing on one leg (affected side), and then clockwise and counterclockwise rotations of the rim will be completed. The participants will perform exercises for 6 weeks and pre and post-measurements will be recorded.</i_keyword>
      <i_keyword>Intervention group 2 (CROSSFIT TRAINING): The session will be divided into 3 parts: a warm-up period, a principal training phase (which is known in CrossFit as the Workout of the Day), and a cool-down aimed at easing recovery after the effort. The warm-up period will consist of cardiovascular activity, dynamic stretching, and progressive-load strength exercises. The main portion of the training session will consist of exercises to address strength, endurance, agility, and functional mobility. The difficulty level of each exercise will be controlled by a certified instructor who monitors the participant's form. Some exercises are based on body weight, such as a squat or burpees, whereas others require specific equipment such as barbells, kettlebells, or medicine balls. The final part of each session will consist of slow cardiovascular activity and foam rolling. The participants will perform exercises for 6 weeks and pre and post-measurements will be recorded for both study groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chronic ankle instability. Timepoint: 0-6 weeks (before and after intervention). Method of measurement: Cumberland Ankle Instability Tool (CAIT).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dynamic Balance. Timepoint: 0-6 weeks (before and after intervention). Method of measurement: Star Excursion Balance Test (SEBT).</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>Riphah International University, Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-03</approval_date>
        <contact_name>Research&amp; Ethical Committee</contact_name>
        <contact_address>25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
