<?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>IRCT20110803007211N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-06</date_registration>
      <primary_sponsor>Research Deputy of Hakim Nizami Higher Education</primary_sponsor>
      <public_title>Evaluating the Effect of Comprehensive Corrective Exercises and Rope Skipping on Ankle Function in Students with Pronation Disorder</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Comprehensive Corrective Exercises and Jumping Rope on Balance and Proprioception of the Ankle in Female Students with Ankle Pronation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81102</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using **cluster sampling**, three schools were randomly selected, and students aged **10 to 12 years** were screened based on the criteria. The sample size was calculated using **G Power software** for **three groups** (effect size **0.25**, alpha **0.05**, power **0.95**) as **251 participants**, and **260 students** were selected to account for dropouts. After screening, **64 female students** with **ankle pronation** were identified, and **45 participants** were randomly assigned to **three groups**: **Corrective Exercise (15)**, **Rope Skipping (15)**, and **Control (15)**, Blinding description: Participants, outcome assessors, and data analysts will be blinded to the allocation of study groups. The blinding process will be implemented as follows: the assignment of participants to intervention and control groups will be conducted by an independent individual who is not involved in data collection, assessment, or analysis. The exercise packages will be pre-coded and distributed without labels indicating group allocation, ensuring that the identity of the intervention and control groups remains concealed. Outcome assessors will work only with coded data and will have no access to information about the type of exercises each group receives. Only the principal investigator responsible for designing the interventions will be aware of the specific exercises assigned to each group. However, this investigator will not participate in the data collection or analysis process to minimize the risk of bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ankle Pronation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 2: The jump rope training protocol consisted of a six-week program, performed three days a week. Each session began with a 10-minute warm-up, including running and dynamic stretching. The exercises were performed at a speed of 120 jumps per minute using a metronome. The intervention included six types of jumps: basic jump, forward and backward double jump, double under, scissor jump, alternate jump, and one-jump-two-rope. Participants used standardized ropes weighing 230 grams, with the length adjusted individually. Rest intervals were 30 seconds between sets and 2 minutes between exercises. Each participant used their designated rope throughout the program. Intervention 2: Intervention group 2: The corrective exercise program was a six-week protocol with three 60-minute sessions per week, focusing on maintaining full-body alignment during exercises. The experimental group followed the program, while the control group continued their usual activities. The program consisted of an educational session and practical exercises. The educational session was a two-hour theoretical class on proper functional movements. The practical part included 21 exercises such as foam rolling for muscles (31 seconds), static stretching for gastrocnemius and soleus, eccentric strengthening of foot muscles, and dynamic exercises like the star balance test, stair climbing, and lunges. Each session included 11 minutes of warm-up, 11 minutes of inhibitory exercises, 35 minutes of stretching, strength, and integration exercises, and 5 minutes of cooldown. The program was conducted over 18 sessions, starting one day after the pre-test, while the control group continued their usual routines. The program was implemented at the Corrective Movement Center in Quchan during the 1403 academic year. Intervention 3: Control group: The control group continued their daily activities during this period without receiving any intervention. This group served as a baseline to compare the effects of the corrective exercises with the experimental 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data files will be available to researchers after the publication of the abstracted article

When:
After publication the article

To whom:
Other researchers

Conditions:
There are no special conditions

Where to obtain:
Corresponding Author: Please contact via email.

How to obtain:
Upon receiving a formal request for data or documentation, the process will involve review and approval by the corresponding author. Once the request is approved, the required data and documents will be prepared and provided to the requester within one week. This process includes thoroughly reviewing the request, preparing the data, and ensuring that the information provided aligns with the original request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Karim Khalaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Opposite Saipa Dealership, Quchan-Mashhad Sento Road</address>
        <city>Qochan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9471787194</zip>
        <telephone>+98 51 4721 1773</telephone>
        <email>karim.khalaghi@yahoo.com</email>
        <affiliation>Hakim Nizami Qochan Institute of Higher Education</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>karim khalaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Opposite Saipa Dealership, Quchan-Mashhad Sento Road</address>
        <city>Qochan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9471787194</zip>
        <telephone>+98 51 4721 1773</telephone>
        <email>karim.khalaghi@yahoo.com</email>
        <affiliation>Hakim Nizami Qochan Institute of Higher Education</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female students aged 10 to 12 years
Navicular drop greater than 10 mm
Grade 2 flat foot
No history of injury, surgery, or fracture in the lower limbs
Free from any specific diseases</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>12 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of fracture or surgery in lower limb joints
Postural disorders such as bowlegs (genu varum), knock knees (genu valgum), or scoliosis
Acute ankle sprain symptoms such as swelling or bruising</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M95.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other acquired deformities of musculoskeletal system and connective tissue</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 2: The jump rope training protocol consisted of a six-week program, performed three days a week. Each session began with a 10-minute warm-up, including running and dynamic stretching. The exercises were performed at a speed of 120 jumps per minute using a metronome. The intervention included six types of jumps: basic jump, forward and backward double jump, double under, scissor jump, alternate jump, and one-jump-two-rope. Participants used standardized ropes weighing 230 grams, with the length adjusted individually. Rest intervals were 30 seconds between sets and 2 minutes between exercises. Each participant used their designated rope throughout the program.</i_keyword>
      <i_keyword>Intervention group 2: The corrective exercise program was a six-week protocol with three 60-minute sessions per week, focusing on maintaining full-body alignment during exercises. The experimental group followed the program, while the control group continued their usual activities. The program consisted of an educational session and practical exercises. The educational session was a two-hour theoretical class on proper functional movements. The practical part included 21 exercises such as foam rolling for muscles (31 seconds), static stretching for gastrocnemius and soleus, eccentric strengthening of foot muscles, and dynamic exercises like the star balance test, stair climbing, and lunges. Each session included 11 minutes of warm-up, 11 minutes of inhibitory exercises, 35 minutes of stretching, strength, and integration exercises, and 5 minutes of cooldown. The program was conducted over 18 sessions, starting one day after the pre-test, while the control group continued their usual routines. The program was implemented at the Corrective Movement Center in Quchan during the 1403 academic year.</i_keyword>
      <i_keyword>Control group: The control group continued their daily activities during this period without receiving any intervention. This group served as a baseline to compare the effects of the corrective exercises with the experimental group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance                                                                                                       and Ankle Proprioception. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (6 weeks after the intervention). Method of measurement: The Navicular Drop Test using Brody's method was performed to assess foot pronation, where a drop of more than 10 mm indicates pronation. In this method, the height of the navicular bone is measured in both a non-weight-bearing and a standing position, and the difference is recorded. Next, the Denis A Footprint Test was used to evaluate second-degree flatfoot. This test involves observing the footprint on a mirror box with the application of talcum powder for accuracy. Flatfoot is confirmed when the central and forefoot areas are of equal width, serving as the criterion for diagnosing the degree of flatfoot.                                                              Joint position sense:   Joint position sense was measured through passive and active reconstruction of previous positions. Non-weight-bearing tests were conducted to assess proprioception in inversion and plantar flexion as these movements often exceed the normal ankle range. Angles of 10° and 30° for plantar flexion and 5° and 20° for inversion were tested. Participants sat on a table with their ankles fixed, and the gyroscope was calibrated to reduce measurement errors. After training, participants repeated the target angles three times, and the mean difference was recorded as an absolute error.                                                       The Y test was performed to assess dynamic balance. The participant stood barefoot at the center of a grid with lines extending in anterior, posteromedial, and posterolateral directions. While keeping one foot in the center, they used the other foot to reach along the lines with the big toe. The test was repeated three times in each direction, and the maximum reach distance was recorded as the raw score. The raw score was divided by the leg length and multiplied by 100 to normalize the data. The average maximum reach distances in all directions were calculated as a percentage. Leg length was measured from the anterior superior iliac spine to the medial malleolus in a supine position.</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>Educational and Research Affairs, Hakim Nizami Qochan Institute of Higher Education</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-05</approval_date>
        <contact_name>Human Ethics Research Committee of the Sport Sciences Research Institute of Iran</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
