<?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>IRCT20210718051938N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-01</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>Effect of neuromuscular training on improving medial tibial stress syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Neuromuscular training program for treatment of male basketball players with medial tibial stress syndrome: emphasis on attentional focus and external cues in functional movement training.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57794</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Following the baseline examination, by using the method on the website http://randomizer.org participants are randomly assigned into the two experimental groups (neuromuscular training with an attentional focus), (therapeutic exercise), and control group. Simple randomization is used. Concealed allocation is performed using a computer generated block randomized table of numbers ( 1 and 2 for experimental groups and 3 for control group) created before the start of data collection by researcher who is not involved in the recruitment or treatment of patients. Then, the random numerical sequence is placed in sealed opaque envelope and processed with treatment according to the group assignment. A blinded outcome assessor who does not know the hypothesis and study methods, measures outcome at baseline, 6 weeks post-intervention, and 12 weeks follow-up, Blinding description: In this study, the outcome assessor was blind to the process of randomization and assignment of individuals into two experimental groups and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Medial tibial stress syndrome.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Benjaminse et al. (2015) training protocol will be used for the first intervention group. These exercises include eight different types of exercises, in each of which the feedback and verbal training appropriate to that exercise is given to the subjects before the exercise and also during the exercise. People will receive the necessary feedback during practice and will perform well. Feedback exercises include eight types of exercises,double-leg squat, single-leg squat, lunges (walking), double-leg drop jump, single-leg standing on an unstable plate, sidestep cutting maneuver, single-leg hop for distance, vertical jump, and Countermovement jump. During the exercises, the feedback instructions verbally and visually, using learning strategies, applied external attention to the subjects, and influenced their movements during the exercise. For example, in order to perform single-leg squat movements, subjects are asked to stand in front of a conical obstacle and slowly bend their legs in the direction of the cone while descending and bending their knees, focusing on the cone. External focus). Intervention 2: Second intervention group: Second intervention group: Exercises include 3 stages of release, stretching, and activation techniques. The subject is asked to participate in the main exercise program after warm-up, which includes release, stretching, and activation exercises. In the first phase, people will use release exercises using a foam roll focusing on the lateral gastrocnemius, peroneals, and biceps femoris (short head) muscles. Exercises with two high intensities (maximum pain tolerance) are performed in 30 seconds or low intensity (minimum pain tolerance) in 90 seconds. Stretching phase exercises are performed focusing on the gastrocnemius/soleus, and biceps femoris (short head). The intensity and volume of the exercises include 3 sets of 30 seconds. The third phase, the activation phase, will focus on increasing the strength of the anterior, posterior tibialis, and medial hamstring muscles. These exercises are performed with 10 to 15 repetitions and each repetition includes 1 to 2 seconds, maintaining isometric contraction at the end of the range of motion and 4 seconds maintaining extroverted contraction. Intervention 3: Control group: The control group will not receive any intervention and will perform their routine (basketball) exercises.</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:
Only data related to demographic and outcomes information is shared.

When:
After publishing the article / articles extracted from the study.

To whom:
The data can be displayed and shared at the reasonable request of the Iranian Clinical Trial Registration Center, journals and university individuals / researchers who are conducting research and scientific activities in this field.

Conditions:
Data analysis and use of documents can only be done provided that their results are presented in systematic review articles conducted by researchers and academic researchers. Necessary conditions for sending data and documents include: 1. Sending an email (preferably with valid university addresses) to one of the researchers of the study. 2. A brief and logical explanation of how to use the data or documents. 3. Ensuring the registration of the protocol Systematic review studies that have requested access to data or documentation.

Where to obtain:
Through requesting from Mojtaba Jahanshahi: Mojtaba-jahanshahi@yahoo.com
Amir Letafatkar: letafatkaramir@yahoo.com
Robert baker: rb415@comcast.net
Michael Fredericson: mfred2@stanford.edu

How to obtain:
The applicant can request details from the researchers within 7 to 14 days using the message sent by email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Letafatkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center for Human Movement Sciences Kharazmi University Mirdamad, South Razan Street, Hesari Street, Keshvari Sport Complex</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1571914911</zip>
        <telephone>+98 21 2222 1008</telephone>
        <email>letafatkaramir@yahoo.com</email>
        <affiliation>Kharazmi Univesity</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Letafatkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center for Human Movement Sciences Kharazmi University Mirdamad, South Razan Street, Hesari Street, Keshvari Sport Complex</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1571914911</zip>
        <telephone>+98 21 2222 1008</telephone>
        <email>letafatkaramir@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male basketball players between 18 and 35 years ages
For at least 3 weeks’ exercise, induced pain located on the posteromedial border of the tibia, palpation of the posteromedial border of the tibia that produces discomfort, will be diagnosed by experienced sports medicine.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a history of tibial fracture
Clinical suspicion of chronic compartment syndrome or stress fracture</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S86.89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other injury of other muscles and tendons at lower leg level</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: Benjaminse et al. (2015) training protocol will be used for the first intervention group. These exercises include eight different types of exercises, in each of which the feedback and verbal training appropriate to that exercise is given to the subjects before the exercise and also during the exercise. People will receive the necessary feedback during practice and will perform well. Feedback exercises include eight types of exercises,double-leg squat, single-leg squat, lunges (walking), double-leg drop jump, single-leg standing on an unstable plate, sidestep cutting maneuver, single-leg hop for distance, vertical jump, and Countermovement jump. During the exercises, the feedback instructions verbally and visually, using learning strategies, applied external attention to the subjects, and influenced their movements during the exercise. For example, in order to perform single-leg squat movements, subjects are asked to stand in front of a conical obstacle and slowly bend their legs in the direction of the cone while descending and bending their knees, focusing on the cone. External focus).</i_keyword>
      <i_keyword>Second intervention group: Second intervention group: Exercises include 3 stages of release, stretching, and activation techniques. The subject is asked to participate in the main exercise program after warm-up, which includes release, stretching, and activation exercises. In the first phase, people will use release exercises using a foam roll focusing on the lateral gastrocnemius, peroneals, and biceps femoris (short head) muscles. Exercises with two high intensities (maximum pain tolerance) are performed in 30 seconds or low intensity (minimum pain tolerance) in 90 seconds. Stretching phase exercises are performed focusing on the gastrocnemius/soleus, and biceps femoris (short head). The intensity and volume of the exercises include 3 sets of 30 seconds. The third phase, the activation phase, will focus on increasing the strength of the anterior, posterior tibialis, and medial hamstring muscles. These exercises are performed with 10 to 15 repetitions and each repetition includes 1 to 2 seconds, maintaining isometric contraction at the end of the range of motion and 4 seconds maintaining extroverted contraction.</i_keyword>
      <i_keyword>Control group: The control group will not receive any intervention and will perform their routine (basketball) exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Baseline, 6 weeks after intervention, 3, 6, and 12 months follow up. Method of measurement: How to measure a variable is using Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Function. Timepoint: Baseline, 6 weeks after intervention, 3, 6, and 12 months follow up. Method of measurement: How to measure a variable is using vertical jump.</sec_outcome>
      <sec_outcome>Muscle strength. Timepoint: Baseline, 6 weeks after intervention, 3, 6, and 12 months follow up. Method of measurement: How to measure a variable is using Biodex System isokinetic.</sec_outcome>
      <sec_outcome>Kinematic. Timepoint: Baseline, 6 weeks after intervention, 3, 6, and 12 months follow up. Method of measurement: How to measure a variable is using Visual3D software (C-motion Inc, Germantown).</sec_outcome>
      <sec_outcome>Kinetic, Tibia acceleration and Time to Stabilization. Timepoint: Baseline, 6 weeks after intervention, 3, 6, and 12 months follow up. Method of measurement: How to measure a variable is using Two three-axis force plates (AMTI model) in vertical, anterior-posterior, and medial-lateral.</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>No governmental fund has been received for this study, and it is conducted by researchers.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-21</approval_date>
        <contact_name>Sport Sciences Research Institute</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
