<?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>IRCT20240309061219N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-05</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Core Exercises on Treatment of Ankle Sprain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Core Muscle Strengthening Exercise on Pain, Static and Dynamic Balance in Amateur Athletes with Sub-Acute Lateral Ankle Sprain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75905</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method is used for individual randomization through the Randomization.com site to randomize interventions on people, Blinding description: Patients are blinded in this study. In fact, they do not understand the type of treatment that is going to be done on them. Also, the assessor and data analyst in this study do not know the type of treatment applied to the patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Our study investigates the effect of strengthening the central muscles of the body on subacute external sprain of the ankle in amateur athletes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:This group will receive routine physiotherapy treatment plus core muscles strengthening exercises. Routine physiotherapy consists of pulsed ultrasound in the first two weeks for 10 minutes of pulse ultrasound with an intensity of 0.3 W/cm2, 30% duty cycle and 3 MHz frequency is used on the painful area of ​​the lateral ankle malleolus. In the second two weeks, ultrasound is used for 6 minutes and intensity of 0.5 W/cm2, duty cycle of 50% and frequency of 3 MHz. Also, high frequency TENS (frequency 120 Hz and pulse duration 50 microseconds for 30 minutes) and range of motion exercises(these exercises include plantar flexion, dorsiflexion, inversion and eversion of the ankle in a painless range and 3 sets and 20 repetitions in each set, which are performed every day) will also be used. In addition to these exercises,will recieve strengthening exercises of the core muscles.In order to strengthen the core muscles of the trunk, we ask the person to lie on the opposite side of the injured side on the bed, and let the trunk and upper limbs hang over the edge of the bed, so that the strengthened (injured) side is up. Then the person tries to move his shoulder towards the pelvis by contracting the lateral muscles of the trunk. The therapist must fix his pelvis and lower limb (slightly above the ankle). To start the exercise, the patient's upper hand is on the hip and the lower hand is on the upper shoulder, and if the muscle strength increases,it can make the exercise more difficult by placing the patient's upper and lower arms behind his back. Finally, to progress the exercise again, the patient can perform the movement while lying on the Swiss ball.  The person maintains the contraction for 15 to 30 seconds (depending on the person's strength) and does it 3 to 5 times a day. The next exercise is the side plank. At first, the person lies on the injured side on elbow and places the upper hand on the hip.While both knees are bent, he lifts the pelvis and trunk. To make the exercise more difficult at the same time as the muscle strength increases, he/she straightens the two knees and then lifts the trunk and pelvis. The person maintains both of these exercises between 10 and 60 seconds and performs between 3 and 5 times. The treatment of this group is done three sessions a week for 12 sessions. Intervention 2: Control group:This group will receive routine physiotherapy treatment.Routine physiotherapy consists of pulsed ultrasound in the first two weeks for 10 minutes of pulse ultrasound with an intensity of 0.3 W/cm2, 30% duty cycle and 3 MHz frequency is used on the painful area of ​​the lateral ankle malleolus. In the second two weeks, ultrasound is used for 6 minutes and intensity of 0.5 W/cm2, duty cycle of 50% and frequency of 3 MHz. Also, high frequency TENS (frequency 120 Hz and pulse duration 50 microseconds for 30 minutes) and range of motion exercises(these exercises include plantar flexion, dorsiflexion, inversion and eversion of the ankle in a painless range and 3 sets and 20 repetitions in each set, which are performed every day) will also be used.The treatment of this group is done three sessions a week for 12 sessions.</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 am making a decision at the moment. There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Hosseinzadeh Chaijan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.1, Somayeh street, Emam Blvd,Kelachay town</address>
        <city>Rudsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4491935651</zip>
        <telephone>+98 13 4268 5050</telephone>
        <email>Alirezahzch77@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Hosseinzadeh Chaijan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.1, Somayeh street, Emam Blvd,Kelachay town</address>
        <city>Rudsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4491935651</zip>
        <telephone>+98 13 4268 5050</telephone>
        <email>Alirezahzch77@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Amateur athletes between 18- 35 years old
Amateur athletes who exercise 2 to 4 hours a week
Grade 1 and 2 lateral ankle sprain that has been determined by an orthopedic specialist.
The injury happened between 5 and 14 days ago</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Grade 3 ankle sprain
Associated fracture of the lower extremities
Chronic ankle injuries and open ankle wounds
Painful medical syndrome, such as fibromyalgia, rheumatoid arthritis
Use of pain medication within 7 days prior to the study
Previous physical therapy intervention
Syndesmosis injuries or medial ligament injuries
Participants who had sensory defects (such as diabetes, previous nerve Injuries)
Serious disease (e.g. disease of CNS, hemophilia, cancer, kidney disease, liver disease)
Disability at doing side plunk for difference reasons</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:This group will receive routine physiotherapy treatment plus core muscles strengthening exercises. Routine physiotherapy consists of pulsed ultrasound in the first two weeks for 10 minutes of pulse ultrasound with an intensity of 0.3 W/cm2, 30% duty cycle and 3 MHz frequency is used on the painful area of ​​the lateral ankle malleolus. In the second two weeks, ultrasound is used for 6 minutes and intensity of 0.5 W/cm2, duty cycle of 50% and frequency of 3 MHz. Also, high frequency TENS (frequency 120 Hz and pulse duration 50 microseconds for 30 minutes) and range of motion exercises(these exercises include plantar flexion, dorsiflexion, inversion and eversion of the ankle in a painless range and 3 sets and 20 repetitions in each set, which are performed every day) will also be used. In addition to these exercises,will recieve strengthening exercises of the core muscles.In order to strengthen the core muscles of the trunk, we ask the person to lie on the opposite side of the injured side on the bed, and let the trunk and upper limbs hang over the edge of the bed, so that the strengthened (injured) side is up. Then the person tries to move his shoulder towards the pelvis by contracting the lateral muscles of the trunk. The therapist must fix his pelvis and lower limb (slightly above the ankle). To start the exercise, the patient's upper hand is on the hip and the lower hand is on the upper shoulder, and if the muscle strength increases,it can make the exercise more difficult by placing the patient's upper and lower arms behind his back. Finally, to progress the exercise again, the patient can perform the movement while lying on the Swiss ball.  The person maintains the contraction for 15 to 30 seconds (depending on the person's strength) and does it 3 to 5 times a day. The next exercise is the side plank. At first, the person lies on the injured side on elbow and places the upper hand on the hip.While both knees are bent, he lifts the pelvis and trunk. To make the exercise more difficult at the same time as the muscle strength increases, he/she straightens the two knees and then lifts the trunk and pelvis. The person maintains both of these exercises between 10 and 60 seconds and performs between 3 and 5 times. The treatment of this group is done three sessions a week for 12 sessions.</i_keyword>
      <i_keyword>Control group:This group will receive routine physiotherapy treatment.Routine physiotherapy consists of pulsed ultrasound in the first two weeks for 10 minutes of pulse ultrasound with an intensity of 0.3 W/cm2, 30% duty cycle and 3 MHz frequency is used on the painful area of ​​the lateral ankle malleolus. In the second two weeks, ultrasound is used for 6 minutes and intensity of 0.5 W/cm2, duty cycle of 50% and frequency of 3 MHz. Also, high frequency TENS (frequency 120 Hz and pulse duration 50 microseconds for 30 minutes) and range of motion exercises(these exercises include plantar flexion, dorsiflexion, inversion and eversion of the ankle in a painless range and 3 sets and 20 repetitions in each set, which are performed every day) will also be used.The treatment of this group is done three sessions a week for 12 sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamic balance in Y balance test. Timepoint: Before intervention, 2 ,4 weeks after intervention. Method of measurement: Y balance test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Static balance in balance error scoring system. Timepoint: Before intervention, 2 ,4 weeks after intervention. Method of measurement: Balance test error system scoring system.</sec_outcome>
      <sec_outcome>Pain. Timepoint: Before intervention, 2 ,4 weeks after intervention. Method of measurement: Short form of Mcgill Pain Questionnaire.</sec_outcome>
      <sec_outcome>Core muscle endurance. Timepoint: Before intervention, 2 ,4 weeks after intervention. Method of measurement: Mcgill isometric endurance test.</sec_outcome>
      <sec_outcome>Ankle function. Timepoint: Before intervention, 2 ,4 weeks after intervention. Method of measurement: Foot and Ankle Ability Measure.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before and 4 weeks after intervention. Method of measurement: World Health Organization Quality of Life Brief Version.</sec_outcome>
      <sec_outcome>General self-efficacy. Timepoint: Before and 4 weeks after intervention. Method of measurement: Schwartz's general self-efficacy questionnaire.</sec_outcome>
      <sec_outcome>Self-esteem. Timepoint: Before and 4 weeks after intervention. Method of measurement: Rosenberg self-esteem scale.</sec_outcome>
      <sec_outcome>Life expectancy. Timepoint: Before and 4 weeks after intervention. Method of measurement: Snyder Adult Hope Questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-06</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran, intersection of Keshavarz Blvd and Qods Street, Central Headquarters Building of Tehran University of Medical Sciences, fifth floor, room 501 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
