<?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>IRCT20210205050256N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-19</date_registration>
      <primary_sponsor>TIMES Institute</primary_sponsor>
      <public_title>Effectiveness of Kinesio Taping versus Mulligan's Mobilization with Movement in Sub-acute Lateral Ankle Sprain in Footballers</public_title>
      <acronym>KTvMWMLAS</acronym>
      <scientific_title>Effectiveness of Kinesio Taping versus Mulligan's Mobilization with Movement in Sub-acute Lateral Ankle Sprain in Footballers – A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70235</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Non-probability, convenient sampling will be used. Subjects will be randomly distributed to two groups using the lottery method of randomization. Slips will be prepared from 1 to 30. They will be homogeneous in shape, color, and size etc. Furthermore, they will be shuffled and placed in a box. The selected 15 slips will be allocated to Group 1, who will receive kinesiotaping with conventional physical therapy, and the other 15 will be allocated to Group 2, who will receive Mulligan’s mobilization with movement with conventional physical therapy, Blinding description: Every patient will be assessed by independent assessor at the start and end of total treatment sessions to keep the assessment unbiased.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ankle sprain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Kinesio Taping with Conventional Physical Therapy: 1st Session: 1. Lymphatic correction approach for the lateral ankle:Requirement: 1 Kinesio Fan strip (5-Strip cut) Position of the subject: Long sitting or supine lying with the lower leg extended and the ankle in plantar flexion (Stretch position) .Protocol: The lymph node on the lateral side of the ankle joint area to which lymph drainage is being directed should be placed just above the base of the fan incision. Apply the fan's tail over the edematous area with zero to very little tension (0–15 percent available).2. Application for Achilles tendon correction: Requirement: 1 Kinesio Y strip. Position of the subject: Lower leg pronated lying outside the plinth. Protocol: At the heel, apply the tape end without applying tension. Hold the tape end to make sure that there won't be any tension on the tape's base. With the patient stretched out, apply moderate to severe tension (50–75%) along the length of the tendon. Keep in mind to relax the muscles around your muscle belly. Slide the hand holding the base up to the position of maximum tension. Apply the tape's base or tails with the proper amount of tension for insertion at the origin.2nd and 3rd Session:1. Application for tibialis anterior muscle: Requirement: 1 Kinesio Y strip. Position of the subject: Supine lying with the affected lower leg out of the plinth. Protocol: The little toe's plantar area receives the base of the Y-strip application. The tail and the lateral malleolus are then placed along the muscle's path till the head of the fibula. This insert-to-origin technique uses paper-off or very light-to-light tension (between 15 and 25 percent of the available). 2. Application for peroneus longus and brevis muscle: Requirement: 1 Kinesio Y strip.Position of the subject: Supine lying with the affected lower leg out of the plinth. Protocol: The base of the heel is covered by the base of Y strip. Both the tail and the muscle's path stop at the lateral aspect of the tibia. The tail passes anteriorly to the lateral malleolus. This insert-to-origin technique uses paper-off or very light-to-light tension (between 15 and 25 percent of the available).However, this group was also given conventional treatment, which was a hot pack for 10 minutes and ankle isometrics to maintain blood circulation and muscle strength. Therapeutic ultrasound therapy was also applied. The experimental results suggest the following parameters: Frequency: 1 MHz, Intensity: 1.5 W/cm2, Duration: 10 minutes, and Mode: Continuous. There were three sessions in total. Intervention 2: Intervention group: Mulligan’s Mobilization with Movement with Conventional Physical Therapy: Position of the subject: A Mulligan's mobilization belt (non-elastic seatbelt) will be applied over the patient's pelvis, distal tibia, and fibula, with foam padding the Achilles tendon, while the patient is in a relaxed stance on a bench. Hand placement: With one hand's web space, stabilize the talus and forefoot near the anterior joint line. To ensure a constant alignment of the distal leg and foot, the other hand will be placed anteriorly over the proximal tibia and fibula to guide the knee over the second and third toes.Application of the technique: During slow active dorsiflexion to the end of the pain-free range, the therapist translated backward, applying tension to the seatbelt and causing a posteroanterior tibial glide. The seat belt was maintained perpendicular to the long axis of the tibia throughout the movement, and it was released after returning to the starting position.Total number of glide: 10 Repetition per set, 3 sets per session, with 1 minute rest between the sets.This group also received conventional treatment, which was a hot pack for 10 minutes and ankle isometrics to maintain blood circulation and muscle strength. Therapeutic ultrasound therapy was also applied. The experimental results suggest the following parameters: Frequency: 1 MHz, Intensity: 1.5 W/cm2, Duration: 10 minutes, and Mode: Continuous. There were three sessions in total.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Samraiz Mughal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Main Boulevard, Peer Khursheed Colony, Multan.</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66666</zip>
        <telephone>+92 321 7676790</telephone>
        <email>drsamraiz@gmail.com</email>
        <affiliation>TIMES Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Samraiz Mughal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Main Boulevard, Peer Khursheed Colony, Multan.</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66666</zip>
        <telephone>+92 321 7676790</telephone>
        <email>drsamraiz@gmail.com</email>
        <affiliation>TIMES Institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 13 to 17 years
Male athletes
More than two years’ participation in football career
History of recurrent ankle sprain with the average of six (five) months since their last sprain
Feeling of ankle instability during training</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>17 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Current assisted ambulation
Acute ankle trauma occurring within 7 days of injury incident
Medial ankle instability
Grade III ankle sprains
A sprain sustained in the previous 12 months
Connective tissue disorder
Inability to bear weight through the affected extremity immediately after injury
Chronic ankle injury on the contralateral side</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S93.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of ankle</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: Kinesio Taping with Conventional Physical Therapy: 1st Session: 1. Lymphatic correction approach for the lateral ankle:Requirement: 1 Kinesio Fan strip (5-Strip cut) Position of the subject: Long sitting or supine lying with the lower leg extended and the ankle in plantar flexion (Stretch position) .Protocol: The lymph node on the lateral side of the ankle joint area to which lymph drainage is being directed should be placed just above the base of the fan incision. Apply the fan's tail over the edematous area with zero to very little tension (0–15 percent available).2. Application for Achilles tendon correction: Requirement: 1 Kinesio Y strip. Position of the subject: Lower leg pronated lying outside the plinth. Protocol: At the heel, apply the tape end without applying tension. Hold the tape end to make sure that there won't be any tension on the tape's base. With the patient stretched out, apply moderate to severe tension (50–75%) along the length of the tendon. Keep in mind to relax the muscles around your muscle belly. Slide the hand holding the base up to the position of maximum tension. Apply the tape's base or tails with the proper amount of tension for insertion at the origin.2nd and 3rd Session:1. Application for tibialis anterior muscle: Requirement: 1 Kinesio Y strip. Position of the subject: Supine lying with the affected lower leg out of the plinth. Protocol: The little toe's plantar area receives the base of the Y-strip application. The tail and the lateral malleolus are then placed along the muscle's path till the head of the fibula. This insert-to-origin technique uses paper-off or very light-to-light tension (between 15 and 25 percent of the available). 2. Application for peroneus longus and brevis muscle: Requirement: 1 Kinesio Y strip.Position of the subject: Supine lying with the affected lower leg out of the plinth. Protocol: The base of the heel is covered by the base of Y strip. Both the tail and the muscle's path stop at the lateral aspect of the tibia. The tail passes anteriorly to the lateral malleolus. This insert-to-origin technique uses paper-off or very light-to-light tension (between 15 and 25 percent of the available).However, this group was also given conventional treatment, which was a hot pack for 10 minutes and ankle isometrics to maintain blood circulation and muscle strength. Therapeutic ultrasound therapy was also applied. The experimental results suggest the following parameters: Frequency: 1 MHz, Intensity: 1.5 W/cm2, Duration: 10 minutes, and Mode: Continuous. There were three sessions in total.</i_keyword>
      <i_keyword>Intervention group: Mulligan’s Mobilization with Movement with Conventional Physical Therapy: Position of the subject: A Mulligan's mobilization belt (non-elastic seatbelt) will be applied over the patient's pelvis, distal tibia, and fibula, with foam padding the Achilles tendon, while the patient is in a relaxed stance on a bench. Hand placement: With one hand's web space, stabilize the talus and forefoot near the anterior joint line. To ensure a constant alignment of the distal leg and foot, the other hand will be placed anteriorly over the proximal tibia and fibula to guide the knee over the second and third toes.Application of the technique: During slow active dorsiflexion to the end of the pain-free range, the therapist translated backward, applying tension to the seatbelt and causing a posteroanterior tibial glide. The seat belt was maintained perpendicular to the long axis of the tibia throughout the movement, and it was released after returning to the starting position.Total number of glide: 10 Repetition per set, 3 sets per session, with 1 minute rest between the sets.This group also received conventional treatment, which was a hot pack for 10 minutes and ankle isometrics to maintain blood circulation and muscle strength. Therapeutic ultrasound therapy was also applied. The experimental results suggest the following parameters: Frequency: 1 MHz, Intensity: 1.5 W/cm2, Duration: 10 minutes, and Mode: Continuous. There were three sessions in total.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: Numeric Pain Rating Scale (NPRS).</prim_outcome>
      <prim_outcome>Function. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Foot and Ankle Ability Measure (FAAM).</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>TIMES Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-09</approval_date>
        <contact_name>Institutional Review Board</contact_name>
        <contact_address>Street 6 Khanewall road hasanabad gate one opposite zic petrol pump, Multan Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
