<?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>IRCT20190715044216N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-09</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>COMPARISON OF THRUST MANIPULATION AND NON-THRUST MOBILIZATION TECHNIQUE ON PAIN AND FUNCTION IN ATHLETES WITH CHRONIC ANKLE SPRAIN.</public_title>
      <acronym></acronym>
      <scientific_title>COMPARISON OF THRUST MANIPULATION AND NON-THRUST MOBILIZATION TECHNIQUE ON PAIN AND FUNCTION IN ATHLETES WITH CHRONIC ANKLE SPRAIN.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60888</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to aforementioned inclusion and exclusion criteria, participants were recruited and requested to take part in the study. Participants will fill written informed consent which is in both English and Urdu. Total 16 participant will be recruited in the study. The subjects will be randomly assigned into two groups A &amp; B with each containing 8 subjects according to their selection by lottery method. There will be 16 slips marking with Group A on 8 slips &amp; Group B on other 8 slips in the box. Each participant will be requested to randomly pick up a slip from the box. Slips which will be picked by the participant would not be put back in the box.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic Ankle Sprain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:                                                                                                                        Treatment method will be thrust manipulation which will include the following techniques.                                                                                                                                        Technique 1: Proximal tibiofibular joint: high-velocity manual intervention.                                                           Description of Technique; The therapist placed his second MCP in the popliteal fossa, then pulled the soft tissue laterally until the MCP was firmly stabilized behind the patient’s fibular head. The therapist used the left hand to grasp the foot and ankle. The therapist externally rotated the leg and flexed the knee to the restrictive barrier. Once the restrictive barrier was met, the therapist applied a high-velocity, low-amplitude force through the tibia (directing the patient’s heel toward his ipsilateral buttock).                                                                                                                                                       Technique 2: Distraction high-velocity manual physical therapy intervention.                                                       Description of Technique: The therapist grasped the dorsum of the patient’s foot with interlaced fingers. Firm pressure with both thumbs was applied in the middle of the plantar surface of the forefoot. The therapist engaged the restrictive barrier by passively dorsiflexing the ankle and applying a long-axis distraction. The therapist pronated and dorsiflexed the foot to fine tune the barrier. The therapist applied a high-velocity, low amplitude force in a caudal direction.                                                          Technique 3: Talo-crural joint distraction thrust manipulation technique.                                                                       Tool/Questionnaire: FAAM, NPRS and GRoC.                                                                                            Participants: 8                                                                                                                                             Duration of study: 6 months                                                                                                                            Frequency: Duration treatment will be 8 weeks (3 sessions per week and each session for 30 min) under the direct supervision of the therapist. Intervention 2: Intervention group 2                                                                                                                                                  Treatment method will be Non-Thrust mobilization which will include the following techniques.                                                                                                                                        Technique 1:  Talocrural joint: anterior-to-posterior low-velocity manual physical therapy intervention. Description of Technique: The therapist used the left hand to firmly stabilize the lower leg at the malleoli. The therapist grasped the anterior, medial, and lateral talus with the right hand. The therapist applied a low-velocity, anterior to posterior oscillatory force to the talus. Tip: the therapist used the thigh to help stabilize the foot and to progressively increase the amount of ankle dorsiflexion. The therapist may need to adjust the amount of supination/pronation to optimize the technique. Technique 2: Weight-bearing talocrural joint: anterior-to-posterior low-velocity manual physical therapy intervention.                                                                                                                       Description of Technique: The therapist supported the arch of the foot and applied a stabilizing force (anterior-to-posterior-directed force) over the anterior talus. A belt (padded) was placed over the patient’s distal posterior tibia and fibula and around the therapist’s buttock region. The patient was guided into dorsiflexion of the involved ankle while, simultaneously, the therapist applied a posterior-to-anterior-directed force to the distal leg by leaning backward/pulling on the belt. As the patient dorsiflexes more, the therapist should squat down while leaning back to keep a direct posterior to anterior force at the talocrural joint (therefore following the plane of the joint).                         Technique 3: Lateral glides and eversion: low velocity manual intervention.                            Description of Technique: Talocrural joint lateral glide: the therapist grasped the malleoli just proximal to the talocrural joint with the left index finger/thumb and used the forearm to stabilize the patient’s left leg against the table. The therapist placed the right thenar eminence on the talus just distal to the malleoli and grasped the rearfoot. The therapist used his body to impart a low-velocity oscillatory force to the talus through the right arm and thenar eminence. Subtalar joint lateral glide: the therapist shifted the left hand/forearm distally and grasped the talus with the left index finger/thumb. The therapist placed his right thenar eminence on the patient’s medial aspect of the calcaneus and grasped the rearfoot. The therapist used his body to impart a low-velocity oscillatory force to the calcaneus through the right arm and thenar eminence.                                                         Tool/Questionnaire: FAAM, NPRS and GRoC.                                                                                            Participants: 8                                                                                                                                             Duration of study: 6 months                                                                                                                            Frequency: Duration treatment will be 8 weeks (3 sessions per week and each session for 30 min) under the direct supervision of the therapist.</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:
COMPARISON OF THRUST MANIPULATION AND NONTHRUST MOBILIZATION TECHNIQUE ON PAIN AND FUNCTION IN ATHLETES WITH CHRONIC ANKLE SPRAIN.

When:
The data will become available after the completion of the study. It will take take up to six months

To whom:
People working in academic institutions

Conditions:
Author will review the request

Where to obtain:
sohaibtahir14@yahoo.com

How to obtain:
Request will be entertained through email after which people working in academic institutions will be granted access

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Naveed Anwar, PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrah-e-aiwane Tijarat, Opp. Governor House, Lahore.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 321 4568429</telephone>
        <email>naveedanwar982@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Naveed Anwar Pt</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrah-e-aiwane Tijarat, Opp. Governor House, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 321 4568429</telephone>
        <email>naveedanwar982@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Athletes with Ankle sprain &gt; 6 weeks; grade 1 or grade 2 ankle sprain, as defined by the West Point Ankle Sprain Grading System Subjects
Between age 16-40 years old Athletes.
Positive Ankle Stress Test:                                                                                                               a)	Anterior talofibular ligament: Plantar flexion – inversion                                                       b)	Calcaeno-fibular ligament: Neutral position – inversion.                                                        c)	Posterior talofibular ligament: Dorsiflexion – inversion.                                                        d)	Deltoid ligament: Plantar flexion – eversion
4.	Have a numeric pain rating scale (NPRS) score greater than 3/10 in the last week.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Exhibited contraindications to manual therapy.
Exclusion criteria were red flags noted in the patient’s medical screening questionnaire (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, or severe vascular disease).
Other exclusions included prior surgery to the distal tibia, fibula, ankle joint, or rear foot region (proximal to the base of the metatarsals); fracture; grade III ankle sprain (as defined by the West Point Ankle Sprain Grading System) fracture, or other absolute contraindications to manual therapy.
Recurrent ankle sprain.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S93.409</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of unspecified ligament of unspecified ankle</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 1:                                                                                                                        Treatment method will be thrust manipulation which will include the following techniques.                                                                                                                                        Technique 1: Proximal tibiofibular joint: high-velocity manual intervention.                                                           Description of Technique; The therapist placed his second MCP in the popliteal fossa, then pulled the soft tissue laterally until the MCP was firmly stabilized behind the patient’s fibular head. The therapist used the left hand to grasp the foot and ankle. The therapist externally rotated the leg and flexed the knee to the restrictive barrier. Once the restrictive barrier was met, the therapist applied a high-velocity, low-amplitude force through the tibia (directing the patient’s heel toward his ipsilateral buttock).                                                                                                                                                       Technique 2: Distraction high-velocity manual physical therapy intervention.                                                       Description of Technique: The therapist grasped the dorsum of the patient’s foot with interlaced fingers. Firm pressure with both thumbs was applied in the middle of the plantar surface of the forefoot. The therapist engaged the restrictive barrier by passively dorsiflexing the ankle and applying a long-axis distraction. The therapist pronated and dorsiflexed the foot to fine tune the barrier. The therapist applied a high-velocity, low amplitude force in a caudal direction.                                                          Technique 3: Talo-crural joint distraction thrust manipulation technique.                                                                       Tool/Questionnaire: FAAM, NPRS and GRoC.                                                                                            Participants: 8                                                                                                                                             Duration of study: 6 months                                                                                                                            Frequency: Duration treatment will be 8 weeks (3 sessions per week and each session for 30 min) under the direct supervision of the therapist.</i_keyword>
      <i_keyword>Intervention group 2                                                                                                                                                  Treatment method will be Non-Thrust mobilization which will include the following techniques.                                                                                                                                        Technique 1:  Talocrural joint: anterior-to-posterior low-velocity manual physical therapy intervention. Description of Technique: The therapist used the left hand to firmly stabilize the lower leg at the malleoli. The therapist grasped the anterior, medial, and lateral talus with the right hand. The therapist applied a low-velocity, anterior to posterior oscillatory force to the talus. Tip: the therapist used the thigh to help stabilize the foot and to progressively increase the amount of ankle dorsiflexion. The therapist may need to adjust the amount of supination/pronation to optimize the technique. Technique 2: Weight-bearing talocrural joint: anterior-to-posterior low-velocity manual physical therapy intervention.                                                                                                                       Description of Technique: The therapist supported the arch of the foot and applied a stabilizing force (anterior-to-posterior-directed force) over the anterior talus. A belt (padded) was placed over the patient’s distal posterior tibia and fibula and around the therapist’s buttock region. The patient was guided into dorsiflexion of the involved ankle while, simultaneously, the therapist applied a posterior-to-anterior-directed force to the distal leg by leaning backward/pulling on the belt. As the patient dorsiflexes more, the therapist should squat down while leaning back to keep a direct posterior to anterior force at the talocrural joint (therefore following the plane of the joint).                         Technique 3: Lateral glides and eversion: low velocity manual intervention.                            Description of Technique: Talocrural joint lateral glide: the therapist grasped the malleoli just proximal to the talocrural joint with the left index finger/thumb and used the forearm to stabilize the patient’s left leg against the table. The therapist placed the right thenar eminence on the talus just distal to the malleoli and grasped the rearfoot. The therapist used his body to impart a low-velocity oscillatory force to the talus through the right arm and thenar eminence. Subtalar joint lateral glide: the therapist shifted the left hand/forearm distally and grasped the talus with the left index finger/thumb. The therapist placed his right thenar eminence on the patient’s medial aspect of the calcaneus and grasped the rearfoot. The therapist used his body to impart a low-velocity oscillatory force to the calcaneus through the right arm and thenar eminence.                                                         Tool/Questionnaire: FAAM, NPRS and GRoC.                                                                                            Participants: 8                                                                                                                                             Duration of study: 6 months                                                                                                                            Frequency: Duration treatment will be 8 weeks (3 sessions per week and each session for 30 min) under the direct supervision of the therapist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Active Daily Living. Timepoint: Pre-Readings than post-readings after 8 weeks. 24 treatment sessions (3 sessions a week) will be given to the subjects. Method of measurement: FAAM, Foot and Ankle Ability measure.</prim_outcome>
      <prim_outcome>Physical Therapy outcomes. Timepoint: Pre-Readings than post-readings after 8 weeks. 24 treatment sessions (3 sessions a week) will be given to the subjects. Method of measurement: GRoC, Global Rating of Change.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Pre-Readings than post-readings after 8 weeks. 24 treatment sessions (3 sessions a week) will be given to the subjects. Method of measurement: NPRS, Numeric Pain Rating Scale.</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>Riphah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-14</approval_date>
        <contact_name>Ethical committee of Riphah College pf Rehabilitation and Allied Health Sciences Faculty of Rehabili</contact_name>
        <contact_address>Riphah International University, Quaid-e-Azam campus, 28-M Quaid e Azam Industrial Estate, Kot Lakhpat, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
