<?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>IRCT20230205057336N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-07</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of ankle joint mobilization and exercise therapy along with dry needling with ankle joint mobilization and exercise therapy on balance, range of motion, pain and function in patients with chronic ankle instability In Hamedan city: Randomized clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of ankle joint mobilization and exercise therapy along with dry needling with ankle joint mobilization and exercise therapy on balance, range of motion, pain and function in patients with chronic ankle instability In Hamedan city: Randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74498</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the randomizer software, 40 numbers are considered for each case and the software creates 10 blocks of 4 using permutation randomization, of which 2 people enter the first group and 2 people enter the second group. and it will be done in this way until number 40, Blinding description: In this study, the person who performs the evaluation is different from the person who performs the treatments. Also, data analysis is done by another person who is unaware of the evaluation and treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Ankle Instability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Ankle mobilization group and dry needling exercise therapy: patients in this group, in addition to ankle mobilization treatment exactly the same as the first group, dry needling for four sessions and once a week, for at least one of the peroneus longus, peroneus muscles Brevis, gastrocnemius and tibialis anterior will receive. Intervention 2: Control group: Ankle mobilization group and therapeutic exercise: joint mobilization will be done when the patient is lying in an open arch and the ankle is out of the edge of the bed. Then the ankle is placed in 20 degrees of plantar flexion so that the talocrural joint is in a loose-packed position. The stabilizer hand is placed above the ankles (to stabilize the leg), while the mobilizer hand grabs the talus with the first web, then the talus is given a 4-grade glide with downward force. Mobilization for the relevant groups will be held for three 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 After preparing and completing the data file it will be available to readers or other scientific people if needed</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Meftahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sadra Shahr Road - Behind Amirul Mominin (AS) Burn Accident Hospital - Shahid Doran Campus - Faculty of Rehabilitation Sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3212 2600</telephone>
        <email>meftahin@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Meftahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sadra Shahr Road - Behind Amirul Mominin (AS) Burn Accident Hospital - Shahid Doran Campus - Faculty of Rehabilitation Sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3212 2600</telephone>
        <email>meftahin@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with unilateral chronic ankle instability aged between 18-50 years
A history of at least one ankle sprain in the past 12 months with symptoms of inflammation that prevented activity for at least one day
At least three months have passed since the last ankle sprain.
People who have a feeling of instability or recurrent ankle sprains (two or more cases in one ankle) or ankle sprains (at least two cases in six months).
Trigger points in at least one of the muscles: Peroneus Longus, peroneus brevis, gastrocnemius and anterior tibialis
ankle instability scores 25 and less in Cumberland ankle instability tool
Foot and Ankle Ability Measurement questionnaire (FAAM) (Home scale&lt;90%, sport scale&lt;80%)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of any musculoskeletal surgery in any of the lower limbs
History of fractures in any of the lower limbs
Having diseases related to imbalance (people with peripheral neuropathy, MS, Parkinson's, migraine, radiculopathy and diseases related to the middle ear)
Individuals who received physical therapy and dry needling for pain from their CAI in the past 6 months
history of skeletal-muscular injuries in other joints of the lower limbs in the last three months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.373</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other instability, unspecified 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: Ankle mobilization group and dry needling exercise therapy: patients in this group, in addition to ankle mobilization treatment exactly the same as the first group, dry needling for four sessions and once a week, for at least one of the peroneus longus, peroneus muscles Brevis, gastrocnemius and tibialis anterior will receive.</i_keyword>
      <i_keyword>Control group: Ankle mobilization group and therapeutic exercise: joint mobilization will be done when the patient is lying in an open arch and the ankle is out of the edge of the bed. Then the ankle is placed in 20 degrees of plantar flexion so that the talocrural joint is in a loose-packed position. The stabilizer hand is placed above the ankles (to stabilize the leg), while the mobilizer hand grabs the talus with the first web, then the talus is given a 4-grade glide with downward force. Mobilization for the relevant groups will be held for three sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Before, immediately after and four weeks after the end of the intervention. Method of measurement: Modified star excursion balance test.</prim_outcome>
      <prim_outcome>Ankle dorsiflexion range of motion. Timepoint: Before, immediately after and four weeks after the end of the intervention. Method of measurement: weight bearing lung test.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before, immediately after and four weeks after the end of the intervention. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Function. Timepoint: Before, immediately after and four weeks after the end of the intervention. Method of measurement: Foot and Ability Measure questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of functional ankle instability. Timepoint: Before, immediately after and four weeks after the end of the intervention. Method of measurement: Cumberland Ankle Instability Tool (CAIT).</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-01</approval_date>
        <contact_name>Ethics committee in shiraz faculty of rehabilitation sciences research</contact_name>
        <contact_address>Sadra Shahr Road - Behind Amirul Mominin (AS) Burn Accident Hospital - Shahid Doran Campus - Faculty of Rehabilitation Sciences Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
