<?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>IRCT20250503065584N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-07</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rehabilitation on gait symmetry and regularity</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supervised rehabilitation on gait symmetry and regularity after acute ankle sprain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83292</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>acute ankle sprain.</hc_freetext>
      <i_freetext>Intervention Group:In this study, the intervention consists of supervised ankle rehabilitation. Supervised ankle rehabilitation refers to the use of electrotherapy and exercise therapy based on current guidelines. The rehabilitation program will be conducted over 10 sessions (approximately 3 sessions per week). The duration of electrotherapy in each session will range from 15 to 30 minutes (using TENS current). Each intervention session, which includes both electrotherapy and exercise therapy, will last between 1.5 to 2 hours.In general, the exercise therapy includes strengthening, neuromuscular, range of motion, and balance exercises. Strengthening exercises for the muscles surrounding the ankle will be performed using resistance bands of varying levels. Balance and proprioception training will be carried out using a balance board and other equipment..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is We do not have ethical approval for this purpose.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Melika Shameli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dormitory of Golestan, School of Rehabilitation Sciences, Madadkaran Street, Shah Nazari Street, Madar Square, Mirdamad, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2225 6434</telephone>
        <email>shamelimelika@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ali Sanjari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Madadkaran Street, Shah Nazari Street, Madar Square, Mirdamad, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>sanjarima@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged between 18 and 50 years
Patients with Grade 1 or 2 ankle sprain
Patients with an acute ankle sprain, meaning the injury occurred between 7 days and 1 month ago
Presence of symptoms such as swelling or pain on the lateral side of the ankle, limited ankle range of motion, and tenderness over the lateral ligaments
Minimum literacy level, with the ability to read and write at least at a middle school level</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with syndesmotic injury in addition to the ankle sprain.
Patients with a history of surgery or fracture in the lower limbs within the past year.
Patients who had sustained an acute injury to the musculoskeletal structures of other lower limb joints within the past three months that affected joint integrity and function—such as a sprain or fracture—and had missed at least one day of their usual physical activity.
Patients with neurological disorders such as stroke, multiple sclerosis (MS), or neuropathy.
Individuals who had experienced an ankle sprain within the past 12 months.

In the treatment of ankle sprains, initial protection is typically provided for one to two weeks, followed by the use of bandages or tape, which does not interfere with our study. However, patients using foot or ankle orthoses were excluded from the study.</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>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group:In this study, the intervention consists of supervised ankle rehabilitation. Supervised ankle rehabilitation refers to the use of electrotherapy and exercise therapy based on current guidelines. The rehabilitation program will be conducted over 10 sessions (approximately 3 sessions per week). The duration of electrotherapy in each session will range from 15 to 30 minutes (using TENS current). Each intervention session, which includes both electrotherapy and exercise therapy, will last between 1.5 to 2 hours.In general, the exercise therapy includes strengthening, neuromuscular, range of motion, and balance exercises. Strengthening exercises for the muscles surrounding the ankle will be performed using resistance bands of varying levels. Balance and proprioception training will be carried out using a balance board and other equipment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Step regularity based on trunk acceleration. Timepoint: Before the intervention and immediately after the tenth session of supervised ankle rehabilitation. Method of measurement: The Phyphox software installed on the mobile phone.</prim_outcome>
      <prim_outcome>Stride regularity based on trunk acceleration. Timepoint: Before the intervention and immediately after the tenth session of supervised ankle rehabilitation. Method of measurement: The Phyphox software installed on the mobile phone.</prim_outcome>
      <prim_outcome>Gait symmetry based on trunk acceleration. Timepoint: Before the intervention and immediately after the tenth session of supervised ankle rehabilitation. Method of measurement: The Phyphox software installed on the mobile phone.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-14</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology, Central Headquarters Building, Iran University of Medical Sciences, Hemmat Expressway, next to Milad Tower, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
