<?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>IRCT20241004063260N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-05</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparing Vibratory foam rolling and a stretching technique to improve ankle function and balance in female athletes with chronic ankle instability participating in high-impact sports</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effects of Vibratory Foam Rolling and PNF Stretching on Calf Muscles Flexibility, Active joint position sense, and Dynamic Balance in Female Athletes with Chronic Ankle Instability in High-Impact Sports</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>23</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92070</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization and Allocation:
Participants were randomly assigned to either the vibrating foam rolling group or the PNF stretching group. A computer-generated random sequence was produced using the "Randomizer" software. The unit of randomization was the individual participant, and no stratification was applied. Allocation concealment was ensured by keeping the group assignment hidden until the point of intervention.

Blinding:
To minimize bias, an assessor-blinded design was implemented. The researcher responsible for performing the functional and balance tests was blinded to the group allocation and the specific intervention received by each participant, Blinding description: A single-blind design (assessor-blinding method) was employed in this study. To implement this process, the interventions (vibrating foam rolling and PNF stretching) were administered by another individual, and the assessor (the researcher) was not present during the intervention sessions. Pre- and post-test evaluations were conducted by an assessor who was unaware of the specific intervention received by the participants. Furthermore, to prevent the disclosure of group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic ankle sprain.</hc_freetext>
      <i_freetext>Intervention 1: Vibratory Foam Roller (VFR): Participants received a single session of vibrating foam rolling intervention. The vibrating foam roller was applied to the gastrocnemius and soleus muscles. The intervention consisted of three 60-second sets with 30 seconds of rest between sets. Intervention 2: PNF stretch: Participants in this group received a PNF stretching session using the Contract-Relax technique. The intervention was performed on the posterior calf muscles (gastrocnemius and soleus) using a TheraBand. It included an isometric muscle contraction followed by passive stretching assisted by the TheraBand according to the study protocol.</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 The data-sharing plan has not yet been finalized. Any future sharing will comply with ethical requirements and participant confidentiality.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Yazdani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sadra City Road, Shahid Doran Campus, Faculty of Rehabilitation Sciences</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7198754361</zip>
        <telephone>+98 71 3212 2600</telephone>
        <email>yazdani_far@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Yazdani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Shahid Doran Campus, after Amir-al-momenin Burn Accident Hospital, Sadra Town Road</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7198754361</zip>
        <telephone>+98 71 3212 2600</telephone>
        <email>yazdani_far@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria were: participation in high‑impact sports (volleyball, basketball, futsal, kickboxing) ≥3 times/week;
at least one ankle sprain within the past year that caused limited activity for at least one day,
self-reported conscious instability in walking or running within the past year,
and a score of ≤25 points on the Cumberland Ankle Instability Tool (CAIT) questionnaire (total score of 30).</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria were joint hypermobility,
any lower‑limb neurovascular or musculoskeletal disorders (excluding ankle sprains),
or a history of head injury, back pain within the last 6 months
Other exclusion criteria included ankle fracture and Grade III ankle sprains requiring surgery
lower limb surgery within the past 12 months,
bone limitations,
vestibular or balance disorders, and neuropathies.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.37</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other instability, ankle and foot</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Vibratory Foam Roller (VFR): Participants received a single session of vibrating foam rolling intervention. The vibrating foam roller was applied to the gastrocnemius and soleus muscles. The intervention consisted of three 60-second sets with 30 seconds of rest between sets.</i_keyword>
      <i_keyword>PNF stretch: Participants in this group received a PNF stretching session using the Contract-Relax technique. The intervention was performed on the posterior calf muscles (gastrocnemius and soleus) using a TheraBand. It included an isometric muscle contraction followed by passive stretching assisted by the TheraBand according to the study protocol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Calf muscles flexibility: Ankle dorsiflexion range of motion was assessed as an indicator of ankle mobility and calf muscle flexibility. Timepoint: Measurements were performed at baseline (before each intervention session) and immediately after completion of each intervention session. Method of measurement: Ankle dorsiflexion ROM was measured using the Weight-Bearing Lunge Test. The maximum distance between the great toe and the wall while maintaining heel contact was recorded.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ankle proprioception (joint position sense) was assessed by measuring the repositioning error at target ankle joint angles. Timepoint: Measurements were performed at baseline (before each intervention session) and immediately after completion of each intervention session. Method of measurement: Joint position sense was measured using the Biodex System 4 Pro. Absolute repositioning error was recorded at target positions of 30° plantarflexion and 20° dorsiflexion.</sec_outcome>
      <sec_outcome>Dynamic balance was assessed as the ability to maintain postural control during multidirectional reaching tasks. Timepoint: Measurements were performed at baseline (before each intervention session) and immediately after completion of each intervention session. Method of measurement: Dynamic balance was measured using the Y-Balance Test. Maximum reach distances in anterior, posteromedial, and posterolateral directions were recorded and normalized to limb length.</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>2025-07-30</approval_date>
        <contact_name>Research Ethics Committees of Shiraz School of Rehabilitation Sciences</contact_name>
        <contact_address>Ethics Committee, Vice President for Research, School of Rehabilitation Sciences, Shahid Doran Campus, after Amir-al-momenin Burn Hospital, Sadra Town Road Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
