<?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>IRCT20201110049330N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-09</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of immediate and short-term use of two new Ankle-Foot- Orthosis on balance in stroke pations</public_title>
      <acronym>NAFO ( newly designed articulated ankle foot orthosis)</acronym>
      <scientific_title>Immediate and after 6 weeks effect of newly design articulated Ankle Foot Orthosis on postural control in static and dynamic conditions in drop foot post stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93896</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, participants will be randomly assigned to two equal groups using a simple lottery method. One group will receive the standard intervention (posterior leaf spring AFO) and the other group will receive the newly designed articulated AFO for a period of 6 weeks, Blinding description: This study utilizes a single-blind design. Due to the visual and physical nature of the ankle-foot orthoses and the type of intervention, blinding of the participants and the healthcare providers (the orthotist fitting the device) is not possible. However, the outcome assessor (the individual recording and extracting force plate data) will be blinded to the group allocation and the type of intervention. Additionally, the data collectors and the statistical analyst will be blinded to the group codes to minimize bias. Data will also be monitored by a Data Safety and Monitoring Committee.".</study_design>
      <phase>N/A</phase>
      <hc_freetext>stroke (hemiplegia) with drop foot.</hc_freetext>
      <i_freetext>Intervention group (Group 1): Using a standard ankle-foot orthosis (posterior leaf spring) for 6 weeks. new intervention (Group 2): Using a newly designed articulated ankle-foot orthosis for 6 weeks. Data from the condition before using the orthosis (wearing shoes only) will be considered as the control condition..</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 As the study is in the execution phase and data has not yet been collected, the decision regarding the sharing of individual participant data (IPD) is postponed until after the study is completed and the results are published</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Soltani Hanafi Por</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan, Research Square, Shahid Fahmideh Boulevard, Central Headquarters of University of Medical Sciences</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۷۳۶</zip>
        <telephone>+98 81 3131 0000</telephone>
        <email>nesa.soltani.hp@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Soltani Hanafi Por</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajoohesh Square, Hamadan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۷۳۶</zip>
        <telephone>+98 81 3131 0000</telephone>
        <email>nesa.soltani.hp@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 40 and65 years
weakness of ankle dorsiflexor muscles
at least 6 month since stroke onset
no involvement or problem in contralateral limb
ability to walk independent without an assistive device
daily use of Posterior Leaf Spring (pls) orthosis
absence of knee hyperflexion
No use of a cane on the unaffected side during walking (since a cane on the unaffected side affects the affected side)
Modified Ashworth Scale score of less than 2
Ability to follow and respond to instructions given by the examiner
Spasticity of plantar flexor muscles with a maximum grade of 2 based on the Modified Ashworth Scale</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of cardiovascular and pulmonary disease
Fixed contracture in the ankle, hip, and knee joints
Patients with knee hyperflexion
Presence of hammer toes5.
Patients with severe visual impairment6.
Individuals with very poor balance based on the Timed Up and Go (TUG) test</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G81.90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hemiplegia, unspecified affecting unspecified side</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (Group 1): Using a standard ankle-foot orthosis (posterior leaf spring) for 6 weeks. new intervention (Group 2): Using a newly designed articulated ankle-foot orthosis for 6 weeks. Data from the condition before using the orthosis (wearing shoes only) will be considered as the control condition.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Center of Pressure (COP) sway in anterior-posterior (AP) and medial-lateral (ML) directions, mean COP velocity, path length, and ellipse area. These parameters will be measured using a Kistler force plate (Model 9260AA) at 100 Hz at the Biomechanics Research Center of Sharif University of Technology. Timepoint: Measurements will be performed at two time points:1. Immediately after receiving the orthosis (baseline)2. After 6 weeks of continuous use of the orthosis (follow-up). Method of measurement: Center of Pressure (COP) parameters will be measured using a Kistler force plate (Model 9260AA) at a sampling frequency of 100 Hz at the Biomechanics Research Center of Sharif University of Technology. Raw data will be analyzed in MATLAB software after filtering with a Butterworth filter (cutoff frequency 10 Hz).</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-09-14</approval_date>
        <contact_name>Ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Central Headquarters of Hamadan University of Medical Sciences, Shahid Fahmideh Blvd., Research Sq., Hamadan Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
