<?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>IRCT20230528058315N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-12</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The immediate effect of the novel spring-damper ankle-foot orthosis on margin of stability of affected and unaffected limbs during walking of patients diseased to MS</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the immediate effect of the novel spring-damper ankle-foot orthosis on margin of stability of affected and unaffected limbs during walking of patients diseased to multiple sclerosis with drop foot</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85206</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention group: Each participant will be evaluated under two conditions: wearing shoes on both sides, and wearing a shoe on the unaffected side along with the new spring-damper orthosis on the affected side, with the evaluation order randomized and a 5-minute rest period between conditions. Kinematic assessment will involve evaluating center of mass (COM) displacement velocity by tracking a sacral marker using a Vicon motion analysis system equipped with six infrared cameras recording at 120 Hz, while two Kistler force plates sampling at 1200 Hz will be used to assess plantar center of pressure (COP) and COM, with synchronized data collection from both the motion capture system and force plates, all conducted at the Mofaghian Research Center in Tehran. There is no control group..</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ensieh Pourhoseingholi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838840</zip>
        <telephone>+98 81 3838 1571</telephone>
        <email>ensihphd@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Tafti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838840</zip>
        <telephone>+98 81 3838 1571</telephone>
        <email>Na.Tafti@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adults with unilateral foot drop caused by multiple sclerosis
Ability to walk at least 25 steps without assistance
Ability to complete at least 25 steps within a duration of 8 to 45 seconds
Maximum grade of 3- (minus) in the manual muscle strength test for dorsiflexors and grade 3+ (plus) in knee extensor muscles
Ability to walk without orthoses for up to ten meters
Ability to achieve at least 5 degrees of passive dorsiflexion
Completion of the Four Square Step Test (FSST) in less than 15 seconds</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having cardiovascular or respiratory problems
Presence of limb impairment or amputation on the opposite side
Concurrent use of other treatment methods (e.g., physiotherapy or surgery) during the study
Having perceptual-cognitive impairments
Presence of polyneuropathy
Instability and imbalance while standing or walking
Severe visual or hearing impairment
History of spinal fracture or pain
Participant's unwillingness to continue cooperation
Absence of spasticity greater than grade 3 in the plantar flexor muscles (according to the Ashworth scale)
scoring less than 5 on the disability scale</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Each participant will be evaluated under two conditions: wearing shoes on both sides, and wearing a shoe on the unaffected side along with the new spring-damper orthosis on the affected side, with the evaluation order randomized and a 5-minute rest period between conditions. Kinematic assessment will involve evaluating center of mass (COM) displacement velocity by tracking a sacral marker using a Vicon motion analysis system equipped with six infrared cameras recording at 120 Hz, while two Kistler force plates sampling at 1200 Hz will be used to assess plantar center of pressure (COP) and COM, with synchronized data collection from both the motion capture system and force plates, all conducted at the Mofaghian Research Center in Tehran. There is no control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Margin of stability. Timepoint: After 5 minutes adaptation with orthosis. Method of measurement: Viacon motion analysis system and Kistler force plate.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stride length. Timepoint: Immediately after receiving the orthosis. Method of measurement: Viacon Motion Analysis System.</sec_outcome>
      <sec_outcome>Stride width. Timepoint: Immediately after receiving the orthosis. Method of measurement: Viacon Motion Analysis System.</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>2025-07-26</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Shahid Fahmideh Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
