<?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>IRCT20200915048725N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-03</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of a Newly Designed Orthosis on the Hallux Valgus Deformity</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of a Newly Designed Orthosis with the Capability of Neuromuscular Electrical Stimulation on the Morphology and Strength of Abductor Hallucis Muscle and Correction of Deformity in  Women with Mild to Moderate Hallux Valgus Deformity</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50957</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hallux Valgus Deformity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group will use the newly designed orthosis with the capability of neuromuscular electrical stimulation for four weeks. Electrical stimulation will be performed based on the schedule for 3 weeks and three times a week. From the middle of the third week, with the gradual exclusion of electrical stimulation, therapeutic exercise will be performed until the end of the fourth week. This is a toe spread out exercise that has three phases and greatly contracts the abductor hallucis muscle. This exercise will be done twice a day for 15 minutes. Clinical evaluations and MRI will be performed before and after treatment. Then the combination of orthosis and exercise therapy will continue for only three months and clinical evaluations will be repeated at the end of 3 months. Intervention 2: Control group: This group will use the newly designed orthosis for four weeks without the capability of neuromuscular electrical stimulation. Therapeutic training will begin in the middle of the third week and will continue until the end of the fourth week. In this group also clinical evaluations and MRI will be performed before and after treatment. Then the combination of orthosis and exercise therapy will continue for only three months and clinical evaluations will be repeated at the end of 3 months.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Shah Nazari St, Madadkaran St, Mother Sq, Mirdamad Blv. Postal Code: 1545913487</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 0947</telephone>
        <email>marjalali@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Shah Nazari St, Madadkaran St, Mother Sq, Mirdamad Blv. Postal Code: 1545913487</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 0947</telephone>
        <email>marjalali@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Bilateral or One Sided Hallux Valgus Deformity at Mild or Moderate Severity
1-10 Score Based on Beck Depression Questionnaire
Age Between 19–44 Years
No Rigid Flat Foot and Foot Posture Index (FPI) above 9
History of Pain only in the First Metatarsophalangeal Joint for at least One Month
Conscious Consent of Participants
Accept Study Conditions (for example: Not Wearing Inappropriate Shoes)
Do not Have any Metal Parts on the Foot (Such as Artificial Joints or Any Type of Metal Plate and Bolts) for Magnetic Resonsnce Imaging (MRI)
No History of Orthosis Treatment for Hallux Valgus Deformity</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>44 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of Foot Surgery
Body Mass Index of 30 or more or Very High Weight (100 kg and above)
History of Systemic Diseases Like Rheumatoid Arthritis, Diabetes, Gout, Leprosy; Neurological Disorders and Dislocation and Fracture of Metatarsophalangeal Joints
Experience pain Somewhere other than the First Metatarsophalangeal Joint. For Example, People with Symptomatic Flat Feet and Heel Pain</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M20.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hallux valgus (acquired), unspecified foot</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This group will use the newly designed orthosis with the capability of neuromuscular electrical stimulation for four weeks. Electrical stimulation will be performed based on the schedule for 3 weeks and three times a week. From the middle of the third week, with the gradual exclusion of electrical stimulation, therapeutic exercise will be performed until the end of the fourth week. This is a toe spread out exercise that has three phases and greatly contracts the abductor hallucis muscle. This exercise will be done twice a day for 15 minutes. Clinical evaluations and MRI will be performed before and after treatment. Then the combination of orthosis and exercise therapy will continue for only three months and clinical evaluations will be repeated at the end of 3 months.</i_keyword>
      <i_keyword>Control group: This group will use the newly designed orthosis for four weeks without the capability of neuromuscular electrical stimulation. Therapeutic training will begin in the middle of the third week and will continue until the end of the fourth week. In this group also clinical evaluations and MRI will be performed before and after treatment. Then the combination of orthosis and exercise therapy will continue for only three months and clinical evaluations will be repeated at the end of 3 months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hallux Valgus Angle. Timepoint: Before and After of the Intervention. Method of measurement: Goniometer and MRI.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Abductor Hallucis Muscle Strength. Timepoint: Before and After the Intervention. Method of measurement: Loadcell.</sec_outcome>
      <sec_outcome>Volume of Abductor Hallucis Muscle. Timepoint: Before and After the Intervention. Method of measurement: MRI.</sec_outcome>
      <sec_outcome>Cross Sectional Area of Abductor Hallucis Muscle. Timepoint: Before and After the Intervention. Method of measurement: MRI.</sec_outcome>
      <sec_outcome>Intermetatarsal Angle. Timepoint: Before and After the Intervention. Method of measurement: MRI.</sec_outcome>
      <sec_outcome>Range of Motion of First Metatarsophalangeal Joint. Timepoint: Before and After the Intervention. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Disability. Timepoint: Before and After the Intervention. Method of measurement: FAAM Questionnaire.</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>2020-07-21</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Golestan Hemmat Dormitory, Faculty of Rehabilitation Sciences, Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd., Tehran. Postal code: 1545913487 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
