<?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>IRCT20170114031942N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-10</date_registration>
      <primary_sponsor>Shahroud University of Technology</primary_sponsor>
      <public_title>Leg related exercises and medial tibial stress syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effect of leg related exercises on foot posture and dynamic force distribution pattern in recreational runner with medial tibial stress syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29485</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Participants are enrolled by one of the research colleagues. An independent assessor, blinded person who has no further involvement in the study creates a random allocation sequence using a computer Software prior to the initiation of the study that use to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 4) are applied to ensure an equal number of participants in each group. Group allocation are concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes are opened after enrolled participants complete all baseline assessments.</study_design>
      <phase>3</phase>
      <hc_freetext>Medial tibial stress syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: In addition to anti-pronation foot orthoses, this group also receives an exercise training intervention. Exercise training intervention is focused in the stretching and strengthening exercises that has been selected based on previous studies that show the effectiveness of these exercises for those with overpronation foot. The strengthening exercises involves of foot intrinsic muscles, toe flexor muscles, plantar flexors and foot inverters muscles. The stretching exercises of the training intervention is provided to enhance the flexibility of the soleus and gastrocnemius muscles. Participants in the intervention group are trained by a corrective training specialist. The training program conduct for 24 weeks, three sessions per week and for 1 hour in each session. Intervention 2: Control group: Participants of this group receives anti-pronation foot orthoses.</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>Aynollah Naderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran avenue, Shahroud, Semnan Province</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3619995161</zip>
        <telephone>+98 23 3239 2204</telephone>
        <email>ay.naderi@shahroodut.ac.ir</email>
        <affiliation>Shahrood University of Technology</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aynollah Naderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran avenue, Shahroud, Semnan Province</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3619995161</zip>
        <telephone>+98 23 3239 2204</telephone>
        <email>ay.naderi@shahroodut.ac.ir</email>
        <affiliation>Shahrood University of Technology</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Leg pain exertion caused by exercise, which lasts for several hours or days after exercise; Place of pain on the posterior-medial border of the tibia; incidence of pain during the palpation should be at least 5 cm; the nature of the diffuse pain in the palpation of the tibia, which is limited to the posterior- medial border of the bone, the rugged surface of the bone in the area of discomfort or pain in the tibia bone.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>A history of paresthesia or other symptoms indicating legs pain caused by exercise (such as tibial fractures stress and chronic compartment syndrome); history of traumatic injury and lower limb surgery during the last 6 months; leg length difference.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In addition to anti-pronation foot orthoses, this group also receives an exercise training intervention. Exercise training intervention is focused in the stretching and strengthening exercises that has been selected based on previous studies that show the effectiveness of these exercises for those with overpronation foot. The strengthening exercises involves of foot intrinsic muscles, toe flexor muscles, plantar flexors and foot inverters muscles. The stretching exercises of the training intervention is provided to enhance the flexibility of the soleus and gastrocnemius muscles. Participants in the intervention group are trained by a corrective training specialist. The training program conduct for 24 weeks, three sessions per week and for 1 hour in each session.</i_keyword>
      <i_keyword>Control group: Participants of this group receives anti-pronation foot orthoses.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamic arch index. Timepoint: Before the intervention and 12 and 24 weeks after the intervention. Method of measurement: By using of Footscan.</prim_outcome>
      <prim_outcome>Dynamic distribution of plantar forces. Timepoint: Before the intervention and 12 and 24 weeks after the intervention. Method of measurement: By using of Footscan.</prim_outcome>
      <prim_outcome>Foot and ankle muscle strength. Timepoint: Before the intervention and 12 and 24 weeks after the intervention. Method of measurement: Dynamometer.</prim_outcome>
      <prim_outcome>Foot and ankle muscle endurance. Timepoint: Before the intervention and 12 and 24 weeks after the intervention. Method of measurement: Dynamometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of physical activity in the previous week. Timepoint: Before the intervention, 12 and 24 weeks after the intervention. Method of measurement: 7-day Physical Activity Recall Questionnaire.</sec_outcome>
      <sec_outcome>Level of impairment caused by injury. Timepoint: Before the intervention, 12 and 24 weeks after the intervention. Method of measurement: Using a numerical rating scale.</sec_outcome>
      <sec_outcome>Activity limitations level. Timepoint: Before the intervention, 12 and 24 weeks after the intervention. Method of measurement: Using a numerical rating scale.</sec_outcome>
      <sec_outcome>Perceived treatment effect. Timepoint: Before the intervention, 12 and 24 weeks after the intervention. Method of measurement: Using a patient perceived treatment effect 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>Shahroud University of Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-06</approval_date>
        <contact_name>Ethics committee of shahroud university of medical sciences</contact_name>
        <contact_address>Seventh Tir Square, Shahroud Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
