<?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>IRCT20190414043268N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-05</date_registration>
      <primary_sponsor>Vice chancellor for research of Tehran University of Medical Science</primary_sponsor>
      <public_title>Study of the effect of local vibration on diabetic neuropathy symptoms</public_title>
      <acronym></acronym>
      <scientific_title>Study of the Effect of Local Vibration on Balance, Protective and Vibration Sensation, Pain and Foot Temperature in Patients with Diabetic Neuropathy (before-After Clinical Trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38849</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic polyneuropathy.</hc_freetext>
      <i_freetext>The patients was left in crook lying with no shoes and socks on the bed and placed one pillow under the knees so that the knees are comfortable on them. Average room temperature was set to 25 °. Both of the feet placed on vibrator and a local vibration with a frequency of 62.5 Hz for 10 minutes was applied to the plantar side of both feet. The device was placed on the platform, which was separated from the bed. Patients referred for the five sessions a day in between, for treatment..</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Sabziparvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of physiotherapy ,School of Rehabilitation , Pitch-e-Shemiran, Enghelab Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65111-11489</zip>
        <telephone>+98 21 7753 5132</telephone>
        <email>sabziparvarm@yahoo.com</email>
        <affiliation>Department of Physiotherapy, School of Rehabilitation ,Tehran University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahsa Sabziparvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physiotherapy ,School of Rehabilitation ,Pitch-e-Shemiran, Enghelab Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65111-11489</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>sabziparvarm@yahoo.com</email>
        <affiliation>Department of Physiotherapy ,School of Rehabilitation ,Tehran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having Diabetic neuropathy based on physician diagnosis (Michigan score 4 and above)
Age between 50-70
Ability to walk independently</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Wound on plantar area of foot
Charcot joint
Suffering from other neurological disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08.42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition with diabetic polyneuropathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The patients was left in crook lying with no shoes and socks on the bed and placed one pillow under the knees so that the knees are comfortable on them. Average room temperature was set to 25 °. Both of the feet placed on vibrator and a local vibration with a frequency of 62.5 Hz for 10 minutes was applied to the plantar side of both feet. The device was placed on the platform, which was separated from the bed. Patients referred for the five sessions a day in between, for treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of Balance Test. Timepoint: Before, at the end of the first and fifth session. Method of measurement: Brief balance evaluation system test (brief-BEST).</prim_outcome>
      <prim_outcome>Protective sensation. Timepoint: Before, at the end of the first and fifth session. Method of measurement: Monofilament (5.07).</prim_outcome>
      <prim_outcome>Threshold of vibration sensation. Timepoint: Before, at the end of the first and fifth session. Method of measurement: Rydel-Seiffer tuning fork (128 Hz).</prim_outcome>
      <prim_outcome>Foot temperature. Timepoint: Before, at the end of the first and fifth session. Method of measurement: Manual- digital thermometer.</prim_outcome>
      <prim_outcome>The status of vibration sensation. Timepoint: Before, at the end of the first and fifth session. Method of measurement: Tuning fork (128 Hz).</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before, at the end of the first and fifth session. Method of measurement: Numerical pain rating scale (NPRS).</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>Vice chancellor for research of Tehran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-25</approval_date>
        <contact_name>Ethics committee of nursing and midwifery and rehabilitation Schools of Tehran University of Medical</contact_name>
        <contact_address>Ghods Ave, Keshavarz blv Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
