<?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>IRCT20191109045369N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-09</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>whole  body vibration and diabetic neuropathy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of whole body vibration on ankle joint proprioception and balance in diabetic neuropathy patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43540</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization is applied by using the random number table. Individuals with diabetic neuropathy are voluntarily recruited to the study and after completing the consent form are included in the study by matching with inclusion and exclusion criteria.Then each participant is devoted a number and the numbers are given to an assignment expert. The expert uses random number table to put individuals into two groups, intervention (whole body vibration) or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic Neuropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They receive  whole body vibration (WBV) progressivly 2 times a week for 6 weeks.In the first week, WBV with 30 Hz frequency, 2mm amplitude is applied five times for 30 seconds , with 1 minute rest between periods. During the following week, the frequency and amplitude   are kept the same, but the WBV change to five times for 45 seconds, with 1 minute rest between periods. During the last week, the patient undergoes WBV five times for 1 minute, with 1 minute rest between periods. Intervention 2: Control group: They do not receive any intervention. In this group, all subjects will be evaluated for static and dynamic balance and  proprioception before beginning the study, after the first session, after 6 weeks of intervention and one month after the end of intervention.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
-

When:
-

To whom:
It will only be available to researchers working in academic institutions.

Conditions:
If there are any relevant studies

Where to obtain:
Atefe Aminian Far.
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Sq
Tel:  0098 23 33654180
Postal code: 3513138111

How to obtain:
-

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefe Aminian Far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Sq</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>aminfar@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe Aminian Far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Sq</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>aminfar@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having diabetes that lasts at least 5 years.
Age 40 to 65 years
BMI  22-30 kg / m2
Earning the score above 2 on the basis of questionnaire on diabetic neuropathy test scale of the University of Göringen in Netherlands that means existence of diabetic neuropathy.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a diabetic wound in the foot
Internal ear disorder
History of ankle dislocation and charcot joint
Neurology and rheumatology diseases
Severe osteoarthritis in the lower limb joints
Visual disorders
Vertigo
Participation in balance, resistance or endurance exercise     programs in the last year</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08.40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: They receive  whole body vibration (WBV) progressivly 2 times a week for 6 weeks.In the first week, WBV with 30 Hz frequency, 2mm amplitude is applied five times for 30 seconds , with 1 minute rest between periods. During the following week, the frequency and amplitude   are kept the same, but the WBV change to five times for 45 seconds, with 1 minute rest between periods. During the last week, the patient undergoes WBV five times for 1 minute, with 1 minute rest between periods.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention. In this group, all subjects will be evaluated for static and dynamic balance and  proprioception before beginning the study, after the first session, after 6 weeks of intervention and one month after the end of intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Static stability index in anteroposterior, mediolateral and overal axes. Timepoint: At the beginning of the study, after the first session, after 6 weeks of intervention and one month after the end of intervention in both groups. Method of measurement: Based on Biodex Balance System (millimeter).</prim_outcome>
      <prim_outcome>Dynamic stability index in anteroposterior, mediolateral and overal axes. Timepoint: At the beginning of the study, after the first session, after 6 weeks of  intervention and one month after the end of intervention in both groups. Method of measurement: Based on Biodex Balance System(milimeter).</prim_outcome>
      <prim_outcome>Functional balance. Timepoint: At the beginning of the study, after the first session, after 6 weeks of  intervention and one month after the end of intervention in both groups. Method of measurement: Berg Balance score.</prim_outcome>
      <prim_outcome>Ankle reconstruction error from a reference angle (proprioception). Timepoint: At the beginning of the study, after the first session, after 6 weeks of intervention and one month after the end of intervention in both groups. Method of measurement: Based on Biodex System (degree).</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-19</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Ethics committee of Semnan University of Medical Sciences, Basij Blvd Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
