<?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>IRCT20200502047260N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-26</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of proprioception practice and auriculotherapy on the balance and proprioception of lower extremity in patients with diabetic neuropathy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of proprioception practice and auriculotherapy on the balance and proprioception of lower extremity in patients with diabetic neuropathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>69</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47653</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible participants in the study are selected from among the available individuals. Once selected, participants will be assigned a random blockchain allocation between the three groups. Eligible individuals will be assigned admission criteria after obtaining informed consent, using the List Randomization site and creating a number of different blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic Neuropathy.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: proprioception practice : Exercises for 6 weeks and 3 sessions per week, each session for 30 minutes and a total of 18 sessions as a group to match the place and time, for patients. The sessions will begin with warm-up exercises for 5 minutes. Warming-up activities include: walking back and forth, running softly and slowly, and performing stretching exercises for different parts of the body, as well as cooling down at the end of the workout. The main proprioception practice  include: 1- Maintaining the position: standing on one leg, jumping to the sides and forward - backward. 2- Strength: Strengthening the front of the thigh, back of the thigh, squat and the sides of the thigh. 3- Plyometric: jumps (single-legged - two-legged, rotations 90 and 180 degrees). 4- Speed ​​and agility exercises: running figure 8, running forward - Back and sides (straight and spiral paths). The intensity of the exercises will be adjusted based on the patients' abilities. The number and duration of exercises will be the same in the first two sessions and will then change according to the patients' abilities. Rest time between exercises will be as much as changing position and being in a new position. All tests, like the pre-test, will be performed 48 hours after completing the 6-week training protocol and the results will be recorded. Intervention 2: Second Intervention Group: auriculotherapy: In this group, patients are taught the required information such as the purpose of the work, the time required to pressurize the desired points, the number of times a day and the length of the auriculotherapy course are also taught to patients. The adhesive of the auriculotherapy seeds, please contact the researcher's phone number given to them so that the seeds can be repositioned on the previous point. The researcher begins auriculotherapy using the Vaccaria seed adhesive at the points designated for the intervention group. The samples were taken 2 times a week for 10 sessions and a total of 5 weeks treated with Vaccaria seed adhesive on the equilibrium points. Both ears are located in the right ear, including the equilibrium point, Thalamic point, Lumbago point, and in the left ear, including Shenmen's point, pancreatic point, and Hippocampus point, and these adhesives are removed by the researcher every 3 days. And at least 1 to 2 hours later (for the rest of the ear, the adhesives are removed for 1 to 2 hours) again, a glue with Vaccaria seed No longer connected. After the intervention sessions, the level of balance and depth is measured again by the researcher. The results are reviewed and statistical analysis is performed according to the research objectives. During this time, 3 phone calls will be made to each patient to answer questions and resolve any potential issues. The results are reviewed in two stages before and after the intervention and statistical study is performed according to the research objectives. Intervention 3: Control group: No intervention: This training group will not be given.</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>Nayereh Ghazavi Khorasgani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 67, 13th Alley, Masjed Ali St., Jay St., Esfahan</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8156173811</zip>
        <telephone>+98 31 3521 0921</telephone>
        <email>nayer.uni@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nayereh Ghazavi Khorasgani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 67, 13th Alley, Masjed Ali St., Jay St., Esfahan</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8156173811</zip>
        <telephone>+98 31 3521 0921</telephone>
        <email>nayer.uni@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diabetes based on the diagnosis of a specialist
Diabetic neuropathy based on Michigan questionnaire
Ability to communicate and answer questions
Be at least 18 years old and at most 65 years old
Satisfaction to participate in the study and signing of the Conscious Consent Form</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of deformity or neurological and rheumatic diseases in the lower extremities
Existence of foot ulcers and no report of history of dizziness and ankle sprains</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with diabetic neuropathy, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: proprioception practice : Exercises for 6 weeks and 3 sessions per week, each session for 30 minutes and a total of 18 sessions as a group to match the place and time, for patients. The sessions will begin with warm-up exercises for 5 minutes. Warming-up activities include: walking back and forth, running softly and slowly, and performing stretching exercises for different parts of the body, as well as cooling down at the end of the workout. The main proprioception practice  include: 1- Maintaining the position: standing on one leg, jumping to the sides and forward - backward. 2- Strength: Strengthening the front of the thigh, back of the thigh, squat and the sides of the thigh. 3- Plyometric: jumps (single-legged - two-legged, rotations 90 and 180 degrees). 4- Speed ​​and agility exercises: running figure 8, running forward - Back and sides (straight and spiral paths). The intensity of the exercises will be adjusted based on the patients' abilities. The number and duration of exercises will be the same in the first two sessions and will then change according to the patients' abilities. Rest time between exercises will be as much as changing position and being in a new position. All tests, like the pre-test, will be performed 48 hours after completing the 6-week training protocol and the results will be recorded.</i_keyword>
      <i_keyword>Second Intervention Group: auriculotherapy: In this group, patients are taught the required information such as the purpose of the work, the time required to pressurize the desired points, the number of times a day and the length of the auriculotherapy course are also taught to patients. The adhesive of the auriculotherapy seeds, please contact the researcher's phone number given to them so that the seeds can be repositioned on the previous point. The researcher begins auriculotherapy using the Vaccaria seed adhesive at the points designated for the intervention group. The samples were taken 2 times a week for 10 sessions and a total of 5 weeks treated with Vaccaria seed adhesive on the equilibrium points. Both ears are located in the right ear, including the equilibrium point, Thalamic point, Lumbago point, and in the left ear, including Shenmen's point, pancreatic point, and Hippocampus point, and these adhesives are removed by the researcher every 3 days. And at least 1 to 2 hours later (for the rest of the ear, the adhesives are removed for 1 to 2 hours) again, a glue with Vaccaria seed No longer connected. After the intervention sessions, the level of balance and depth is measured again by the researcher. The results are reviewed and statistical analysis is performed according to the research objectives. During this time, 3 phone calls will be made to each patient to answer questions and resolve any potential issues. The results are reviewed in two stages before and after the intervention and statistical study is performed according to the research objectives.</i_keyword>
      <i_keyword>Control group: No intervention: This training group will not be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Equilibrium at the beginning of the study (before the start of the intervention) and after the start of the study. Method of measurement: Star Excursion Balance Test(SEBT) &amp; Balance Error Scoring System test(BESS) &amp; Vaccaria seed.</prim_outcome>
      <prim_outcome>Proprioception. Timepoint: Proprioception at the beginning of the study (before the intervention begins) and after the study begins. Method of measurement: Goniometer &amp; Vaccaria seed.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-11</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj, Shahid Motahari Blvd., Yasuj University of Medical Sciences Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
