<?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>IRCT20230612058468N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-19</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of balance practice and stability exercises on kinetic factors of balance, pain intensity and disability in patients with non-specific chronic low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of balance practice and stability exercises on kinetic factors of balance, pain intensity and disability in patients with non-specific chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71229</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization
Individual randomization unit
Dice randomization tool
How to make a random sequence: In this study, there are three groups. Numbers 1-2 are used for the first group, numbers 3-4 are used for the second group, and numbers 5-6 are used for the third group.
Concealment using non-transparent sealed envelopes: based on the sample size, a number of envelopes are prepared and each of the random sequences created is recorded on the card, and the card is placed inside the envelope and the lid of the envelopes is glued and It is placed in the box, according to the order of arrival of the participants, one of the envelopes is opened and the participating group is revealed, Blinding description: The patient does not know which of the research groups he/she is placed in, so our study is  single blinded.</study_design>
      <phase>3</phase>
      <hc_freetext>non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group 1 is a group that receives balance exercises that include eleven exercises for 60 minutes (15 minutes of warming up - 15 minutes of cooling down - 30 minutes of main exercise), .three times a week for 6 weeks . Intervention 2: Control group:  They do not receive any treatment, only the studied variables are measured for them once at the beginning of the study and once at the end of the study and compared with the other groups. Intervention 3: Intervention group:   is a group that receives stability exercises that include eight exercises for 60 minutes (15 minutes of warm-up - 15 minutes of cooling down - 30 minutes of main exercise), three times a week for 6 weeks.</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:
All data can potentially be shared after de-identifying individuals, including: background information. The amount of changes in the center of pressure - the amount of changes in the time to reach stability - the amount of changes in the distance traveled in the Star test - the amount of changes in the time in the Stork test - the amount of changes in the score of the visual scale analogue - the amount of changes in the score of the oswestry questionnaire

When:
One month after publication

To whom:
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them

Conditions:
Students who are doing a research  and people working in the field of treatment

Where to obtain:
Sosan Shah Hosseini- Phone: 09121243936 Email: shahhosseinisousan@gmai.com

How to obtain:
The request and its reason should be registered via e-mail and the data will be sent within five working days

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Susan Shahhosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.29 4th street chehelsotoon ave . jahad square .teheran town</address>
        <city>Teheran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1431684316</zip>
        <telephone>+98 21 8839 2182</telephone>
        <email>shahhosseiniali@ymail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>رزیتا هدایتی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1431684316</zip>
        <telephone>+98 23 3332 8502</telephone>
        <email>hedayati@semums.ac.ircom</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have been diagnosed as non-specific back pain with or without referring pain to the leg that lasts at least three months. .
The pain intensity should be at least 3 according to the pain questionnaire
their age should be between 20 and 60 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People who are pregnant .
People who have a history of back surgery.
People who have cancer.
People who have vestibular system problems.
People who have neurological problems.
People who have pathology in the spinal cord.
People who have nerve root disorders .
People who have fractured vertebra.
People who have arthritis in the ankle or knee.
People who have congenital deformities of the foot and wrist such as genovalgum genovarum genu recuratum.
People who have  ankle sprains  And those who have knee and leg ligament injuries.</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>Rehabilitation</i_code>
      <i_code>N/A</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group 1 is a group that receives balance exercises that include eleven exercises for 60 minutes (15 minutes of warming up - 15 minutes of cooling down - 30 minutes of main exercise), .three times a week for 6 weeks .</i_keyword>
      <i_keyword>Control group:  They do not receive any treatment, only the studied variables are measured for them once at the beginning of the study and once at the end of the study and compared with the other groups.</i_keyword>
      <i_keyword>Intervention group:   is a group that receives stability exercises that include eight exercises for 60 minutes (15 minutes of warm-up - 15 minutes of cooling down - 30 minutes of main exercise), three times a week for 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Evaluation of static balance by measuring time during standing  stork test - evaluation of static balance by measuring the speed of changes in the center of pressure -evaluation of  static balance by measuring the displacement of changes in the center of pressure . Timepoint: Before the intervention and 1 week after the end of the intervention. Method of measurement: Static balance checking tool: Force .plate. Static balance checking tool:  standing Stork test.</prim_outcome>
      <prim_outcome>Evaluation of dynamic balance by measuring the covered distance during  Star excursion balance  test - evaluation of  dynamic balance by measuring time  to stability . Timepoint: Before the intervention and 1 week after the end of the intervention. Method of measurement: Dynamic balance checking tool: Force plate. Dynamic balance checking tool: Star excursion balance Test.</prim_outcome>
      <prim_outcome>Examining the level of pain through the visual analogue  scale's scores. Timepoint: Before the intervention and 1 week after the end of the intervention. Method of measurement: Pain assessment tool: Visual analogue  Scale.</prim_outcome>
      <prim_outcome>- Examining the level of disability through the oswestry disability questionnaire's scores. Timepoint: Before the intervention and 1 week after the end of the intervention. Method of measurement: - Disability assessment tool: oswestry Questionnaire.</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>2023-06-25</approval_date>
        <contact_name>ethics committee of semnan university of medical sciences</contact_name>
        <contact_address>No29, east 4th ave, seyed jamaledin asad abadi , tehran town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
