<?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>IRCT20200101045970N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-01</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of stabilizing exercises on MS patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Dynamic Neuromuscular Stabilization on Balance and Balance Confidence in patients with Multiple Sclerosis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57219</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are randomly divided into one of two experimental and control groups after examining the inclusion and exclusion criteria. In this study, due to the small number of samples, in consultation with a statistician, it was decided to use the random blocking method. Blocking is usually used to balance the number of samples assigned to each of the groups studied. The statistician used the website https://www.sealedenvelope.com/simple-randomiser/v1/lists, Considering that we had 2 groups, they designed 20 two-person blocks. . A person who divides patients into two groups based on this table is unaware of the study, Blinding description: In this study, because sufficient information about the exercises is given to the participants and it is explained to each of them that they may be randomly placed in one of the two groups, so the participants are not blind. In this study, the evaluator of balance and confidence in balance does not know which group the participant is in, so our evaluator is blind. In addition, the person analyzing the data does not know which person is in which group and only compares the data between the two groups, so they are also blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receive dynamic neuromuscular stabilization exercises. These exercises are performed in different positions that are actually modeled on the positions of the growing baby. Exercises start with simple situations and gradually become more complex. In fact, the exercises start with the supine and then progress to the rolling, sitting, bear and squat-like postures. In each training session, 3 different situations are taught. Each exercise is maintained 3 times for 10 seconds and the patient is given 10 seconds of rest between each. Patients are treated for 4 weeks with a regimen of 3 sessions per week, every other day. The duration of each treatment session is 30 minutes. Intervention 2: Control group: Routine balance exercises that include both movement and sensory strategies. Movement strategy includes stabilizing exercises, dual exercises, and ankle balance strategy. Double exercises are generally changed from static to dynamic and walking to make them more advanced. Sensory strategy also tries to strengthen vestibular and sensory-physical information by reducing visual input. Therefore, to achieve this goal, we do some movement phase exercises with closed eyes. Patients are treated for 4 weeks with a regimen of 3 sessions per week, every other day. The duration of each treatment session is 30 minutes.</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 Because of confidentiality</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3669 3089</telephone>
        <email>eghasemi@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ehsan Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences,Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3669 3089</telephone>
        <email>eghasemi@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least one year has passed since the diagnosis
Age range 15 to 55 years and being in the disease remission period
Having a mild to moderate degree of disability (EDSS = 0-5.5) as determined by your doctor.
No recurrence of the disease during the last month
No other diseases such as cardiovascular, osteoarthritis, respiratory, skin, cognitive disorders, diabetes and cancer
Stability of the patient's vital signs
Being able to walk without an aid</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of regular participation in training sessions
Recurrence of the disease during the project
Having certain illnesses, such as heart disease, or problems such as fatigue, so that continuing to exercise is detrimental to her.
Use of pharmacological agents to control fatigue
Depressive and sleep disorders that lead to fatigue.
Participate in an exercise program 8 weeks in past and during treatment
Serious balance problems that put a person at risk of falling.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Receive dynamic neuromuscular stabilization exercises. These exercises are performed in different positions that are actually modeled on the positions of the growing baby. Exercises start with simple situations and gradually become more complex. In fact, the exercises start with the supine and then progress to the rolling, sitting, bear and squat-like postures. In each training session, 3 different situations are taught. Each exercise is maintained 3 times for 10 seconds and the patient is given 10 seconds of rest between each. Patients are treated for 4 weeks with a regimen of 3 sessions per week, every other day. The duration of each treatment session is 30 minutes.</i_keyword>
      <i_keyword>Control group: Routine balance exercises that include both movement and sensory strategies. Movement strategy includes stabilizing exercises, dual exercises, and ankle balance strategy. Double exercises are generally changed from static to dynamic and walking to make them more advanced. Sensory strategy also tries to strengthen vestibular and sensory-physical information by reducing visual input. Therefore, to achieve this goal, we do some movement phase exercises with closed eyes. Patients are treated for 4 weeks with a regimen of 3 sessions per week, every other day. The duration of each treatment session is 30 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Before the start of treatment, after the end of treatment and 2 months after the end of the last treatment session. Method of measurement: Use of Mini BES Test.</prim_outcome>
      <prim_outcome>Balance Confidence. Timepoint: Before the start of treatment, after the end of treatment and 2 months after the end of the last treatment session. Method of measurement: Use of ABC Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Assessment of functional mobility. Timepoint: Before the start of treatment, after treatment and 2 months after the end of the last treatment session. Method of measurement: Use of TUG test.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-08</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib Ave Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
