<?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>IRCT20140222016680N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-07</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of spine stabilizing exercises on balance and falling in people with multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of dynamic neuromuscular stabilization exercises in comparison to core stability exercises on balance, falling and spasticity in people with multiple sclerosis: a double blind randomized control trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46429</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random blocks (permuted block randomization) with four blocks will be used for randomization. According to the sample size of 66, approximately17 blocks will be generated using the online site (www.sealedenvelope.com). For concealment in the randomization process, unique code will be used on each envelope with the type of training specified inside, Blinding description: In this study, َََََََََََََََََAssessor who evaluates the outcome measures of study will be blind to the allocation of the two treatment groups. َAditionally the data also will be evaluated by a person who is blind to the allocation and treatment of groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, Dynamic Neuromuscular Stabilization exercises, will be given in a period of 5 weeks, three sessions per week. During fifteen sessions, progressively 21 exercises are given with focus on improving  trunk control in supine, prone, sitting, quadruped and standing positions. Each treatment session, depending on the  patient needs to rest, lasts between 60 and 75 minutes. Required equipment are mats, gymnastics ball, chair. Intervention 2: Control group: Core Stability exercises a period of 5 weeks, will be given in a period of 5 weeks, three sessions per week. During fifteen sessions, progressively 16 exercises are given with focus on improving  trunk control in supine, prone, sitting, and standing positions. Each treatment session, depending on the  patient needs to rest, lasts between 60 and 75 minutes. Required equipment are mats, gymnastics balls, chair and wall bar.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shohreh Noorizadeh Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15459-13487</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>noorizadeh.sh@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shohreh Noorizadeh Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15459-13487</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>noorizadeh.sh@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having age range between 30 and 50 years
Having medium disability rates, between 2 and 5 base on the "Expanded Disability Status Scale"
obtaining a minimum score of 21 base on the "Mini Mental Scale Examination"
Willingness to participate in the study and sign the consent
Having at least middle high school graduation to fill out self-declaration questionnaires</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from other neurological disorders such as stroke, traumatic brain injury, Ataxia, etc
Multiple sclerosis exacerbation during the last month
Having apraxia (due to inability to learn and practice the exercises)
Severe spasticity (score above 3 based on the "Modified Ashworth Scale")
Having a history of major surgery in the lower extremities
Explicit postural abnormalities in the spine and lower limbs such as scoliosis and kyphosis
Having cardiovascular disease
Having uncontrolled diabetes
Pregnancy</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: In this group, Dynamic Neuromuscular Stabilization exercises, will be given in a period of 5 weeks, three sessions per week. During fifteen sessions, progressively 21 exercises are given with focus on improving  trunk control in supine, prone, sitting, quadruped and standing positions. Each treatment session, depending on the  patient needs to rest, lasts between 60 and 75 minutes. Required equipment are mats, gymnastics ball, chair.</i_keyword>
      <i_keyword>Control group: Core Stability exercises a period of 5 weeks, will be given in a period of 5 weeks, three sessions per week. During fifteen sessions, progressively 16 exercises are given with focus on improving  trunk control in supine, prone, sitting, and standing positions. Each treatment session, depending on the  patient needs to rest, lasts between 60 and 75 minutes. Required equipment are mats, gymnastics balls, chair and wall bar.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Balance score in "Berg Balance Scale". Timepoint: A day before first treatment session, a day after 15th session (last session) and 3 months after the last session. Method of measurement: "Berg Balance Scale ".</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The number of falls by asking the patients or their care givers. Timepoint: A day before first treatment session, a day after 15th session (last session) and 3 months after the last session. Method of measurement: by asking patients: "During last 6 months, how many times have you fallen?".</sec_outcome>
      <sec_outcome>Fear of falling by "Activities-specific Balance Confidence". Timepoint: A day before first treatment session, a day after 15th session (last session) and 3 months after the last session. Method of measurement: "Activities-specific Balance Confidence".</sec_outcome>
      <sec_outcome>Patient mobility by the "Multiple Sclerosis Walking Scale-12" and the "Timed Up and Go Test". Timepoint: A day before first treatment session, a day after 15th session (last session) and 3 months after the last session. Method of measurement: "Timed Up and Go" and "Multiple Sclerosis Walking Scale-12" and.</sec_outcome>
      <sec_outcome>Spasticity score by "Multiple Sclerosis Spasticity Scale-88" and "Modified Ashworth Scale". Timepoint: A day before first treatment session, a day after 15th session (last session) and 3 months after the last session. Method of measurement: "Multiple Sclerosis Spasticity Scale-88" and "Modified Ashworth Scale".</sec_outcome>
      <sec_outcome>"sway in the "Biodex balance system". Timepoint: A day before first treatment session, a day after 15th session (last session) and 3 months after the last session. Method of measurement: sway in the "Biodex balance system".</sec_outcome>
      <sec_outcome>Trunk function in "Trunk Impairment Scale". Timepoint: A day before first treatment session, a day after 15th session (last session) and 3 months after the last session. Method of measurement: "Trunk Impairment Scale".</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 Cancellor for Research of Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-15</approval_date>
        <contact_name>Ethic committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemmat Expressway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
