<?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>IRCT20180523039792N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-13</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of dual task training on somatosensory, balance, Community participation and activity of daily living in Multiple sclerosis</public_title>
      <acronym>Dual Task Training   DTT</acronym>
      <scientific_title>Effect of dual task training on somatosensory, balance, activity of daily living and Community participation  in patient with relapsing-remitting Multiple sclerosis:  Double Blind Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31443</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Method: Restricted Randomization by random
allocation rule method: first, a sample size determine and then randomly assign a set of them to Group A and assign the remainder to Group B.
Random unit: Individual
Non-transparent envelopes are used to hide random assignments
In this method, first, a random sequence is created using the above method. Then, based on the sample size of the research, a number of envelopes with an aluminum wrapper (in order to avoid the clarity of the contents of the envelopes) are prepared and each random sequence created on a card is recorded and the cards is placed inside the envelopes.
At the time of the start of the registration of the participants, one of the envelopes shall be opened in accordance with the order of entry of the eligible participants, and the group allocated to that participant shall be revealed.
Process execution:One person will create a random sequence, the other will examine the participants in terms of inclusion and exclusion criteria and enroll them in the study, and the third person will assign the participants to the groups, Blinding description: The participant will be notified in two groups whose programs are different. Practitioners who train the intervention program do not know about the intervention and control group program.</study_design>
      <phase>N/A</phase>
      <hc_freetext>multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dual cognitive-motor exercises. At the beginning of the session, warm-up exercises are performed for 10 minutes, then balanced exercises begin. Each exercise consists of 2 courses, depending on the person's level of ability, each course performed one to two minutes and for repetitive exercises 10 to 15 repetitions. The rest time between each period is also 1 to 2 minutes. The intervention group performs the second cycle exercises with cognitive activity. At the end, the cooling exercises will take about 10 minutes. Intervention 2: Control group:  Dual cognitive-motor exercises. At the beginning of the session, warm-up exercises are performed for 10 minutes, then balanced exercises begin. Each exercise consists of 2 courses, depending on the person's level of ability, each course performed one to two minutes and for repetitive exercises 10 to 15 repetitions. The rest time between each period is also 1 to 2 minutes. At the end, the cooling exercises will take about 10 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>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 data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shirin Saberimobarake</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Musculoskeletal research center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jrib Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81745-164</zip>
        <telephone>+98 31 3792 5229</telephone>
        <email>shirin.saberi69@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shirin Saberimobarake</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Musculoskeletal research center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jrib Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81745-164</zip>
        <telephone>+98 31 3792 5229</telephone>
        <email>shirin.saberi69@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of Neurologist
EDSS Score 2-5/5(To be able to complete walking tests)
Ability to stand without any support
Having a sensory problem on the soles of the foot
relapsing During the last 30 days
Having the ability to read and write
The doctor confirmed to participate in research</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diseases such as diabetes, epilepsy and ...
Any problem in the musculoskeletal system: history of surgery, history of fractures, etc., which disturbs the balance.
Corticosteroid treatment one month before the study
MMSE less than 24
Uncorrected visual disorders
Exacerbation of symptoms
Inability to walk 25 ft with or without assisstive device
Major depression</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: Dual cognitive-motor exercises. At the beginning of the session, warm-up exercises are performed for 10 minutes, then balanced exercises begin. Each exercise consists of 2 courses, depending on the person's level of ability, each course performed one to two minutes and for repetitive exercises 10 to 15 repetitions. The rest time between each period is also 1 to 2 minutes. The intervention group performs the second cycle exercises with cognitive activity. At the end, the cooling exercises will take about 10 minutes.</i_keyword>
      <i_keyword>Control group:  Dual cognitive-motor exercises. At the beginning of the session, warm-up exercises are performed for 10 minutes, then balanced exercises begin. Each exercise consists of 2 courses, depending on the person's level of ability, each course performed one to two minutes and for repetitive exercises 10 to 15 repetitions. The rest time between each period is also 1 to 2 minutes. At the end, the cooling exercises will take about 10 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Somatosensory. Timepoint: Before the intervention, immediately after the intervention, one week after the end of the intervention. Method of measurement: monofilament.</prim_outcome>
      <prim_outcome>Balance. Timepoint: Before the intervention, immediately after the intervention, one week after the end of the intervention. Method of measurement: Berg balance scale.</prim_outcome>
      <prim_outcome>Balance. Timepoint: Before the intervention, immediately after the intervention, one week after the end of the intervention. Method of measurement: Force plate.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Activities of daily living (basic, instrumental). Timepoint: Before the intervention, immediately after the intervention, one month after the end of the intervention. Method of measurement: Barthel index score                                                                                                                      Lawton instrumental activity of daily living.</sec_outcome>
      <sec_outcome>Community integration. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Community integration Questionnaire.</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>2018-11-14</approval_date>
        <contact_name>Ethics committee of Isfahan university of medical sciences</contact_name>
        <contact_address>Isfahan university of medical sciences, Hezarjrib Ave. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
