<?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>IRCT20181107041588N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-13</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Balance in MS patients</public_title>
      <acronym>MS</acronym>
      <scientific_title>Comparing the effect of mental exercise and routine occupational therapy on balance and walking performance among  patients suffering from multiple sclerosis (MS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35940</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Via simple randomization method using number box, the subjects will be individually assigned to two groups. Using random allocation rule (RAR), a bog box is provided for all samples, i. e., each subject is allocated a code number between one to last number, after final sample allocation. All codes are placed in a non-transparent envelope, and then, some numbers are transferred blindly from the first envelope to second, until half of the code numbers are been transferred. Then, each envelope will be allocated to experimental and control groups via dropping coin. Finally, the numbers in each envelope are matched to the name of the subjects and will refer to receiving relevant interventions, Blinding description: 1- The researcher encodes patients after compliance with the entry criteria (each patient receives a code)
2. the assessor is Blind to the subjects assignment to the intervention group. He/she Assesses patients, refer them to rehabilitation services.
3. The subject's blindness to the intervention group: The patient receives special care for the group by providing a card containing the code without informing or communicating with other patients.
4. Blindness of the occupational therapist to the subjects assignment to the intervention group. The therapist provides occupational therapy services according to the protocol to each patient-code.
5. Patients with code belonging to the experimental group will refer to the special training site and receive the relevant services.
 6. Blindness of the information analyzer on the subjects’ assignment to the intervention group. Data will be evaluated and compared in three steps (before and after intervention and follow up). Then, two groups with different codes (blind to assigning code to the intervention group) are also compared.</study_design>
      <phase>2</phase>
      <hc_freetext>patients whit MS.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: 11 patients with MS are selected as the intervention group. These subjects will receive mental practice for 20 minutes, in addition to the common occupational therapy exercises. The intervention will be conducted for 3 sessions per week and for 6 weeks. Individuals are evaluated in three times  (1) before interventions (2) after interventions (3) 2 weeks after the last session of the intervention. Intervention 2: Control group 1: 11 patients with MS will be assigned as control group 1 and will receive common occupational therapy exercises for 3 45-minute sessions per week for 6 weeks. The participants will be evaluated in three times (1) before intervention (2) after intervention (3) 2 weeks after the last session of the intervention.</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 have not yet made a decision on this issue and its publication plan is unclear. In consultation with the professors, it will be decided after this work.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Hoseinpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar St, Daneshjoo Blvd , Evin, Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۳۸۷۱</zip>
        <telephone>+98 22180083</telephone>
        <email>h.hoseinpour_ot@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hojjat Allah Haghgoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar St, ِDaneshjoo Blvd, Evin,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۳۸۷۱</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>h.haghgoo@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of MS by an specialist physician
People with mild to moderate disability scale (EDSS = 1-5)
Age range of 18-65 years old
At least 2 years after the onset of MS
Voluntarily participation in the research
َAbility to perform exercises
MMSE scores above 23 to ensure required cognitive function</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
having mental problems as well as fractures and the presence of implants in the body (according to patient records)
having a history of attack and recurrence within the last 2 months (according to patient records)
history of other neurological diseases (according to patient records)
previous history of the epilepsy, tumors, osteoporosis, diabetes, etc. according to the physician diagnosis
corticosteroid medication till 28 days before the evaluation
visual and/or auditory problems that may interfere with the tests
Failure to have mental retardation
previous history of psychiatric illness that interferes with the examination process
previous history of addiction and using psychoactive substances</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 1: 11 patients with MS are selected as the intervention group. These subjects will receive mental practice for 20 minutes, in addition to the common occupational therapy exercises. The intervention will be conducted for 3 sessions per week and for 6 weeks. Individuals are evaluated in three times  (1) before interventions (2) after interventions (3) 2 weeks after the last session of the intervention.</i_keyword>
      <i_keyword>Control group 1: 11 patients with MS will be assigned as control group 1 and will receive common occupational therapy exercises for 3 45-minute sessions per week for 6 weeks. The participants will be evaluated in three times (1) before intervention (2) after intervention (3) 2 weeks after the last session of the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Walking function. Timepoint: Before receiving interventions, after the last intervention session and two weeks after the intervention. Method of measurement: Using the questionnaire and patient records.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Independence in activities of daily living performances (ADL). Timepoint: Pretest, post test, two weeks follow-up. Method of measurement: Barthel Index.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-11</approval_date>
        <contact_name>Ethics Committee of The University of Social welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koodak Yar Street, Daneshjoo Boulevard,Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
