<?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>IRCT20190715044226N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-25</date_registration>
      <primary_sponsor>The University of Arak</primary_sponsor>
      <public_title>The Effect of a Cognitive-motor program on balance and gait, quality of life, and stress management in patients with multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of a Combined Intervention program on objective and subjective measures related to balance and walking, quality of life, and stress in people with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41241</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The study groups included a group that is receiving the intervention and group without intervention, Randomization description: Simple randomization with purposeful randomization unit.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: The participation group: The testing  group will do the balancing exercises for 6 week and 45 minutes a session. The training plan includes the following: 5 warmup sessions(5 minutes), initial stretch(5 minutes), strength exercises for lower body(15 minutes), balancing exercises(15minutes) and cooling down(5 minutes), all of these will be done under the close supervition of a coach in a standard gym. The 5 minute-warmup includes walking, The 5 minute-initial stretch, flat arms stretch, upper head stretch, triceps stretch, shoulder stretch, quadriceps femoris stretch, Hamestring stretch while grounded(sitting down), strength training for lower body for 15 minutes, Hamstring flexion, crus extension, knee lifting, thighbone abduction and adoction, leaning and opening the ankle, ankle whirl, (Bottom squeeze) scot with a chair, scot with the wall, pulling up the legs from the sides, balancing exercises for 15 minutes, balancing with one leg, up-right sitting on a ball, dynamic sitting on a ball, turning to the sides, leaning the hands to the sides from up the head, The last stretch(cool down) 5 minutes. These exercises all exist in the initial stretches. To control the stress in this experiment, stress management will be done cognitive-behavioral style, during 10 sessions of 60 minutes and in groups. Sessions will start with relaxation trainings which include practicing relaxation techniques, in the second port of every session cognitive-behavioral techniques are taught combined with issues related to patients health. Every session includes the following details: First session: in troduction, introducing the plans, getting to know the stress-makers, and stress reactions, muscular relaxation training for 16 muscle groups. Second session: gradual muscle relaxation training for 8 muscle groups and knowing how stress affects thoughts, feelings and behavior. Third session: breathing exercise, visualization, and mutual analysis of thoughts and feelings and in active gradual muscular relaxation and the introduction of some common negative thoughts and cognitive deviations. Fifth session:Training self-born weight and heat, and illogical thought replace ment with logical thoughts. Sixth session: self-born training for heart beat, abdominal and for head breath, training different practical reaction styles. Seventh session: self-born training along with visualization and self-telling and using effective check responses. Eighth session: practicing mantra meditation and training anger management techniques. Nineth session: meditation and breath count training and training expressions in interpersonal relationships. Tenth session: descriping the benefits of social support, measuring the social support domain, perceiving it´s maintenance drawbacks and training social support techniques and planning personal stress management. Intervention 2: Control group: The control group pre-test will be taken at the same time as the test group. During the 6 weeks of the test group doing the training protocol, the control group has no exercise or training and continues the ordinary life and again after this time, they will have their post-test with the test group.</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 plan has been given for submitting the data according to the information given the sampling data of this essay will end until then.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>HadisTahmasbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karbala Boulevard., Basij Square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848177584</zip>
        <telephone>+98 86 3417 3492</telephone>
        <email>Tahmasbi.Hadis@gmail.com</email>
        <affiliation>The University of Arak</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Dariush Khajavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karbala Boulevard., Basij Square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848177584</zip>
        <telephone>+98 86 3417 3492</telephone>
        <email>D-khajavi@araku.ac.ir</email>
        <affiliation>Arak university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Selection of persons with a score of 2 to 4 scale, as the physical disability scale of the subjects group
The age range of subjects was 20-60 years
Patients except multiple sclerosis were not affected by another diseas
Patients had the ability to participate in all training sessions
Patients were good sampling of society with multiple sclerosis</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The participation group: The testing  group will do the balancing exercises for 6 week and 45 minutes a session. The training plan includes the following: 5 warmup sessions(5 minutes), initial stretch(5 minutes), strength exercises for lower body(15 minutes), balancing exercises(15minutes) and cooling down(5 minutes), all of these will be done under the close supervition of a coach in a standard gym. The 5 minute-warmup includes walking, The 5 minute-initial stretch, flat arms stretch, upper head stretch, triceps stretch, shoulder stretch, quadriceps femoris stretch, Hamestring stretch while grounded(sitting down), strength training for lower body for 15 minutes, Hamstring flexion, crus extension, knee lifting, thighbone abduction and adoction, leaning and opening the ankle, ankle whirl, (Bottom squeeze) scot with a chair, scot with the wall, pulling up the legs from the sides, balancing exercises for 15 minutes, balancing with one leg, up-right sitting on a ball, dynamic sitting on a ball, turning to the sides, leaning the hands to the sides from up the head, The last stretch(cool down) 5 minutes. These exercises all exist in the initial stretches. To control the stress in this experiment, stress management will be done cognitive-behavioral style, during 10 sessions of 60 minutes and in groups. Sessions will start with relaxation trainings which include practicing relaxation techniques, in the second port of every session cognitive-behavioral techniques are taught combined with issues related to patients health. Every session includes the following details: First session: in troduction, introducing the plans, getting to know the stress-makers, and stress reactions, muscular relaxation training for 16 muscle groups. Second session: gradual muscle relaxation training for 8 muscle groups and knowing how stress affects thoughts, feelings and behavior. Third session: breathing exercise, visualization, and mutual analysis of thoughts and feelings and in active gradual muscular relaxation and the introduction of some common negative thoughts and cognitive deviations. Fifth session:Training self-born weight and heat, and illogical thought replace ment with logical thoughts. Sixth session: self-born training for heart beat, abdominal and for head breath, training different practical reaction styles. Seventh session: self-born training along with visualization and self-telling and using effective check responses. Eighth session: practicing mantra meditation and training anger management techniques. Nineth session: meditation and breath count training and training expressions in interpersonal relationships. Tenth session: descriping the benefits of social support, measuring the social support domain, perceiving it´s maintenance drawbacks and training social support techniques and planning personal stress management.</i_keyword>
      <i_keyword>Control group: The control group pre-test will be taken at the same time as the test group. During the 6 weeks of the test group doing the training protocol, the control group has no exercise or training and continues the ordinary life and again after this time, they will have their post-test with the test group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Static balance. Timepoint: One day before the start of the Static balance training protocol is assessed and participants are performed for 6 weeks, three sessions a week, and 48 hours after the last day of training, re-Static balance will be assessed. Method of measurement: One-leg balance.</prim_outcome>
      <prim_outcome>Speed walking. Timepoint: One day before the start of the Speed walking training protocol is assessed and participants are performed for 6 weeks, three sessions a week, and 48 hours after the last day of training, re-Speed walking will be assessed. Method of measurement: Timed 25-Foot Walk.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: One day before the start of the quality of life training protocol is assessed and participants are performed for 6 weeks, three sessions a week, and 48 hours after the last day of training, re-quality of life will be assessed. Method of measurement: Multiple Sclerosis Impact Scale (MSIS-29).</prim_outcome>
      <prim_outcome>Stress. Timepoint: One day before the start of the stress training protocol is assessed and participants are performed for 6 weeks, three sessions a week, and 48 hours after the last day of training, re-stress will be assessed. Method of measurement: Stress Scale-DASS-21.</prim_outcome>
      <prim_outcome>Dynamic balance. Timepoint: One day before the start of the Dynamic balance training protocol is assessed and participants are performed for 6 weeks, three sessions a week, and 48 hours after the last day of training, re-Dynamic balance will be assessed. Method of measurement: Timed Up and Go Test.</prim_outcome>
      <prim_outcome>Fear of falling. Timepoint: One day before the start of the Fear of falling training protocol is assessed and participants are performed for 6 weeks, three sessions a week, and 48 hours after the last day of training, re-Fear of falling will be assessed. Method of measurement: Short scale "Falling efficiency" international form in multiple sclerosis patients.</prim_outcome>
      <prim_outcome>Trust balance. Timepoint: One day before the start of the Trust balance training protocol is assessed and participants are performed for 6 weeks, three sessions a week, and 48 hours after the last day of training, re-Trust balance will be assessed. Method of measurement: Scale of trust in the special balance of activities.</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>The University of Arak</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-03</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Pardis site of University Medical Science., Deputy of research., Basij Square., Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
