<?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>IRCT20210505051194N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-03</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of energy conservation strategies on fatigue, function and quality of life in adult with motor neuron disease</public_title>
      <acronym></acronym>
      <scientific_title>Effect of energy conservation strategies on fatigue, function and quality of life in adult with motor neuron disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56365</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After initial evaluation, samples will be assigned into one of the 2 groups A or B group using sealed envelops, the patients have to pick up one the sealed envelops, so their group will be defined randomly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Motor neuron disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group(A): Patients in the intervention group participated in 3 weekly, 1-hour energy conservation programs provided by an experienced OT.The principles used during the ECM program include The importance of rest during the day, energy budgeting, setting rest periods during the day, administration of proper body mechanics and posture, separating of each daily activity to several components, prioritizing activities, teaching ergonomic principles, analyzing and utilization of the way that ADLs are performed, and environmental change. The training sessions were based on the theory of psychoeducational group development and included discussions about the nature of illness and fatigue, setting short-term and long-term goals, doing homework, and execution of strategies at home. In the first session, patients were taught about the MND nature, the effects of fatigue on ADL, and the importance of rest and adjusting rest periods during the day. Patients were asked to explain their daily routine and the barriers they encounter during activities. The patient, along with the OT, sets short rest periods between daily activities at certain times of the day. In the second session, the therapist spoke about the importance of correct body posturing and emphasized on the performing tasks in the sitting position rather than standing. Patients were taught to divide each activity into smaller, easier steps. The third session focused on prioritizing activities during the day, emphasizing on performing hard and exhausting work at the beginning of the day, and the importance of ergonomics and environment modifications. Intervention 2: Control group(B): Patients participated in 3 weekly, 1-hour occupational therapy sessions provided by an experienced OT in shariati hospital.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The findings of this study will be published as soon as possible.

When:
2023

To whom:
results will be available for journals readers data will be available for reasonable requests for example systematic reviews

Conditions:
systematic review and meta analysis

Where to obtain:
Shariati Hospital, Tehran, Rehabilitation Department

How to obtain:
Through email; (niloofar.ot92@gmail.com)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloofar Shirzad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1418815516</zip>
        <telephone>+98 21 8490 2110</telephone>
        <email>niloofar.ot92@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Niloofar Shirzad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1418815516</zip>
        <telephone>+98 21 8490 2110</telephone>
        <email>niloofar.ot92@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18-65 year
Mini mental status exam score more than 24
Beck depression inventory score less than 17
Pittsburgh Sleep Quality Index score less than 5
Fatigue severity scale more than 4
Patients able to walk with or without crutches</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with cardiopulmonary problems
Patients with no interests in participation in study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G12.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Motor neuron disease</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(A): Patients in the intervention group participated in 3 weekly, 1-hour energy conservation programs provided by an experienced OT.The principles used during the ECM program include The importance of rest during the day, energy budgeting, setting rest periods during the day, administration of proper body mechanics and posture, separating of each daily activity to several components, prioritizing activities, teaching ergonomic principles, analyzing and utilization of the way that ADLs are performed, and environmental change. The training sessions were based on the theory of psychoeducational group development and included discussions about the nature of illness and fatigue, setting short-term and long-term goals, doing homework, and execution of strategies at home. In the first session, patients were taught about the MND nature, the effects of fatigue on ADL, and the importance of rest and adjusting rest periods during the day. Patients were asked to explain their daily routine and the barriers they encounter during activities. The patient, along with the OT, sets short rest periods between daily activities at certain times of the day. In the second session, the therapist spoke about the importance of correct body posturing and emphasized on the performing tasks in the sitting position rather than standing. Patients were taught to divide each activity into smaller, easier steps. The third session focused on prioritizing activities during the day, emphasizing on performing hard and exhausting work at the beginning of the day, and the importance of ergonomics and environment modifications</i_keyword>
      <i_keyword>Control group(B): Patients participated in 3 weekly, 1-hour occupational therapy sessions provided by an experienced OT in shariati hospital.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Function. Timepoint: Before, after and one months after treatment. Method of measurement: Canadian occupational performance measure.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: Before, after and one months after treatment. Method of measurement: Fatigue severity scale.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before, after and one months after treatment. Method of measurement: SF36 questionnaire.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-03</approval_date>
        <contact_name>Ethics committee of Shahid beheshti University of Medical Sciences</contact_name>
        <contact_address>Damavand street, across from Buali hospital, Tehran, Iran.  SBMU School of Rehabilitation Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
