<?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>IRCT20180908040970N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-19</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Occupation-Based Interventions</public_title>
      <acronym></acronym>
      <scientific_title>The Investigation of the effect of Occupation-Based Interventions on hand and upper extermity function in patients with hand burn injury</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35458</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: After selecting and determining the number of samples, individuals are completely randomized  using the random number table in two groups (standard protocol and standard protocol with CO-OP protocol), Blinding description: In this study, none of the participants are aware of which intervention and control groups are involved, the assessor is not aware of how the exercises are carried out and the placement of people in each group at all stages of the study. The final analyst will not be aware of any interventions in each of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hand Burn Injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group received interventional interventions after two weeks (6 sessions) and received conventional interventions such as stretching, exercises for increasing passive and active motion, sensory improvement exercises, splinting, exercises for increasing tolerance and muscle strength, managing oscillation and edema; receiving interventions based on acupuncture The CO-OP protocol is used in this group. Intervention 2: Control group: The control group only received the most common rehabilitation interventions, including stretching, exercising of the passive and active motion amplification, sensory improvement exercises, splinting, exercises, increased tolerance and muscle strength, and management of scars and edema.</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:
All of the data and information on the main and secondary outcomes of the post-print study are shared.

When:
The access period begins 6 months after the results are published.

To whom:
Learn to pronounce
Data will be available only to researchers working in academic and scientific institutions.

Conditions:
1. Use data only to evaluate effective therapies.
2. Applicants must be legal entities registered in educational or scientific centers.
3. The applicant shall undertake not to use the data for personal gain or unrelated scientific studies and in other fields.
3. The requesting person shall undertake not to misuse data in unrelated contexts.

Where to obtain:
The data can be accessed by contacting the following people and sending the requested information up to one week after receiving the request and confirming the conditions:
1.Mahnoosh Khanipour by Email Address:
mah.pouroushan@gmail.com
2. Dr. Laleh Lajevardi by Email Address:
laleh23275@yahoo.com
3. Dr. Ghorban Taghizadeh by Email Address:
gh_taghizade@yahoo.com

How to obtain:
Access to the data can be done first via e-mail with the lead researcher studying the correspondence. Subsequently, the necessary information is sent by providing substantiated evidence of the eligibility requirements for the data and confirming the stated evidence and reasons. If the principal investigator fails to respond, the necessary guidance and counseling correspondence can be provided, which will be resubmitted in accordance with the above-mentioned conditions and steps.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnoosh Khanipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.17,Habibnejad street,Estakhr Ave,Tehranpars</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1656945469</zip>
        <telephone>+98 21 7711 2441</telephone>
        <email>Mah.pouroushan@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnoosh Khanipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.17,Habibnejad street,Estakhr Ave,Tehranpars</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1656945469</zip>
        <telephone>+98 21 7711 2441</telephone>
        <email>Mah.pouroushan@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18-65 years old
3-5 days after surgery
Having an acceptable level of cognitive performance, score 21 and above, in the Expedient Examination Test (MMSE).
Depth of burn 2 and 3, and burn circumference 2.5%.
Not having any injuries such as fractures, tendon injuries, or injured infections.
Psychological problems that lead to non-cooperation with the implementation of therapeutic protocols</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of cooperation and willingness to continue cooperation.
Missing more than two sessions.
Unwanted side effects after surgery such as infection, severe swelling and recurrence of ulcers.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T23.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn of unspecified degree of wrist and hand</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: The intervention group received interventional interventions after two weeks (6 sessions) and received conventional interventions such as stretching, exercises for increasing passive and active motion, sensory improvement exercises, splinting, exercises for increasing tolerance and muscle strength, managing oscillation and edema; receiving interventions based on acupuncture The CO-OP protocol is used in this group.</i_keyword>
      <i_keyword>Control group: The control group only received the most common rehabilitation interventions, including stretching, exercising of the passive and active motion amplification, sensory improvement exercises, splinting, exercises, increased tolerance and muscle strength, and management of scars and edema</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Occupational Performance rate in the Canadian Occupational Performance Measure. Timepoint: Time intervals for evaluation at the beginning of the study (before the intervention), after the second week, after the eighth week and after the sixteenth week. Method of measurement: Canadian occupational Performance measure (COPM).</prim_outcome>
      <prim_outcome>Hand Performance rate in the Michigan Hand Questionnaire. Timepoint: Time intervals for evaluation at the beginning of the study (before the intervention), after the second week, after the eighth week and after the sixteenth week. Method of measurement: Michigan Hand Questionnaire (MHQ).</prim_outcome>
      <prim_outcome>Disability rate in Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire. Timepoint: Time intervals for evaluation at the beginning of the study (before the intervention), after the second week, after the eighth week and after the sixteenth week. Method of measurement: Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire(Q-DASH).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of pain. Timepoint: Time intervals for evaluation at the beginning of the study (before the intervention), after the second week, after the eighth week and after the sixteenth week. Method of measurement: Visual Analog Scale.</sec_outcome>
      <sec_outcome>Goniometer. Timepoint: Time intervals for evaluation at the beginning of the study (before the intervention), after the second week, after the eighth week and after the sixteenth week. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Edema rate. Timepoint: Time intervals for evaluation at the beginning of the study (before the intervention), after the second week, after the eighth week and after the sixteenth week. Method of measurement: meter.</sec_outcome>
      <sec_outcome>Muscle strength. Timepoint: Time intervals for evaluation at the beginning of the study (before the intervention), after the second week, after the eighth week and after the sixteenth week. Method of measurement: Dynamometer.</sec_outcome>
      <sec_outcome>Ability to perform Activities of Daily Living. Timepoint: Time intervals for evaluation at the beginning of the study (before the intervention), after the second week, after the eighth week and after the sixteenth week. Method of measurement: Modified Barthel Index (MBI).</sec_outcome>
      <sec_outcome>Quality Of Life level. Timepoint: Time intervals for evaluation at the beginning of the study (before the intervention), after the second week, after the eighth week and after the sixteenth week. Method of measurement: World Health Organization Quality Of Life-Brief  (WHOQOL-BRIEF ).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-10</approval_date>
        <contact_name>Ethics committee of Iran university of medical Sciences</contact_name>
        <contact_address>school of rehabilitation science,  madadkaran Lane, Shahid Shah Nazari Street, Mother Square,  Mirdamad. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
