<?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>IRCT20211024052860N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-14</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effect of virtual reality camera-based mirror therapy on upper extremity motor function in patients with hemiplegic cerebral palsy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of virtual reality camera-based mirror therapy on upper extremity motor function in patients with hemiplegic cerebral palsy 8 to 12 years: a pilot study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59732</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before starting the study, a list of letters A and B is generated using the randomization site, which indicates the assignment of individuals to study groups, and individuals are placed in groups according to the order of entering the research, Blinding description: The evaluator is unaware of the assignment of individuals to the groups and the participants are divided into two groups of control and intervention by randomized program.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hemiplegic cerebral palsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mirror Therapy group will receive a virtual reality-based camera-based mirror therapy program in addition to conventional treatments three sessions per week for 8 weeks. The duration of each session will be 45 minutes, of which 20 minutes belong to the camera-based mirror therapy program based on virtual reality. Intervention 2: Control group: Common rehabilitation treatment group - Patients in this group will receive occupational therapy sessions three times a week for 8 weeks and the duration of each session will be 45 minutes. Patients in the standard rehabilitation group will perform standard therapy, routine rehabilitation therapy based on neuromuscular facilitation techniques (diagonal patterns), and Bobet neurodevelopmental technique with emphasis on practicing functional tasks as much as possible and fine motor activities. Weightlifting, reflex inhibition patterns, torso rotation, and scapula protrusion will also be used to reduce spasticity, if necessary, during exercise. Nearly 25 percent of the usual rehabilitation treatment time will be spent on compensatory techniques using a healthy limb to perform functional tasks and help the affected limb with a healthy hand during homework.</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 dissertation is kept in the occupational therapy department of the University of Rehabilitation Sciences and Social Health and the relevant articles are published in the relevant journals.

When:
Access period starts 6 months after the publication of the article

To whom:
All experts who work in this field

Conditions:
For clinical studies and in treatment

Where to obtain:
Refer to the Department of Occupational Therapy at the University of Rehabilitation Sciences and Social Health

How to obtain:
Obtaining permission from the Department of Occupational Therapy of the University of Rehabilitation Sciences and Social Health is required

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Hossein Nasiri Naeini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 22, First Floor, Shahid Navarani Blvd., Intersection of DaryaBlvd., Farahzadi Blvd., Sanat Sq., Gharb Town, Tehran,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1468973841</zip>
        <telephone>+98 21 8808 8666</telephone>
        <email>ah.nasiri@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Hossein Nasiri Naeini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 22, First Floor, Shahid Navarani Blvd., Intersection of DaryaBlvd., Farahzadi Blvd., Sanat Sq., Gharb Town, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1468973841</zip>
        <telephone>+98 21 8808 8666</telephone>
        <email>ah.nasiri@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 8 to 12 years
Hemiplegic cerebral palsy, diagnosed by a neurologist
Being at levels I, II and III of the MACS (manual ability classification system)
Ability to study at school
Mild spasticity involved in wrist flexor (modified Ashworth scale less than 2)</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study (not completing the consent form)
Use mirror therapy approaches before the intervention
Injection of Botox or surgery on the upper limb for up to 1 year before the intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spastic hemiplegic cerebral palsy</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: Mirror Therapy group will receive a virtual reality-based camera-based mirror therapy program in addition to conventional treatments three sessions per week for 8 weeks. The duration of each session will be 45 minutes, of which 20 minutes belong to the camera-based mirror therapy program based on virtual reality.</i_keyword>
      <i_keyword>Control group: Common rehabilitation treatment group - Patients in this group will receive occupational therapy sessions three times a week for 8 weeks and the duration of each session will be 45 minutes. Patients in the standard rehabilitation group will perform standard therapy, routine rehabilitation therapy based on neuromuscular facilitation techniques (diagonal patterns), and Bobet neurodevelopmental technique with emphasis on practicing functional tasks as much as possible and fine motor activities. Weightlifting, reflex inhibition patterns, torso rotation, and scapula protrusion will also be used to reduce spasticity, if necessary, during exercise. Nearly 25 percent of the usual rehabilitation treatment time will be spent on compensatory techniques using a healthy limb to perform functional tasks and help the affected limb with a healthy hand during homework.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Selective Control of the Upper Extremity Scale. Timepoint: The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks. Method of measurement: Selective Control of the Upper Extremity Scale Test.</prim_outcome>
      <prim_outcome>Gross manual dexterity. Timepoint: The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks. Method of measurement: Box and block test.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Large hand muscles strength. Timepoint: The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks. Method of measurement: Dynamometer.</prim_outcome>
      <prim_outcome>The strength of the delicate muscles of the hand. Timepoint: The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks. Method of measurement: Pinched gauge.</prim_outcome>
      <prim_outcome>Quality of Upper Extremity Skills. Timepoint: The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks. Method of measurement: Quality of Upper Extremity Skills Test.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-20</approval_date>
        <contact_name>Research Ethics Committees of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Kodakyar Ave., Daneshjo Blvd.,Evin, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
