<?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>IRCT20210616051599N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-08</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Effectiveness of Leap Motion on hand function in children with cerebral palsy</public_title>
      <acronym>LMC</acronym>
      <scientific_title>Effectiveness of Leap Motion controller on the functionality of the upper limb in children with bilateral spastic cerebral palsy: Randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63095</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: In this study, the randomization method is simple. It is an individual randomization unit and its tool is using even and odd numbers that are provided to families in the envelope and those who choose odd numbers in the control group and people who choose even numbers in the intervention group Placed, Blinding description: In this study, occupational therapy graduates who were unaware of the division of children into control and intervention groups were used for evaluation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cerebral palsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, the intervention will be a clinical trial in two groups of intervention and control. At the beginning of the intervention phase, an assessment is made of the individuals. Then 12 weeks of intervention is performed by Leap Motion. The intervention is that the child performs all kinds of grip and pinch on the device and receives visual feedback and corrects it if necessary. At the end of 12 weeks, the evaluation is done again. Children are re-evaluated 4 weeks after the end of the intervention period. Intervention 2: Control group: In this study, the control group receives common occupational therapy interventions. At the beginning of the research, this group is evaluated. This evaluation will be performed again after 12 weeks. At 16 weeks, the third evaluation is performed.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The principle of confidentiality and moral principles</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sajjad sabbaghi siuki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>gharahni street. gharahni 5. No13</address>
        <city>torbat heiydariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9518943400</zip>
        <telephone>+98 51 5222 8297</telephone>
        <email>sajadsss1375@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>sajjad sabbaghi siuki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>garahni street. gahrani 5. No13</address>
        <city>torbat heydarieh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9518943400</zip>
        <telephone>+98 51 5222 8297</telephone>
        <email>sajadsss1375@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age category 5 to 8 years.
Ability to understand and follow simple verbal commands.
Diagnosis of bilateral spastic cerebral palsy by a neurologist based on medical records.
Level one or two or three manual ability classification system.
Level one or two or three systems of gross motor function.
No history of Botox injections, surgery and upper limb fractures during the last 6 months, according to a family report.
Grade 2 or less spastic tone based on the modified Ashworth scale in the flexor muscle group of the wrist and elbow joints.
Absence of obvious and noticeable deformity in the upper limbs based on clinical examination.
Non-participation in research using "Leap motion" during the last six months.
Absence of severe visual impairment.</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>8 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance / ability of the child and family to continue participating in the research.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral palsy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, the intervention will be a clinical trial in two groups of intervention and control. At the beginning of the intervention phase, an assessment is made of the individuals. Then 12 weeks of intervention is performed by Leap Motion. The intervention is that the child performs all kinds of grip and pinch on the device and receives visual feedback and corrects it if necessary. At the end of 12 weeks, the evaluation is done again. Children are re-evaluated 4 weeks after the end of the intervention period.</i_keyword>
      <i_keyword>Control group: In this study, the control group receives common occupational therapy interventions. At the beginning of the research, this group is evaluated. This evaluation will be performed again after 12 weeks. At 16 weeks, the third evaluation is performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Manual skill score in QUEST questionnaire. Timepoint: At the beginning of the study and in the 12th and 16th weeks after the start of the study. Method of measurement: QUEST questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Power grip. Timepoint: At the beginning of the study and at weeks 12 and 16 after the start of the study. Method of measurement: Dynamometer device.</sec_outcome>
      <sec_outcome>Lateral pinch, palmar pinch. Timepoint: At the beginning of the study and at weeks 12 and 16 after the start of the study. Method of measurement: pinch gauge device.</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>2021-06-09</approval_date>
        <contact_name>ethics committee of university of social welfare and rehabilitation sciences</contact_name>
        <contact_address>kodakyar Ave, Daneshjo Blvd, Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
