<?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>IRCT20220616055192N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-11</date_registration>
      <primary_sponsor>The university of Faisalabad</primary_sponsor>
      <public_title>effects of virtual rehabilitation on upper extremity motor learning in hemiplegic cerebral palsy</public_title>
      <acronym></acronym>
      <scientific_title>effects of virtual rehabilitation on upper extremity motor learning in hemiplegic cerebral palsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64345</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: The method used for randomization was simple randomization. The randomization unit was done on an individual basis. A computer software randomized tool is used, Blinding description: the participants will be unaware in which group they will be allocated after meeting the inclusion criteria an informed consent will be taken from them by physiotherapist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cerebral palsy is a prevalent neurodevelopmental disorder that ranging from 1.5 to 2.5/1000 births beginning in the early childhood and continues throughout life. It causing the non-progressive disturbance of motor function that influences posture and movement, motor coordination with secondary complications of contractures and bone deformity. These alternations leading to hindrance in independent performance of daily activities.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group Patients in this group will be given through regular physiotherapy as well as virtual rehabilitation. The Upper extremity Virtual Rehabilitation training sessions will be two times each week for eight weeks (2 months). For training, non-Immersion Microsoft Xbox Kinect will be used. The Xbox-Kinect display place used an infrared camera to detect handlers' physical motions in 3-D space for interactive activities inside the game, eliminating the requirement for the user to carry an interface device.  In Intervention sessions each child will participate in a total of sixteen sessions of forty minute each. Intervention 2: Control group: In this group patients will underwent routine physiotherapy program. The protocol includes passive stretching and strengthening exercises. On the affected side, the therapist will use resistance to strengthen the muscles. Each exercise will takes place for 20 minutes 10 repetitions, twice a week, for 8 weeks.</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 collected deidentified participant data set for the outcome measures

When:
4 months after publication

To whom:
people working in the academic institutions

Conditions:
IPD and any additional supporting documents will be provided for research on similar topic and can be obtained by asking through contact person

Where to obtain:
contact person: Fizza Hussain Mobile No. 923041676206
email address : drfizzahussain206@gmail.com

How to obtain:
Data files will be provided after talking to contact person mentioned above

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sidra Majeed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4 km, Sargodha Road, University Town, Faisalabad, Pakistan</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 334 7731241</telephone>
        <email>sidra.majeed@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fizza Hussain</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>83/A Millat colony No. 2 D type Colony Faisalabad, Pakistan</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38080</zip>
        <telephone>+92 304 1676206</telephone>
        <email>drfizzahussain206@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients between 5 to 10 years old
Diagnosed as hemiplegic cerebral palsy
Both genders will include
Being able to cooperate and being motivated will include in the study
Patients who are able to understand and clearly follow verbal instructions and command that include in training and evaluation.
Patients with Gross Motor Function Classification Scale  level 1, 2 and 3 will include</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with visual impairments and auditory problem
Patients with severe spasticity (Modified Ashworth spasticity score of 4)  excluded from the study
Patients with Psychological illness
Participants Suffered from uncontrolled seizures
Patients injected with Botulinum toxin injections within past three months were excluded
Patients having prior surgery for spasticity within past 3 months were excluded from study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral palsy, unspecified</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 Patients in this group will be given through regular physiotherapy as well as virtual rehabilitation. The Upper extremity Virtual Rehabilitation training sessions will be two times each week for eight weeks (2 months). For training, non-Immersion Microsoft Xbox Kinect will be used. The Xbox-Kinect display place used an infrared camera to detect handlers' physical motions in 3-D space for interactive activities inside the game, eliminating the requirement for the user to carry an interface device.  In Intervention sessions each child will participate in a total of sixteen sessions of forty minute each.</i_keyword>
      <i_keyword>Control group: In this group patients will underwent routine physiotherapy program. The protocol includes passive stretching and strengthening exercises. On the affected side, the therapist will use resistance to strengthen the muscles. Each exercise will takes place for 20 minutes 10 repetitions, twice a week, for 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spasticity and impaired range of motion in the upper extremity. Timepoint: motor function will be measured at start of treatment sessions and after eight weeks after treatment sessions finished. Method of measurement: modified ashworth scale will use.</prim_outcome>
      <prim_outcome>Motor dysfunction in the upper limb. Timepoint: motor function will be measured at start of treatment sessions and after eight weeks after treatment sessions finished. Method of measurement: ABILHAND - KIDS and PMAL scale will use.</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 Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-07</approval_date>
        <contact_name>Ethics Committee of The University of Faisalabad</contact_name>
        <contact_address>4-km, Sargodha road, University Town, Faisalabad, Pakistan Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
