<?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>IRCT20180427039440N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-17</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effects of hydrotherapy for cerebral palsy</public_title>
      <acronym></acronym>
      <scientific_title>Effects of hydrotherapy on the motor development and spasm scores of the cerebral palsy  infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31302</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Translate
Turn off instant translation
980/5000
Selection of available research units is easy for children suffering from cerebral palsy who have criteria for entering the study. Subsequently, the units were randomly assigned and homogenized into two groups of intervention (receiving hydrotherapy) and dividing control They must be homogeneous in terms of gender and age before intervention. Before the sampling begins, by assigning either a pair or a person to a control or intervention group, the random numbers are sequentially numbered n (the sample size is a total of two The group is selected based on the number of pairs or individuals. The sequence of children selected by group Control and intervention. For example, if the individual numbers are assigned to the control group and the pair numbers to the intervention group, then the sequence of the numbers selected from the random number table is 8.5.1.4.2.1-6.0.7.7 The allocation of children to The two groups will be based on the sequence of referrals: intervention "control" intervention control "intervention" control "intervention" none "control. Choosing this random allocation method is due to the allocation of resources before the study begins, and no factor affects it during the research, Blinding description: Given the random selection of participants and their insertion in the control and intervention group and the use of code instead of the name for data analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cerebral palsy.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, the patients will be under the supervision of a researcher and physiotherapist, who will be held for 8 weeks a weekly 3 times in 1-hour sessions, 15 minutes for maternity leave and alternate dresses on individual or coupled days. will be. Due to administrative conflicts in the morning shift and the relative relaxation of the hospital in the shift in the era of intervention in the shift of the evening. Measurement of the second stage: After the intervention in the intervention group (the eighth week after the intervention), the second stage will measure the criteria for fine motor development and the score for spasticity, which is similar to the first stage in the evolutionary clinic of Ghayegh  Hospital Billy and Ashworth evolutionary tools will be used to measure the evolutionary criteria in the sensory-motor field and the spasm score. The control group will be evaluated without any intervention at the beginning and end of the work. Intervention 2: Control group: In the control group, without any intervention, will be evaluated only at the beginning of the work and the end (end of the two months).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zainab Razmyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.3, HEJAB1, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3523 5505</telephone>
        <email>razmyarz931@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zainab Razmyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO:37, HEJAB11, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3523 5505</telephone>
        <email>razmyarz931@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of cerebral palsy for the infant will be confirmed by the relevant physician.
The age of the infant is between 1 and 10 months.
Parents have a tendency to participate in the study.
According to a physician's diagnosis, with cerebral palsy, there is no physical illness or disorder in other systems of the body, such as any kidney and digestive problems and diabetes.
No malnutrition.</inclusion_criteria>
      <agemin>1 month</agemin>
      <agemax>10 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The child's primary caregiver does not want to cooperate.
The infant is admitted or required to undergo surgery.
During the intervention, diagnose any disease that affects the development process by the doctor for infants.
The infant dies during the intervention.</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>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, the patients will be under the supervision of a researcher and physiotherapist, who will be held for 8 weeks a weekly 3 times in 1-hour sessions, 15 minutes for maternity leave and alternate dresses on individual or coupled days. will be. Due to administrative conflicts in the morning shift and the relative relaxation of the hospital in the shift in the era of intervention in the shift of the evening. Measurement of the second stage: After the intervention in the intervention group (the eighth week after the intervention), the second stage will measure the criteria for fine motor development and the score for spasticity, which is similar to the first stage in the evolutionary clinic of Ghayegh  Hospital Billy and Ashworth evolutionary tools will be used to measure the evolutionary criteria in the sensory-motor field and the spasm score. The control group will be evaluated without any intervention at the beginning and end of the work.</i_keyword>
      <i_keyword>Control group: In the control group, without any intervention, will be evaluated only at the beginning of the work and the end (end of the two months).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motor Development and Spasm of the infants. Timepoint: Before and after the intervention. Method of measurement: Billy and Ashworth tools.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fine moor development, Groos motor development and spasm the Infanti. Timepoint: Before and after the intervention. Method of measurement: Billy and Ashworth tools.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-21</approval_date>
        <contact_name>The Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing University Street, Crossroad of the Ph.D. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
