<?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>IRCT2013082614481N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-10-25</date_registration>
      <primary_sponsor>University of Social Welfare and  Rehabilitation Sciences</primary_sponsor>
      <public_title>The effect of vestibular interventions on balance and function in children with spastic Cerebral Palsy</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of active and passive vestibular intervention on balance and function in children with spastic Cerebral Palsy (7-12y) Tehran-Iran</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>14</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14103</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cerebral palsy.</hc_freetext>
      <i_freetext>Intervention 1: Control group will receive traditional Occupational Therapy program for 45 minutes. Traditional Occupational Therapy program Consists of: muscle tone moderate, reflexes moderate, muscle stretch, balance training. Intervention duration will be 6 weeks, 3 times in week. Intervention 2: First intervention group will receive active vestibular stimulation according to special program for 15 minutes. This program developed by Hossieny(2007).Also they will receive traditional Occupational Therapy program (muscle tone moderate, reflexes moderate, muscle stretch, balance training) for 30 minutes. Intervention duration will be 6 weeks, 3 times in week. Intervention 3: Second intervention group will receive passive vestibular stimulation by vestibular bed for 15 minutes. Vestibular bed implements controlled vestibular stimulation according to angle, direction and speed of movement. Also they will use traditional Occupational Therapy program (muscle tone moderate, reflexes moderate, muscle stretch, balance training) for 30 minutes. Intervention duration will be 6 weeks, 3 times in week.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>      Title: The Effect of Active and Passive Vestibular Intervention on Balance and Function in Children with  Spastic Cerebral Palsy (7-12Y)&lt;br /&gt;&#13;
Background and Objectives: Postural control dysfunction is a serious problem in children with cerebral palsy, and the vestibular system is known to play an important role. This Randomized Control Trail study with blinded evaluator was conducted to examine the effect of vestibular intervention on static balance; and the relationship between balance changes and Quality of Life and Activity of Daily Living in school aged cerebral palsy children (CP) aged 7-12 years.&lt;br /&gt;&#13;
Methods: Frothy two children with Spastic CP with 1-2 level of Gross Motor Function Classification System )GMFCS (aged7-12 years were enrolled and randomly assigned in to three groups: control, active and passive. Berg and Bruniniks-Oserstsky Test of Motor Proficiency II (BOT II) and Force Plat (during eyes closed and open) were measured functional and laboratory parameters of balance changes, respectively. Function was assessed by Activities Scale for Kids (ASK) for Activity of Daily Living and Cerebral Palsy Quality of Life questionnaire (CP-QOL) for Quality of Life. Participants in active or passive group received active and passive vestibular stimulation for 20 minutes and traditional Occupational Therapy (OT) program for 40 minutes. Children in control group received traditional OT program for 60 minutes. Interventions were provided 3 d/week for 6 weeks. Participants assessed at three stages: after, before and 8 weeks after intervention. Data analyzed by "Repeated Measure ANOVA” and liner Regression.&lt;br /&gt;&#13;
Results: The passive intervention significantly increased Berg scores (p=0/006), decreased the area (P=0.025) and the range of Center of Pressure displacement in Anterior-Posterior plan during eyes closed(P=0.047). Changes score relationship between Berg and ASK (r =0.51 p0.05).&lt;br /&gt;&#13;
Conclusion: This study showed that passive stimulation can improve some balance parameters in children with Spastic CP. It may be related to re-organization of vestibular system with controlled and precise application of stimuli.  &lt;br /&gt;&#13;
Keywords: Cerebral Palsy, Active Vestibular Stimulation, Passive Vestibular Stimulation, Balance, Quality of Life, Activity of Daily Living&lt;br /&gt;&#13;
     </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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Khodaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Ave,  Daneshjo Blvd, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0016</telephone>
        <email>amozesh@uswr.ac.irkh.ardakani@uswr.ac.ir</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Ali Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Ave,  Daneshjo Blvd, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0123</telephone>
        <email>sahosseini@uswr.ac.ir</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
Diagnosis of spastic Cerebral Palsy; age of  7-12 y; to understand  experimental procedures; to stand independently for at least 30 seconds;    GMFCS( Gross Motor Function Classification System) level l or ll; Modified Ashworth 0-3 score of ankle.   &#13;
Exclusion criteria:    &#13;
 Orthopedic surgery of the lower limbs within 6 months; history of dislocation, Subluxation,the difference between the length or other obvious deformity in hip ,knee and ankle joint; botulinum toxin injections within 6 months; uncontrolled seizure; moderate to severe intellectual disability; visual or hearing impairment .</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80.0, G80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>G80.0, Spastic quadriplegic cerebral palsy Spastic tetraplegic cerebral palsy G80.1 Spastic diplegic cerebral palsy Congenital spastic paralysis (cerebral) Spastic cerebral palsy NOS G80.2 Spastic hemiplegic cerebral palsy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group will receive traditional Occupational Therapy program for 45 minutes. Traditional Occupational Therapy program Consists of: muscle tone moderate, reflexes moderate, muscle stretch, balance training. Intervention duration will be 6 weeks, 3 times in week.</i_keyword>
      <i_keyword>First intervention group will receive active vestibular stimulation according to special program for 15 minutes. This program developed by Hossieny(2007).Also they will receive traditional Occupational Therapy program (muscle tone moderate, reflexes moderate, muscle stretch, balance training) for 30 minutes. Intervention duration will be 6 weeks, 3 times in week.</i_keyword>
      <i_keyword>Second intervention group will receive passive vestibular stimulation by vestibular bed for 15 minutes. Vestibular bed implements controlled vestibular stimulation according to angle, direction and speed of movement. Also they will use traditional Occupational Therapy program (muscle tone moderate, reflexes moderate, muscle stretch, balance training) for 30 minutes. Intervention duration will be 6 weeks, 3 times in week</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Function. Timepoint: Before,  6 weeks after  intervention and 8 weeks later. Method of measurement: Activities Scale for Kids, Cerebral Palsy Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Balance. Timepoint: Before,  6 weeks after  intervention and 8 weeks later. Method of measurement: Force plate, Berg.</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>2012-09-24</approval_date>
        <contact_name>University of Social Welfare and  Rehabilitation Sciences</contact_name>
        <contact_address>Kodakyar Ave., Daneshjo Blvd.,Evin Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
