<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03234959</url>
  </required_header>
  <id_info>
    <org_study_id>RF-2013-02358095 CareToy</org_study_id>
    <nct_id>NCT03234959</nct_id>
  </id_info>
  <brief_title>CareToy Early Intervention in Infants at Risk for Cerebral Palsy</brief_title>
  <official_title>CareToy: a Smart System for Early Home-based Intervention in Infants at High Risk for Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Fondazione Stella Maris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Fondazione Stella Maris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cerebral Palsy (CP), due to pre-perinatal brain lesions, is a main cause of childhood&#xD;
      disabilities with high cost for individuals and society. Early Intervention (EI), if&#xD;
      intensive enough but affordable by patients, family and health services can improve its&#xD;
      outcome. A recent Cochrane review indicates the positive effects of Infant Massage (IM) in&#xD;
      gross and fine motor skills, visual development and parent infants interaction in preterm&#xD;
      infants. Recently, a new technological tool, called CareToy has been developed as a&#xD;
      tele-rehabilitation tool for delivering at home EI. The effects of CT training on&#xD;
      neurodevelopmental outcome have been recently tested in a sample of low-risk preterm infants&#xD;
      with very promising results. The aim of the project is to provide evidence, by a RCT, of the&#xD;
      efficacy of CareToy (CT) training versus Infant Massage, in a sample of 45 infants aged 3-12&#xD;
      months (or with motor competencies from initial head control to unstable sitting position) at&#xD;
      high risk for CP according to strict clinical and neuroradiological signs. Enrolled infants&#xD;
      will be randomized in 2 groups: CareToy and Infant Massage. Infants allocated in CT group&#xD;
      will perform a training with CT while the others will perform infant massage. Both trainings&#xD;
      will be carried out at home by parents with the monitoring of the therapists. Both&#xD;
      interventions will last 8 weeks. All enrolled infants will be evaluated at baseline (T0),9&#xD;
      wks after the CT/IM (T1), 9 wks after T1 (T2) and at 18 months of post term age (T3). Infant&#xD;
      Motor Profile will be the primary outcome measure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The eligibility of infants, i.e. infants who meet the criteria for inclusion and exclusion&#xD;
      (i.e infants at high-risk for CP) will be evaluated by the Neonatology team and the&#xD;
      recruitment will be done after discharge from Neonatal Intensive Care Unit (NICU) during the&#xD;
      follow up performed by infants previously enrolled in the first observational phase (aimed to&#xD;
      identify infants at high risk for CP) and will begin with the signing of the participation&#xD;
      agreement by the parents. The study is designed as randomized clinical trial. Recruited&#xD;
      infants will be randomized in two groups: CareToy intervention vs Infant Massage. All infants&#xD;
      will perform the home based and family centered early intervention according to their&#xD;
      allocation group for 8 weeks. Before (T0), after the intervention period (T1) and in follow&#xD;
      up (at T2, 8 wks after T1 and at 18 mths of post term age) all infants will be evaluated with&#xD;
      standardized scales and questionnaires in order to evaluate the effects of EI on motor,&#xD;
      cognitive and visual development and parent-infant interaction. Moreover the sleep&#xD;
      organization, before and after the intervention, will be studied using actigraphs. The sample&#xD;
      size has been calculated on the basis of the primary outcome measure (Infant Motor Profile).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2017</start_date>
  <completion_date type="Actual">November 4, 2020</completion_date>
  <primary_completion_date type="Actual">September 7, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Infant Motor Profile (IMP)</measure>
    <time_frame>Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the CT/IM period (T1); 8 weeks after the end of CT/IM periods (T2); at 18 mths of post term age (T3)</time_frame>
    <description>It is a video-based and qualitative assessment of motor behaviour in infancy, applicable in preterm and at term infants aged 3 to 18 months. It consists of 80 items addressed to explore the child's motor abilities and to evaluate motor behaviour.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Peabody Developmental Motor Scales Second Edition (PDMS-2)</measure>
    <time_frame>Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the CT/IM period (T1); 8 weeks after the end of CT/IM periods (T2), at 18 mths of post term age (T3)</time_frame>
    <description>PDMS-2 is composed of six subtests that measure interrelated abilities in early motor development. It was designed to assess gross and fine motor skills in children from birth through five years of age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Teller Acuity Cards</measure>
    <time_frame>Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the CT/IM period (T1); 8 weeks after the end of CT/IM periods (T2); at 18 mths of post term age (T3)</time_frame>
    <description>Teller Acuity Cards are used to evaluate visual acuity in infants and children. It is based on judgement of the infant attention to a series of cards showing stripes of different widths. This tool allows rapid assessment of resolution (grating) visual acuity in infants and young children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Bayley Cognitive subscale (BSID-III)</measure>
    <time_frame>Baseline (i.e within 1 week before the beginning of study, T0); at 18 mths of post term age (T3)</time_frame>
    <description>This scale is sensitive in detecting differences between a normative sample and children at risk for delayed development, such as premature infants. Bayley III is appropriate for administration to children between the ages of 1 month and 42 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Care-Index</measure>
    <time_frame>Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the CT/IM period (T1); 8 weeks after the end of CT/IM periods (T2); at 18 mths of post term age (T3)</time_frame>
    <description>It assesses caregiver-infant interaction from birth to about two years of age based on a short, videotaped play interaction of 3-5 minutes. The measure assesses caregivers on three scales: sensitivity, control and unresponsiveness. There are also four scales for infants: cooperativeness, compulsivity, difficultness, and passivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sleep organization</measure>
    <time_frame>Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the end of the CT/IM period (T1)</time_frame>
    <description>It is simpler and less invasive survey instrument for the objective assessment of the sleep, which allows for prolonged monitoring (from days to months). It uses acceleration sensors, the size of a watch, usually worn on the wrist the non-dominant hand. Dedicated algorithms have been developed to the identification of sleep in pediatric populations.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>CareToy Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants will perform individualized goal-directed activities for 30-45 minutes per day with CT system, while continuing SC. The CT training will be monitored and modified remotely by clinical staff, according to infants' developmental needs, abilities and progresses. It will last 8 wks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infant Massage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infants and their caregivers will perform 4-5 sessions (around 1 hour every 2 weeks) of Infant massage conducted by an expert child therapist. The therapist will instruct the parent in the baby's massage and provide advises on promoting development. Parents will be invited to perform infant massage five days a week, for 8 weeks. Parent will take a diary in which will record the frequency of the IM.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CareToy intervention</intervention_name>
    <description>Infants will perform goal directed activities inside the CareToy System</description>
    <arm_group_label>CareToy Intervention</arm_group_label>
    <other_name>CT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infant Massage</intervention_name>
    <description>Infants will received IM by their parents</description>
    <arm_group_label>Infant Massage</arm_group_label>
    <other_name>IM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  i) abnormal neurological signs (i.e. neurological signs at the Hammersmith Infant&#xD;
             Neurological Assessment -HINE- and according to Prechtl's Assessment GMA) at 2-4 mts&#xD;
             post term age&#xD;
&#xD;
          -  ii) neuroimaging evidence of brain lesion indicated by MRI performed around the term&#xD;
             age (4-6 wks post term)&#xD;
&#xD;
          -  iii) achieved predefined motor development scores assessed by Ages and Stages&#xD;
             Questionnaire-3&#xD;
&#xD;
          -  iv) informed consent agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  i) Drug resistant seizures,&#xD;
&#xD;
          -  ii) Severe sensory deficits (blindness or deafness)&#xD;
&#xD;
          -  iii) Progressive neurological disorders&#xD;
&#xD;
          -  iv) Malformation of CNS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IRCCS Fondazione Stella Maris</name>
      <address>
        <city>Marina di Pisa-Tirrenia-Calambrone</city>
        <state>Toscana</state>
        <zip>56128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Sgandurra G, Beani E, Giampietri M, Rizzi R, Cioni G; CareToy-R Consortium. Early intervention at home in infants with congenital brain lesion with CareToy revised: a RCT protocol. BMC Pediatr. 2018 Sep 5;18(1):295. doi: 10.1186/s12887-018-1264-y.</citation>
    <PMID>30185165</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Early Intervention</keyword>
  <keyword>Cerebral Palsy</keyword>
  <keyword>CareToy Intervention</keyword>
  <keyword>Infant Massage</keyword>
  <keyword>Information Communication Technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03234959
org study id: RF-2013-02358095 CareToy
nct id: NCT03234959
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cerebral Palsy (CP), due to pre-perinatal brain lesions, is a main cause of childhood
      disabilities with high cost for individuals and society. Early Intervention (EI), if
      intensive enough but affordable by patients, family and health services can improve its
      outcome. A recent Cochrane review indicates the positive effects of Infant Massage (IM) in
      gross and fine motor skills, visual development and parent infants interaction in preterm
      infants. Recently, a new technological tool, called CareToy has been developed as a
      tele-rehabilitation tool for delivering at home EI. The effects of CT training on
      neurodevelopmental outcome have been recently tested in a sample of low-risk preterm infants
      with very promising results. The aim of the project is to provide evidence, by a RCT, of the
      efficacy of CareToy (CT) training versus Infant Massage, in a sample of 45 infants aged 3-12
      months (or with motor competencies from initial head control to unstable sitting position) at
      high risk for CP according to strict clinical and neuroradiological signs. Enrolled infants
      will be randomized in 2 groups: CareToy and Infant Massage. Infants allocated in CT group
      will perform a training with CT while the others will perform infant massage. Both trainings
      will be carried out at home by parents with the monitoring of the therapists. Both
      interventions will last 8 weeks. All enrolled infants will be evaluated at baseline (T0),9
      wks after the CT/IM (T1), 9 wks after T1 (T2) and at 18 months of post term age (T3). Infant
      Motor Profile will be the primary outcome measure.
The eligibility of infants, i.e. infants who meet the criteria for inclusion and exclusion
      (i.e infants at high-risk for CP) will be evaluated by the Neonatology team and the
      recruitment will be done after discharge from Neonatal Intensive Care Unit (NICU) during the
      follow up performed by infants previously enrolled in the first observational phase (aimed to
      identify infants at high risk for CP) and will begin with the signing of the participation
      agreement by the parents. The study is designed as randomized clinical trial. Recruited
      infants will be randomized in two groups: CareToy intervention vs Infant Massage. All infants
      will perform the home based and family centered early intervention according to their
      allocation group for 8 weeks. Before (T0), after the intervention period (T1) and in follow
      up (at T2, 8 wks after T1 and at 18 mths of post term age) all infants will be evaluated with
      standardized scales and questionnaires in order to evaluate the effects of EI on motor,
      cognitive and visual development and parent-infant interaction. Moreover the sleep
      organization, before and after the intervention, will be studied using actigraphs. The sample
      size has been calculated on the basis of the primary outcome measure (Infant Motor Profile).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Changes in Infant Motor Profile (IMP)
time frame: Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the CT/IM period (T1); 8 weeks after the end of CT/IM periods (T2); at 18 mths of post term age (T3)
description: It is a video-based and qualitative assessment of motor behaviour in infancy, applicable in preterm and at term infants aged 3 to 18 months. It consists of 80 items addressed to explore the child's motor abilities and to evaluate motor behaviour.
measure: Changes in Peabody Developmental Motor Scales Second Edition (PDMS-2)
time frame: Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the CT/IM period (T1); 8 weeks after the end of CT/IM periods (T2), at 18 mths of post term age (T3)
description: PDMS-2 is composed of six subtests that measure interrelated abilities in early motor development. It was designed to assess gross and fine motor skills in children from birth through five years of age.
measure: Changes in Teller Acuity Cards
time frame: Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the CT/IM period (T1); 8 weeks after the end of CT/IM periods (T2); at 18 mths of post term age (T3)
description: Teller Acuity Cards are used to evaluate visual acuity in infants and children. It is based on judgement of the infant attention to a series of cards showing stripes of different widths. This tool allows rapid assessment of resolution (grating) visual acuity in infants and young children.
measure: Changes in Bayley Cognitive subscale (BSID-III)
time frame: Baseline (i.e within 1 week before the beginning of study, T0); at 18 mths of post term age (T3)
description: This scale is sensitive in detecting differences between a normative sample and children at risk for delayed development, such as premature infants. Bayley III is appropriate for administration to children between the ages of 1 month and 42 months.
measure: Changes in Care-Index
time frame: Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the CT/IM period (T1); 8 weeks after the end of CT/IM periods (T2); at 18 mths of post term age (T3)
description: It assesses caregiver-infant interaction from birth to about two years of age based on a short, videotaped play interaction of 3-5 minutes. The measure assesses caregivers on three scales: sensitivity, control and unresponsiveness. There are also four scales for infants: cooperativeness, compulsivity, difficultness, and passivity.
measure: Changes in sleep organization
time frame: Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the end of the CT/IM period (T1)
description: It is simpler and less invasive survey instrument for the objective assessment of the sleep, which allows for prolonged monitoring (from days to months). It uses acceleration sensors, the size of a watch, usually worn on the wrist the non-dominant hand. Dedicated algorithms have been developed to the identification of sleep in pediatric populations.
arm group label: CareToy Intervention
arm group type: Experimental
description: Infants will perform individualized goal-directed activities for 30-45 minutes per day with CT system, while continuing SC. The CT training will be monitored and modified remotely by clinical staff, according to infants' developmental needs, abilities and progresses. It will last 8 wks.
arm group label: Infant Massage
arm group type: Active Comparator
description: Infants and their caregivers will perform 4-5 sessions (around 1 hour every 2 weeks) of Infant massage conducted by an expert child therapist. The therapist will instruct the parent in the baby's massage and provide advises on promoting development. Parents will be invited to perform infant massage five days a week, for 8 weeks. Parent will take a diary in which will record the frequency of the IM.
intervention type: Device
intervention name: CareToy intervention
description: Infants will perform goal directed activities inside the CareToy System
arm group label: CareToy Intervention
other name: CT
intervention type: Other
intervention name: Infant Massage
description: Infants will received IM by their parents
arm group label: Infant Massage
other name: IM
criteria: 
gender: All
minimum age: 3 Months
maximum age: 12 Months
healthy volunteers: No
facility: 
country: Italy
citation: Sgandurra G, Beani E, Giampietri M, Rizzi R, Cioni G; CareToy-R Consortium. Early intervention at home in infants with congenital brain lesion with CareToy revised: a RCT protocol. BMC Pediatr. 2018 Sep 5;18(1):295. doi: 10.1186/s12887-018-1264-y.
PMID: 30185165
responsible party type: Sponsor
mesh term: Paralysis
mesh term: Cerebral Palsy