CareToy Early Intervention in Infants at Risk for Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

CareToy: a Smart System for Early Home-based Intervention in Infants at High Risk for Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234959
• Other study ID #: RF-2013-02358095 CareToy
• Status: Completed
• Phase: N/A
• Start date: August 4, 2017
• Est. completion date: November 4, 2020

Study information

• Verified date: October 2019
• Source: IRCCS Fondazione Stella Maris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 4, 2020
• Est. primary completion date: September 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Months

Eligibility

Inclusion Criteria:

• i) abnormal neurological signs (i.e. neurological signs at the Hammersmith Infant Neurological Assessment -HINE- and according to Prechtl's Assessment GMA) at 2-4 mts post term age
• ii) neuroimaging evidence of brain lesion indicated by MRI performed around the term age (4-6 wks post term)
• iii) achieved predefined motor development scores assessed by Ages and Stages Questionnaire-3
• iv) informed consent agreement

Exclusion Criteria:

• i) Drug resistant seizures,
• ii) Severe sensory deficits (blindness or deafness)
• iii) Progressive neurological disorders
• iv) Malformation of CNS

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Device:
• CareToy intervention
Infants will perform goal directed activities inside the CareToy System

Other:
• Infant Massage
Infants will received IM by their parents

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Stella Maris	Marina di Pisa-Tirrenia-Calambrone	Toscana

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Fondazione Stella Maris

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Infant Motor Profile (IMP)	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.	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)
Secondary	Changes in Peabody Developmental Motor Scales Second Edition (PDMS-2)	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.	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)
Secondary	Changes in Teller Acuity Cards	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.	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)
Secondary	Changes in Bayley Cognitive subscale (BSID-III)	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.	Baseline (i.e within 1 week before the beginning of study, T0); at 18 mths of post term age (T3)
Secondary	Changes in Care-Index	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.	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)
Secondary	Changes in sleep organization	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.	Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the end of the CT/IM period (T1)