CareToy Early Intervention in Infants at Risk for Cerebral Palsy

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: CareToy intervention; Other: Infant Massage

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Toscana
    • Marina di Pisa-Tirrenia-Calambrone, Toscana, Italy, 56128
      • IRCCS Fondazione Stella Maris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CareToy Intervention; 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.	Device: CareToy intervention; Infants will perform goal directed activities inside the CareToy System; Other Names: CT
Active Comparator: Infant Massage; 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.	Other: Infant Massage; Infants will received IM by their parents; Other Names: IM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: IRCCS Fondazione Stella Maris

Publications and helpful links

General Publications

• 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.
• Menici V, Antonelli C, Beani E, Mattiola A, Giampietri M, Martini G, Rizzi R, Cecchi A, Cioni ML, Cioni G, Sgandurra G; Caretoy-R Consortium. Feasibility of Early Intervention Through Home-Based and Parent-Delivered Infant Massage in Infants at High Risk for Cerebral Palsy. Front Pediatr. 2021 Jul 19;9:673956. doi: 10.3389/fped.2021.673956. eCollection 2021.
• Rizzi R, Menici V, Cioni ML, Cecchi A, Barzacchi V, Beani E, Giampietri M, Cioni G, Sgandurra G; Clinical CareToy-R Consortium. Concurrent and predictive validity of the infant motor profile in infants at risk of neurodevelopmental disorders. BMC Pediatr. 2021 Feb 6;21(1):68. doi: 10.1186/s12887-021-02522-5.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2017
• Primary Completion (Actual): September 7, 2020
• Study Completion (Actual): November 4, 2020

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Early Intervention; CareToy Intervention; Infant Massage; Information Communication Technology
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: RF-2013-02358095 CareToy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No