CareToy Early Intervention in Infants at Risk for Cerebral Palsy

NCT ID: NCT03234959

Last Updated: 2020-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-04
• Study Completion Date: 2020-11-04

Brief 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.

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).

Conditions

Cerebral Palsy

Keywords

Early Intervention; Cerebral Palsy; CareToy Intervention; Infant Massage; Information Communication Technology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

CareToy intervention

Intervention Type: DEVICE

Infants will perform goal directed activities inside the CareToy System

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.

Group Type: ACTIVE_COMPARATOR

Infant Massage

Intervention Type: OTHER

Infants will received IM by their parents

Interventions

CareToy intervention

Infants will perform goal directed activities inside the CareToy System

Intervention Type: DEVICE

Infant Massage

Infants will received IM by their parents

Intervention Type: OTHER

Other Intervention Names

CT; IM

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Fondazione Stella Maris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Fondazione Stella Maris

Tirrenia, Tuscany, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 30185165 (View on PubMed)

Franchi De' Cavalieri M, Filogna S, Martini G, Beani E, Maselli M, Cianchetti M, Dubbini N, Cioni G, Sgandurra G; CareToy-R Consortium. Wearable accelerometers for measuring and monitoring the motor behaviour of infants with brain damage during CareToy-Revised training. J Neuroeng Rehabil. 2023 May 6;20(1):62. doi: 10.1186/s12984-023-01182-z.

Reference Type: DERIVED

PMID: 37149595 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34350144 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33549070 (View on PubMed)

Other Identifiers

RF-2013-02358095 CareToy

Identifier Type: -

Identifier Source: org_study_id