CareToy Early Intervention in Infants at Risk for Cerebral Palsy

NCT03234959 | Completed DMC

• 1 other identifier: RF-2013-02358095 CareToy
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in Peabody Developmental Motor Scales Second Edition (PDMS-2)

  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

  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)

  Baseline (i.e within 1 week before the beginning of study, T0); at 18 mths of post term age (T3)

• Changes in Care-Index

  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

  Baseline (i.e within 1 week before the beginning of study, T0); within 1 week after the end of the CT/IM period (T1)

Study Arms (2)

CareToy Intervention

EXPERIMENTAL

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

Infant Massage

ACTIVE COMPARATOR

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

Interventions

CareToy intervention DEVICE

Infants will perform goal directed activities inside the CareToy System

Also known as: CT

CareToy Intervention

Infant Massage OTHER

Infants will received IM by their parents

Also known as: IM

Infant Massage

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead

Study Sites (1)

IRCCS Fondazione Stella Maris

Tirrenia, Tuscany, 56128, Italy

Location

Related Publications (4)

• 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 BACKGROUND

• 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.

  PMID: 37149595 DERIVED

• 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.

  PMID: 34350144 DERIVED

• 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.

  PMID: 33549070 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: August 4, 2017
• Primary Completion: September 7, 2020
• Study Completion: November 4, 2020
• Last Updated: November 17, 2020

Record last verified: 2019-10

Locations

IT (1)