Investigators aimed to assess effectiveness of early and continuous enrichment intervention on motor, cognitive, and functional skills in infants with CP.
Cerebral palsy (CP), a group of disorders that affect a person's ability to move and maintain balance, is the most common motor disability in childhood.1,2
According to a poster session presented at the 2024 Pediatric Academic Societies (PAS) Meeting held in Toronto, Canada, limited data for early intervention efficacy is available, as diagnosis typically occurs between 12 to 24 months of age.1
Catherine J. Morgan, PhD, of Cerebral Palsy Alliance in Camperdown, New South Wales, Australia, presented the session, highlighting a phase 3 randomized controlled trial (RCT) to assess "effectiveness of an early, continuous Goals-Activity-Motor Enrichment (GAME) intervention on motor, cognitive, and functional skills in infants with CP."
CP symptoms can vary with each individual, according to the Centers for Disease Control and Prevention (CDC), which states an individual with severe CP might need to use special equipment to walk, while another may not be able to walk at all, requiring lifelong care.2
The CDC adds that CP, which does not get worse over time though symptoms can change, is the result of abnormal brain development or damage to the developing brain.2
Signs of CP can vary, as there are many different levels of the disability, though a main sign is a delay in reaching motor or movement milestones, such as sitting, rolling over, standing, or walking. In a baby under 6 months of age, other signs include2:
The design of the trial highlighted at PAS was an evaluator-blinded RCT that featured participants recruited from intensive care and the community in metropolitan Australia across 4 states.1
Infants aged 3 to 6.5 months, home discharge, a CP diagnosis or "high risk of CP," defined by International Early Diagnostic Guideline criteria, were eligibility requirements. Eligible individuals were assigned randomly to receive usual care or weekly, 1-hour home sessions with a GAME-trained therapist in conjunction with a daily home program until 2 years of age.1
According to the investigators, the primary outcome was 2-year motor performance. Secondary outcomes, assessed at 1 and 2 years of age, including cognition, gross motor function, functional independence, and social-emotional development. Investigators noted that outcome assessors were blinded to group allocation.1
From 2017 to 2023, 302 infants were randomized and treated, and on all measures, groups were equivalent at baseline. GAME intervention protocol fidelity exceeded 80% according to study investigators, and no significant between-group differences were found in 2-year Peabody Developmental Motor Scales (PDMS-2), which evaluated motor performance or on any secondary measures.1
Authors reported that survey data indicated intervention contamination occurred, possibly explaining no differences. However, in a pre-defined modified intention-to-treat analysis, "infants with severe physical disabilities (baseline HINE score < 40) who received GAME showed improved independence in daily activities (P = 0.033), and in families of low socioeconomic (SES) backgrounds infants had enhanced adaptive behavior (P = 0.034) at age [2]."1
Overall, no motor performance gains were observed, but investigators did observe increased independence in daily activities for infants with severe physical disability. Improved adaptive behavior in low SES families was also observed.1
"Independence in daily living and behavior produces the highest likelihood of employment and independent living in adulthood, which is promising for infants with CP and broader society," concluded the authors in the abstract.1
References:
1. Morgan CJ. Harnessing Neuroplasticity to Improve Motor Performance, Cognition, and Function in Infants with Cerebral Palsy: a Phase III Randomized Controlled Trial. Poster abstract presented at: Pediatric Academic Societies. May 2-6, 2024. Toronto, Canada. https://2024.pas-meeting.org/fsPopup.asp?efp=TE1NSk5TTFcyMDcyOA&PosterID=646871&rnd=0.5172558&mode=posterInfo
2. What is CP? Centers for Disease Control and Prevention. Updated February 28, 2024. Accessed May 7, 2024. https://www.cdc.gov/ncbddd/cp/facts.html
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