351 - Harnessing Neuroplasticity to Improve Motor Performance, Cognition, and Function in Infants with Cerebral Palsy: a Phase III Randomized Controlled Trial

Poster Number: 351
Publication Number: 351.2802

Background: Cerebral palsy (CP) is the most prevalent congenital physical disability worldwide. Traditionally, diagnosis occurred between 12-24 months, limiting data on efficacy of early intervention.

Objective: To assess the effectiveness of an early, continuous Goals-Activity-Motor Enrichment intervention on motor, cognitive, and functional skills in infants with CP.

Design/Methods: A phase III evaluator-blinded randomized controlled trial (RCT). Participants were recruited from Intensive Care and the community in metropolitan Australia across four states. Eligibility criteria included infants aged 3-6.5 months (corrected for prematurity), home discharge, and a CP diagnosis or "high risk of CP" per International Early Diagnostic Guideline criteria. Consented, eligible participants, were randomly assigned to receive usual care or weekly one-hour home sessions with a GAME-trained therapist, alongside a daily home program until age two. The primary outcome was two-year motor performance (Peabody Developmental Motor Scales, PDMS-2), with secondary outcomes assessed at one and two years, including gross motor function, cognition, functional independence, and social-emotional development. Outcome assessors were blinded to group allocation.

Results: Between 2017-2023, 302 infants were randomized and treated. The groups were equivalent at baseline on all measures. GAME intervention protocol fidelity exceeded 80%. No significant between group differences were found in two-year PDMS-2 motor performance or on any secondary measures. Survey data indicated intervention contamination occurred and may explain the nil findings. However, in a pre-defined modified intention-to-treat analysis (published elsewhere), 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 two.

Conclusion(s): In the largest RCT of infants with CP, we observed no motor performance gains but observed increased independence in daily activities for infants with severe physical disability and improved adaptive behavior in low SES families. 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.