GAME: Harnessing Neuroplasticity to Improve Motor Performance in Infants with Cerebral Palsy: A Pragmatic Randomized Controlled Trial

Chief Investigators: Prof Iona Novak, Dr Cathy Morgan, Prof Nadia Badawi, Prof Roslyn Boyd, A/Prof Alicia Spittle, Prof Russell Dale, Ms Adrienne Kirby, Prof Rod Hunt, Dr Kerstin Pannek, Dr Koa Whittingham.

Associate Investigators: A/Prof Andrea Guzzetta, Claire Galea, Dr Karen Walker, Kristina Prelog, Prof Michael Fahey, Shannon Clough, Prof Stephen Rose.

Funding: NHMRC project grant 1120031 (2017-2021) $2,736,349

Rationale: A meta-analysis suggested the benefits for enriched environments to improve motor outcomes of infants at high risk of CP. GAME infant training has been tested in 2 pilot RCTs. The first RCT (n=13) examined short-term feasibility after 3-months of treatment and the 2nd RCT (n=30) examined long-term effects, after 9-months of GAME versus traditional intervention. GAME participants had significantly and clinically important greater motor total motor skill score after 3-months of short-term treatment; and after 9-months of long-term treatment, GAME participants had significantly and clinically important greater motor and cognitive skills measured on the Peabody Developmental Motor Scales (PDMS-2) and Bayley Scales of Infant and Toddler Development (BSID-III).

Design: A larger single blind RCT (n=300, 150 per group, 80% power, p<0.05) has received NHMRC funding from 2017. The experimental group will receive GAME intervention until 2 years of age. The control group will receive standard care therapy.

New knowledge: This RCT will advance the evidence for early intervention, determine critical periods for intervening and increase knowledge of early development of infants with brain injuries.