Chief Investigators: Novak, Morgan, Badawi, Boyd, Hunt, Fahey, Pannek; NHMRC 2016-21 $2.7M
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.
Update: Two pilots totalling n=43 complete, 5 publications, New RCT has recruited n=248/300.
New Knowledge: Largest RCT worldwide of early intervention for CP.