The purpose of the proposed project is to compare the efficacy of two fully developed physical therapy
interventions in 8-24 months olds with or at high risk of having Cerebral Palsy (CP). Sitting Together And
Reaching To Play (START-Play) targets sitting, reaching and motor-based problem solving in infancy to
improve global development. Usual Care Physical Therapy (UCPT) focuses on advancing motor skills and
preventing impairments. The project builds on a nearly complete clinical trial evaluating the efficacy of the
START-Play intervention compared to a non-dose matched comparison group. The proposed study directly
addressed the need for a dose-matched clinical trial to consider the impact of dose of intervention on efficacy.
A direct comparison of START-Play with the dose matched (24 visits in 3 months) UCPT provided in the same
environment (homes) and provided by licensed physical therapists will allow for a direct comparison of the
efficacy of interventions based on two different set of key principles. START-Play is based on developmental
and basic science, motor learning, and neuroplasticity, in addition to our extensive preliminary efficacy data.
START-Play has been fully described with a protocol manual, training documents, and fidelity measures. The
UCPT intervention is based on videotaped session of the comparison group community based intervention
sessions and parent report for the ongoing clinical trial. A fidelity measure used the previous research
quantifies differences in the focus of these interventions and will be used to maintain adherence to both
Three sites in different regions of the United States will recruit from local intervention and medical
centers for a total of 150 infants with or at high risk of having cerebral palsy between ages 4-24 months of age,
when they show readiness skills for early sitting and reaching. Risk for CP will be based on the early detection
guidelines and all outcome measures are included in the NIH supported Common Data Elements for Cerebral
Palsy. Each infant will be randomized into a group and will receive the START-Play or the UCPT intervention
for 3 months, with follow up extending for 12 months from baseline.
The primary objectives examine change over time in sitting gross motor and cognitive development.
Differences in outcomes between the two intervention groups will be examined. In addition, we will begin to
identify predictors of response to developmental motor interventions by evaluating the relationship between
intervention outcomes and 1) infant and family characteristics, 2) presence of white matter, cerebellar, basal
ganglion, or gray matter injury.