The SIT-PT Trial Protocol: A Dose-Matched Randomized Clinical Trial Comparing 2 Physical Therapist Interventions for Infants and Toddlers with Cerebral Palsy

Objective: Although early intervention for infants at risk for cerebral palsy is routinely recommended, the content of intervention is poorly described, varies widely, and has mixed supporting evidence. The purpose of this study was to compare efficacy of 2 interventions grounded in differing domains of the International Classification of Functioning, Disability and Health on developmental outcomes of infants with or at high risk of cerebral palsy. Methods: Infants who meet inclusion criteria will be randomized into either Sitting Together and Reaching To Play or Movement, Orientation, Repetition, Exercise Physical Therapy groups. Both groups will receive intervention twice weekly for 3 months and follow-up at 3, 6, 9, and 12 months from baseline. The primary objectives compare changes over time and between groups in sitting, gross motor, and cognitive development. The setting is the infant's home unless the caregiver requests otherwise. One hundred and fifty infants between 8 and 24 months of age will be enrolled in 3 geographically, racially, and ethnically diverse sites: Los Angeles, California; Omaha, Nebraska; and Seattle, Washington. Enrolled infants will demonstrate motor delays, emerging sitting skills, and signs of neurologic impairment. Sitting Together and Reaching To Play targets activities including sitting, reaching, and motor-based problem solving to improve global development. In contrast, Movement, Orientation, Repetition, Exercise Physical Therapy focuses on strengthening and musculoskeletal alignment while encouraging repeated movement practice. Outcome measures include the Gross Motor Function Measure, Bayley Scales of Infant Development-IV, Assessment of Problem Solving in Play, and a Parent Child Interaction assessment. Enrolled children will maintain usual intervention services due to ethical concerns with intervention withdrawal. Impact: This will be the first study, to our knowledge, comparing efficacy of early physical therapy with dose-matched interventions and well-defined key principles. The outcomes will inform selection of key principle of intervention in this population.