Objective: Our objective was to evaluate the efficacy of the Sitting Together and Reaching to Play (START-Play) intervention in young infants with neuromotor disorders. Method: This randomized controlled trial compared usual care early intervention (UC-EI) with START-Play plus UC-EI. Analyses included 112 infants with motor delay (55 UC-EI, 57 START-Play) recruited at 7 to 16 months of age across 5 sites. START-Play included twice-weekly home visits with the infant and caregiver for 12 weeks provided by physical therapists trained in the START-Play intervention; UC-EI was not disrupted. Outcome measures were the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley); the Gross Motor Function Measure; reaching frequency; and the Assessment of Problem Solving in Play (APSP). Comparisons for the full group as well as separate comparisons for infants with mild motor delay and infants with significant motor delay were conducted. Piecewise linear mixed modeling estimated short- and long-term effects. Results: For infants with significant motor delay, positive effects of START-Play were observed at 3 months for Bayley cognition, Bayley fine motor, and APSP and at 12 months for Bayley fine motor and reaching frequency outcomes. For infants with mild motor delay, positive effects of START-Play for the Bayley receptive communication outcome were found. For the UC-EI group, the only difference between groups was a positive effect for the APSP outcome, observed at 3 months. Conclusion: START-Play may advance reaching, problem solving, cognitive, and fine motor skills for young infants with significant motor delay over UC-EI in the short term. START-Play in addition to UC-EI may not improve motor/cognitive outcomes for infants with milder motor delays over and above usual care. Impact: Concepts of embodied cognition, applied to early intervention in the START-Play intervention, may serve to advance cognition and motor skills in young infants with significant motor delays over usual care early intervention. Lay Summary: If you have a young infant with significant delays in motor skills, your physical therapist can work with you to develop play opportunities to enhance your child’s problem solving, such as that used in the START-Play intervention, in addition to usual care to help your child advance cognitive and motor skills.

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. 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. 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.

Purpose: This study examines object permanence development in infants with motor delays (MD) compared with infants with typical development (TD) and in relation to sitting skill. Methods: Fifty-six infants with MD (mean age = 10 months) and 36 with TD (mean age = 5.7 months) were assessed at baseline and then at 1.5, 3, and 6 months postbaseline. A scale was developed to measure object permanence (Object Permanence Scale [OPS]), and the Gross Motor Function Measure sitting subsection (GMFM-SS), and the Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) were administered. Results: Interrater reliability of the OPS was excellent and correlation between the OPS and Bayley-III cognitive scores was moderately positive. Compared with TD, infants with MD were delayed in development of object permanence but demonstrated increased understanding over time and as sitting skills improved. Conclusion: In children with MD, object permanence, as quantified by the OPS, emerges in conjunction with sitting skill.

This study aimed to explore whether early developmental abilities are related to future executive function (EF) in children with motor delays. Fourteen children with motor delays (Mean age = 10.76, SD = 2.55) were included from a larger study. Object interaction and developmental outcomes (Bayley-III) were evaluated at baseline and 3, 6, and 12 months post-baseline. Bayley-III and EF assessments (Minnesota Executive Function Scale) were conducted at 36 months post-baseline. Children with high EF demonstrated advanced early bimanual, visual–bimanual, receptive language, expressive language, and fine motor skills compared to children with low EF. Significant positive correlations between later Bayley-III and EF scores were found for cognitive, expressive language, and fine motor scores. These preliminary results suggest that early developmental skills support the emergence of EF in children with motor delays.

Therapies for children with cerebral palsy (CP) often fail to address essential components of early rehabilitation: intensity, child initiation, and an embodied approach. Sitting Together And Reaching To Play (START-Play) addresses these issues while incorporating intensive family involvement to maximize therapeutic dosage. While START-Play was developed and tested on children aged 7–16 months with motor delays, the theoretical construct can be applied to intervention in children of broader ages and skills levels. This study quantifies the impact of a broader START-Play intervention combined with Botulinum toxin-A (BoNT-A) and phenol on the developmental trajectory of a 24 month-old child with bilateral spastic CP. In this AB +1 study, A consisted of multiple baseline assessments with the Gross Motor Function Measure-66 and the Assessment of Problem Solving in Play. The research participant demonstrated a stable baseline during A and changes in response to the combination of BoNT-A/phenol and 12 START-Play sessions during B, surpassing the minimal clinically important difference on the Gross Motor Function Measure-66. The follow-up data point (+1) was completed after a second round of BoNT-A/phenol injections. While the findings suggest the participant improved his gross motor skills with BoNT-A/phenol and START-Play, further research is needed to generalize these findings.

This paper explores the importance of fidelity in strengthening clinical translation and implementation of rehabilitation research interventions and in reducing unwarranted variation in practice patterns. Fidelity, or accurate and faithful delivery of an intervention, is critical for all aspects of the clinical translational research continuum. Fidelity intentionally defines and tracks the key or active ingredients of a research intervention, ensures adherence to and dose of these key ingredients across therapists and research sites, and clearly establishes what is new or different about an intervention as compared to usual or standard practice. Measurement and reporting standards for fidelity in rehabilitation research vary widely. Historically, rehabilitation researchers have not reported their fidelity process clearly, if at all. This reporting gap creates a multi-faceted conundrum for replication of research findings and eventual clinical implementation of rehabilitation interventions. Without clear fidelity metrics, researchers fail to establish what is novel or unique about an intervention and fail to differentiate a new intervention from other established approaches. Without seeking and applying fidelity metrics, clinicians have no way of replicating a new intervention or understanding which key ingredients replace or supersede old practice habits. Thus, failure of researchers to transparently communicate and of clinicians to understand and apply fidelity metrics widens unwarranted practice variations rather than improving our precision with rehabilitation interventions. Using 2 recent pediatric clinical trials as exemplars, we describe how the development and tracking of metrics defining fidelity for the Sitting Together and Reaching to Play (START-Play) intervention informed key ingredients and program differentiation as researchers moved from an efficacy to an effectiveness trial; and then propose how clinicians might use these same metrics to inform implementation of START-Play. This example will demonstrate how robust fidelity might serve as a common language for successful implementation of and improved precision with rehabilitation research interventions.