Impact of the COVID-19 Pandemic on a Clinical Trial: A Quantitative Report on Study Engagement and Strategies.

INTRODUCTION: The COVID-19 pandemic impacted clinical research worldwide potentially altering research findings. The study purpose was to measure the effect of the pandemic on recruitment, retention, assessment, and intervention completion rates. METHODS: Enrollment and participation data from a clinical trial evaluating efficacy of a physical therapy intervention for high-risk preterm infants were compared across 3 pandemic periods (February 2019 through November 2021). RESULTS: Recruitment, retention, assessment, and intervention completion rates were lowest during the peak pandemic period. CONCLUSIONS: In compliance with the Human Subjects Review Board, and for the participants' and staff safety, transition from in-person to telehealth or hybrid visits was required to continue this longitudinal study. Despite the negative effect of the pandemic, parental resilience and commitment to the study was clear. Flexibility, quick action, dedication, and efficiency of the research team were key elements enabling study continuation with successful transition to telehealth assessments/interventions during the peak pandemic period.

Effect of Contingency Paradigm-Based Interventions on Developmental Outcomes in Young Infants: A Systematic Review.

PURPOSE: The purpose of this systematic review was to identify controlled trials evaluating the efficacy of contingency paradigm-based interventions to improve feeding, motor, or cognitive outcomes during the first year of life. SUMMARY OF KEY POINTS: Seventeen studies, including 10 randomized controlled trials, incorporating contingency paradigm-based interventions were identified. Three of 3 trials reported improvements in nutritive sucking using pacifier-activated lullaby in preterm infants before term age. Seven of 12 trials reported improvements in reaching, manual exploration, and kicking behaviors in term and preterm infants; and 6 of 10 trials reported gains in early cognition using sticky mittens and contingent toys. CONCLUSION AND RECOMMENDATIONS FOR CLINICAL PRACTICE: Contingency paradigm-based interventions can improve feeding outcomes in the neonatal intensive care unit in very preterm infants, and increase reaching, and perceptual-cognitive behaviors in term infants. Future research is needed to establish contingency paradigms as an effective early intervention strategy. WHAT THIS ADDS TO THE EVIDENCE: This review synthesizes a body of literature on contingency paradigm-based interventions and highlights its potential paradigm-based interventions to improve developmental outcomes in infants.

Infant posture and caregiver-provided cognitive opportunities in typically developing infants and infants with motor delay.

Infants' developing motor skills-including mastery of new postures such as sitting and standing-affect opportunities for learning that facilitate cognitive development. But how infant posture affects caregiver behavior is largely unexplored. Moreover, we know little about effects of posture on learning opportunities in infants with motor delay. This study asked how infants with typical development and infants with significant motor delay use various postures during play, and whether posture is related in real time to caregiver-provided cognitive learning opportunities. Infants were videotaped five times over the course of a year in a free play session with a caregiver, starting when they demonstrated initial sitting skills. Posture and cognitive opportunities were coded moment-by-moment to assess duration and temporal overlap. We found that infants with typical development and infants with motor delay displayed similar use of postures initially, but infants with typical development demonstrated more mature postures over time. We also found that for both groups of infants, caregivers were most likely to provide cognitive opportunities when infants were sitting independently, and least likely when infants were supine. Our findings highlight the importance of upright sitting in typical and atypical infant development and suggest potential areas of intervention for infants with motor delay.

Longitudinal Changes in the Sensorimotor Pathways of Very Preterm Infants During the First Year of Life With and Without Intervention: A Pilot Study.

Objective: Evaluate longitudinal changes in brain microstructure and volumes in very preterm infants during the first year of life with and without intervention.Design: Descriptive pilot study.Methods: Five preterm infants in a three-arm clinical trial, one SPEEDI Early, two SPEEDI Late, and two usual care. Brain structural and diffusion MRI's were acquired within 72 hours after neonatal intensive care unit discharge (n = 5), three months post-baseline (n = 5), and six months post-baseline (n = 3). Fractional anisotropy (FA), Mean diffusivity (MD), and volume metrics were computed for five brain regions.Results: More than 60% of eligible participants completed 100% of the scheduled MRIs. FA and volume increased from baseline to six months across all brain regions. Rate of white matter volume change from baseline to six months was highest in SPEEDI Early.Conclusions: Non-sedated longitudinal MRI is feasible in very preterm infants and appears to demonstrate longitudinal changes in brain structure and connectivity.

Targeted Physical Therapy Combined with Spasticity Management Changes Motor Development Trajectory for a 2-Year-Old with Cerebral Palsy.

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.

Physical therapy interventions to improve sitting ability in children with or at-risk for cerebral palsy: a systematic review and meta-analysis.

AIM: To conduct a systematic review and meta-analysis on the effectiveness of physical therapy interventions to improve sitting ability in young children with or at risk for cerebral palsy (CP). METHOD: A systematic literature search was performed using five databases. Study selection criteria were randomized controlled trials published in English on physical therapy interventions targeting sitting, reporting developmental or functional sitting outcomes, and focused on young children with or at risk for CP (mean age ≤5y). Risk of bias (ROB) was assessed using the Cochrane ROB 2.0 tool. RESULTS: Twelve unique studies met the inclusion criteria and were categorized into one of two categories: (1) comparison of two physical therapy interventions or (2) physical therapy plus adjunct versus physical therapy alone. The combined pooled effect size (g) for the 10 studies included in meta-analysis was large (g=0.78) but non-significant. Pooled effect for category 1 was small (g=-0.06) and non-significant. Interventions in category 2 showed a large and significant effect (g=1.90, p=0.022). INTERPRETATION: There is a lack of strong evidence for physical therapy interventions targeting sitting in young children with or at-risk for CP due to limitations in methodological rigor and sample sizes. Components of impairment remediation combined with functional balance training should be explored to improve sitting in children diagnosed with CP. Given the benefits of early achievement of sitting, strong evidence-based research is needed. WHAT THIS PAPER ADDS: Strong evidence is lacking for physical therapy interventions to improve sitting ability in young children with/at risk for cerebral palsy (CP). Kinesio-taping may be an effective adjunct to conventional physical therapy in improving sitting ability in children with spastic bilateral CP. Task-specific, intensive, and child-initiated intervention components show promise for improving sitting in young infants at risk for CP.