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.

Factors Influencing Receipt and Type of Therapy Services in the NICU.

Understanding the type and frequency of current neonatal intensive care unit (NICU) therapy services and predictors of referral for therapy services is a crucial first step to supporting positive long-term outcomes in very preterm infants. This study enrolled 83 very preterm infants (<32 weeks, gestational age mean 26.5 ± 2.0 weeks; 38 male) from a longitudinal clinical trial. Race, neonatal medical index, neuroimaging, and frequency of therapy sessions were extracted from medical records. The Test of Infant Motor Performance and the General Movement Assessment were administered. Average weekly sessions of occupational therapy, physical therapy, and speech therapy were significantly different by type, but the magnitude and direction of the difference depended upon the discharge week. Infants at high risk for cerebral palsy based on their baseline General Movements Assessment scores received more therapy sessions than infants at low risk for cerebral palsy. Baseline General Movements Assessment was related to the mean number of occupational therapy sessions but not physical therapy or speech therapy sessions. Neonatal Medical Index scores and Test of Infant Motor Performance scores were not predictive of combined therapy services. Medical and developmental risk factors, as well as outcomes from therapy assessments, should be the basis for referral for therapy services in the neonatal intensive care unit.

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.

Efficacy of Supporting Play Exploration and Early Development Intervention in the First Months of Life for Infants Born Very Preterm: 3-Arm Randomized Clinical Trial Protocol.

OBJECTIVE: The aim of this project is to study the effect of a physical therapist intervention provided in the first months of life on developmental outcomes of infants born very preterm. Secondary aims are to investigate the impact of intervention timing on the efficacy and impact of the intervention on infants with and without cerebral palsy. METHODS: This study is a multisite longitudinal controlled trial comparing developmental outcomes from infants in the Supporting Play, Exploration, and Early Development Intervention (SPEEDI)_Late or SPEEDI_Early group to a usual care group. SETTINGS ARE URBAN: Urban and rural areas surrounding 2 academic medical centers. There will be 90 preterm infants enrolled in this study born at <29 weeks of gestation. SPEEDI is a developmental intervention provided by collaboration between a physical therapist and parent to support a child's motor and cognitive development. The primary outcome measure is the Bayley Scale of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores. Secondary measures include behavioral coding of early problem solving skills, the Gross Motor Function Measure, and Test of Infant Motor Performance. IMPACT: More than 270,000 infants are born very preterm in the United States each year, 50% of whom will have neurological dysfunction that limits their ability to keep pace with peers who are typically developing. This study is a step toward understanding the impact that intensive developmental intervention could have in this population in the first months of life.

Effect of neonatal therapy on the motor, cognitive, and behavioral development of infants born preterm: a systematic review.

AIM: To synthesize the existing literature and determine the efficacy of neonatal therapy, starting in the neonatal intensive care unit (NICU), on the motor, cognitive, and behavioral outcomes of infants born preterm. METHOD: Databases were searched for randomized controlled trials or quasi-randomized controlled trials of direct therapy early intervention for infants with a gestational age of less than 37 weeks, initiated in the NICU and delivered by a therapist or parent with therapist support. Quality was evaluated using the Cochrane standardized risk of bias assessment tool. Recommendations were made using the Grading of Recommendations, Assessment, Development and Evaluations approach. RESULTS: Fifteen studies met the inclusion criteria. Studies were categorized into four intervention categories: (1) parent-delivered motor intervention (PDMI); (2) therapist-delivered postural control intervention (TDPCI); (3) developmental care; and (4) oromotor intervention. Risk of bias varied from low (10 studies) to high (three studies) or was unclear (two studies). INTERPRETATION: Preliminary support indicates that daily PDMI improves motor and cognitive outcomes in the short-term and possibly long-term. TDPCI is effective in promoting short-term gains in motor development. Developmental care programs designed by a neonatal therapist appear to be effective in improving short-term behavior but are inconclusive for motor and cognitive outcomes or long-term behavioral outcomes. Regarding oromotor interventions, there is insufficient research to be confident in their efficacy on improving developmental outcomes. WHAT THIS PAPER ADDS: Parent-delivered motor interventions (PDMIs) are more effective in improving motor and cognitive outcomes than other interventions. Preliminary support indicates that daily PDMI improves motor and cognitive outcomes in the short- and possibly long-term. Therapist-delivered postural control interventions are effective in promoting short-term gains in motor development. Developmental care programs designed by a neonatal therapist are effective in improving the short-term behavior of infants born preterm. Oral motor interventions were found to have no effect on improving developmental outcomes.

Efectos de la terapia neonatal en el desarrollo motor, cognitivo y conducta de los niños nacidos pretérmino: una revisión sistemática OBJETIVO: Sintetizar la literatura existente y determinar la eficacia de la terapia neonatal, comenzando en la unidad de cuidados intensivos neonatales (UCIN), en el desarrollo motor, cognitivo y conducta de niños pretérmino. MÉTODO: En diferentes bases de datos buscamos ensayos aleatorios y controlados o ensayos cuasi aleatorios y controlados de intervención temprana en niños con edad gestacional menor a 37 semanas, iniciadas en UCIN y realizadas por un terapeuta o un padre con el apoyo de un terapeuta. La calidad se evaluó usando la herramienta de evaluación estandarizada de riesgo de sesgo de Cochrane. Las recomendaciones se realizaron utilizando el enfoque de Calificación de Recomendaciones, Valoración, Desarrollo y evaluaciones. RESULTADOS: Quince estudios reunieron los criterios de inclusión. Los estudios se dividieron en 4 categorías de intervención: (1) intervenciones motoras realizadas por padres (PDMI); (2) intervención de control postural administrada por terapeutas; (3) cuidados del desarrollo; y (4) intervención oromotora. El riesgo de sesgo vario de bajo (10 estudios) a alto (3 estudios) o no estaba claro (2 estudios). INTERPRETACIÓN: El soporte preliminar indica que el PDMI diario mejora los resultados motores y cognitivos a corto plazo y posiblemente a largo plazo. La intervención de control postural administrada por terapeuta es efectiva para promover ganancias a corto plazo en el desarrollo motor. Los programas de atención del desarrollo diseñados por un terapeuta neonatal parecen ser efectivos para mejorar el comportamiento a corto plazo, pero no son concluyentes para los resultados motores y cognitivos o los resultados conductuales a largo plazo. Con respecto a las intervenciones oromotoras, no hay investigaciones suficientes para confiar en su eficacia para mejorar los resultados del desarrollo.

Efeito da terapia neonatal no desenvolvimento motor, cognitivo e comportamental de lactentes nascidos prematuros: uma revisão sistemática OBJETIVO: Sintetizar a literatura existente e determinar a eficácia da terapia neonatal, iniciando na unidade de terapia intensiva neonatal (UTIN) nos resultados motores, cognitivos, e comportamentais de lactentes nascidos prematuros. MÉTODO: Bases de dados foram pesquisadas quanto a estudos clínicos randomizados ou quasi-randomizados sobre a intervenção precoce direta para crianças com idade gestacional menor do que 37 semanas, iniciada na UTIN e realizada por um terapeuta ou pai/mãe com suporte de terapeuta. A qualidade foi avaliada usando a ferramenta padronizada Cochrane para risco de viés. Recomendações foram feitas usando a abordagem Grade para Recomendações, Avaliação, Desenvolvimento e Acompanhamento. RESULTADOS: Quinze estudos atenderam aos critérios de inclusão. Os estudos foram categorizados em quatro categorias de intervenção: (1) intervenção motora realizada pelos pais (IMRP); (2) intervenção de controle postural realizada por terapeuta; (3) cuidado desenvolvimental; e (4) intervenção oromotora. O risco de viés variou de baixo (10 estudos) a alto (três estudos) ou não estava claro (dois estudos). INTERPRETAÇÃO: Estudos preliminares indicam que a IMRP melhora os resultados motores e cognitivos no curto prazo e provavelmente no longo prazo. Intervenção para controle postural realizada por terapeutas é efetiva em promover ganhos em curto prazo no desenvolvimento motor. Programas de atenção ao desenvolvimento traçados por terapeuta neonatal parecem ser efetivos para melhorar o comportamento em curto prazo, mas são inconclusivos para resultados motores e cognitivos, ou resultados comportamentais no longo prazo. Com relação às intervenções oromotoras, as pesquisas são insuficientes para dar confiança sobre sua eficácia em melhorar resultados desenvolvimentais.

Knowledge Translation Lecture: Providing Best Practice in Neonatal Intensive Care and Follow-up: A Clinician-Researcher Collaboration.

Knowledge translation is the process by which we take new information that is evidence based and incorporate it into our practice. While we can each incorporate evidence into our practice, the collaboration between a researcher and a clinician can advance the implementation of evidence-based practice. We highlight the use of the Plan-Do-Study-Act cycle that includes a researcher and clinical partner on a journey of research question development, knowledge generation, clinical implementation, and policy change that advances the care to infants in the neonatal intensive care unit and in a developmental follow-up clinic. The team provides examples of implementation and highlights the clinical care differences following a decade of collaboration. Pediatric physical therapists have a responsibility to embrace and support knowledge translation to advance our profession and the care of infants, children, and families.

A Physical Therapy Intervention to Advance Cognitive and Motor Skills: A Single Subject Study of a Young Child With Cerebral Palsy.

BACKGROUND: Physical therapy interventions for children with severe motor impairments do not address the relationship between motor and cognitive development. PURPOSE: Evaluate the potential of a physical therapy intervention focusing on enhancing cognitive and motor outcomes in a child with severe motor impairments. DESIGN: AB phase design without reversal. METHODS: One child participated in 8 assessments from 4 to 29 months of age. The START-Play intervention was provided for 3 months following 4 baseline assessments over 12 months. Total Gross Motor Function Measure (GMFM), Sitting, Reaching, and Problem Solving assessments were completed. Visual inspection, 2 standard deviation (SD) Band Method, and percent of nonoverlapping data methods evaluated change. RESULTS: This child had improved GMFM total and sitting scores, increased frequency of toys contacts, and increased rate of problem-solving behaviors following intervention. CONCLUSION: START-Play shows promise for children with severe motor impairments. Additional research is needed to evaluate efficacy.

Assessment of Parent-Child Interaction Is Important With Infants in Rehabilitation and Can Use High-Tech or Low-Tech Methods.

Parents are their infant's first teachers and play a very important role in early development. Early intervention strives to enhance infant participation in the family, and regulations require the engagement of families in assessment and intervention. Infants born preterm or with motor impairments demonstrate altered social engagements that can influence parent-child interaction and the efficacy of therapy services. However, in research focused on the efficacy of interventions or in clinical practice, therapists rarely assess or report on the quality of parent-infant interaction. Understanding these interactions can help determine what perceptual motor opportunities parents provide that can enhance learning. This Perspective article will: (1) present evidence on the need for early assessment and ongoing measurement of parent-infant interaction; (2) describe an example of each of 3 methods for assessment of parent-child interaction-low-tech, low-resource (Dyadic Mutuality Code), low-tech, high-resource (Parent Children Early Relational Assessment), and high-tech, high-resource (customized behavioral coding); (3) compare 3 approaches theoretically highlighting the strengths and weaknesses of each assessment; and (4) reflect on the challenges and value of adding these measures to future research on the efficacy of interventions and clinical practice.

Supporting Play Exploration and Early Development Intervention From NICU to Home: A Feasibility Study.

PURPOSE: To determine the feasibility of completing a clinical trial of Supporting Play Exploration and Early Development Intervention (SPEEDI) that blends early and intense intervention with family support during the transition from the neonatal intensive care unit (NICU) to home and the community. METHODS: Ten infants born preterm were randomly assigned to intervention or usual care groups. Data on intervention frequency and parent feedback were used to determine the feasibility of SPEEDI. Effect sizes were calculated for motor and problem-solving outcome measures at the end of the intervention, 3 months adjusted age. RESULTS: Infants received on average 96.4% and 100.3% of anticipated NICU and home intervention. Only 28% of infants were receiving early intervention services during the SPEEDI period. Effect sizes were large and in the anticipated direction. CONCLUSIONS: SPEEDI is a feasible intervention and appropriate for future clinical trials. VIDEO ABSTRACT: For more insights from the authors, see Supplemental Digital Content 1, available at http://links.lww.com/PPT/A83.

Instituting parent education practices in the neonatal intensive care unit: an administrative case report of practice evaluation and statewide action.

BACKGROUND AND PURPOSE: Infants born preterm are at high risk of developmental disabilities and benefit from early developmental intervention programs. Physical therapists with neonatal expertise are ideally suited to educate parents about ways to support their infant's development in the first months of life. However, administrative policies are needed to support the therapist in providing adequate parent education in the neonatal intensive care unit (NICU). This administrative case report describes the process used by a team of neonatal therapists to evaluate clinical practice, determine the need for change, and develop and implement a new parent education program in the NICU. CASE DESCRIPTION: Physical therapy parent education practices were evaluated in an academic medical center with a 36-bed, level-3 NICU. Physical therapists with neonatal expertise covered multiple units within the hospital each day. A series of focus groups, a small descriptive study, and staff discussion were used to evaluate parent education practices in this academic medical center. A new parent education program was developed based on data collected and literature to improve clinical care. OUTCOMES: The new parent education model was implemented over the course of several months using overlapping initiatives. Administrative support for the change was developed through collaboration, open communication, and presentation of clinical data. In addition, this hospital-based program contributed to the development of a statewide initiative to educate parents of preterm infants about the importance of supporting development in the first months of life. DISCUSSION: A collaborative and data-driven approach to evaluating parent education practices supported the development of a new parent education practice while acknowledging the need to meet staff productivity standards and provide excellent care throughout the hospital.