Protocol for a randomized controlled trial to evaluate a year-long (NICU-to-home) evidence-based, high dose physical therapy intervention in infants at risk of neuromotor delay.

INTRODUCTION: Developmental disabilities and neuromotor delay adversely affect long-term neuromuscular function and quality of life. Current evidence suggests that early therapeutic intervention reduces the severity of motor delay by harnessing neuroplastic potential during infancy. To date, most early therapeutic intervention trials are of limited duration and do not begin soon after birth and thus do not take full advantage of early neuroplasticity. The Corbett Ryan-Northwestern-Shirley Ryan AbilityLab-Lurie Children's Infant Early Detection, Intervention and Prevention Project (Project Corbett Ryan) is a multi-site longitudinal randomized controlled trial to evaluate the efficacy of an evidence-based physical therapy intervention initiated in the neonatal intensive care unit (NICU) and continuing to 12 months of age (corrected when applicable). The study integrates five key principles: active learning, environmental enrichment, caregiver engagement, a strengths-based approach, and high dosage (ClinicalTrials.gov identifier NCT05568264). METHODS: We will recruit 192 infants at risk for neuromotor delay who were admitted to the NICU. Infants will be randomized to either a standard-of-care group or an intervention group; infants in both groups will have access to standard-of-care services. The intervention is initiated in the NICU and continues in the infant's home until 12 months of age. Participants will receive twice-weekly physical therapy sessions and caregiver-guided daily activities, assigned by the therapist, targeting collaboratively identified goals. We will use various standardized clinical assessments (General Movement Assessment; Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4); Test of Infant Motor Performance; Pediatric Quality of Life Inventory Family Impact Module; Alberta Infant Motor Scale; Neurological, Sensory, Motor, Developmental Assessment; Hammersmith Infant Neurological Examination) as well as novel technology-based tools (wearable sensors, video-based pose estimation) to evaluate neuromotor status and development throughout the course of the study. The primary outcome is the Bayley-4 motor score at 12 months; we will compare scores in infants receiving the intervention vs. standard-of-care therapy.

Barcoding, linear and nonlinear analysis of full-day leg movements in infants with typical development and infants at risk of developmental disabilities: Cross-sectional study.

Traditional methods do not capture the multidimensional domains and dynamic nature of infant behavioral patterns. We aim to compare full-day, in-home leg movement data between infants with typical development (TD) and infants at risk of developmental disabilities (AR) using barcoding and nonlinear analysis. Eleven infants with TD (2-10 months) and nine infants AR (adjusted age: 2-14 months) wore a sensor on each ankle for 7 days. We calculated the standard deviation for linear variability and sample entropy (SampEn) of leg acceleration and angular velocity for nonlinear variability. Movements were also categorized into 16 barcoding states, and we calculated the SampEn and proportions of the barcoding. All variables were compared between the two groups using independent-samples t-test or Mann-Whitney U test. The AR group had larger linear variability compared to the TD group. SampEn was lower in the AR group compared to TD group for both acceleration and angular velocity. Two barcoding states' proportions were significantly different between the two groups. The results showed that nonlinear analysis and barcoding could be used to identify the difference of dynamic multidimensional movement patterns between infants AR and infants with TD. This information may help early diagnosis of developmental disabilities in the future.

Correlation between performance and quantity/variability of leg exploration in a contingency learning task during infancy.

Quantity and quality of motor exploration are proposed to be fundamental for infant motor development. However, it is still not clear what types of motor exploration contribute to learning. To determine whether changes in quantity of leg movement and/or variability of leg acceleration are related to performance in a contingency learning task, twenty 6-8-month-old infants with typical development participated in a contingency learning task. During this task, a robot provided reinforcement when the infant's right leg peak acceleration was above an individualized threshold. The correlation coefficient between the infant's performance and the change in quantity of right leg movement, linear variability, and nonlinear variability of right leg movement acceleration from baseline were calculated. Simple linear regression and multiple linear regression were calculated to explain the contribution of each variable to the performance individually and collectively. We found significant correlation between the performance and the change in quantity of right leg movement (r = 0.86, p < 0.001), linear variability (r = 0.71, p < 0.001), and nonlinear variability (r = 0.62, p = 0.004) of right leg movement acceleration, respectively. However, multiple linear regression showed that only quantity and linear variability of leg movements were significant predicting factors for the performance ratio (p < 0.001, adjusted R2 = 0.94). These results indicated that the quantity of exploration and variable exploratory strategies could be critical for the motor learning process during infancy.

Leg Movement Rate before and after a Caregiver-Provided Intervention for Infants at Risk of Developmental Disability: A Pilot Study.

AIM: Our purpose was to assess daily leg movement rate before and after a caregiver-provided in-home intervention for infants at risk for developmental disability. We also assessed adherence and quality of caregiver-child interaction. METHODS: Twelve infants, at risk for developmental disabilities, and their caregivers participated in an intervention focused on increasing leg movements. Intervention started between 3- and 6-months corrected age and ended once the infant was able to sit independently or at 9 months corrected age, whichever occurred first. Infants were assessed monthly. RESULTS: Infants at risk for developmental disabilities who were moving less than 1200 leg movements per hour awake at the start of the intervention increased their daily leg movement rate following the intervention (Median [range]: pre-1047 [506-1056], post- 1104 [655-1359], p = 0.040). Additionally, the caregivers had a high adherence (Median: 89%, Range: 11.43%-329.17%) and good quality of caregiver-child interaction (Median NCAST total: 46, Range: 34-59); and maintained similar amounts of adherence (p = 0.575) and quality of caregiver-child interaction (p = 0.432) throughout the intervention. CONCLUSION: This study provides preliminary evidence that leg movement rate has the potential to be used as an outcome measure to assess an infant's progress and motor practice during an intervention.

How Many Days are Necessary to Represent Typical Daily Leg Movement Behavior for Infants at Risk of Developmental Disabilities?

BACKGROUND: Movement characteristics can differentiate between infants at risk and infants with typical development. However, it is unknown how many days are needed to accurately represent typical daily behavior for infants at risk of developmental disabilities when using wearable sensors. To consider the balance between participant burden and the amount of data collected and optimizing the efficiency of data collection, our study determined (1) how many days were necessary to represent typical movement behavior for infants at risk of developmental disabilities and (2) whether movement behavior was different on weekend days and weekdays. METHODS: We used Opal wearable sensors to collect at least 5 days of 11 infants' leg movement data. The standard (average of 5 days) was compared with four methods (average of the first 1/2/3/4 days) using the Bland-Altman plots and the Spearman correlation coefficient. We also compared the data from the average of 2 weekend days to the average of the first 2 weekdays for 8 infants. RESULTS: The Spearman correlation coefficient comparing the average of the first 2 days of data and the standards were all above 0.7. The absolute differences between them were all below 10% of the standards. The Bland-Altman plots showed more than 90% of the data points comparing the average of 2 days and the standards fell into the limit of agreement for each variable. The absolute difference between weekend days and weekdays for the leg movement rate, duration, average acceleration, and peak acceleration was 15.2%, 1.7%, 6.8% and 6.3% of the corresponding standard, respectively. CONCLUSION: Our results suggest 2 days is the optimal amount of data to represent typical daily leg movement behavior of infants at risk of developmental disabilities while minimizing participant burden. Further, leg movement behavior did not differ distinctly across weekend days and weekdays. These results provide supportive evidence for an efficient amount of data collections when using wearable sensors to evaluate movement behavior in infants at risk of developmental disabilities.

Infant Leg Activity Intensity Before and After Naps.

Wearable sensors are being used to measure intensity of infant physical activity across full days. The variability of infant activity intensity within and across days is important to study given the potential impact of physical activity on developmental trajectories. Using retrospective data, we analyzed the intensity of leg movements in 10 typically-developing infants before and after naptimes. Leg movement data were captured from 20 minutes before and after multiple events of naps across seven days for each infant. We hypothesized that leg movement intensity would be lower before a nap than after a nap potentially due to lower arousal and increased fatigue prior to attaining sleep. However, our results showed that leg movement intensity was not significantly different when comparing the 20-minute period pre- and post-naps (F(1,7)=3.91, p=0.089, ηp 2=0.358). Our results are a first step in describing patterns of infant activity across days and highlights the need for further research regarding infant energy expenditure and physical activity.

How Many Days Are Necessary to Represent an Infant's Typical Daily Leg Movement Behavior Using Wearable Sensors?

BACKGROUND: Characteristics of movement can differentiate infants with typical development and infants with or at risk of developmental disabilities. We used wearable sensors to measure infants' typical movement patterns in the natural environment. OBJECTIVE: Our objectives were to determine (1) how many days were sufficient to represent an infant's typical daily performance, and (2) if there was a difference in performance between weekdays and weekend days. DESIGN: This was a prospective, observational study. METHODS: We used wearable sensors to collect 7 consecutive days of data for leg movement activity, from 10 infants with typical development (1-5 months old). We identified each leg movement, and its average acceleration, peak acceleration, and duration. Bland-Altman plots were used to compare the standard (average of 7 days) with 6 options (1 day, the average of days 1 and 2, through the average of days 1 through 6). Additionally, the average of the first 2 weekdays was compared with the average of 2 weekend days. RESULTS: The absolute difference between the average of the first 2 days and the standards fell below 10% of the standards (movement rate = 8.5%; duration = 3.7%; average acceleration = 2.8%; peak acceleration = 3.8%, respectively). The mean absolute difference between weekdays and weekends for leg movement rate, duration, average acceleration, and peak acceleration was 11.6%, 3.7%, 7.2%, and 7.3% of the corresponding standard. LIMITATIONS: The small sample size and age range limit extrapolation of the results. CONCLUSIONS: Our results suggest the best option is to collect data for 2 consecutive days and that movement did not differ between weekdays and weekend days. Our results will inform the clinical measurement of full-day infant leg movement for neuromotor assessment and outcome purposes.

Relationships between full-day arm movement characteristics and developmental status in infants with typical development as they learn to reach: An observational study.

Background: Advances in wearable sensor technology now allow us to quantify the number, type and kinematic characteristics of bouts of infant arm movement made across a full day in the natural environment. Our aim here was to determine whether the amount and kinematic characteristics of arm movements made across the day in the natural environment were related to developmental status in infants with typical development as they learned to reach for objects using their arms. Methods: We used wearable sensors to measure arm movement across days and months as infants developed arm reaching skills. In total, 22 infants with typical development participated, aged between 38 and 203 days. Of the participants, 2 infants were measured once and the other 20 infants were measured once per month for 3 to 6 visits. The Bayley Scales of Infant Development was used to measure developmental level. Results: Our main findings were: 1) infant arm movement characteristics as measured by full-day wearable sensor data were related to Bayley motor, cognitive and language scores, indicating a relationship between daily movement characteristics and developmental status; 2) infants who moved more had larger increases in language and cognitive scores across visits; and 3) larger changes in movement characteristics across visits were related to higher motor scores. Conclusions: This was a preliminary, exploratory, small study of the potential importance of infant arm movement characteristics as measured by full-day wearable sensor data. Our results support full-day arm movement activity as an area of interest for future study as a biomarker of neurodevelopmental status and as a target for early intervention.

Differences in Spontaneous Leg Movement Patterns Between Infants With Typical Development and Infants at Risk for Developmental Delay: Cross-sectional Observation Prior to Sitting Onset.

PURPOSE: To investigate differences in the patterns of supine spontaneous leg movements produced before sitting onset between infants with typical development (TD) and infants at risk for developmental delay (AR). METHOD: Cross-sectional, observational study. Thirty-five infants were included, 18 infants with TD (130.4 ±38.0 days) and 17 infants AR (124.1± 65.7 days). Infants were placed in the supine position and video taped for 4 to 5 minutes while in an alert, content state. After the recording, videos were coded frame by frame to identify the type of each leg movement produced: single flexion, single extension, alternate flexion, alternate extension, parallel flexion, parallel extension, leg wave, leg circle, leg thump, foot rub, foot flexion, or foot rotation. RESULTS: Unilateral movements (single flexion and single extension) were the most common leg movements in TD group. Infants AR produced a significantly lower proportion of unilateral and foot rub movements than infants with TD. CONCLUSION: These results provide a foundation of the types of leg movement pattern differences to build on in future research. Knowledge about differences in spontaneous movement patterns between infants AR and infants with TD has relevance both for early identification of neuromotor impairment and clinical practice.

Development of a Wearable Sensor Algorithm to Detect the Quantity and Kinematic Characteristics of Infant Arm Movement Bouts Produced across a Full Day in the Natural Environment.

We developed a wearable sensor algorithm to determine the number of arm movement bouts an infant produces across a full day in the natural environment. Full-day infant arm movement was recorded from 33 infants (22 infants with typical development and 11 infants at risk of atypical development) across multiple days and months by placing wearable sensors on each wrist. Twenty second sections of synchronized video data were used to compare the algorithm against visual observation as the gold standard for counting the number of arm movement bouts. Overall, the algorithm counted 173 bouts and the observer identified 180, resulting in a sensitivity of 90%. For each bout produced across the day, we then calculated the following kinematic characteristics: duration, average and peak acceleration, average and peak angular velocity, and type of movement (one arm only, both arms for some portion of the bout, or both arms for the entire bout). As the first step toward developing norms, we present average values of full-day arm movement kinematic characteristics across the first months of infancy for infants with typical development. Identifying and quantifying infant arm movement characteristics produced across a full day has potential application in early identification of developmental delays and the provision of early intervention therapies to support optimal infant development.