Disentangling the effects of metabolic cost and accuracy on movement speed.

On any given day, we make countless reaching movements to objects around us. While such ubiquity may suggest uniformity, each movement's speed is unique-why is this? Reach speed is known to be influenced by accuracy; we slow down to sustain high accuracy. However, in other forms of movement like walking or running, metabolic cost is often the primary determinant of movement speed. Here we bridge this gap and ask: how do metabolic cost and accuracy interact to determine speed of reaching movements? First, we systematically measure the effect of increasing mass on the metabolic cost of reaching across a range of movement speeds. Next, in a sequence of three experiments, we examine how added mass affects preferred reaching speed across changing accuracy requirements. We find that, while added mass consistently increases metabolic cost thereby leading to slower metabolically optimal movement speeds, self-selected reach speeds are slower than those predicted by an optimization of metabolic cost alone. We then demonstrate how a single model that considers both accuracy and metabolic costs can explain preferred movement speeds. Together, our findings provide a unifying framework to illuminate the combined effects of metabolic cost and accuracy on movement speed and highlight the integral role metabolic cost plays in determining reach speed.

Validation of Proprietary and Novel Step-counting Algorithms for Individuals Ambulating With a Lower Limb Prosthesis.

OBJECTIVE: To compare the accuracy and reliability of 10 different accelerometer-based step-counting algorithms for individuals with lower limb loss, accounting for different clinical characteristics and real-world activities. DESIGN: Cross-sectional study. SETTING: General community setting (ie, institutional research laboratory and community free-living). PARTICIPANTS: Forty-eight individuals with a lower limb amputation (N=48) wore an ActiGraph (AG) wGT3x-BT accelerometer proximal to the foot of their prosthetic limb during labeled indoor/outdoor activities and community free-living. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Intraclass correlation coefficient (ICC), absolute and root mean square error (RMSE), and Bland Altman plots were used to compare true (manual) step counts to estimated step counts from the proprietary AG Default algorithm and low frequency extension filter, as well as from 8 novel algorithms based on continuous wavelet transforms, fast Fourier transforms (FFTs), and peak detection. RESULTS: All algorithms had excellent agreement with manual step counts (ICC>0.9). The AG Default and FFT algorithms had the highest overall error (RMSE=17.81 and 19.91 steps, respectively), widest limits of agreement, and highest error during outdoor and ramp ambulation. The AG Default algorithm also had among the highest error during indoor ambulation and stairs, while a FFT algorithm had the highest error during stationary tasks. Peak detection algorithms, especially those using pre-set parameters with a trial-specific component, had among the lowest error across all activities (RMSE=4.07-8.99 steps). CONCLUSIONS: Because of its simplicity and accuracy across activities and clinical characteristics, we recommend the peak detection algorithm with set parameters to count steps using a prosthetic-worn AG among individuals with lower limb loss for clinical and research applications.

Miniaturized wireless, skin-integrated sensor networks for quantifying full-body movement behaviors and vital signs in infants.

Early identification of atypical infant movement behaviors consistent with underlying neuromotor pathologies can expedite timely enrollment in therapeutic interventions that exploit inherent neuroplasticity to promote recovery. Traditional neuromotor assessments rely on qualitative evaluations performed by specially trained personnel, mostly available in tertiary medical centers or specialized facilities. Such approaches are high in cost, require geographic proximity to advanced healthcare resources, and yield mostly qualitative insight. This paper introduces a simple, low-cost alternative in the form of a technology customized for quantitatively capturing continuous, full-body kinematics of infants during free living conditions at home or in clinical settings while simultaneously recording essential vital signs data. The system consists of a wireless network of small, flexible inertial sensors placed at strategic locations across the body and operated in a wide-bandwidth and time-synchronized fashion. The data serve as the basis for reconstructing three-dimensional motions in avatar form without the need for video recordings and associated privacy concerns, for remote visual assessments by experts. These quantitative measurements can also be presented in graphical format and analyzed with machine-learning techniques, with potential to automate and systematize traditional motor assessments. Clinical implementations with infants at low and at elevated risks for atypical neuromotor development illustrates application of this system in quantitative and semiquantitative assessments of patterns of gross motor skills, along with body temperature, heart rate, and respiratory rate, from long-term and follow-up measurements over a 3-mo period following birth. The engineering aspects are compatible for scaled deployment, with the potential to improve health outcomes for children worldwide via early, pragmatic detection methods.

Sleep Monitoring during Acute Stroke Rehabilitation: Toward Automated Measurement Using Multimodal Wireless Sensors.

Sleep plays a critical role in stroke recovery. However, there are limited practices to measure sleep for individuals with stroke, thus inhibiting our ability to identify and treat poor sleep quality. Wireless, body-worn sensors offer a solution for continuous sleep monitoring. In this study, we explored the feasibility of (1) collecting overnight biophysical data from patients with subacute stroke using a simple sensor system and (2) constructing machine-learned algorithms to detect sleep stages. Ten individuals with stroke in an inpatient rehabilitation hospital wore two wireless sensors during a single night of sleep. Polysomnography served as ground truth to classify different sleep stages. A population model, trained on data from multiple patients and tested on data from a separate patient, performed poorly for this limited sample. Personal models trained on data from one patient and tested on separate data from the same patient demonstrated markedly improved performance over population models and research-grade wearable devices to detect sleep/wake. Ultimately, the heterogeneity of biophysical signals after stroke may present a challenge in building generalizable population models. Personal models offer a provisional method to capture high-resolution sleep metrics from simple wearable sensors by leveraging a single night of polysomnography data.

The impact of a yoga-based physical therapy group for individuals with traumatic brain injury: results from a pilot study.

OBJECTIVE: To compare the impacts of yoga-based physical therapy versus a seated rest within the context of standard rehabilitation practice on sleep, heart rate variability (HRV), anxiety, and fatigue during acute traumatic brain injury (TBI) rehabilitation. METHODS: Eleven individuals participated in this crossover study involving the following interventions in a randomized order: group yoga-based physical therapy (YPT), conventional physical therapy (CPT), and group seated rest in a relaxing environment (SR). HRV and self-reported anxiety and fatigue were measured immediately before and after each group, and sleep after each condition and at baseline. Data was analyzed using generalized linear mixed models with repeated measures. RESULTS: The interaction between time and treatment was statistically significant (p = .0203). For the SR treatment, wake after sleep onset (WASO) rate was reduced from 14.99 to 10.60 (IRR = 0.71; p = .006). Time and treatment were not found to be statistically significantly associated with any of the secondary outcomes. CONCLUSION: Yoga-based physical therapy is feasible and safe in the inpatient rehabilitation setting following TBI. Sleep quality improved following the addition of a one-hour seated rest in a relaxing environment to a standard rehabilitation daily schedule, suggesting that structured rest time may be beneficial to sleep hygiene during inpatient rehabilitation following TBI. ClinicalTrials.Gov Registration Number: NCT03701594.

Inpatient stroke rehabilitation: prediction of clinical outcomes using a machine-learning approach.

BACKGROUND: In clinical practice, therapists often rely on clinical outcome measures to quantify a patient's impairment and function. Predicting a patient's discharge outcome using baseline clinical information may help clinicians design more targeted treatment strategies and better anticipate the patient's assistive needs and discharge care plan. The objective of this study was to develop predictive models for four standardized clinical outcome measures (Functional Independence Measure, Ten-Meter Walk Test, Six-Minute Walk Test, Berg Balance Scale) during inpatient rehabilitation. METHODS: Fifty stroke survivors admitted to a United States inpatient rehabilitation hospital participated in this study. Predictors chosen for the clinical discharge scores included demographics, stroke characteristics, and scores of clinical tests at admission. We used the Pearson product-moment and Spearman's rank correlation coefficients to calculate correlations among clinical outcome measures and predictors, a cross-validated Lasso regression to develop predictive equations for discharge scores of each clinical outcome measure, and a Random Forest based permutation analysis to compare the relative importance of the predictors. RESULTS: The predictive equations explained 70-77% of the variance in discharge scores and resulted in a normalized error of 13-15% for predicting the outcomes of new patients. The most important predictors were clinical test scores at admission. Additional variables that affected the discharge score of at least one clinical outcome were time from stroke onset to rehabilitation admission, age, sex, body mass index, race, and diagnosis of dysphasia or speech impairment. CONCLUSIONS: The models presented in this study could help clinicians and researchers to predict the discharge scores of clinical outcomes for individuals enrolled in an inpatient stroke rehabilitation program that adheres to U.S. Medicare standards.

Role of data measurement characteristics in the accurate detection of Parkinson's disease symptoms using wearable sensors.

BACKGROUND: Parkinson's disease (PD) is a progressive neurological disease, with characteristic motor symptoms such as tremor and bradykinesia. There is a growing interest to continuously monitor these and other symptoms through body-worn sensor technology. However, limited battery life and memory capacity hinder the potential for continuous, long-term monitoring with these devices. There is little information available on the relative value of adding sensors, increasing sampling rate, or computing complex signal features, all of which may improve accuracy of symptom detection at the expense of computational resources. Here we build on a previous study to investigate the relationship between data measurement characteristics and accuracy when using wearable sensor data to classify tremor and bradykinesia in patients with PD. METHODS: Thirteen individuals with PD wore a flexible, skin-mounted sensor (collecting tri-axial accelerometer and gyroscope data) and a commercial smart watch (collecting tri-axial accelerometer data) on their predominantly affected hand. The participants performed a series of standardized motor tasks, during which a clinician scored the severity of tremor and bradykinesia in that limb. Machine learning models were trained on scored data to classify tremor and bradykinesia. Model performance was compared when using different types of sensors (accelerometer and/or gyroscope), different data sampling rates (up to 62.5 Hz), and different categories of pre-engineered features (up to 148 features). Performance was also compared between the flexible sensor and smart watch for each analysis. RESULTS: First, there was no effect of device type for classifying tremor symptoms (p > 0.34), but bradykinesia models incorporating gyroscope data performed slightly better (up to 0.05 AUROC) than other models (p = 0.01). Second, model performance decreased with sampling frequency (p < 0.001) for tremor, but not bradykinesia (p > 0.47). Finally, model performance for both symptoms was maintained after substantially reducing the feature set. CONCLUSIONS: Our findings demonstrate the ability to simplify measurement characteristics from body-worn sensors while maintaining performance in PD symptom detection. Understanding the trade-off between model performance and data resolution is crucial to design efficient, accurate wearable sensing systems. This approach may improve the feasibility of long-term, continuous, and real-time monitoring of PD symptoms by reducing computational burden on wearable devices.

WITHDRAWN: Immediate Adaptations to Poststroke Walking Performance Using a Wearable Robotic Exoskeleton.

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Augmenting Clinical Outcome Measures of Gait and Balance with a Single Inertial Sensor in Age-Ranged Healthy Adults.

Gait and balance impairments are linked with reduced mobility and increased risk of falling. Wearable sensing technologies, such as inertial measurement units (IMUs), may augment clinical assessments by providing continuous, high-resolution data. This study tested and validated the utility of a single IMU to quantify gait and balance features during routine clinical outcome tests, and evaluated changes in sensor-derived measurements with age, sex, height, and weight. Age-ranged, healthy individuals (N = 49, 20-70 years) wore a lower back IMU during the 10 m walk test (10MWT), Timed Up and Go (TUG), and Berg Balance Scale (BBS). Spatiotemporal gait parameters computed from the sensor data were validated against gold standard measures, demonstrating excellent agreement for stance time, step time, gait velocity, and step count (intraclass correlation (ICC) > 0.90). There was good agreement for swing time (ICC = 0.78) and moderate agreement for step length (ICC = 0.68). A total of 184 features were calculated from the acceleration and angular velocity signals across these tests, 36 of which had significant correlations with age. This approach was also demonstrated for an individual with stroke, providing higher resolution information about balance, gait, and mobility than the clinical test scores alone. Leveraging mobility data from wireless, wearable sensors can help clinicians and patients more objectively pinpoint impairments, track progression, and set personalized goals during and after rehabilitation.

Activity Recognition for Persons With Stroke Using Mobile Phone Technology: Toward Improved Performance in a Home Setting.

BACKGROUND: Smartphones contain sensors that measure movement-related data, making them promising tools for monitoring physical activity after a stroke. Activity recognition (AR) systems are typically trained on movement data from healthy individuals collected in a laboratory setting. However, movement patterns change after a stroke (eg, gait impairment), and activities may be performed differently at home than in a lab. Thus, it is important to validate AR for gait-impaired stroke patients in a home setting for accurate clinical predictions. OBJECTIVE: In this study, we sought to evaluate AR performance in a home setting for individuals who had suffered a stroke, by using different sets of training activities. Specifically, we compared AR performance for persons with stroke while varying the origin of training data, based on either population (healthy persons or persons with stoke) or environment (laboratory or home setting). METHODS: Thirty individuals with stroke and fifteen healthy subjects performed a series of mobility-related activities, either in a laboratory or at home, while wearing a smartphone. A custom-built app collected signals from the phone's accelerometer, gyroscope, and barometer sensors, and subjects self-labeled the mobility activities. We trained a random forest AR model using either healthy or stroke activity data. Primary measures of AR performance were (1) the mean recall of activities and (2) the misclassification of stationary and ambulatory activities. RESULTS: A classifier trained on stroke activity data performed better than one trained on healthy activity data, improving average recall from 53% to 75%. The healthy-trained classifier performance declined with gait impairment severity, more often misclassifying ambulatory activities as stationary ones. The classifier trained on in-lab activities had a lower average recall for at-home activities (56%) than for in-lab activities collected on a different day (77%). CONCLUSIONS: Stroke-based training data is needed for high quality AR among gait-impaired individuals with stroke. Additionally, AR systems for home and community monitoring would likely benefit from including at-home activities in the training data.

Sensorimotor recalibration during split-belt walking: task-specific and multisensory?

Motor adaptations not only recalibrate movement execution but also can lead to altered movement perception in multiple sensory domains. Vazquez, Statton, Busgang, and Bastian (J Neurophysiol 114: 3255-3267, 2015) recently showed that split-belt walking affects perception of leg speed during walking, but not perceptions of leg position during standing and walking or perception of contact force during stepping. Considering their findings within the broader scope of sensorimotor recalibration in other tasks, we suggest that sensorimotor recalibrations are task specific and can be multisensory.

Rationality in Human Movement.

It long has been appreciated that humans behave irrationally in economic decisions under risk: they fail to objectively consider uncertainty, costs, and rewards and instead exhibit risk-seeking or risk-averse behavior. We hypothesize that poor estimates of motor variability (influenced by motor task) and distorted probability weighting (influenced by relevant emotional processes) contribute to characteristic irrationality in human movement decisions.

Machine Learning Models for Parkinson Disease: Systematic Review.

Background: With the increasing availability of data, computing resources, and easier-to-use software libraries, machine learning (ML) is increasingly used in disease detection and prediction, including for Parkinson disease (PD). Despite the large number of studies published every year, very few ML systems have been adopted for real-world use. In particular, a lack of external validity may result in poor performance of these systems in clinical practice. Additional methodological issues in ML design and reporting can also hinder clinical adoption, even for applications that would benefit from such data-driven systems. Objective: To sample the current ML practices in PD applications, we conducted a systematic review of studies published in 2020 and 2021 that used ML models to diagnose PD or track PD progression. Methods: We conducted a systematic literature review in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines in PubMed between January 2020 and April 2021, using the following exact string: "Parkinson's" AND ("ML" OR "prediction" OR "classification" OR "detection" or "artificial intelligence" OR "AI"). The search resulted in 1085 publications. After a search query and review, we found 113 publications that used ML for the classification or regression-based prediction of PD or PD-related symptoms. Results: Only 65.5% (74/113) of studies used a holdout test set to avoid potentially inflated accuracies, and approximately half (25/46, 54%) of the studies without a holdout test set did not state this as a potential concern. Surprisingly, 38.9% (44/113) of studies did not report on how or if models were tuned, and an additional 27.4% (31/113) used ad hoc model tuning, which is generally frowned upon in ML model optimization. Only 15% (17/113) of studies performed direct comparisons of results with other models, severely limiting the interpretation of results. Conclusions: This review highlights the notable limitations of current ML systems and techniques that may contribute to a gap between reported performance in research and the real-life applicability of ML models aiming to detect and predict diseases such as PD.

Early Prediction of Poststroke Rehabilitation Outcomes Using Wearable Sensors.

OBJECTIVE: Inpatient rehabilitation represents a critical setting for stroke treatment, providing intensive, targeted therapy and task-specific practice to minimize a patient's functional deficits and facilitate their reintegration into the community. However, impairment and recovery vary greatly after stroke, making it difficult to predict a patient's future outcomes or response to treatment. In this study, the authors examined the value of early-stage wearable sensor data to predict 3 functional outcomes (ambulation, independence, and risk of falling) at rehabilitation discharge. METHODS: Fifty-five individuals undergoing inpatient stroke rehabilitation participated in this study. Supervised machine learning classifiers were retrospectively trained to predict discharge outcomes using data collected at hospital admission, including patient information, functional assessment scores, and inertial sensor data from the lower limbs during gait and/or balance tasks. Model performance was compared across different data combinations and was benchmarked against a traditional model trained without sensor data. RESULTS: For patients who were ambulatory at admission, sensor data improved the predictions of ambulation and risk of falling (with weighted F1 scores increasing by 19.6% and 23.4%, respectively) and maintained similar performance for predictions of independence, compared to a benchmark model without sensor data. The best-performing sensor-based models predicted discharge ambulation (community vs household), independence (high vs low), and risk of falling (normal vs high) with accuracies of 84.4%, 68.8%, and 65.9%, respectively. Most misclassifications occurred with admission or discharge scores near the classification boundary. For patients who were nonambulatory at admission, sensor data recorded during simple balance tasks did not offer predictive value over the benchmark models. CONCLUSION: These findings support the continued investigation of wearable sensors as an accessible, easy-to-use tool to predict the functional recovery after stroke. IMPACT: Accurate, early prediction of poststroke rehabilitation outcomes from wearable sensors would improve our ability to deliver personalized, effective care and discharge planning in the inpatient setting and beyond.

Wireless wearable sensors can facilitate rapid detection of sleep apnea in hospitalized stroke patients.

STUDY OBJECTIVES: To evaluate wearable devices and machine learning for detecting sleep apnea in patients with stroke at an acute inpatient rehabilitation facility (IRF). METHODS: A total of 76 individuals with stroke wore a standard home sleep apnea test (ApneaLink Air), a multimodal, wireless wearable sensor system (ANNE), and a research-grade actigraphy device (ActiWatch) for at least one night during their first week after IRF admission as part of a larger clinical trial. Logistic regression algorithms were trained to detect sleep apnea using biometric features obtained from the ANNE sensors and ground truth apnea rating from the ApneaLink Air. Multiple algorithms were evaluated using different sensor combinations and different apnea detection criteria based on the Apnea-Hypopnea Index (AHI≥5, AHI≥15). RESULTS: Seventy-one (96%) participants wore the ANNE sensors for multiple nights. In contrast, only forty-eight participants (63%) could be successfully assessed for OSA by ApneaLink; 28 (37%) refused testing. The best-performing model utilized photoplethysmography (PPG) and finger temperature features to detect moderate-severe sleep apnea (AHI≥15), with 88% sensitivity and a positive likelihood ratio (LR+) of 44.00. This model was tested on additional nights of ANNE data achieving 71% sensitivity (10.14 LR+) when considering each night independently and 86% accuracy when averaging multi-night predictions. CONCLUSIONS: This research demonstrates the feasibility of accurately detecting moderate-severe sleep apnea early in the stroke recovery process using wearable sensors and machine learning techniques. These findings can inform future efforts to improve early detection for post-stroke sleep disorders, thereby enhancing patient recovery and long-term outcomes.

Does risk-sensitivity transfer across movements?

An intriguing finding in motor control studies is the marked effect of risk on movement decision making. However, there are inconsistent reports of risk-sensitivity across different movements and tasks, with both risk-seeking and risk-averse behavior observed. This raises the question of whether risk-sensitivity in movement decision making is context dependent and specific to the movement or task being performed. We investigated whether risk-sensitivity transfers between dissimilar movements within a single task. Healthy young adults made arm-reaching movements or whole-body leaning movements to move a cursor as close to the edge of a virtual cliff as possible without moving beyond the edge. They received points on the basis of the cursor's final proximity to the cliff edge. Risk was manipulated by increasing the point penalty associated with the cliff region and/or adding Gaussian noise to the cursor. We compared subjects' movement endpoints with endpoints predicted by a subject-specific, risk-neutral model of movement planning. Subjects demonstrated risk-seeking behavior in both movements that was consistent across risk environments, moving closer to the cliff than the model predicted. However, subjects were significantly more risk-seeking in whole-body movements. Our results present the first evidence of risk-sensitivity in whole-body movements. They also demonstrate that the direction of risk-sensitivity (i.e., risk-seeking or risk-averse) is similar between arm-reaching and whole-body movements, although degree of risk-sensitivity did not transfer from one movement to another. This finding has important implications for the ability of quantitative descriptions of decision making to generalize across movements and, ultimately, decision-making contexts.

AI in Rehabilitation Medicine: Opportunities and Challenges.

Artificial intelligence (AI) tools are increasingly able to learn from larger and more complex data, thus allowing clinicians and scientists to gain new insights from the information they collect about their patients every day. In rehabilitation medicine, AI can be used to find patterns in huge amounts of healthcare data. These patterns can then be leveraged at the individual level, to design personalized care strategies and interventions to optimize each patient's outcomes. However, building effective AI tools requires many careful considerations about how we collect and handle data, how we train the models, and how we interpret results. In this perspective, we discuss some of the current opportunities and challenges for AI in rehabilitation. We first review recent trends in AI for the screening, diagnosis, treatment, and continuous monitoring of disease or injury, with a special focus on the different types of healthcare data used for these applications. We then examine potential barriers to designing and integrating AI into the clinical workflow, and we propose an end-to-end framework to address these barriers and guide the development of effective AI for rehabilitation. Finally, we present ideas for future work to pave the way for AI implementation in real-world rehabilitation practices.

Validity and reliability of a commercial wearable sensor system for measuring spatiotemporal gait parameters in a post-stroke population: the effects of walking speed and asymmetry.

Objective.Commercial wearable sensor systems are a promising alternative to costly laboratory equipment for clinical gait evaluation, but their accuracy for individuals with gait impairments is not well established. Therefore, we investigated the validity and reliability of the APDM Opal wearable sensor system to measure spatiotemporal gait parameters for healthy controls and individuals with chronic stroke.Approach.Participants completed the 10 m walk test over an instrumented mat three times in different speed conditions. We compared performance of Opal sensors to the mat across different walking speeds and levels of step length asymmetry in the two populations.Main results. Gait speed and stride length measures achieved excellent reliability, though they were systematically underestimated by 0.11 m s-1and 0.12 m, respectively. The stride and step time measures also achieved excellent reliability, with no significant errors (median absolute percentage error <6.00%,p> 0.05). Gait phase duration measures achieved moderate-to-excellent reliability, with relative errors ranging from 4.13%-21.59%. Across gait parameters, the relative error decreased by 0.57%-9.66% when walking faster than 1.30 m s-1; similar reductions occurred for step length symmetry indices lower than 0.10.Significance. This study supports the general use of Opal wearable sensors to obtain quantitative measures of post-stroke gait impairment. These measures should be interpreted cautiously for individuals with moderate-severe asymmetry or walking speeds slower than 0.80 m s-1.

Effect of Transcranial Direct Current Stimulation versus Virtual Reality on Gait for Children with Bilateral Spastic Cerebral Palsy: A Randomized Clinical Trial.

Impaired gait is a common sequela in bilateral spastic cerebral palsy. We compared the effects of two novel research interventions-transcranial direct current stimulation and virtual reality-on spatiotemporal and kinetic gait impairments in children with bilateral spastic CP. Forty participants were randomized to receive either transcranial direct current stimulation or virtual reality training. Both groups received standard-of-care gait therapy during the assigned intervention and for the subsequent 10 weeks afterward. Spatiotemporal and kinetic gait parameters were evaluated at three different times: (i) before starting the intervention, (ii) after two weeks of intervention, and (iii) 10 weeks after intervention completion. Both groups exhibited higher velocity and cadence, as well as longer stance time, step length, and stride length after intervention (p < 0.001). Only the transcranial direct current stimulation group exhibited increased maximum force and maximum peak pressure after intervention (p's ≤ 0.001), with continued improvements in spatiotemporal parameters at follow-up. The transcranial direct current stimulation group had higher gait velocities, stride length, and step length at follow-up compared to the virtual reality group (p ≤ 0.02). These findings suggest that transcranial direct current stimulation has a broader and longer-lasting effect on gait than virtual reality training for children with bilateral spastic cerebral palsy.

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.