Noninvasive spinal stimulation improves walking in chronic stroke survivors: a proof-of-concept case series.

BACKGROUND: After stroke, restoring safe, independent, and efficient walking is a top rehabilitation priority. However, in nearly 70% of stroke survivors asymmetrical walking patterns and reduced walking speed persist. This case series study aims to investigate the effectiveness of transcutaneous spinal cord stimulation (tSCS) in enhancing walking ability of persons with chronic stroke. METHODS: Eight participants with hemiparesis after a single, chronic stroke were enrolled. Each participant was assigned to either the Stim group (N = 4, gait training + tSCS) or Control group (N = 4, gait training alone). Each participant in the Stim group was matched to a participant in the Control group based on age, time since stroke, and self-selected gait speed. For the Stim group, tSCS was delivered during gait training via electrodes placed on the skin between the spinous processes of C5-C6, T11-T12, and L1-L2. Both groups received 24 sessions of gait training over 8 weeks with a physical therapist providing verbal cueing for improved gait symmetry. Gait speed (measured from 10 m walk test), endurance (measured from 6 min walk test), spatiotemporal gait symmetries (step length and swing time), as well as the neurophysiological outcomes (muscle synergy, resting motor thresholds via spinal motor evoked responses) were collected without tSCS at baseline, completion, and 3 month follow-up. RESULTS: All four Stim participants sustained spatiotemporal symmetry improvements at the 3 month follow-up (step length: 17.7%, swing time: 10.1%) compared to the Control group (step length: 1.1%, swing time 3.6%). Additionally, 3 of 4 Stim participants showed increased number of muscle synergies and/or lowered resting motor thresholds compared to the Control group. CONCLUSIONS: This study provides promising preliminary evidence that using tSCS as a therapeutic catalyst to gait training may increase the efficacy of gait rehabilitation in individuals with chronic stroke. Trial registration NCT03714282 (clinicaltrials.gov), registration date: 2018-10-18.

Validity and reliability study of a novel surface electromyography sensor using a well-consolidated electromyography system in individuals with cervical spinal cord injury.

STUDY DESIGN: Non-interventional, cross-sectional pilot study. OBJECTIVES: To establish the validity and reliability of the BioStamp nPoint biosensor (Medidata Solutions, New York, NY, USA [formerly MC10, Inc.]) for measuring electromyography in individuals with cervical spinal cord injury (SCI) by comparing the surface electromyography (sEMG) metrics with the Trigno wireless electromyography system (Delsys, Natick, MA, USA). SETTING: Participants were recruited from the Shirley Ryan AbilityLab registry. METHODS: Individuals aged 18-70 years with cervical SCI were evaluated with the two biosensors to capture activity on upper-extremity muscles during two study sessions conducted over 2 days (day 1-consent alone; day 2-two data collections in same session). Time and frequency metrics were captured, and signal-to-noise ratio was determined for each muscle group. Test-retest reliability was determined using Pearson's correlation. Validation of the BioStamp nPoint system was based on Bland-Altmann analysis. RESULTS: Among the 11 participants, 30.8% had subacute cervical injury at C5-C6; 53.8% were injured within 1 year of the study. Results from the test-retest reliability assessment revealed that most Pearson's correlations between the two sensory measurements were strong (≥0.50). The Bland-Altman analysis found values of the signal-to-noise ratio, frequency, and peak amplitude were within the level of agreement. Signal-to-noise ratios ranged from 7.06 to 22.1. CONCLUSIONS: In most instances, the performance of the BioStamp nPoint sensors was moderately to strongly correlated with that of the Trigno sensors in all muscle groups tested. The BioStamp nPoint system is a valid and reliable approach to assess sEMG measures in individuals with cervical SCI. SPONSORSHIP: The present study was supported by AbbVie Inc.

Efficacy and safety of using auditory-motor entrainment to improve walking after stroke: a multi-site randomized controlled trial of InTandemTM.

Walking slowly after stroke reduces health and quality of life. This multi-site, prospective, interventional, 2-arm randomized controlled trial (NCT04121754) evaluated the safety and efficacy of an autonomous neurorehabilitation system (InTandemTM) designed to use auditory-motor entrainment to improve post-stroke walking. 87 individuals were randomized to 5-week walking interventions with InTandem or Active Control (i.e., walking without InTandem). The primary endpoints were change in walking speed, measured by the 10-meter walk test pre-vs-post each 5-week intervention, and safety, measured as the frequency of adverse events (AEs). Clinical responder rates were also compared. The trial met its primary endpoints. InTandem was associated with a 2x larger increase in speed (Δ: 0.14 ± 0.03 m/s versus Δ: 0.06 ± 0.02 m/s, F(1,49) = 6.58, p = 0.013), 3x more responders (40% versus 13%, χ2(1) ≥ 6.47, p = 0.01), and similar safety (both groups experienced the same number of AEs). The auditory-motor intervention autonomously delivered by InTandem is safe and effective in improving walking in the chronic phase of stroke.

Circulating T cell specific extracellular vesicle profiles in cardiac allograft acute cellular rejection.

There is a critical need for biomarkers of acute cellular rejection (ACR) in organ transplantation. We hypothesized that ACR leads to changes in donor-reactive T cell small extracellular vesicle (sEV) profiles in transplant recipient circulation that match the kinetics of alloreactive T cell activation. In rodent heart transplantation, circulating T cell sEV quantities (P < .0001) and their protein and mRNA cargoes showed time-specific expression of alloreactive and regulatory markers heralding early ACR in allogeneic transplant recipients but not in syngeneic transplant recipients. Next generation sequencing of their microRNA cargoes identified novel candidate biomarkers of ACR, which were validated by stem loop quantitative reverse transcription polymerase chain reaction (n = 10). Circulating T cell sEVs enriched from allogeneic transplant recipients mediated targeted cytotoxicity of donor cardiomyocytes by apoptosis assay (P < .0001). Translation of the concept and EV methodologies to clinical heart transplantation demonstrated similar upregulation of circulating T cell sEV profiles at time points of grade 2 ACR (n = 3 patients). Furthermore, T cell receptor sequencing of T cell sEV mRNA cargo demonstrated expression of T cell clones with intact complementarity determining region 3 signals. These data support the diagnostic potential of T cell sEVs as noninvasive biomarker of ACR and suggest their potential functional roles.

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.

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.

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.

Evaluation of a carepartner-integrated telehealth gait rehabilitation program for persons with stroke: study protocol for a feasibility study.

BACKGROUND: Despite family carepartners of individuals post-stroke experiencing high levels of strain and reduced quality of life, stroke rehabilitation interventions rarely address carepartner well-being or offer training to support their engagement in therapeutic activities. Our group has developed creative intervention approaches to support families during stroke recovery, thereby improving physical and psychosocial outcomes for both carepartners and stroke survivors. The purpose of this study is to test the feasibility of an adapted, home-based intervention (Carepartner Collaborative Integrative Therapy for Gait-CARE-CITE-Gait) designed to facilitate positive carepartner involvement during home-based training targeting gait and mobility. METHODS: This two-phased design will determine the feasibility of CARE-CITE-Gait, a novel intervention that leverages principles from our previous carepartner-focused upper extremity intervention. During the 4-week CARE-CITE-Gait intervention, carepartners review online video-based modules designed to illustrate strategies for an autonomy-supportive environment during functional mobility task practice, and the study team completes two 2-h home visits for dyad collaborative goal setting. In phase I, content validity, usability, and acceptability of the CARE-CITE-Gait modules will be evaluated by stroke rehabilitation content experts and carepartners. In phase II, feasibility (based on measures of recruitment, retention, intervention adherence, and safety) will be measured. Preliminary effects of the CARE-CITE-Gait will be gathered using a single-group, quasi-experimental design with repeated measures (two baseline visits 1 week apart, posttest, and 1-month follow-up) with 15 carepartner and stroke survivor dyads. Outcome data collectors will be blinded. Outcomes include psychosocial variables (family conflict surrounding stroke recovery, strain, autonomy support, and quality of life) collected from carepartners and measures of functional mobility, gait speed, stepping activity, and health-related quality of life collected from stroke survivors. DISCUSSION: The findings of the feasibility testing and preliminary data on the effects of CARE-CITE-Gait will provide justification and information to guide a future definitive randomized clinical trial. The knowledge gained from this study will enhance our understanding of and aid the development of rehabilitation approaches that address both carepartner and stroke survivor needs during the stroke recovery process. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05257928. Registered 25 February 2022. TRIAL STATUS: This trial was registered on ClinicalTrials.gov (NCT05257928) on March 25, 2022. Recruitment of participants was initiated on May 18, 2022.

A Research Protocol to Study the Priming Effects of Breathing Low Oxygen on Enhancing Training-Related Gains in Walking Function for Persons With Spinal Cord Injury: The BO2ST Trial.

Brief episodes of low oxygen breathing (therapeutic acute intermittent hypoxia; tAIH) may serve as an effective plasticity-promoting primer to enhance the effects of transcutaneous spinal stimulation-enhanced walking therapy (WALKtSTIM) in persons with chronic (>1 year) spinal cord injury (SCI). Pre-clinical studies in rodents with SCI show that tAIH and WALKtSTIM therapies harness complementary mechanisms of plasticity to maximize walking recovery. Here, we present a multi-site clinical trial protocol designed to examine the influence of tAIH + WALKtSTIM on walking recovery in persons with chronic SCI. We hypothesize that daily (eight sessions, 2 weeks) tAIH + WALKtSTIM will elicit faster, more persistent improvements in walking recovery than either treatment alone. To test our hypothesis, we are conducting a placebo-controlled clinical trial on 60 SCI participants who randomly receive one of three interventions: tAIH + WALKtSTIM; Placebo + WALKtSTIM; and tAIH + WALKtSHAM. Participants receive daily tAIH (fifteen 90-sec episodes at 10% O2 with 60-sec intervals at 21% O2) or daily placebo (fifteen 90-sec episodes at 21% O2 with 60-sec intervals at 21% O2) before a 45-min session of WALKtSTIM or WALKtSHAM. Our primary outcome measures assess walking speed (10-Meter Walk Test), endurance (6-Minute Walk Test), and balance (Timed Up and Go Test). For safety, we also measure pain levels, spasticity, sleep behavior, cognition, and rates of systemic hypertension and autonomic dysreflexia. Assessments occur before, during, and after sessions, as well as at 1, 4, and 8 weeks post-intervention. Results from this study extend our understanding of the functional benefits of tAIH priming by investigating its capacity to boost the neuromodulatory effects of transcutaneous spinal stimulation on restoring walking after SCI. Given that there is no known cure for SCI and no single treatment is sufficient to overcome walking deficits, there is a critical need for combinatorial treatments that accelerate and anchor walking gains in persons with lifelong SCI. Trial Registration: ClinicalTrials.gov, NCT05563103.

Understanding corticomotor mechanisms for activation of non-target muscles during unilateral isometric contractions of leg muscles after stroke.

PURPOSE: Muscle activation often occurs in muscles ipsilateral to a voluntarily activated muscle and to a greater extent after stroke. In this study, we measured muscle activation in non-target, ipsilateral leg muscles and used transcranial magnetic stimulation (TMS) to provide insight into whether corticomotor pathways contribute to involuntary activation. MATERIALS AND METHODS: Individuals with stroke performed unilateral isometric ankle dorsiflexion, ankle plantarflexion, knee extension, and knee flexion. To quantify involuntary muscle activation in non-target muscles, muscle activation was measured during contractions from the ipsilateral tibialis anterior (TA), medial gastrocnemius (MG), rectus femoris (RF), and biceps femoris (BF) and normalized to resting muscle activity. To provide insight into mechanisms of involuntary non-target muscle activation, TMS was applied to the contralateral hemisphere, and motor evoked potentials (MEPs) were recorded. RESULTS: We found significant muscle activation in nearly every non-target muscle during isometric unilateral contractions. MEPs were frequently observed in non-target muscles, but greater non-target MEP amplitude was not associated with greater non-target muscle activation. CONCLUSIONS: Our results suggest that non-target muscle activation occurs frequently in individuals with chronic stroke. The lack of association between non-target TMS responses and non-target muscle activation suggests that non-target muscle activation may have a subcortical or spinal origin. Non-target muscle activation has important clinical implications because it may impair torque production, out-of-synergy movement, and muscle activation timing.

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.

Applying machine learning to consumer wearable data for the early detection of complications after pediatric appendectomy.

When children are discharged from the hospital after surgery, their caregivers often rely on subjective assessments (e.g., appetite, fatigue) to monitor postoperative recovery as objective assessment tools are scarce at home. Such imprecise and one-dimensional evaluations can result in unwarranted emergency department visits or delayed care. To address this gap in postoperative monitoring, we evaluated the ability of a consumer-grade wearable device, Fitbit, which records multimodal data about daily physical activity, heart rate, and sleep, in detecting abnormal recovery early in children recovering after appendectomy. One hundred and sixty-two children, ages 3-17 years old, who underwent an appendectomy (86 complicated and 76 simple cases of appendicitis) wore a Fitbit device on their wrist for 21 days postoperatively. Abnormal recovery events (i.e., abnormal symptoms or confirmed postoperative complications) that arose during this period were gathered from medical records and patient reports. Fitbit-derived measures, as well as demographic and clinical characteristics, were used to train machine learning models to retrospectively detect abnormal recovery in the two days leading up to the event for patients with complicated and simple appendicitis. A balanced random forest classifier accurately detected 83% of these abnormal recovery days in complicated appendicitis and 70% of abnormal recovery days in simple appendicitis prior to the true report of a symptom/complication. These results support the development of machine learning algorithms to predict onset of abnormal symptoms and complications in children undergoing surgery, and the use of consumer wearables as monitoring tools for early detection of postoperative events.

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.

Activity Monitoring in Parkinson Disease: A Qualitative Study of Implementation Determinants.

BACKGROUND AND PURPOSE: There is interest in incorporating digital health technology in routine practice. We integrate multiple stakeholder perspectives to describe implementation determinants (barriers and facilitators) regarding digital health technology use to facilitate exercise behavior change for people with Parkinson disease in outpatient physical therapy. METHODS: The purposeful sample included people with Parkinson disease (n = 13), outpatient physical therapists (n = 12), and advanced technology stakeholders including researchers and reimbursement specialists (n = 13). Semistructured interviews were used to elicit implementation determinants related to using digital health technology for activity monitoring and exercise behavior change. Deductive codes based on the Consolidated Framework for Implementation Research were used to describe implementation determinants. RESULTS: Key implementation determinants were similar across stakeholder groups. Essential characteristics of digital health technology included design quality and packaging, adaptability, complexity, and cost. Implementation of digital health technology by physical therapists and people with Parkinson disease was influenced by their knowledge, attitudes, and varied confidence levels in using digital health technology. Inner setting organizational determinants included available resources and access to knowledge/information. Process determinants included device interoperability with medical record systems and workflow integration. Outer setting barriers included lack of external policies, regulations, and collaboration with device companies. DISCUSSION AND CONCLUSIONS: Future implementation interventions should address key determinants, including required processes for how and when physical therapists instruct people with Parkinson disease on digital health technology, organizational readiness, workflow integration, and characteristics of physical therapists and people with Parkinson disease who may have ingrained beliefs regarding their ability and willingness to use digital health technology. Although site-specific barriers should be addressed, digital health technology knowledge translation tools tailored to individuals with varied confidence levels may be generalizable across clinics.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content available at: http://links.lww.com/JNPT/A436 ).

The Year in Cardiothoracic Transplant Anesthesia: Selected Highlights From 2021 Part II: Cardiac Transplantation.

This article spotlights the research highlights of this year that specifically pertain to the specialty of anesthesia for heart transplantation. This includes the research on recent developments in the selection and optimization of donors and recipients, including the use of donation after cardiorespiratory death and extended criteria donors, the use of mechanical circulatory support and nonmechanical circulatory support as bridges to transplantation, the effect of COVID-19 on heart transplantation candidates and recipients, and new advances in the perioperative management of these patients, including the use of echocardiography and postoperative outcomes, focusing on renal and cerebral outcomes.

Evaluation of a Carepartner-Integrated Telehealth Gait Rehabilitation Program for Persons with Stroke : Study Protocol for a Feasibility Study.

Background: Despite family carepartners of individuals post-stroke experiencing high levels of strain and reduced quality of life, stroke rehabilitation interventions rarely address carepartner well-being or offer training to support their engagement in therapeutic activities. Our group has developed creative intervention approaches to support families during stroke recovery, thereby improving physical and psychosocial outcomes for both carepartners and stroke survivors. The purpose of this preliminary clinical trial is to test the feasibility of an adapted, home-based intervention (Carepartner Collaborative Integrative Therapy for Gait-CARE-CITE-Gait) designed to facilitate positive carepartner involvement during home-based training targeting gait and mobility. Methods: This two-phased study will determine the feasibility of CARE-CITE-Gait, a novel intervention developed by our team that leverages principles from our previous carepartner-focused upper extremity intervention. During the 4-week CARE-CITE-Gait intervention, carepartners review online video-based modules designed to illustrate strategies for an autonomy-supportive environment during functional mobility task practice, and the study team completes two 2-hour (home-based) visits for dyad collaborative goal setting. In Phase I, the usability and acceptability of the CARE-CITE-Gait modules will be evaluated by stroke rehabilitation content experts and carepartners. In Phase II, feasibility (based on measures of recruitment, retention, and intervention adherence) will be measured. Preliminary effects of the CARE-CITE-Gait will be gathered using a single-group, evaluator blinded, quasi-experimental design with repeated measures (two baseline visits one week apart, post-test, and one-month follow-up) with 15 carepartner and stroke survivor dyads. Outcomes include psychosocial variables (strain, family conflict surrounding stroke recovery, autonomy support and life changes) collected from carepartners, and measures of functional mobility, gait speed, stepping activity, and health-related quality of life collected from stroke survivors. Discussion: The findings of the feasibility testing and preliminary data on the effects of CARE-CITE-Gait will provide justification and information to guide a future definitive randomized clinical trial. The knowledge gained from this study will enhance our understanding of and aid the development of rehabilitation approaches that address both carepartner and stroke survivor needs during the stroke recovery process. Trial Registration: ClinicalTrials.gov, NCT05257928. Registered 25 February 2022, https://clinicaltrials.gov/ct2/show/NCT05257928.

Developing better digital health measures of Parkinson's disease using free living data and a crowdsourced data analysis challenge.

One of the promising opportunities of digital health is its potential to lead to more holistic understandings of diseases by interacting with the daily life of patients and through the collection of large amounts of real-world data. Validating and benchmarking indicators of disease severity in the home setting is difficult, however, given the large number of confounders present in the real world and the challenges in collecting ground truth data in the home. Here we leverage two datasets collected from patients with Parkinson's disease, which couples continuous wrist-worn accelerometer data with frequent symptom reports in the home setting, to develop digital biomarkers of symptom severity. Using these data, we performed a public benchmarking challenge in which participants were asked to build measures of severity across 3 symptoms (on/off medication, dyskinesia, and tremor). 42 teams participated and performance was improved over baseline models for each subchallenge. Additional ensemble modeling across submissions further improved performance, and the top models validated in a subset of patients whose symptoms were observed and rated by trained clinicians.

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.

Cost-effectiveness analysis of overground robotic training versus conventional locomotor training in people with spinal cord injury.

BACKGROUND: Few, if any estimates of cost-effectiveness for locomotor training strategies following spinal cord injury (SCI) are available. The purpose of this study was to estimate the cost-effectiveness of locomotor training strategies following spinal cord injury (overground robotic locomotor training versus conventional locomotor training) by injury status (complete versus incomplete) using a practice-based cohort. METHODS: A probabilistic cost-effectiveness analysis was conducted using a prospective, practice-based cohort from four participating Spinal Cord Injury Model System sites. Conventional locomotor training strategies (conventional training) were compared to overground robotic locomotor training (overground robotic training). Conventional locomotor training included treadmill-based training with body weight support, overground training, and stationary robotic systems. The outcome measures included the calculation of quality adjusted life years (QALYs) using the EQ-5D and therapy costs. We estimate cost-effectiveness using the incremental cost utility ratio and present results on the cost-effectiveness plane and on cost-effectiveness acceptability curves. RESULTS: Participants in the prospective, practice-based cohort with complete EQ-5D data (n = 99) qualified for the analysis. Both conventional training and overground robotic training experienced an improvement in QALYs. Only people with incomplete SCI improved with conventional locomotor training, 0.045 (SD 0.28), and only people with complete SCI improved with overground robotic training, 0.097 (SD 0.20). Costs were lower for conventional training, $1758 (SD $1697) versus overground robotic training $3952 (SD $3989), and lower for those with incomplete versus complete injury. Conventional overground training was more effective and cost less than robotic therapy for people with incomplete SCI. Overground robotic training was more effective and cost more than conventional training for people with complete SCI. The incremental cost utility ratio for overground robotic training for people with complete spinal cord injury was $12,353/QALY. CONCLUSIONS: The most cost-effective locomotor training strategy for people with SCI differed based on injury completeness. Conventional training was more cost-effective than overground robotic training for people with incomplete SCI. Overground robotic training was more cost-effective than conventional training for people with complete SCI. The effect estimates may be subject to limitations associated with small sample sizes and practice-based evidence methodology. These estimates provide a baseline for future research.

Effect of using of a lower-extremity exoskeleton on disability of people with multiple sclerosis.

BACKGROUND: Although ongoing exercise is known to reduce disability in people with multiple sclerosis (MS), participation in lower-extremity exercise programs can be limited by their existing mobility impairments. Lower-extremity exoskeletons could address this problem by facilitating home and community locomotion and enhancing exercise capability but little data is available on the potential of this technology for reducing disability of people with MS. METHODS: We evaluated the Keeogo™ exoskeleton for people with MS using an open-label randomised cross-over design. The trial design allowed us to quantify rehabilitation effects (tested without device) and training effects (tested with device) using functional outcomes: 6-minute walk test (6MWT), timed stair test (TST), and timed up-and-go (TUG). Baseline and post-study self-report instruments included Medical Outcomes Survey Short Form-36 (SF36), MS Walking Scale (MSWS), and others. Amount of home use was documented by daily activity log. Partial correlation analysis was used to explore the relationships between changes in functional outcomes and self-report disability, controlling for amount of home use of the device. RESULTS: Twenty-nine participants with MS completed the trial. Change scores for MSWS, SF36 physical function and SF36 emotional well-being correlated positively with changes in 6MWT which was explained by amount of home use. CONCLUSIONS: The benefits in physical functioning and emotional well-being from using the exoskeleton at home were linked to amount of device usage. Low-profile robotic exoskeletons could be used to deliver facilitated exercise while assisting with locomotor activities of daily living, such as walking and stair climbing in the home and community environment.IMPLICATIONS FOR REHABILITATIONExoskeletons for home use may have the potential to benefit people with MS in terms of physical functioning and emotional well-being.The benefits in physical functioning and emotional well-being appeared to be linked to amount of usage.Exoskeletons might be useful for delivering facilitated exercise while assisting with walking and stair climbing in the home.