Modern methods of data science have become powerful tools for analyzing complex, heterogeneous biomedical datasets, including those specific to spinal cord injury (SCI), enabling personalized predictions of recovery, identification of prognostic biomarkers, and insights into functional outcomes. This article summarizes the one-day Data Science Precourse, held at the 2025 annual scientific meeting of the American Spinal Injury Association (ASIA). The course was designed to illustrate advances in data science and their application to SCI research, while analyzing the unique challenges posed by SCI-specific data, such as sparse longitudinal measurements, variable injury characteristics, and diverse clinical and functional assessments. The precourse combined expert-led discussions with hands-on learning opportunities tailored for both clinical and data science audiences. Topics included addressing key challenges of artificial intelligence methods in SCI data analyses, such as learning from limited or incomplete datasets, implementing causal frameworks to understand recovery mechanisms, and ensuring robust and interpretable predictions for clinical decision-making. The event also showcased real-world applications of data science in SCI research, highlighting both solved and ongoing problems, including prognostic modeling, patient stratification, lesion analysis, and optimization of clinical trial design. The precourse culminated in the presentation by the winning teams of the 2025 ASIA Data Science Challenge.

The Integrated Neurological Change Score (INCS) combines changes in sensory and motor subscores from the International Standards for Spinal Cord Injury Classification (ISNCSCI) into a composite measure. We evaluated the INCS sensitivity to therapeutic outcomes, robustness against ceiling effects, and association to functional improvement in patients with acute cervical spinal cord injury (SCI). To this end, we conducted a retrospective analysis of data from the Nogo Inhibition in Spinal Cord Injury (NISCI) clinical trial alongside a matched cohort from the European Multicenter Study about Spinal Cord Injury (EMSCI). The NISCI trial assessed the safety and efficacy of the anti-Nogo-A antibody (NG-101) in acute cervical SCI, reporting a potential therapeutic effect in motor incomplete patients. Our findings show that the sensitivity of INCS to the effect of NG-101 is comparable to that obtained employing the changes in the Upper Extremity Motor Score (the primary outcome in the NISCI trial). Moreover, the INCS is less susceptible to ceiling effects compared to measures of upper and lower extremity or total motor scores, as observed in the NISCI trial and in the matched EMSCI cohort. This robustness may facilitate the design of more inclusive clinical trials without compromising statistical power. Finally, INCS correlates strongly with functional outcomes in self-care and walking ability, outperforming ISNCSCI motor scores. In conclusion, the INCS represents a sensitive measure of neurological change corroborating the value of ISNCSCI standards for use in SCI trials.

Abstract NG101 is a recombinant antibody that neutralizes the nerve growth inhibitor Nogo-A, promoting neural repair and improving upper extremity motor function in spinal cord injury (SCI). This study evaluated spinal cord MRI biomarkers to detect treatment-related structural changes and enhance patient stratification using data from 106 participants with acute cervical SCI in the phase 2b NISCI trial. We assessed lesion volume, tissue bridges, and remote changes in cross-sectional cord area (CSA), and tract-specific myelin-sensitive magnetization transfer saturation (MTsat) over six months. Compared to placebo, NG101-treated participants exhibited faster lesion volume reduction and a slower decline of CSA and MTsat in the corticospinal tracts and dorsal columns. Crucially, multimodal stratification incorporating MRI and electrophysiological measures substantially enhanced the detection of clinical treatment effects. These findings suggest NG101 slows trauma-induced progressive macro- and microstructural degeneration or promotes fiber sprouting. Combining MRI with electrophysiology enables sensitive detection of treatment effects and efficient trial designs. ClinicalTrials.gov identifier: NCT03935321.

There are no approved interventional therapies, aside from neurorehabilitation, that enhance neurological recovery after acute traumatic spinal cord injury. A key challenge is the lack of biomarkers surpassing clinical standards for optimal stratification. We evaluated electrophysiological markers of preserved neuronal function to improve enrichment strategies over clinical measures. We hypothesized that participants with preserved electrophysiological markers would achieve greater neurological and functional recovery in response to a plasticity-inducing intervention. We conducted a retrospective stratification analysis of data from the recently completed randomized, placebo-controlled, phase 2b Nogo Inhibition in spinal cord injury (NISCI) trial (NCT03935321) investigating the efficacy of NG101, a recombinant human antibody that neutralizes the neurite outgrowth-inhibiting protein Nogo-A. Participants aged 18-70 years with acute (4-28 days) cervical spinal cord injury were eligible. At screening, all participants underwent clinical neurological examination and electrophysiological recordings (i.e. somatosensory evoked potentials). Treatment effect sizes for the recovery of upper extremity motor scores and spinal cord independence measure of self-care (6-month change) between NG101 and placebo groups were compared for stratification based on clinical versus electrophysiological criteria. Power analyses were conducted to estimate the required sample sizes needed for each method. The cohort included 116 participants (45.5 ± 16.8 years old, 74 NG101 and 41 placebo). Clinical stratification showed greater functional recovery in motor-incomplete participants treated with NG101 versus placebo [estimate 0.02 (95% confidence interval: 0.006-0.038), P = 0.007]. Electrophysiological stratification revealed greater functional recovery in participants with preserved somatosensory evoked potentials treated with NG101 versus placebo [0.04 (0.015-0.054), P < 0.001]. Effect sizes were large for electrophysiological stratification (Cohen's d = 0.94) but small for clinical stratification (Cohen's d = 0.46). Power analyses demonstrated smaller required sample sizes for electrophysiological stratification (required n = 32) versus clinical stratification (required n = 120). This study shows the value of electrophysiology in comparison to clinical measures for biomarker-driven enrichment and improved power in acute spinal cord injury trials. We emphasize the importance of functionally spared neuronal pathways in promoting recovery in response to plasticity-inducing interventions, such as anti-Nogo-A antibodies.

BACKGROUND:Spinal cord injury (SCI) leads to lifelong disability with highly variable neurological recovery, complicating prognostication and conceptualization of clinical trials. The American Spinal Injury Association Impairment Scale (AIS) is widely used to classify injury severity. Although AIS A injuries are considered sensorimotor complete, they show substantial heterogeneity in residual function and recovery. Data-driven approaches offer an opportunity to uncover latent subgroups beyond conventional classifications. We evaluate whether unsupervised, data-driven clustering can identify distinct subgroups within patients with traumatic SCI and characterize neurological patterns in sensorimotor complete SCI. METHODS:We applied an unsupervised clustering model to International Standards of Neurological Classification of Spinal Cord Injury (ISNCSCI) examination scores from the European Multicenter Study about Spinal Cord Injury dataset (3165 patients), to derive neurological groupings independent of predefined ISNCSCI classifications. Clusters were derived from the full cohort, followed by focused analyses of individuals classified as AIS A at their first documented assessment. External reproducibility was evaluated using data from the Sygen clinical trial. RESULTS:Six distinct clusters were identified. Patients graded as AIS A were represented in 5 clusters, which differed markedly in injury level (paraplegic vs tetraplegic) and indicators of recovery potential, including neurological sparing, upper and lower extremity motor scores, and AIS conversion rates. These patterns were consistently reproduced in the Sygen cohort. CONCLUSIONS:Proposed framework complements conventional AIS grading by revealing distinct neurological conditions related to the variability among patients with baseline sensorimotor complete injuries. Proposed data-driven framework enables more comprehensive prognostic assessments and improves patient stratification in clinical trials.

Background and Objectives Spinal cord injury (SCI) incidence is rising among the elderly, yet the relationship between age and recovery remains controversial. The aim of this study was to evaluate the relationship between age and neurologic and functional outcomes and to identify an age cutoff associated with a decline in recovery. Methods We conducted a prospective cohort study using data from patients with traumatic and ischemic SCI enrolled in the European Multicenter Study about Spinal Cord Injury between 2001 and 2022. Linear regression models assessed the relationship between age and changes from baseline to 1 year after SCI in the total motor score (TMS) of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and in the Spinal Cord Independence Measure (SCIM) total score. Additional analyses examined the relationship between age and the evolution of ISNCSCI light-touch and pinprick scores, as well as ambulation parameters (6-minute walking test, 10-meter walking test, and Walking Index for Spinal Cord Injury). Models were adjusted for baseline scores, sex, year of injury, American Spinal Injury Association Impairment Scale (AIS) grade, and level of injury. The age cutoff was determined using a change-point model. Results A total of 2,171 patients (median age 47 years, 77.9% male, 51.9% injured at the cervical level, and 50.0% with a motor complete injury [AIS-A and AIS-B]) were included in the analysis. Increased age was not associated with changes in TMS (p = 0.896) but was significantly associated with reduced SCIM improvement (p < 0.001), with an estimated decline of 4.3 SCIM points per decade of age. Sensory outcomes were not significantly affected by age (Delta light-touch: p = 0.273; Delta pinprick: p = 0.520) while ambulation recovery declined with increasing age (all outcomes p < 0.01). A noticeable reduction in functional recovery was observed in patients older than 70 years. Discussion Older age does not seem to affect neurologic recovery but is linked to poorer functional and ambulation outcomes. These findings, including the identified age cutoff, should inform future clinical trial design and guide tailored care strategies for older adults with SCI.

Neurological recovery following spinal cord injury (SCI) is commonly studied through changes in high-level descriptors of injury severity, such as the American Spinal Injury Association Impairment Scale (AIS) grade, or total upper and/or lower extremity motor scores. More recently, the analysis of segmental motor scores has attracted interest as it provides a more detailed understanding of the exact location and extent of changes occurring during recovery. We propose to augment the analysis of segmental motor recovery with a qualitative descriptor of local motor score patterns, which is defined for all upper and lower extremity myotomes below the neurological level of injury (NLI) and based on a categorization of the changes along the rostrocaudal motor score sequence. Our hypothesis is that recovery of segmental motor scores depends on the residual function as described by the newly proposed descriptors of local motor score patterns. Using data of 1385 patients from the European Multicenter Study about SCI, we analyze differences in recovery at approximately 6 months after injury between local motor score patterns and find an increased probability of full motor recovery for myotomes associated with increased motor scores in the caudal direction. We further use an aggregated descriptor of motor score patterns focusing on increases of motor scores in the caudal direction as an alternative or complementary feature to the AIS grade in prediction models for segmental motor scores at recovery. We observe equivalent predictive performance as measured by the root mean square error between actual and predicted motor scores below the NLI for models using the same set of features and additionally either the AIS grade (median = 0.79) or local pattern (median = 0.80). This is noteworthy as the definition of local motor score patterns requires only the examination of the 10 key muscles of the International Standards for Neurological Classification of SCI on each side of the body, while the AIS grade can only be reliably determined if extensive sensory testing is performed in addition. These results indicate the potential benefits of considering information inherent to the rostrocaudal sequence of motor scores for a better understanding of motor recovery. Furthermore, it supports the development and use of abbreviated sensorimotor examinations specifically in the early phase after SCI.

BackgroundThe aim of clinical trials for spinal cord injury (SCI) is to improve everyday-life activity outcomes, which requires reliable methods for monitoring patient activity. This study evaluates sensor-derived activity metrics in comparison to established clinical assessment methods.MethodsWearable inertial sensors collected data from 69 individuals with acute, traumatic cervical SCI participating in the Nogo-A Inhibition in Spinal Cord Injury trial (NCT03935321), a phase 2b, multicenter, randomized, placebo-controlled trial. During inpatient rehabilitation, participants wore up to 5 inertial sensors for up to 3 consecutive days each week. An estimation of average daily energy expenditure (EE) was used as an indicator of physical activity and compared to the recovery of Upper Extremity Motor Scores (UEMS) and Spinal Cord Independence Measures (SCIM).ResultsParticipants in the verum (n = 41; 59.4%) and placebo (n = 28; 40.6%) groups showed similar initial activity levels, however, the verum group exhibited a significantly greater weekly increase in average daily EE (ΔEE = 11.6 kcal/day/week, 95% CI [1.5, 21.8], P = .025). In contrast, no significant group differences were observed in changes in UEMS (ΔUEMS = 0.1/week, 95% CI [-0.2, 0.3], P = .603) or SCIM (ΔSCIM = 0.2, per week 95% CI [-0.7, 1.1], P = .644).ConclusionContinuous sensor-based activity monitoring offers objective and sensitive insights into changes in physical capabilities, effectively complementing periodic clinical assessments. Thus, sensor-derived outcome measures offer potential for improving the evaluation of clinical studies in individuals with SCI.Clinical Trail Registration:https://clinicaltrials.gov; NCT03935321.

BACKGROUND AND OBJECTIVES:Spinal cord injury (SCI) incidence is rising among the elderly, yet the relationship between age and recovery remains controversial. The aim of this study was to evaluate the relationship between age and neurologic and functional outcomes and to identify an age cutoff associated with a decline in recovery. METHODS:We conducted a prospective cohort study using data from patients with traumatic and ischemic SCI enrolled in the European Multicenter Study about Spinal Cord Injury between 2001 and 2022. Linear regression models assessed the relationship between age and changes from baseline to 1 year after SCI in the total motor score (TMS) of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and in the Spinal Cord Independence Measure (SCIM) total score. Additional analyses examined the relationship between age and the evolution of ISNCSCI light-touch and pinprick scores, as well as ambulation parameters (6-minute walking test, 10-meter walking test, and Walking Index for Spinal Cord Injury). Models were adjusted for baseline scores, sex, year of injury, American Spinal Injury Association Impairment Scale (AIS) grade, and level of injury. The age cutoff was determined using a change-point model. RESULTS:A total of 2,171 patients (median age 47 years, 77.9% male, 51.9% injured at the cervical level, and 50.0% with a motor complete injury [AIS-A and AIS-B]) were included in the analysis. Increased age was not associated with changes in TMS (p = 0.896) but was significantly associated with reduced SCIM improvement (p < 0.001), with an estimated decline of 4.3 SCIM points per decade of age. Sensory outcomes were not significantly affected by age (Δlight-touch: p = 0.273; Δpinprick: p = 0.520) while ambulation recovery declined with increasing age (all outcomes p < 0.01). A noticeable reduction in functional recovery was observed in patients older than 70 years. DISCUSSION:Older age does not seem to affect neurologic recovery but is linked to poorer functional and ambulation outcomes. These findings, including the identified age cutoff, should inform future clinical trial design and guide tailored care strategies for older adults with SCI. TRIAL REGISTRATION INFORMATION:ClinicalTrials.gov Identifier NCT01571531.

Background Spinal cord injury results in permanent neurological impairment and disability due to the absence of spontaneous regeneration. NG101, a recombinant human antibody, neutralises the neurite growth-inhibiting protein Nogo-A, promoting neural repair and motor recovery in animal models of spinal cord injury. We aimed to evaluate the efficacy of intrathecal NG101 on recovery in patients with acute cervical traumatic spinal cord injury. Methods This randomised, double-blind, placebo-controlled phase 2b clinical trial was done at 13 hospitals in the Czech Republic, Germany, Spain, and Switzerland. Patients aged 18-70 years with acute, complete or incomplete cervical spinal cord injury (neurological level of injury C1-C8) within 4-28 days of injury were eligible for inclusion. Participants were initially randomly assigned 1:1 to intrathecal treatment with 45 mg NG101 or placebo (phosphate- buffered saline); 18 months into the study, the ratio was adjusted to 3:1 to achieve a final distribution of 2:1 to improve enrolment and drug exposure. Randomisation was done using a centralised, computer-based randomisation system and was stratified according to nine distinct outcome categories with a validated upper extremity motor score (UEMS) prediction model based on clinical parameters at screening. Six intrathecal injections were administered every 5 days over 4 weeks, starting within 28 days of injury. Investigators, study personnel, and study participants were masked to treatment allocation. The primary outcome was change in UEMS at 6 months, analysed alongside safety in the full analysis set. The completed trial was registered at ClinicalTrials.gov, NCT03935321. Findings From May 20, 2019, to July 20, 2022, 463 patients with acute traumatic cervical spinal cord injury were screened, 334 were deemed ineligible and excluded, and 129 were randomly assigned to an intervention (80 patients in the NG101 group and 49 in the placebo group). The full analysis set comprised 78 patients from the NG101 group and 48 patients from the placebo group. 107 (85%) patients were male and 19 (15%) patients were female, with a median age of 515 years (IQR 300-600). Across all patients, the primary endpoint showed no significant difference between groups (with UEMS change at 6 months 137 [95% CI -144 to 418]; placebo group mean 1920 [SD 1178] at baseline and 3091 [SD 1549] at day 168; NG101 group mean 1823 [SD 1514] at baseline and 3131 [1954] at day 168). Treatment-related adverse events were similar between groups (nine in the NG101 group and six in the placebo group). 25 severe adverse events were reported: 18 in 11 (14%) patients in the NG101 group and seven in six (13%) patients in the placebo group. Although no treatment-related fatalities were reported in the NG101 group, one fatality not related to treatment occurred in the placebo group. Infections were the most common adverse event affecting 44 (92%) patients in the placebo group and 65 (83%) patients in the NG101 group. Interpretation NG101 did not improve UEMS in patients with acute spinal cord injury. Post-hoc subgroup analyses assessing UEMS and Spinal Cord Independence Measure of self-care in patients with motor-incomplete injury indicated potential beneficial effects that require investigation in future studies.

Successfully completing clinical trials for rare and heterogeneous disorders, like spinal cord injuries (SCI), remains challenging, thereby reducing the ability to test and translate promising preclinical findings. We propose synthetic controls, derived from data-driven predictions of recovery in patients undergoing standard treatments, to mitigate these challenges, in particular related to patient recruitment. Based on data from the European Multicenter Study about Spinal Cord Injury (EMSCI) and the Sygen trial, we construct synthetic controls from personalized predictions of neurological recovery of sequences of segmental motor scores. A total of six architectures (linear, tree, and deep learning models) are compared. We demonstrate the applicability of synthetic controls through a simulation framework modeling the randomization process in a clinical trial and a case study that re-evaluates the recently completed Nogo Inhibition in SCI (NISCI) trial as a single-arm trial post hoc. The primary dataset included 4196 patients from EMSCI and 587 patients from the Sygen trial for external validation. We identified a convolutional neural network as the best-performing architecture to predict segmental motor score sequences, achieving a median root mean squared error below the neurological level of injury of 0.55. Our trial simulations demonstrate that synthetic controls are a viable alternative to randomization, as the proposed solution reduces intercohort heterogeneity and leads to no significant differences with randomized controls in our case study reassessing a clinical trial. We provide a comprehensive benchmark of data-driven prediction architectures for neurological recovery after SCI. Apart from offering individual patients a specific recovery prediction, these models constitute the basis for synthetic controls. Using real-world data from a completed trial in SCI, we show that synthetic controls could mitigate the challenges of small cohorts and patient recruitment in rare disorders, offering the opportunity to maximize the number of patients receiving an investigative treatment. https://gitlab.ethz.ch/BMDSlab/publications/sci/sci-in-silico-trials .

Numerous uncontrolled observational studies suggest that early spinal decompression and stabilization within 24 h of spinal cord injury (SCI) improve neurological recovery, forming the basis for recently published best practice guidelines. In this study, we aim to investigate current surgical practices in trauma centers across Germany, Austria, and Switzerland and to elucidate trauma- and patient-related factors influencing the timing of spine surgery. We identified patients aged 16 years or older with traumatic SCI and permanent neurological deficits from the TraumaRegister DGU® of the German Trauma Society (2008–2022). Trauma severity was assessed using the Abbreviated Injury Scale. Patients were categorized based on the timing of spine surgery (early surgery: day of admission; late surgery: subsequent days) and functional impairment (moderate vs. severe, based on the Glasgow Outcome Scale). Multivariate regression analyses were conducted to correlate patient and trauma-related factors with these endpoints. A total of 9938 patients with SCI at cervical, thoracic, and lumbar levels were identified. Among the 5025 patients who underwent spine surgery, 69

In light of growing biomedical data, machine learning (ML) models offer tremendous potential for personalized prediction in medicine. However, the additional value provided by these computational tools should always be critically evaluated. Using the example of predicting walking ability after spinal cord injury (SCI), we highlight a popular scenario in which data-driven predictions are feasible but not clinically meaningful, as the task can be performed equally well by humans. We asked 11 human observers from diverse backgrounds (five researchers without clinical training but proven knowledge of SCI and the International Standards for Neurological Classification of SCI [ISNCSCI], and six neurologists experienced in SCI) to predict walking ability following SCI based on acute phase neurological status assessed by the ISNCSCI motor and sensory scores (≤40 days after injury [DAI]). Following an established clinical prediction rule, walking ability was defined by a binary label derived from the indoor walking ability subitem of the Spinal Cord Independence Measure. We compared the performance of human observers with extreme gradient boosting and logistic regression-based models, which represent popular approaches in clinical literature on SCI. Using 794 patients from the European Multicenter Study about SCI, we show that all approaches provide similar, excellent performance at population level (area under the receiver operating characteristic 0.93-0.95; accuracy 0.88-0.90). Importantly, predictions combined from multiple neurologists (accuracy: 0.89) were comparable with model-based predictions (accuracy: 0.88-0.90), whereas individual neurologists (accuracy: 0.79 [0.01]; mean [standard deviation]) were marginally outperformed by computational approaches (accuracy: 0.88-0.90), particularly for more heterogeneous incomplete injuries. Individual SCI researchers performed equally well compared with neurologists (accuracy: 0.78 [0.02]). Our results show that prediction of walking function following SCI, if described through a binary label, does not benefit from ML, as ensembles of clinical experts and researchers each achieve performance similar to a range of ML models and an established clinical prediction rule. This highlights two key considerations in clinical applications of data-driven prediction models in SCI: first, the importance of carefully choosing clinical outcome measures to target in a prediction task to achieve a true benefit, and second, the necessity of benchmarking human performance on specific tasks to determine whether meaningful differences are present.

Background: The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is the most widely accepted system for characterizing sensorimotor impairments after spinal cord injury (SCI). There have been a number of ISNCSCI revisions, with the most recent edition published in 2019. Newer concepts, including the revised definitions of the zones of partial preservation (ZPPs) and documentation of non-SCI conditions, require training and practice for successful utilization. The International Standards Committee developed an ISNCSCI workbook of 26 practice cases, each with detailed explanations of the correct classification components. In this article, we present seven cases, which were selected from the workbook to reinforce the changes implemented in 2019. Methods: Hypothetical ISNCSCI cases were created to illustrate important classification rules, definitions, and nuances. All cases were reviewed by members of the American Spinal Injury Association (ASIA) International Standards Committee, and if any discrepancies were identified, they were discussed until a consensus was reached. To confirm agreement, cases were also entered into online algorithms, which are compliant with the 2019 ISNCSCI revision. The seven cases in this article highlight newer classification concepts and include a discussion of key elements. Cases: Each case reinforces the revised definitions of the ZPPs, such as the applicability of sensory ZPPs in all injuries without sensory sacral sparing and applicability of motor ZPPs in all injuries without voluntary anal contraction (VAC). Non-SCI-related impairments and their impact on the classification are reviewed in Cases 4-7. Conclusion: The seven cases presented in this article feature key concepts from the 2019 ISNCSCI revision. These cases, as well as the full ISNCSCI workbook, can serve as valuable training tools to improve classification accuracy.

BACKGROUND:Mobility is crucial for participation and quality of life in individuals with sensorimotor impairments, yet scientific evidence on its course in real-world settings is limited. So-called wearables for measuring physical activity might help to overcome this knowledge gap allowing daily measurements of mobility. The aim of the present study is to examine the relationship between clinical walking tests and inertial measurement unit-based mobility tracking in the community setting of stroke and spinal cord injury (SCI) survivors. METHODS:At a single observational time point, the precision of the activity tracker was evaluated in a standardized parcours in healthy subjects and stroke or SCI survivors (n=57). This was followed by a multicenter observational cohort study (n=116 participants), in which the mobility of stroke and SCI survivors was assessed over 8 months immediately after discharge from acute inpatient rehabilitation. Daily distances covered in the community setting were recorded using the activity tracker. Established walking tests-including the 10-meter walk test (10MWT) and the timed up and go test (TUG)-were conducted at baseline, as well as at 4- and 8-month follow up visits. The relationship between daily distances in the ambulatory setting and 10MWT or TUG performance at discrete study visits (baseline, 4 months (midterm), and 8 months (final) after hospital discharge) was analyzed using regression models. RESULTS:The precision of the activity tracker in measuring covered distance in a standardized parcours varied by mobility type. The highest precision was achieved in manual wheelchair users (deviation from zero: -1.5±1.03% (p=0.15) while the least favorable precision was observed in participants with SCI and significant walking impairment (-14.6±2% (p<0.001). The widely used 10MWT speed showed a relationship with the ambulatory daily distance. The regression coefficients [m/(1m/s)] were: 874 (95% CI: 578-1171) at baseline (p<0.001), 895 (95% CI: 614-1176) at midterm (p<0.001), and 824 (95% CI: 537-1112) at the final visit (p<0.001). Interestingly, in the category of good walkers with the most favorable walking speeds the daily covered distance unmasked distinct subgroups with shorter and longer daily distances. CONCLUSIONS:For SCI and stroke survivors, especially medium to fast walkers, activity tracking in real-world settings adds valuable insight beyond clinical walking tests. Clinical studies on rehabilitative interventions for mobility improvement should consider real-life daily distance as a key endpoint.

IntroductionThe ABLE Exoskeleton has been tested to be safe and feasible for persons with spinal cord injury (SCI) to complete basic skills in clinical settings but has not been tested for use in home and community environments. A user-centered design process was employed to test the feasibility of the current ABLE Exoskeleton (designed for clinical use) for persons with SCI to perform the basic and advanced skills required for home and community environments, to gain crucial feedback for the development of a novel personal-use exoskeleton.MethodsIn this prospective pretest-posttest quasi-experimental study across two SCI centers (Germany, Spain), in-and outpatients with SCI were included into a 22-session training and assessment protocol, utilizing the ABLE Exoskeleton. Feasibility and usability measures [level of assistance (LoA) for basic and advanced skills, donning/doffing-time and LoA] were recorded together with safety outcomes, and participant and therapist satisfaction with the device.Results10 participants (44.4 ± 24 years), with SCI from C5 to T11, (American Spinal Injury Association Impairment Scale A–D) completed the study. In 209 sessions, six device-related adverse events (pain and skin lesions) were reported. Average total time for don and doff was 10:23 ± 3:30 min. Eight participants were able to complete don and doff with minimal assistance or less. Independence to carry out all skills in the device increased significantly for all participants (p < 0.05). Participants with chronic SCI required a significantly (p < 0.05) lower LoA for six of the nine advanced skills than those in the sub-acute phase.DiscussionThis study shows that the ABLE Exoskeleton is safe, feasible and usable for people with SCI in respect to independent donning, doffing and performance of basic and advanced exoskeleton skills. The supervised exoskeleton use in the clinical environment was a highly valuable approach for identifying the challenging tasks and the necessary technological developments that need to be carried out for a personal-use exoskeleton, including a more independent sit-to-stand transition, faster speed of transitions between states and a richer display on the remote control for the user.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT05643313.

In interventional clinical trials for persons with spinal cord injury (SCI), the influence of experimental biological, pharmacological, or device-related interventions must be differentiated from that of physical and occupational therapy interventions, as rehabilitation influences motor-related outcomes. The International Spinal Cord Injury (ISCI) Physical Therapy-Occupational Therapy Basic Data Set (PT-OT BDS) was developed with the intent to track the content and time of rehabilitation interventions that are delivered concurrently with experimental interventions. We assessed the reliability of the PT-OT BDS based on agreement between users. Following an online training session, physical therapists (PTs) and occupational therapists (OTs) from 10 SCI clinical centers across 7 countries participated. At each center, pairs of therapists (a treating therapist and an observing therapist; PT/PT, OT/OT, or PT/OT) used the PT-OT BDS to record the content and time of therapy sessions for 20 patients. Data were analyzed to determine agreement between therapist pairs regarding the content of the therapy session. The influence of therapist characteristics (professional discipline [PT/OT], years of experience working with individuals with SCI), patient characteristics (level [tetraplegia/paraplegia] and severity [complete/incomplete] of injury), setting (inpatient/outpatient), and whether the center was U.S.- versus non-U.S.-based were also analyzed. There was high agreement for five of seven categories and medium agreement for the remaining two categories. For six of the seven intervention categories, there were no significant differences between the treating and the observing therapists in the percentage of instances that a specific category was selected. Characteristics of the therapists, characteristics of the patient, therapy setting, and global location of the center had no meaningful influence on level of agreement between therapist pairs. The BDS is reliable for use across settings, countries, and with patients of various impairment levels. The study also helped identify additional areas where refinement of the syllabus would be of value.

PURPOSE:Mobility impairments are a common consequence of stroke and spinal cord injury (SCI). Assistive products (APs) such as wheelchairs are often needed for activities and participation. The aim of the study was to explore the provision and use of APs in Germany and to identify associated factors underlying this practice. MATERIALS AND METHODS:Semi-structured interviews were conducted with 19 professionals from outpatient neurorehabilitation services (three general practitioners, five physical therapists, five occupational therapists, one speech therapist, one neuropsychologist, two outpatient nurses, one rehab technician and one social worker), two patient advocates (long-term survivors, each stroke and SCI) and 20 patients (10 each after stroke and SCI with mobility impairment, and first-ever affected). Analysis was performed by qualitative content analysis. RESULTS:Reported experiences were mixed, varying from high satisfaction to unusable APs and unmet needs. Identified factors associated with these experiences were related to care pathways, care coordination, inter-professional collaboration, professionals' knowledge and patient information, cost coverage, and approval procedures. CONCLUSION:Overall, patients seem satisfied with the APs they receive, but patients with more severe mobility impairments in particular experience deficits in the provision and use of APs. Further research is needed to develop and test strategies for the provision and use of APs.

Background The selection of data elements is a decisive task within the development of a health registry. Having the right metadata is crucial for answering the particular research questions. Furthermore, the set of data elements determines the registries' readiness of interoperability and data reusability to a major extent. Six health registries shared and published their metadata within a German funding initiative. As one step in the direction of a common set of data elements, a selection of those metadata was evaluated with regard to their appropriateness for a broader usage.Methods Each registry was asked to contribute a 10%-selection of their data elements to an evaluation sample. The survey was set up with the online survey tool ,,LimeSurvey Cloud". The registries and an accompanying project participated in the survey with one vote for each project. The data elements were offered in content groups along with the question of whether the data element is appropriate for health registries on a broader scale. The question could be answered using a Likert scale with five options. Furthermore, "no answer" was allowed. The level of agreement was assessed using weighted Cohen's kappa and Kendall's coefficient of concordance.Results The evaluation sample consisted of 269 data elements. With a grade of "perhaps recommendable" or higher in the mean, 169 data elements were selected. These data elements belong preferably to groups' demography, education/occupation, medication, and nutrition. Half of the registries lost significance compared with their percentage of data elements in the evaluation sample, one remained stable. The level of concordance was adequate.Conclusions The survey revealed a set of 169 data elements recommended for health registries. When developing a registry, this set could be valuable help in selecting the metadata appropriate to answer the registry's research questions. However, due to the high specificity of research questions, data elements beyond this set will be needed to cover the whole range of interests of a register. A broader discussion and subsequent surveys are needed to establish a common set of data elements on an international scale.