arXiv subjects

Letizia Leocani

Publications and source records attributed to Letizia Leocani.

3 recordsLinked to original sources

arXiv2026

Establishing the Minimal Clinically Important Difference (MCID) for Smartphone-Derived Gait Measures in Multiple Sclerosis

Background: Digital health technologies allow for frequent, remote gait monitoring in people with multiple sclerosis (MS). However, to differentiate daily variability from actual disease progression in longitudinal data, established minimal clinically important differences (MCID) are required. Currently, there is limited literature defining these thresholds for digital gait metrics. Objective: To establish MCIDs for digital gait measures reflecting progression in MS. Methods: Digital gait measures were captured via daily, remote, smartphone-based Two-Minute Walk Tests in CONSONANCE (NCT03523858), a phase 3b study of ocrelizumab in progressive MS. Using an anchor-based approach, median changes from baseline at Week 96 on digital gait measures were computed for patients showing clinically meaningful worsening on either Timed 25-Foot Walk, Ambulation Score, Expanded Disability Status Scale, or 12-item Multiple Sclerosis Walking Scale. These changes were subsequently triangulated to derive the MCID estimates. Results: 243 patients with progressive MS (female: n=125 (51%); mean [SD] age: 49.3 [9.3]; mean [SD] EDSS: 4.8 [1.4]) had digital gait data available at baseline and Week 96. Median changes were generally consistent across anchors. Triangulated MCIDs are: Step Velocity = -0.16 m/s, Step Velocity Scaled to Walking Time = -0.18 m/s, Step Duration = 0.06 s, Step Length = -0.07 m, Total Number of Steps = -28, and Total Distance Walked = -24 m. Conclusion: These MCIDs provide a framework for interpreting meaningful gait changes and integrating digital measures into MS outcome evaluation. Beyond facilitating novel clinical trial endpoints to evaluate treatment efficacy, they enable objective, real-world monitoring to advance personalized patient care.

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arXiv2021

The utility of wearable devices in assessing ambulatory impairments of people with multiple sclerosis in free-living conditions

Multiple sclerosis (MS) is a progressive inflammatory and neurodegenerative disease of the central nervous system affecting over 2.5 million people globally. In-clinic six-minute walk test (6MWT) is a widely used objective measure to evaluate the progression of MS. Yet, it has limitations such as the need for a clinical visit and a proper walkway. The widespread use of wearable devices capable of depicting patients activity profiles has the potential to assess the level of MS-induced disability in free-living conditions. In this work, we extracted 96 activity features in different temporal granularities (from minute-level to day-level) and explored their utility in estimating 6MWT scores in a European (Italy, Spain, and Denmark) MS cohort of 337 participants over an average of 10-month duration. We combined these features with participant demographics using three regression models including elastic net, gradient boosted trees and random forest. In addition, we quantified the individual feature contribution using feature importance in these regression models, linear mixed-effects models, generalized estimating equations, and correlation-based feature selection (CFS). The results showed promising estimation performance with R2 of 0.30, which was derived using random forest after CFS. This model was able to distinguish the participants with low disability from those with high disability. Furthermore, we observed that the minute-level (no longer than 8 minutes) step count, particularly those capturing the upper end of the step count distribution, had a stronger association with 6MWT. The use of a walking aid was indicative of ambulatory function measured through 6MWT. This study provides a basis for future investigation into the clinical relevance and utility of wearables in assessing MS progression in free-living conditions.

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arXiv2020

Using smartphones and wearable devices to monitor behavioural changes during COVID-19

We aimed to explore the utility of the recently developed open-source mobile health platform RADAR-base as a toolbox to rapidly test the effect and response to NPIs aimed at limiting the spread of COVID-19. We analysed data extracted from smartphone and wearable devices and managed by the RADAR-base from 1062 participants recruited in Italy, Spain, Denmark, the UK, and the Netherlands. We derived nine features on a daily basis including time spent at home, maximum distance travelled from home, maximum number of Bluetooth-enabled nearby devices (as a proxy for physical distancing), step count, average heart rate, sleep duration, bedtime, phone unlock duration, and social app use duration. We performed Kruskal-Wallis tests followed by post-hoc Dunns tests to assess differences in these features among baseline, pre-, and during-lockdown periods. We also studied behavioural differences by age, gender, body mass index (BMI), and educational background. We were able to quantify expected changes in time spent at home, distance travelled, and the number of nearby Bluetooth-enabled devices between pre- and during-lockdown periods. We saw reduced sociality as measured through mobility features, and increased virtual sociality through phone usage. People were more active on their phones, spending more time using social media apps, particularly around major news events. Furthermore, participants had lower heart rate, went to bed later, and slept more. We also found that young people had longer homestay than older people during lockdown and fewer daily steps. Although there was no significant difference between the high and low BMI groups in time spent at home, the low BMI group walked more. RADAR-base can be used to rapidly quantify and provide a holistic view of behavioural changes in response to public health interventions as a result of infectious outbreaks such as COVID-19.

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