학술논문

A smartphone sensor-based digital outcome assessment of multiple sclerosis
Document Type
article
Source
Multiple Sclerosis Journal. 28(4)
Subject
Biomedical and Clinical Sciences
Clinical Sciences
Clinical Trials and Supportive Activities
Autoimmune Disease
Neurodegenerative
Multiple Sclerosis
Clinical Research
Brain Disorders
Neurosciences
4.2 Evaluation of markers and technologies
Detection
screening and diagnosis
Neurological
Gait
Humans
Outcome Assessment
Health Care
Reproducibility of Results
Smartphone
Multiple sclerosis
smartphone
sensors
digital health technology
wearable electronic devices
mobile phone
Neurology & Neurosurgery
Clinical sciences
Biological psychology
Language
Abstract
BackgroundSensor-based monitoring tools fill a critical gap in multiple sclerosis (MS) research and clinical care.ObjectiveThe aim of this study is to assess performance characteristics of the Floodlight Proof-of-Concept (PoC) app.MethodsIn a 24-week study (clinicaltrials.gov: NCT02952911), smartphone-based active tests and passive monitoring assessed cognition (electronic Symbol Digit Modalities Test), upper extremity function (Pinching Test, Draw a Shape Test), and gait and balance (Static Balance Test, U-Turn Test, Walk Test, Passive Monitoring). Intraclass correlation coefficients (ICCs) and age- or sex-adjusted Spearman's rank correlation determined test-retest reliability and correlations with clinical and magnetic resonance imaging (MRI) outcome measures, respectively.ResultsSeventy-six people with MS (PwMS) and 25 healthy controls were enrolled. In PwMS, ICCs were moderate-to-good (ICC(2,1) = 0.61-0.85) across tests. Correlations with domain-specific standard clinical disability measures were significant for all tests in the cognitive (r = 0.82, p < 0.001), upper extremity function (|r|= 0.40-0.64, all p < 0.001), and gait and balance domains (r = -0.25 to -0.52, all p < 0.05; except for Static Balance Test: r = -0.20, p > 0.05). Most tests also correlated with Expanded Disability Status Scale, 29-item Multiple Sclerosis Impact Scale items or subscales, and/or normalized brain volume.ConclusionThe Floodlight PoC app captures reliable and clinically relevant measures of functional impairment in MS, supporting its potential use in clinical research and practice.