Background: Remote smartphone-based 2-minute walking tests (s2MWTs) allow frequent and potentially sensitive measurements of ambulatory function.
Objective: To investigate the s2MWT on assessment of, and responsiveness to change in ambulatory function in MS.
Methods: One hundred two multiple sclerosis (MS) patients and 24 healthy controls (HCs) performed weekly s2MWTs on self-owned smartphones for 12 and 3 months, respectively. The timed 25-foot walk test (T25FW) and Expanded Disability Status Scale (EDSS) were assessed at 3-month intervals. Anchor-based (using T25FW and EDSS) and distribution-based (curve fitting) methods were used to assess responsiveness of the s2MWT. A local linear trend model was used to fit weekly s2MWT scores of individual patients.
Results: A total of 4811 and 355 s2MWT scores were obtained in patients (n = 94) and HC (n = 22), respectively. s2MWT demonstrated large variability (65.6 m) compared to the average score (129.5 m), and was inadequately responsive to anchor-based change in clinical outcomes. Curve fitting separated the trend from noise in high temporal resolution individual-level data, and statistically reliable changes were detected in 45% of patients.
Conclusions: In group-level analyses, clinically relevant change was insufficiently detected due to large variability with sporadic measurements. Individual-level curve fitting reduced the variability in s2MWT, enabling the detection of statistically reliable change in ambulatory function.
Keywords: Multiple sclerosis; ambulatory function; digital technology; outpatient monitoring; patient-specific modeling; smartphone.