Abstract

Background: The aim of this study was to examine the impact of intravenous methylprednisolone therapy (IVMP) on the recovery of walking ability in patients experiencing multiple sclerosis (MS) relapses, to compare the responsiveness of walking-based measures, and to estimate the impact of different walking-based measures responsiveness on clinical trials.
Material/Methods: The study included 49 consecutive patients with relapsing-remitting MS who received Solu-Medrol 1000 mg/day over 3 days for relapse with difficulties in walking. The following walking-based measures were administered before and a month after IVMP: the Multiple Sclerosis Walking Scale-12 (MSWS-12), the Expanded Disability Status Scale (EDSS), the 2-minute timed walk (2-minTW), the 25-foot walk test (25FWT), the Six Spot Step Test (SSST). All patients had worn the step activity monitor accelerometer (SAM) 1 week prior to IVMP was applied and wore it again the fourth week upon the corticosteroid therapy was completed. The SAM analysis utilized the average daily step count and data regarding frequency and intensity of walking over a continuous time interval. We examined: (1) the impact of IVMP on the recovery of walking ability; (2) the responsiveness of each walking-based measure; (3) the relative responsiveness of competing walking-based measures; and (4) the impact of different walking-based measures responsiveness on clinical trials.
Results: All walking-based measures showed significant improvement of walking ability 1 month after the IVMP. The most responsive were MSWS-12 and EDSS. Different responsiveness implied a greater than 6-fold impact on sample size estimates.
Conclusions: All applied walking-based measures showed significant improvement of walking ability 1 month after the IVMP. Responsiveness of various walking-based measures notably differ, thus affecting sample size calculations.

Keywords: Recurrence, Multiple Sclerosis - physiopathology, Methylprednisolone - therapeutic use, Injections, Intravenous, Glucocorticoids - therapeutic use, Demography, Adolescent, Sample Size, Walking - physiology, young adult