Abstract
ImportanceDisability measures in multiple sclerosis (MS) fail to capture potentially important variability in walking behavior. More sensitive and ecologically valid outcome measures are needed to advance MS research.ObjectivesTo assess continuous step count activity remotely among individuals with MS for 1 year and determine how average daily step count is associated with other measures of MS disability.Design, Setting, and ParticipantsIn a prospective longitudinal observational cohort study, 95 adults with relapsing or progressive MS who were able to walk more than 2 minutes with or without an assistive device were recruited between June 15, 2015, and August 8, 2016, and remotely monitored in their natural environment for 1 year. Patients were excluded if they had a clinical relapse within 30 days or comorbidity contributing to ambulatory impairment. Longitudinal analysis was performed from October 2017 to March 2018. Revised analysis was performed in December 2018.InterventionActivity monitoring of step count using a wrist-worn accelerometer.Main Outcomes and MeasuresAverage daily step count compared with in-clinic assessments and patient-reported outcomes.ResultsOf the 95 participants recruited (59 women and 36 men; mean [SD] age, 49.6 [13.6] years [range, 22.0-74.0 years]), 35 (37%) had progressive MS, and the median baseline Expanded Disability Status Scale score was 4.0 (range, 0-6.5). At 1 year, 79 participants completed follow-up (83% retention). There was a modest reduction in accelerometer use during the 1 year of the study. A decreasing average daily step count during the study was associated with worsening of clinic-based outcomes (Timed 25-Foot Walk, β = −13.09; P < .001; Timed-Up-and-Go, β = −9.25; P < .001) and patient-reported outcomes (12-item Multiple Sclerosis Walking Scale, β = −17.96; P < .001). A decreasing average daily step count occurred even when the Expanded Disability Status Scale score remained stable, and 12 of 25 participants (48%) with a significant decrease in average daily step count during the study did not have a reduction on other standard clinic-based metrics. Participants with a baseline average daily step count below 4766 (cohort median) had higher odds of clinically meaningful disability (Expanded Disability Status Scale score) worsening at 1 year, adjusting for age, sex, and disease duration (odds ratio, 4.01; 95% CI, 1.17-13.78; P = .03).Conclusions and RelevanceContinuous remote activity monitoring of individuals with MS for 1 year appears to be feasible. In this study, a decreasing average daily step count during a 1-year period was associated with worsening of standard ambulatory measures but could also occur even when traditional disability measures remained stable. These results appear to support the prospect of using the average daily step count as a sensitive longitudinal outcome measure in MS and as a clinically relevant metric for targeted intervention.
Highlights
IntroductionMultiple sclerosis (MS) is a leading cause of nontraumatic disability in the developed world, with walking impairment a major contributing factor.[1,2,3] Despite its widespread use in clinical trials, the Expanded Disability Status Scale (EDSS), a rater-based categorical measure of disability in patients with MS, has limitations with reliability and insufficient sensitivity as an outcome measure for small but still clinically meaningful changes in ambulatory function.[4,5] For example, a person who walks 1.6 km (1 mile) a day with a cane and a person who can barely walk around his or her home using a cane (but past a minimal distance threshold of 120 m) are both assigned the same EDSS score (6.0; based on need for unilateral assistance) despite a clear disparity in ambulatory disability functioning
A decreasing average daily step count during the study was associated with worsening of clinic-based outcomes (Timed 25-Foot Walk, β = −13.09; P < .001; Timed-Up-and-Go, β = −9.25; P < .001) and patient-reported outcomes (12-item Multiple Sclerosis Walking Scale, β = −17.96; P < .001)
Participants with a baseline average daily step count below 4766 had higher odds of clinically meaningful disability (Expanded Disability Status Scale score) worsening at 1 year, adjusting for age, sex, and disease duration
Summary
Multiple sclerosis (MS) is a leading cause of nontraumatic disability in the developed world, with walking impairment a major contributing factor.[1,2,3] Despite its widespread use in clinical trials, the Expanded Disability Status Scale (EDSS), a rater-based categorical measure of disability in patients with MS, has limitations with reliability and insufficient sensitivity as an outcome measure for small but still clinically meaningful changes in ambulatory function.[4,5] For example, a person who walks 1.6 km (1 mile) a day with a cane and a person who can barely walk around his or her home using a cane (but past a minimal distance threshold of 120 m) are both assigned the same EDSS score (6.0; based on need for unilateral assistance) despite a clear disparity in ambulatory disability functioning. Clinic-based performance measures, such as timed walks, provide informative snapshots about ambulatory function but do not capture performance fluctuations in the natural environment.[6] Patient-reported outcomes provide valuable insights but are subject to recall bias and may be associated with variable perception of similar deficits. More objective and ecologically valid outcome measures of walking are needed to advance MS research and help make clinical trials more efficient by having more sensitive outcome measures to improve power. Other neurologic disorders that affect walking pose similar methodological challenges to MS research and could benefit from better ambulatory outcome metrics
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