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. 2022 Feb;28(2):289-299.
doi: 10.1177/13524585211017013. Epub 2021 Jun 8.

The timed 25-foot walk in a large cohort of multiple sclerosis patients

Anissa Kalinowski  1 , Gary Cutter  2 , Nina Bozinov  1 , Jessica A Hinman  1 , Michael Hittle  1 , Robert Motl  3 , Michelle Odden  1 , Lorene M Nelson  1
Affiliations

The timed 25-foot walk in a large cohort of multiple sclerosis patients

Anissa Kalinowski et al. Mult Scler. 2022 Feb.

Abstract

Background: The timed 25-foot walk (T25FW) is a key clinical outcome measure in multiple sclerosis patient management and clinical research.

Objectives: To evaluate T25FW performance and factors associated with its change in the Multiple Sclerosis Outcome Assessments Consortium (MSOAC) Placebo Database (n = 2465).

Methods: We created confirmed disability progression (CDP) variables for T25FW and Expanded Disability Status Scale (EDSS) outcomes. We used intraclass correlation coefficients (ICCs) and Bland Altman plots to evaluate reliability. We evaluated T25FW changes and predictive validity using a mixed-effects model, survival analysis, and nested case-control analysis.

Results: The mean baseline score for the T25FW in this study population was 9.2 seconds, median = 6.1 (standard deviation = 11.0, interquartile range (IQR) = 4.8, 9.0). The T25FW measure demonstrated excellent test-retest reliability (ICC = 0.98). Walk times increased with age, disability, disease type, and disease duration; relapses were not associated with an increase. Patients with T25FW progression had a faster time to EDSS-CDP compared to those without (hazards ratio (HR): 2.6; confidence interval (CI): 2.2, 3.1). Changes in the T25FW were more likely to precede changes in EDSS.

Conclusion: This research confirms the association of the T25FW with disability and provides some evidence of predictive validity. Our findings support the continued use of the T25FW in clinical practice and clinical trials.

Keywords: Expanded Disability Status Scale; Multiple Sclerosis Outcomes Assessment Consortium; Multiple sclerosis; annual change; benchmarking; clinical trial; disease progression; natural history; predictive validity; timed 25-foot walk); walking.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: N.B., R.M., J.A.H., and M.H. declare no conflicts of interest in preparing this article. A.K. was previously employed by Roche and Biogen. M.O. serves as consultant for Cricket Health. G.C. served on Data and Safety Monitoring Boards for Astra-Zeneca, Avexis Pharmaceuticals, Biolinerx, Brainstorm Cell Therapeutics, Bristol Meyers Squibb/Celgene, CSL Behring, Galmed Pharmaceuticals, GreenValley Pharma Ltd, Mapi Pharmaceuticals Ltd, Merck, Merck/Pfizer, Opko Biologics, OncoImmune, Neurim, Novartis, Ophazyme, Sanofi-Aventis, Reata Pharmaceuticals, Teva pharmaceuticals, VielaBio Inc, Vivus, NHLBI (Protocol Review Committee), and NICHD (OPRU oversight committee). G.C. served on consulting or Advisory Boards for Biodelivery Sciences International, Biogen, Click Therapeutics, Genzyme, Genentech, GW Pharmaceuticals, Immunic, Klein-Buendel Incorporated, Medimmune/Viela Bio, Medday, Merck/Serono, Neurogenesis LTD, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Recursion/Cerexis Pharmaceuticals, Regeneron, Reckover Pharmaceuticals, Roche, and TG Therapeutics. G.C. is President of Pythagoras, Inc., a private consulting company located in Birmingham AL. L.M.N. has received grants from the Centers for Disease Control and Prevention, National Institutes of Health, and National MS Society and contracts from the Agency for Toxic Substances and Diseases Registry. L.M.N. receives compensation for serving as a consultant to Acumen, Inc.

Figures

Figure 1.
Figure 1.
Distribution of T25FW outcome measured at baseline in seconds, n = 2413.
Figure 2.
Figure 2.
Estimate of concordance for the two replicate T25FW tests conducted at baseline visit, n = 2403.
Figure 3.
Figure 3.
Survival analysis for confirmed disability progression among patients with and without T25FW progression, defined as ⩾ 20% increase sustained at ⩾ 3 months; N = 2395.
See this image and copyright information in PMC

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