Timed 25-foot walk: direct evidence that improving 20% or greater is clinically meaningful in MS.

Jeremy Hobart*, Andrew R. Blight, Andrew Goodman, Frances Lynn, Norman Putzki

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVE: In this study, we used data from clinical trials of dalfampridine (fampridine outside the United States) to re-examine the clinical meaningfulness of Timed 25-Foot Walk (T25FW) changes. METHODS: Pooled data were analyzed from 2 phase III randomized placebo-controlled clinical trials of dalfampridine in multiple sclerosis (MS) (n = 533). Walking speed (T25FW) and patient-reported walking ability (MS Walking Scale-12 [MSWS-12]) were measured, concurrently, multiple times before and during treatment. We examined T25FW speed variability within and between visits, correlations of T25FW speed with MSWS-12 score, and changes in MSWS-12 (mean scores, effect sizes) associated with percent T25FW changes. RESULTS: T25FW speed variability was small (within- and between-visit averages = 7.2%-8.7% and 14.4%-16.3%). Correlations between T25FW and MSWS-12 values were low (-0.20 to -0.30), but relatively stronger between their change values (-0.33 to -0.41). Speed improvements of >20%, and possibly 15%, were associated with clinically meaningful changes in self-reported walking ability using MSWS-12 change score and effect size criteria. CONCLUSIONS: This study builds on existing research and provides direct evidence that improvements in T25FW speed of ≥ 20% are meaningful to people with MS. The dalfampridine data enabled examinations previously not possible, including spontaneous and induced speed changes, speed change anchored to change in self-reported walking ability, and a profile of speed changes. Results support the T25FW as a clinically meaningful outcome measure for MS clinical trials.
Original languageEnglish
Pages (from-to)1509-1517
Number of pages0
JournalNeurology
Volume80
Issue number16
DOIs
Publication statusPublished - 16 Apr 2013

Keywords

  • 4-Aminopyridine
  • Adult
  • Aged
  • Clinical Trials
  • Phase III as Topic
  • Female
  • Gait
  • Gait Disorders
  • Neurologic
  • Humans
  • Male
  • Meta-Analysis as Topic
  • Middle Aged
  • Multiple Sclerosis
  • Neurologic Examination
  • Potassium Channel Blockers
  • Randomized Controlled Trials as Topic
  • Reproducibility of Results
  • Walking

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