The Effect of Repeated abobotulinumtoxinA (Dysport®) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury

Alberto Esquenazi, Allison Brashear, Thierry Deltombe, Monika Rudzinska-Bar, Malgorzata Krawczyk, Alexander Skoromets, Michael W O'Dell, Anne-Sophie Grandoulier, Claire Vilain, Philippe Picaut, Jean-Michel Gracies, Alberto Esquenazi, Allison Brashear, Thierry Deltombe, Monika Rudzinska-Bar, Malgorzata Krawczyk, Alexander Skoromets, Michael W O'Dell, Anne-Sophie Grandoulier, Claire Vilain, Philippe Picaut, Jean-Michel Gracies

Abstract

Background: Botulinum toxin (BoNT) injections were shown to improve muscle tone of limbs in patients with spasticity. However, limited data are available regarding the effects of repeated BoNT injections on walking ability.

Objective: To assess changes in walking velocity (WV), step length, and cadence under different test conditions after repeated treatment with abobotulinumtoxinA (aboBoNT-A; Dysport) in spastic lower limb muscles.

Design: Secondary analysis of an open-label, multiple-cycle extension (National Clinical Trials number NCT01251367) to a phase III, double-blind, randomized, placebo-controlled, single-treatment cycle study, in adults with chronic hemiparesis (NCT01249404).

Setting: Fifty-two centers across Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia, and the United States.

Patients: 352 Ambulatory adults (18-80 years) with spastic hemiparesis and gait dysfunction caused by stroke or traumatic brain injury, with a comfortable barefoot WV of 0.1 to 0.8 m/s.

Interventions: Up to four aboBoNT-A treatment cycles, administered to spastic lower limb muscles.

Main outcome measurements: Changes from baseline in comfortable and maximal barefoot and with shoes WV (m/s), step length (m/step), and cadence (steps/minutes).

Results: At Week 12 after four injections, WV improved by 0.08 to 0.10 m/s, step length by 0.03 to 0.04 m/step, and cadence by 3.9 to 6.2 steps/minutes depending on test condition (all P < .0001 to .0003 vs baseline). More patients (7% to 17%) became unlimited community ambulators (WV ≥0.8 m/s) across test conditions compared with baseline, with 39% of 151 patients classified as unlimited community ambulators in at least one test condition and 17% in all four test conditions.

Conclusions: Clinically meaningful and statistically significant improvements in WV, step length, and cadence under all four test conditions were observed in patients with spastic hemiparesis after each aboBoNT-A treatment cycle.

© 2020 The Authors. PM&R published by Wiley Periodicals LLC on behalf of American Academy of Physical Medicine and Rehabilitation.

Figures

Figure 1
Figure 1
Mean change from baseline for walking velocity under four conditions at Week 12 of each cycle from the double‐blind study to the open‐label study (all doses combined). †219 for maximal WV with shoes; ‡219 for maximal WV with shoes; §317 for maximal WV barefoot, 319 for comfortable WV with shoes, 318 for maximal WV with shoes; ¶254 for comfortable WV with shoes and maximal WV with shoes; ††151 for comfortable WV with shoes and maximal WV with shoes. WV = walking velocity.
Figure 2
Figure 2
Mean change from baseline for step length under four conditions at Week 12 of each cycle from the double‐blind study to the open‐label study (all doses combined). †219 for maximal with shoes; ‡219 for maximal with shoes; §317 for maximal barefoot, 319 for comfortable with shoes, 318 for maximal with shoes; ¶254 for comfortable with shoes and maximal with shoes; ††151 for comfortable with shoes and maximal with shoes.
Figure 3
Figure 3
Mean change from baseline for cadence under four conditions at Week 12 of each cycle from the double‐blind study to the open‐label study (all doses combined). †219 for maximal with shoes; ‡219 for maximal with shoes; §317 for maximal barefoot, 319 for comfortable with shoes, 318 for maximal with shoes; ¶254 for comfortable with shoes and maximal with shoes; ††151 for comfortable with shoes and maximal with shoes.

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