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Optimal Muscle Selection for OnabotulinumtoxinA Injections in Poststroke Lower-Limb Spasticity: A Randomized Trial.

Alberto Esquenazi1, Theodore H Wein, Anthony B Ward

  • 1From the MossRehab Gait and Motion Analysis Laboratory, Elkins Park, Pennsylvania (AE); McGill University, Division of Neurology, Montreal General Hospital, Montreal, Quebec, Canada (THW); Staffordshire University, Faculty of Health and North Staffordshire Rehabilitation Centre, Haywood Hospital, Stoke-on-Trent, United Kingdom (ABW); Halifax Health, Brooks Rehabilitation, Daytona Beach, Florida (CG); Allergan plc, Bridgewater, New Jersey (CL); and Allergan plc, Irvine, California (RD).

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Adding toe muscle injections to onabotulinumtoxinA treatment for post-stroke lower-limb spasticity significantly improved outcomes. This approach is particularly effective for patients treated more than 24 months after stroke.

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Area of Science:

  • Neurology
  • Rehabilitation Medicine
  • Pharmacology

Background:

  • Post-stroke lower-limb spasticity affects mobility and quality of life.
  • OnabotulinumtoxinA is a treatment option, but optimal muscle selection requires further investigation.

Purpose of the Study:

  • To identify optimal muscle selection patterns for onabotulinumtoxinA treatment in post-stroke lower-limb spasticity.
  • To evaluate the efficacy of targeted muscle injections beyond the primary plantar flexors.

Main Methods:

  • Randomized controlled trial comparing onabotulinumtoxinA (300 U) with placebo in adults with post-stroke lower-limb spasticity (Modified Ashworth Scale ≥3).
  • Post hoc analysis of muscle selection patterns, assessing ankle Modified Ashworth Scale and Clinical Global Impression of Change.
  • Comparison of mandatory ankle plantar flexors alone versus additional injections into toe flexors.

Main Results:

  • OnabotulinumtoxinA improved ankle spasticity and physician-assessed global change compared to placebo.
  • Mandatory plantar flexor injections alone were insufficient unless administered within 24 months post-stroke.
  • Additional injections into toe flexors (flexor digitorum longus, flexor hallucis longus) improved outcomes regardless of time since stroke.

Conclusions:

  • Targeted onabotulinumtoxinA injections into toe flexors enhance treatment efficacy for post-stroke lower-limb spasticity.
  • This strategy is beneficial for patients with delayed treatment initiation (over 24 months post-stroke).
  • OnabotulinumtoxinA demonstrated a favorable safety profile in this patient cohort.