Anthony B. Ward, Jörg Wissel, Jörgen Borg, Per Ertzgaard, Christoph Herrmann, Jai Kulkarni, Kristina Lindgren, Iris Reuter, Mohamed Sakel, Patrik Säterö, Satyendra Sharma, Theodore Wein, Nicola Wright, Antony Fulford-Smith, on behalf of the BEST Study Group
North Staffordshire Rehabilitation Centre, Haywood Hospital, High Lane, Burslem, Stoke on Trent, UK-ST6 7AG Staffordshire, United Kingdom. E-mail: Anthony.Ward@uhns.nhs.uk
DOI: 10.2340/16501977-1817

Objective: Evaluate changes in active and passive function with onabotulinumtoxinA + standard of care within goal-oriented rehabilitation programmes in adults with focal post-stroke spasticity.
Methods: Prospective, 24-week double-blind study with an open-label extension. Subjects were randomized to onabotulinumtoxinA + standard of care or placebo + standard of care, at baseline and at 12 weeks, if judged appropriate, with follow-up to 52 weeks. The primary endpoint was the number of patients achieving their principal active functional goal at 24 weeks (or 10 weeks after an optional second injection). Secondary endpoints included achievement of a different active or a passive goal at this timepoint.
Results: The intent-to-treat population comprised 273 patients. The proportion of patients achieving their principal active functional goal and secondary active functional goal with onabotulinumtoxinA + standard of care was not statistically different from placebo + standard of care. Significantly more patients achieved their secondary passive goal with onabotulinumtoxinA + standard of care (60. 0%) vs. placebo + standard of care (38. 6%) (odds ratio, 2. 46; 95% confidence interval, 1. 18–5. 14) as well as higher Goal Attainment Scaling levels for upper limb and ankle flexor subgroups.
Conclusions: Addition of onabotulinumtoxinA to standard of care as part of goal-oriented rehabilitation in post-stroke spasticity patients significantly increased passive goal achievement and was associated with higher levels of active function.

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