Functional goal achievement in post-stroke spasticity patients: The BOTOX® Economic Spasticity Trial (BEST)
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
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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