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  • Title: Functional goal achievement in post-stroke spasticity patients: the BOTOX® Economic Spasticity Trial (BEST).
    Author: Ward AB, Wissel J, Borg J, Ertzgaard P, Herrmann C, Kulkarni J, Lindgren K, Reuter I, Sakel M, Säterö P, Sharma S, Wein T, Wright N, Fulford-Smith A, BEST Study Group.
    Journal: J Rehabil Med; 2014 Jun; 46(6):504-13. PubMed ID: 24715249.
    Abstract:
    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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