Journal
JOURNAL OF REHABILITATION MEDICINE
Volume 46, Issue 6, Pages 504-513Publisher
FOUNDATION REHABILITATION INFORMATION
DOI: 10.2340/16501977-1817
Keywords
botulinum neurotoxin A; functional change; goal attainment scaling; onabotulinumtoxinA; post-stroke spasticity; rehabilitation
Categories
Funding
- Allergan
- Ipsen
- Medtronic
- Merz
- Eisai
- Sanofi
- Bristol Myers Squibb
- Pfizer
- National Institutes of Health
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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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