Article

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.

Langue : ANGLAIS