http://nnr.sagepub.com/content/26/7/812.abstract?etoc
Abstract
Background. Botulinum neurotoxin type A (BoNT-A) reduces upper-extremity poststroke spasticity when given 6 or more months after stroke.
Effects on functional use of the arm and hand are less apparent. Objective. To determine the effect and safety of very early use of BoNT-A for patients with upper-limb spasticity. Methods. The Asia Botulinum Toxin-A Clinical Trial Designed for Early Post-stroke Spasticity (ABCDE-S; NCT00234546)
was a multicenter, randomized, placebo-controlled trial conducted in
patients recruited within 2 -12 weeks of first-ever
stroke. Participants with a Modified Ashworth Scale
(MAS) score of 1+ or above received BoNT-A (Dysport) 500 U or placebo
to one or more wrist and elbow mover muscles, plus
unstructured rehabilitation. The primary outcome was the MAS score in
the
most affected joint 4 weeks after first injection.
Follow-up was 24 weeks. Results. A total of 163 patients were
enrolled and assigned to placebo (n = 83) or BoNT-A (n = 80). Mean time
since stroke was about
7 weeks. At 4 weeks postinjection, BoNT-A
significantly improved MAS scores. Treatment effect-size estimates
increased with
higher baseline MAS scores from 0.45 (Q1) to 0.70
(Q3). MAS scores for all secondary end points improved with BoNT-A
versus
placebo at all time points (P < .0001,
all visits). The Functional Motor Assessment Scale did not reveal
clinically significant differences. No group differences
in adverse events were found. Interpretation.
BoNT-A 500 U can provide a sustained reduction in poststroke upper-limb
spasticity when combined with rehabilitation in Asian
patients who have mild-to-moderate hypertonicity
and voluntary movement, within 2 -12 weeks of stroke. Functional use of
the
arm and hand was not affected.
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