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Title: Botulinum toxin injection for hypertonicity of the upper extremity within 12 weeks after stroke: A randomized controlled trial
Authors: Raymond L. Rosales
Keng He Kong
Khean Jin Goh
Witsanu Kumthornthip
Vincent Chung Tong Mok
Mary Mildred Delgado-De Los Santos
Karen Sui Geok Chua
Saini Jeffery Bin Freddy Abdullah
Benjamin Zakine
Pascal Maisonobe
Axel Magis
K. S.Lawrence Wong
University of Santo Tomas, Manila
Metropolitan Medical Center, Manila
Tan Tock Seng Hospital
University of Malaya
Mahidol University
Prince of Wales Hospital Hong Kong
Keywords: Medicine;Neuroscience
Issue Date: 1-Sep-2012
Citation: Neurorehabilitation and Neural Repair. Vol.26, No.7 (2012), 812-821
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. © The Author(s) 2012.
ISSN: 15526844
Appears in Collections:Scopus 2011-2015

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