• Elie P Elovic, Allison Brashear, Darryl Kaelin, Jingyu Liu, Scott R Millis, Richard Barron, and Catherine Turkel.
• Kessler Medical Rehabilitation Research and Education Center, West Orange, NJ, USA. eelovic@kmrrec.org
• Arch Phys Med Rehabil. 2008 May 1;89(5):799-806.

ObjectiveTo assess the safety and evaluate the effects of repeated treatments with botulinum toxin type A (BTX-A) on functional disability, quality of life (QOL), and muscle tone of patients with upper-limb poststroke spasticity, as well as its effect on caregivers.DesignMulticenter, open-label, repeated-dose study.SettingThirty-five clinical sites in North America.ParticipantsPatients (N=279) with upper-limb poststroke spasticity at 6 months or more poststroke.InterventionUp to 5 intramuscular injections of BTX-A (200-400U) divided among the wrist, finger, thumb, and elbow flexors, with at least 200U in the wrist and finger flexors. Retreatment was permitted at 12 weeks or more after the last treatment.Main Outcome MeasuresInvestigators rated disability using the Disability Assessment Scale and muscle tone using the Ashworth Scale. Each patient's health-related QOL was assessed by using the Stroke Adapted Sickness Impact Profile and the visual analog scale of the European Quality of Life-5 Dimensions questionnaires.ResultsPatients treated with BTX-A reported improvements in muscle tone, disability, and ability to function that were statistically significant and clinically meaningful. Significant improvements were observed at week 30 and at subsequent time points in QOL in the overall group and the high-dose group.ConclusionsUp to 5 treatments with BTX-A every 12 weeks for up to 56 weeks in patients with poststroke spasticity was well tolerated and significantly improved muscle tone, lessened disability, and improved patients' QOL. Further research is required to examine the effectiveness of repeated injections of BTX-A in patients with poststroke spasticity.

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