Repeated treatments with botulinum toxin type a produce sustained decreases in the limitations associated with focal upper-limb poststroke spasticity for caregivers and patients.
OBJECTIVE
To 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.


METHODS
Multicenter, open-label, repeated-dose study.


METHODS
Thirty-five clinical sites in North America.


METHODS
Patients (N=279) with upper-limb poststroke spasticity at 6 months or more poststroke.


METHODS
Up 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.


METHODS
Investigators 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.


RESULTS
Patients 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.


CONCLUSIONS
Up 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.
Elovic
Elie P
EP
Kessler Medical Rehabilitation Research and Education Center, West Orange, NJ, USA. eelovic@kmrrec.org
Brashear
Allison
A
Kaelin
Darryl
D
Liu
Jingyu
J
Millis
Scott R
SR
Barron
Richard
R
Turkel
Catherine
C
D000203:Activities of Daily Living; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D017028:Caregivers; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D009129:Muscle Tonus / Q000187:drug effects; D018482:Muscle, Skeletal / Q000187:drug effects; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D011446:Prospective Studies; D011788:Quality of Life; D020521:Stroke / Q000150:complications*; D016896:Treatment Outcome; D034941:Upper Extremity / Q000503:physiopathology*
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A