Abstract
Background.
Onabotulinum toxinA injections improve upper-limb spasticity after stroke, but their effect on arm function remains uncertain.
Objective.
To determine whether a single treatment with onabotulinumtoxinA
injections combined with upper-limb physiotherapy improves grasp release
compared with physiotherapy alone after stroke.
Methods. A total
of 28 patients, at least 1 month poststroke, were randomized to receive
either onabotulinum toxinA or placebo injections to the affected upper
limb followed by standardized upper-limb physiotherapy (10 sessions over
4 weeks). The primary outcome was time to release grasp during a
functionally relevant standardized task. Secondary outcomes included
measures of wrist and finger spasticity and strength using a customized
servomotor, clinical assessments of stiffness (modified Ashworth Scale),
arm function (Action Research Arm Test [ARAT], Nine Hole Peg Test), arm
use (Arm Measure of Activity), Goal Attainment Scale, and quality of
life (EQ5D).
Results. There was no significant difference between
treatment groups in grasp release time 5 weeks post injection (placebo
median = 3.0 s, treatment median = 2.0 s; t(24) = 1.20; P =
.24; treatment effect = −0.44, 95% CI = −1.19 to 0.31). None of the
secondary measures passed significance after correcting for multiple
comparisons. Both groups achieved their treatment goals (placebo = 65%;
treatment = 71%), and made improvements on the ARAT (placebo +3,
treatment +5) and in active wrist extension (placebo +9°, treatment
+11°).
Conclusions. In this group of stroke patients with mild to
moderate spastic hemiparesis, a single treatment with
onabotulinumtoxinA did not augment the improvements seen in grasp
release time after a standardized upper-limb physiotherapy program.
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