Functional goal achievement in post-stroke spasticity patients: the BOTOX® Economic Spasticity Trial (BEST).
OBJECTIVE
Evaluate changes in active and passive function with onabotulinumtoxinA + standard of care within goal-oriented rehabilitation programmes in adults with focal post-stroke spasticity.


METHODS
Prospective, 24-week double-blind study with an open-label extension. Subjects were randomized to onabotulinumtoxinA + standard of care or placebo + standard of care, at baseline and at 12 weeks, if judged appropriate, with follow-up to 52 weeks. The primary endpoint was the number of patients achieving their principal active functional goal at 24 weeks (or 10 weeks after an optional second injection). Secondary endpoints included achievement of a different active or a passive goal at this timepoint.


RESULTS
The intent-to-treat population comprised 273 patients. The proportion of patients achieving their principal active functional goal and secondary active functional goal with onabotulinumtoxinA + standard of care was not statistically different from placebo + standard of care. Significantly more patients achieved their secondary passive goal with onabotulinumtoxinA + standard of care (60.0%) vs. placebo + standard of care (38.6%) (odds ratio, 2.46; 95% confidence interval, 1.18-5.14) as well as higher Goal Attainment Scaling levels for upper limb and ankle flexor subgroups.


CONCLUSIONS
Addition of onabotulinumtoxinA to standard of care as part of goal-oriented rehabilitation in post-stroke spasticity patients significantly increased passive goal achievement and was associated with higher levels of active function.
North Staffordshire Rehabilitation Centre, Haywood Hospital, High Lane, Burslem, Stoke on Trent, UK-ST6 7AG Staffordshire , United Kingdom. anthony@bward2.freeserve.co.uk, Anthony.Ward@uhns.nhs.uk.
Anthony B
AB
Ward
Jörg
J
Wissel
Jörgen
J
Borg
Per
P
Ertzgaard
Christoph
C
Herrmann
Jai
J
Kulkarni
Kristina
K
Lindgren
Iris
I
Reuter
Mohamed
M
Sakel
Patrik
P
Säterö
Satyendra
S
Sharma
Theodore
T
Wein
Nicola
N
Wright
Antony
A
Fulford-Smith
D000124:Achievement; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006040:Goals; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy / Q000209:etiology; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D010919:Placebos; D011446:Prospective Studies; D020521:Stroke / Q000150:complications; D000071939:Stroke Rehabilitation; D055815:Young Adult
D009465:Neuromuscular Agents; D010919:Placebos; D019274:Botulinum Toxins, Type A