Journal of Rehabilitation Medicine 51-10 | Page 95

Table I. Baseline demographics and characteristics of patients
included in the post hoc analysis
Patients injected at both TC3 and TC4
Characteristics
Age, years, mean (SD)
54.4 (10.6)
Sex, male, n (%)
48 (76.2)
Affected leg, left, n (%)
32 (50.8)
Cause, n (%)
Stroke
58 (92.1)
Traumatic brain injury
5 (7.9)
Time since event, years, mean (SD)
Stroke
4.64 (4.7)
Traumatic brain injury
9.67 (4.3)
Treatment naïve a , n (%)
47 (74.6)
Injected in LL only
(n  = 64)
50.6 (14.1)
45 (70.3)
37 (57.8)
52 (81.3)
12 (18.8)
4.73 (5.7)
9.62 (14.7)
46 (71.9)
a
Naïve to treatment with any form of botulinum neurotoxin administered to
the affected LL.
LL: lower limb; SD: standard deviation; TC: treatment cycle; UL: upper limb.
(61.9% vs 63.5%), the flexor digitorum profundus
(52.4% vs 44.4%), and the flexor carpi radialis (42.9%
vs 41.3%).
Efficacy
At baseline, unassisted CBWS (mean) was similar
between patients injected in the LL+UL (0.419 m/s
(SD 0.195), n = 63) and LL only (0.420 m/s (SD 0.199),
n = 64). In the subgroup of patients who received LL
injections only at TC3 and TC4, a consistently greater
change from baseline in CBWS was observed at week 4
of the DB study through to OL TC2 (mean change, m/s,
DB to TC2: 0.072 (SD 0.084) to 0.080 (SD 0.132)),
compared with patients who received co-injection into
the UL at TC3 and TC4 (DB to TC2: 0.027 (SD 0.095)
to 0.060 (SD 0.135); Fig. 2).
At the first TC to include UL injections (TC3), both
subgroups had continued improvements from baseline
at week 4 (mean change: LL+UL: 0.063 (SD 0.131);
Table II. Doses (units) of aboBoNT-A administered
Patients injected at both TC3 and TC4
Statistic
Injected in LL+UL
(n  =63)
Mean (SD)
[range] Injected in LL only
(n  =64)
Mean (SD)
[range]
1,493.7 (35.3)
[1,300.0–1,500.0]
1,006.7 (57.2)
[800.0–1,300.0]
486.9 (56.1)
[200.0–600.0] 1,381.8 (215.4)
[937.5–1,500.0]
1,381.8 (215.4)
[937.5–1,500.0]
NA
1,492.1 (63.0)
[1,000.0–1,500.0]
1,001.1 (58.3)
[666.7–1,300.0]
491.0 (44.5)
[200.0–500.0] 1,367.2 (222.6)
[1,000.0–1,500.0]
1,367.2 (222.6)
[1,000.0–1,500.0]
NA
TC3
Overall dose a
LL dose
UL dose
TC4
Overall dose a
LL dose
UL dose
Injected in LL+UL
(n  = 63)
a
Overall dose is the treatment dose received in LL and/or UL.
AboBoNT-A: abobotulinumtoxinA; LL: lower limb; NA: not applicable; SD:
standard deviation; TC: treatment cycle; UL: upper limb.
0.10
Effect of abobotulinumtoxinA split injections in spastic hemiparesis
0.093
0.09
0.08
0.072
0.07
0.086
0.080
0.078
0.070
0.06
0.086
0.063
0.060
0.05
815
0.04
0.03
0.02
LL only (n=64)
0.027
LL+UL (n=63)
0.01
0.00
DB cycle
TC1
TC2
TC3
TC4
Fig. 2. Mean change in comfortable barefoot walking speed (CBWS) at
week 4 of each treatment cycle (TC) for patients who received lower
limb (LL)+ upper limb (UL) injections or LL only injections at both TC3
and TC4 (doses combined). CBWS was assessed using the 10-m walk
test (10MWT). DB: double-blind.
LL only: 0.078 (SD 0.114)). Further improvements
were observed at week 4 of TC4 in both subgroups
(LL+UL: 0.086 (SD 0.166); LL only: 0.086 (SD
0.123)). These values equate to improvements of
20.8% and 19.8% from baseline in unassisted CBWS
in the LL+UL and LL group, respectively.
DISCUSSION
In patients with spastic hemiparesis treated with
aboBoNT-A, walking speed improved from the first in-
jection and continued with repeated treatment through­
out the OL phase. For patients requiring simultaneous
treatment of muscle overactivity in the LL and UL, the
total aboBoNT-A dose of 1,500 U split between LL and
UL provided similar improvements in walking speed
to those observed in patients injected in the LL only.
Retrospectively, the observed mean change in
CBWS during the DB phase was markedly different
between groups, with patients in the LL+UL group
displaying less improvement than the group who did
not require UL injections and received LL injections
only (Fig. 2). In patients requiring concomitant UL
injection, muscle overactivity in the UL may have
had an impact on gait (5); thus in the LL+UL group,
LL injections alone may not have been sufficient to
overcome this overactivity. This may have explained
the smaller improvements in CBWS compared with
the LL only group prior to TC3. When UL injection
became available, further improvements in CBWS
were observed in this group, eventually reaching the
same level as the LL only group by TC4.
Treatment of muscle overactivity in the UL with
BoNT-A to improve gait has been associated with
walking speed improvement in previous, smaller stu-
dies in patients with hemiparesis due to upper motor
neurone syndrome or following a stroke (5, 12). How­
ever, these studies focused on specific UL muscles that
were expected to improve walking speed by improving
J Rehabil Med 51, 2019