Comparing botulinum
ities in children with spastic cerebral palsy (CP; Gage 1991).
toxin A with casting for
treatment of dynamic
equinus in children with
cerebral palsy
Jeffrey D Ackman MD;
Barry S Russman MD;
Susan Sienko Thomas* MA;
Cathleen E Buckon MS;
Michael D Sussman MD;
Peter Masso MD;
James Sanders MD;
Jacques D’Astous MD;
Michael D Aiona MD;
The Shriners Hospitals BTX-A Study Group, Shriners
Hospitals for Children: Chicago, Erie, Intermountain,
Portland, and Springfield, USA.
*Correspondence to third author at Shriners Hospital
for Children, 3101 SW Sam Jackson Park Road, Portland,
OR 97239, USA.
E-mail: SST@SHCC.org
The purpose of this study was to compare the cumulative
efficacy (three treatment sessions) of botulinum toxin A (BTX-
A) alone, casting alone, and the combination of BTX-A and
casting in the management of dynamic equinus in ambulatory
children with spastic cerebral palsy (CP). Thirty-nine children
with spastic CP (mean age 5y 10mo, range 3 to 9y) were
enrolled in the study. A multicenter, randomized, double blind,
placebo-controlled prospective study was used. Children were
randomly assigned to one of three treatment groups: BTX-A
only (B), placebo injection plus casting (C), or BTX-A plus
casting (B+C). The dosage for the BTX-A injections was 4U/kg
per extremity. Assessments were performed at baseline, 3, 6, 7.5,
and 12 months with a total of three treatments administered
after the evaluations at baseline, 3, and 6 months. Primary
outcome measures were ankle kinematics, velocity, and stride
length. Secondary outcome measures were ankle spasticity,
strength, range of motion, and ankle kinetics. Group B made no
significant change in any variable at any time. Groups C and
B+C demonstrated significant improvements in ankle
kinematics, spasticity, passive range of motion, and dorsiflexor
strength. Results of this 1-year study indicate that BTX-A alone
provided no improvement in the parameters measured in this
study, while casting and BTX-A/casting were effective in the
short- and long-term management of dynamic equinus in
children with spastic CP.
See end of paper for list of abbreviations.
620 Developmental Medicine & Child Neurology 2005, 47: 620–627
Dynamic equinus is one of the most common ankle abnormal-
Non-operative interventions are preferred in young children
(less than 6 years of age) as surgical outcomes are less pre-
dictable because of the potential for over-lengthening, weak-
ness, and recurrence (Graham and Fixsen 1988, Rattey et al.
1993). Casting, a non-operative intervention used to ‘stretch
out’ mild contractures of the triceps surae and reduce dynam-
ic equinus, often results in transient improvements in ankle
motion (Sussman 1983, Flett et al. 1999). More recently, botu-
linum toxin A (BTX-A) has shown the ability to provide a short-
term reduction in spasticity with consequent improvement in
dynamic equinus in children with spastic CP (Cosgrove et al.
1994, Corry et al. 1998, Ubhi et al. 2000, Desloovere et al.
2001, Gormley et al. 2001, Baker et al. 2002, Polak et al. 2002).
Comparisons between BTX-A and casting suggest that BTX-A
is more effective than casting in reducing dynamic equinus in
children with spastic CP (Corry et al. 1998, Flett et al. 1999);
whereas the combination of BTX-A and casting has been
found to have greater and longer-lasting effects than BTX-A
alone (Bottos et al. 2003). Although many studies have deter-
mined the effectiveness of BTX-A, BTX-A/casting, and casting
after a single treatment, no studies have evaluated the single
and cumulative effectiveness of these three interventions to
determine the differences or similarities in functional out-
come after treatment over one year.
The purpose of this study was to investigate the single and
cumulative effectiveness (three repeated treatments) of BTX-A,
casting, and or the combination of BTX-A and casting at reduc-
ing dynamic equinus during gait in children with spastic CP.
Method
PROTOCOL
Specific inclusion and exclusion criteria were established a pri-
ori (Table I) and children were recruited into the study from
outpatient clinics at five Shriners Hospitals for Children
(Chicago, Erie, Intermountain, Portland, and Springfield). All
parents signed an informed consent form approved by each
local Institutional Review Board. The Research Integrity Office
at Oregon Health and Sciences University gave ethical approval
to this study. Assessments were performed five times over one
year: baseline, 3, 6, 7.5, and 12 months. All participants rec-
eived a total of three treatments (injections and/or casting)
which followed evaluations at baseline, 3, and 6 months (Fig.
1). The 3- and 6-month assessments were established to
address the question of whether repeated treatments pro-
duced cumulative improvements in outcomes. The 7.5-month
assessment was chosen because it was 6 weeks after injection
or initiation of casts when treatment effects should be optimal.
The 12-month assessment was performed to determine the
longevity of treatment outcome, because the final intervention
was carried out 6 months previously.
The initial power calculations determined the need for 25
children per group to give a 90% probability of detecting at
least a 5˚ change in ankle kinematics, 0.15m/s change in veloc-
ity, and a 0.10m change in stride length.
OUTCOME MEASURES
Primary outcome measures included the gait parameters of
velocity and stride length and the ankle kinematics of ankle
dorsiflexion at initial contact (DFIC), peak dorsiflexion in stance
(PDFSt), and peak dorsiflexion in swing (PDFSw). Each center

used a Vicon motion system to assess ankle kinematics and
kinetics. Retroreflective markers were placed on the partici-
pant according to the positions outlined in the Vicon Clinical
Manager manual. All gait data were processed with Vicon
Clinical Manager at the data center by one of two clinicians
(CEB, SST) to maintain consistency in data processing. To
decrease interrater variability, all examiners participated in a
yearly protocol review and training session for passive range
of motion of the ankle, spasticity and strength, and marker
placement techniques. The examiner was held constant for each
participant at each visit to minimize intrarater variability.
Secondary outcome measures were triceps surae spasticity
(Ashworth and Tardieu), passive and active ankle dorsiflexion,
ankle dorsiflexion and plantarflexion strength, and ankle power
generation (APG). Triceps surae spasticity was assessed with
both the modified Ashworth Scale and the Tardieu assessment.
For the modified Ashworth scale score the child was placed
prone with the knee flexed to 90˚ while a quick stretch to the tri-
ceps surae was applied and the response graded on a 0 to 5 scale
with 0 equal to hypotonic and 5 equal to extreme (Bohannon
and Smith 1987). The Tardieu was also performed with the
participant prone and the knee at 90˚. Three rapid stretches
to the triceps surae were applied and the position of the
ankle was measured with a goniometer after the third stretch
(Boyd and Graham 1999). Dorsiflexor strength was assessed
by manual muscle test and scored on a scale of 0 to 5 (Hislop
and Montgomery 1995). Triceps surae muscle strength was
assessed by the ability to perform unilateral heel rises, 20 heel
rises equaling a score of 5 (Hislop and Montgomery 1995).
Passive ankle dorsiflexion was assessed with the participant
positioned prone with the knee flexed to 90˚ and fully extended.
Active dorsiflexion was assessed with the participant sitting
with the hip and knee at 90˚.
RANDOMIZATION AND BLINDING
A randomized, double-blind, placebo-controlled design was
Table I: Inclusion/exclusion criteria for enrollment into study
Inclusion
Diagnosis of spastic hemiplegia or diplegia
Between the ages of 3 and 10 years
Independent ambulators without assistive devices
Ambulate in functional equinus (toe–toe or toe–heel pattern)
Neutral ankle position with full knee extension
Table II: Participant demographics by treatment
BTX-A (B)
Number of participants
Mean age, mo
Age range, mo
Number with hemiplegia
Number with diplegia
Males
Females
GMFCS Level I
GMFCS level II
Botulinum Toxin A versus Casting for Dynamic Equinus Jeffrey D Ackman et al.
14698749, 2005, 9, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1469-8749.2005.tb01215.x by Nat Prov Indonesia, Wiley Online Library on [14/09/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
used in this study. A block design randomization sequence was
used such that for every three children enrolled at each cen-
ter, one child would be randomly assigned to each of the three
groups. Children were randomized within each diagnostic
group to ensure equal distribution of children with hemiplegia
and diplegia into each treatment option. The randomization
sequence was identical for all participating centers and was
provided only to the individual responsible for coordinat-
ing/facilitating the injection procedure. Neither the evaluat-
ing clinicians nor the parents were aware of whether the
child received BTX-A or placebo before the application of the
casts. For the children who received an injection of BTX-A only,
the children and parents were instructed not to discuss their
treatment with the evaluating clinician to ensure that the clini-
cian maintained blinding to the treatment group. The physi-
cian or site coordinator was aware of which group the
participant was randomized to and subsequently revealed
group assignments at the completion of the participant’s
involvement in the study to facilitate future treatment plans.
Individuals at the data center, who were blinded to the group
designation during data processing and entering into the
database, analyzed all data. The groups were revealed upon
completion of data analysis.
INJECTION AND CASTING PROCEDURE
The physician-investigator at each hospital performed BTX-A
or placebo injection(s). Sedation method and pain management
were left to the discretion of the physician. Injections were
made into the medial and lateral gastrocnemius muscles using
a 23 to 27 gauge needle. The BTX-A dosage was 4U/kg body
weight for each gastrocnemius muscle injected at a concen-
tration of 100U/cm3, which was the recommended dosage for
BTX-A at the start of the study. At each treatment visit, children
received a cast(s) which remained on for 3 weeks. Casts were
applied by the same physical therapist, physician, or casting
technician during each visit. The child was positioned prone
Exclusion
Previous orthopedic surgery to tendo-achilles or subtalar joint
No BTX-A injections in previous 6 months
Hip or knee flexion contractures greater than 10˚
Placebo/cast (C) BTX-A/cast (B+C)
12 14 13
69 68 72
40–105 36–108 41–99
8 10 8
4 4 5
6 6 6
6 8 7
11 14 12
1 0 1
621

with the knee flexed to 90˚. The foot was placed in subtalar
neutral with the ankle in 0 to 5˚ of dorsiflexion. A layer of
stockinette was applied over the foot and calf. Cast padding
and fiberglass casting tape were applied starting at the foot
and moving up the calf. The bottom of the cast was flattened
and a cast shoe was provided to allow walking during the 3
weeks of cast wear. After cast removal, children were instructed
to wear their ankle–foot orthoses (AFOs) during the day and
night, with removal of the AFO for 2 to 4 hours during the
evening. AFO configuration was based on the physician’s dis-
cretion at each center and included solid ankle, posterior
leaf spring, and articulated. Children who received BTX-A
only were given similar instructions for AFO wear during the
study. No difference was found in the number of hours of AFO
wear between the treatment groups.
DATA ANALYSIS
Data were analyzed with two-way repeated measure ANOVAs
(analysis of variance) and linear contrasts to determine bet-
ween-group differences at each assessment time and within-
group differences across time (Statview 4.1 and SuperANOVA).
Significance was set at p<0.05. Although it would have been
ideal to analyze data from the children with hemiplegia and
diplegia separately, the small number of children with spastic
diplegia in each treatment group prohibited a separate analy-
sis. For children with spastic diplegia, there were no significant
differences between the left and right sides for any primary out-
come variables; therefore, the left side was randomly chosen
14698749, 2005, 9, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1469-8749.2005.tb01215.x by Nat Prov Indonesia, Wiley Online Library on [14/09/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
for use in the analysis. For the children with hemiplegia, the
involved (injected) side was used in the analysis. Use of only
one limb for the children with spastic diplegia allowed all chil-
dren in the study to have equal weighting during data analysis.
Results
Despite the involvement of five centers, enrolling a sufficient
number of participants was difficult, leading to early termina-
tion of the study before obtaining the projected number of chil-
dren. At most centers there was a 50% or higher refusal rate by
parents of children who met the inclusion/exclusion criteria.
The primary reason for refusal to participate was that parents
did not want their children to receive a placebo when they
could receive BTX-A clinically, at no cost to them, without
adhering to the rigorous follow-up schedule. Approximately
90 children met the inclusion/exclusion criteria, yet a total of
only 39 with CP agreed to participate in the study. Mean age of
the entire group was 5 years 10 months with a range of 3 to 9
years. There were 19 males and 20 females, equally distributed
within each treatment group (Table II). All children were Gross
Motor Function Classification System (GMFCS; Palisano et al.
1997) level I, except one child in the group B and one child in
group B+C who were GMFCS level II (Table II). Twelve chil-
dren were randomized to group B, 14 children to group C, and
13 children to group B+C (Table II). A post-hoc power analysis
based on the observed variability indicated that with 13 chil-
dren per group, the power to detect a 5˚ change in ankle kine-
matics was reduced to 66%, whereas the power to detect

Assessments 0 3 6 7.5 12

Months

Treatments 0 3 6

Figure 1: Treatment and assessment schedule for all groups. Time displayed in months.

Velocity Stride length

1.5 1.5
Stride length (m)
Velocity (m/s)

1 1

0.5 0.5

0 0
0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12
Assessment times (mo) Assessment times (mo)

Figure 2: Velocity and stride length by treatment. ◆ BTX-A only (B); ■ placebo/cast (C); ● BTX-A/cast (B+C).

622 Developmental Medicine & Child Neurology 2005, 47: 620–627


change in velocity of 0.15m/s and stride length of 0.10m was
reduced to 55%.
BASELINE DIFFERENCES
At baseline, groups B and C were significantly different
(p≤0.0036) in dorsiflexion at initial contact only (group B –8˚
versus group C –14˚). No significant between-group difference
was seen at successive assessments. No group interaction was
found in any of the primary or secondary variables. There was
no significant difference in primary outcome variables at base-
line between the children who dropped out and the children
who completed the study.
GAIT PARAMETERS AND ANKLE KINEMATICS AND KINETICS
No significant change in velocity or stride length was seen in
any of the three groups at any assessment time, although all
groups demonstrated a trend toward an increase in stride
length over the year that may be related to growth (Fig. 2).
Group B made no significant change in ankle kinematics at any
time (Fig. 3). Group C demonstrated significant improvements
in all ankle kinematic variables: DFIC (p≤0.007), PDFSt
(p≤0.01), and PDFSw (p≤0.02) between baseline and each
assessment time, excluding PDFSw at 1 year. Significant short-
term gains in ankle kinematics were seen in group C between 6
and 7.5 months (p≤0.02); and although gains decreased from
7.5 months to 1 year, values remained above baseline. Group
B+C demonstrated significant gains in stance phase variables
(p≤0.03) between baseline and 6, 7.5, and 12 months, whereas
14698749, 2005, 9, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1469-8749.2005.tb01215.x by Nat Prov Indonesia, Wiley Online Library on [14/09/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
PDFSw (p≤0.02) significantly improved at all assessment times
(Fig. 3). Peak power generation at the ankle during push-off
did not change in any group (Fig. 3).
ANKLE SPASTICITY, PASSIVE RANGE OF MOTION, AND STRENGTH
Ankle spasticity, as measured by the Ashworth and the Tardieu
scales, was not significantly decreased in group B at any time
period (Fig. 4). Group C demonstrated a significant decrease in
spasticity on both the Ashworth and the Tardieu scales (p≤0.02)
from baseline to each follow-up assessment (Fig. 4). From 6 to
7.5 months a significant decrease in spasticity was detected
using the Tardieu (p≤0.02), but not the Ashworth scale. Group
B+C did not demonstrate significant changes in spasticity on
the Ashworth scale at any time, but did demonstrate a signifi-
cant decrease in spasticity on the Tardieu scale (p≤0.05) from
baseline to 6, 7.5, and 12 months (Fig. 4). Although spasticity
increased significantly in groups C and B+C on the Tardieu
scale (p≤0.05), and Group C on the Ashworth scale (p≤0.05),
between 7.5 months and 1 year, the degree of spasticity rem-
ained below the pretreatment values at 1 year follow-up.
No significant changes in passive ankle dorsiflexion with
knee flexion (KF) or knee extension (KE) were seen in group B
at any time (Fig. 5). Group C demonstrated significant gains in
passive ankle dorsiflexion with KF and KE (p≤0.03) between
baseline and 7.5 months; however, most of the gain occurred
between 6 and 7.5 months, the six-week post-treatment assess-
ment (Fig. 5). Group B+C demonstrated significant gains in
passive ankle dorsiflexion with KF (p≤0.01) between baseline

Dorsiflexion at initial contact Peak dorsiflexion in stance

20 *
* * *
10 * * * * * *
* * * 15
*
0 10
5
–10
Degrees
Degrees

0
–20 –5

–30 –10
0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12
–15
–40 Assessment times (mo) –20 Assessment times (mo)

Peak dorsiflexion in swing Ankle peak power generation

2.5

10 2
Peak power (W/kg)

* * *
* * *
*
0 1.5
Degrees

1
–10
0.5
–20
0
0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12
–30 Assessment times (mo) Assessment times (mo)

Figure 3: Ankle kinematics and kinetics by treatment. ◆ BTX-A only (B); ■ placebo/cast (C); ● BTX-A/cast (B+C).
* Significantly different from baseline.

Botulinum Toxin A versus Casting for Dynamic Equinus Jeffrey D Ackman et al. 623

and 7.5 months, whereas significant improvements in dorsi-
flexion with KE (p≤0.04) were seen between baseline and 3, 6,
and 7.5 months. No significant difference in ankle dorsiflexion
was seen between baseline and the 12-month follow-up in
either group C or B+C, secondary to a relapse in passive ankle
dorsiflexion values toward baseline from 7.5 months to 1 year.
No significant gain in active ankle dorsiflexion was seen in any
group; however, groups C and B+C demonstrated a trend
toward successive improvement at each assessment.
Ankle dorsiflexor strength did not change in group B (Fig.
6). Group C demonstrated significant gains in dorsiflexor
14698749, 2005, 9, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1469-8749.2005.tb01215.x by Nat Prov Indonesia, Wiley Online Library on [14/09/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
strength (p≤0.04) between baseline and 6, 7.5, and 12 months.
A significant gain in dorsiflexor strength was seen in group
B+C (p≤0.01) from 7.5 months to 1 year, secondary to a tran-
sient decrease in strength between 6 and 7.5 months (Fig. 6).
No significant changes in ankle plantarflexor strength were
seen in any group.
DROPOUTS
Children were randomized to the treatment groups equally;
however, five children did not complete the study. Group B
had the greatest number of dropouts (three), resulting in an

Ashworth scale Tardieu scale

5 10 * *
* * * * *
4
Ashworth score

0
*

Degrees
3 * * *
–10
2
–20
1
–30
0
0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12
–40
Assessment times (mo) Assessment times (mo)

Figure 4: Muscle tone and Tardieu measurements by treatment. ◆ BTX-A only (B); ■ placebo/cast (C); ● BTX-A/cast (B+C).
* Significantly different from baseline.

PROM dorsiflexion/knee flexion PROM dorsiflexion/knee extension

25
40 *
35 20 *
* * *
30 15
*
Degrees
Degrees

25
20 10
15 5
10
5 0
0 –5
0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12
Assessment times (mo) Assessment times (mo)

Active dorsiflexion

20
10
0
Degrees

–10
–20
–30
–40
–50
0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12
Assessment times (mo)

Figure 5: Passive and active range by treatment. ◆ BTX-A only (B); ■ placebo/cast (C); ● BTX-A/cast (B+C). PROM, passive
range of motion. * Significantly different from baseline.

624 Developmental Medicine & Child Neurology 2005, 47: 620–627


n=9 versus one dropout in group C, leaving an n=13 and one
dropout for group B+C, leaving an n=12. One child in group
B discontinued the study after the 3-month evaluation because
the parent did not like the tripping and falling that occurred
after an injection of BTX-A; this child’s family subsequently
chose to have orthopedic surgery. Two children in group B dis-
continued the study at the 6-month visit because the parents
chose to manage their child’s equinus with orthopedic surgery.
The child in group C was discontinued from the study owing to
repeat no-shows for the 6-month appointment. The one child
in group B+C discontinued the study after the 3-month visit
because of relocation of the family to another state.
ADVERSE EVENTS
One family in group B and one family in group B+C com-
plained that their child fell more often immediately after treat-
ment, which resolved within 1 to 2 weeks. There were no press-
ure sores resulting from the casts, no injuries during cast
removal, nor any early removal of the cast for any of the chil-
dren in groups C or B+C.
Discussion
In this study no significant improvement in ankle kinematics
was found after BTX-A alone, in contrast to previous studies
(Corry et al. 1998, Sutherland et al. 1999). Eames reported that
the magnitude of improvement in muscle length is directly
related to the dynamic equinus present immediately before
an injection and that repeated injections display a similar cor-
relation (Eames et al. 1999). The BTX-A only group had the
least amount of dynamic equinus and the greatest passive
ankle dorsiflexion at the onset of the study, which may have
influenced our ability to detect significant change in this
group. Despite the lack of significant changes in the BTX-A
group, it should be noted that there was not a regression
below baseline values at the 1 year follow-up, as may be
expected in untreated children with CP walking in dynamic
equinus. Short-term improvements in stance and swing phase
kinematics occurred after the use of casting or BTX-A/casting
in this study. In contrast to the short-term findings of our
study, Corry et al. (1998) reported that casting was as effec-
tive as BTX-A over the short term, yet the cast group tended
toward a relapse at 12 weeks, whereas the BTX-A group main-
tained their initial improvement (Corry et al. 1998). In this
study, both casting and BTX-A/casting resulted in progressive
Dorsiflexor strength
Manual muscle strength score
5 *
*
*
4 10
3
2
1
0 –5
0 3 6 7.5 12 0 3 6 7.5 12 0
Assessment times (mo)
Figure 6: Ankle muscle strength by treatment. ◆ BTX-A only (B); ■ placebo/cast (C); ● BTX-A/cast (B+C).* Significantly
different from baseline.
14698749, 2005, 9, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1469-8749.2005.tb01215.x by Nat Prov Indonesia, Wiley Online Library on [14/09/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
improvements in ankle kinematics after each intervention,
which is similar to the findings of Ruiz who injected 4U/kg
BTX-A every 3 months (Ruiz et al. 2000).
Despite the improvements in ankle kinematics, minimal
changes in velocity were seen after any of the interventions,
similar to the findings of Sutherland (Sutherland et al. 1999).
The lack of significant changes in velocity may be related to the
functional level of the participants at the onset of the study.
At baseline, the children in this study walked at a velocity that
was 80 to 90% of their age-matched peers and, thus, an improve-
ment in velocity resulting from these treatment interventions
may not be realistic for this high-functioning group.
Although short-term decreases in spasticity have been report-
ed after injections, this was not seen in our study after BTX-A
only. Corry et al. (1998) reported a significant decrease in gas-
trocnemius spasticity 2 weeks after BTX-A injection (6 to
8U/kg); however, spasticity had returned to a baseline level at
12 weeks follow-up. Although changes in spasticity are often
reported in the literature on BTX-A, the method of quantify-
ing spasticity is often absent, resulting in a subjective inter-
pretation of the longevity of the treatment effect. Contrary to
the findings of Corry et al (1998), our study found that cast-
ing produced a significant reduction in gastrocnemius spas-
ticity, which was sustained for 3 months after intervention.
The combination of BTX-A and casting also produced a sig-
nificant reduction in gastrocnemius spasticity, which was
maintained for 3 months. Although the lack of a significant
reduction in spasticity after BTX-A can be explained to some
degree by this study design and the dosage level, more sensi-
tive and valid measures of muscle spasticity are needed to
detect the subtle intervention effects that are characteristic of
mildly involved ambulatory children.
The Ashworth scale is a widely used clinical measure of
spasticity; however, recent investigations of its validity and
precision indicate that it lacks the sensitivity to detect small
degrees of change, or changes in spasticity (Pandyan et al.
1999, Damiano et al. 2002, Fosang et al. 2003). The modified
Tardieu scale, which has been proposed to be a more effective
in quantifying changes in spasticity, identified significant
changes in gastrocnemius spasticity more frequently in this
study than the Ashworth scale (Boyd and Graham 1999).
Using an electromechanical torque measure of spasticity, Hays
et al. (2003) reported a significant reduction in gastrocnemius
spasticity 8 weeks after BTX-A injections (6U/kg) that was not
Heel raises
15
Number of heel raises
5
0
3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12 0 3 6 7.5 12
Assessment times (mo)
Botulinum Toxin A versus Casting for Dynamic Equinus Jeffrey D Ackman et al. 625

detected with the Ashworth scale, indicating the increased
sensitivity of this device. These reductions in gastrocnemius
spasticity preceded gains in ankle range of motion, strength,
and functional motor skills, leading the authors to conclude
that the early visco-elastic changes in the muscle tissue ind-
uced by BTX-A promote gains in muscle length that normalize
ankle motion and, thus, improve functional motor skills
(Bjornson et al. 2003, Hays et al. 2003).
In this study, gains in muscle length, as measured by passive
range of motion, were not seen after BTX-A alone. Casting
alone produced brief (6-week) gains in muscle length, whereas
the combination of BTX-A/casting produced a more sustained
improvement in muscle length (greater than 3 months). These
findings are in contrast to those of Corry et al. (1998), who
reported significant gains in passive range of motion 2 weeks
after either casting or BTX-A, which were maintained in the
BTX-A group but not the casting group at the 12-week follow-
up. Cosgrove reported that the short-term increase in muscle
length seen at 2 and 12 weeks after injections of BTX-A in chil-
dren with CP, was not translated into a long-term increase in
muscle length, as seen in the animal model (Cosgrove et al.
1994, Cosgrove and Graham 1994). The results of this study
demonstrated that the combination of BTX-A/casting main-
tained gains in muscle length better than either treatment in
isolation, which is similar to the findings of Bottos et al.( 2003).
In this study none of the interventions created a reduction
in gastrocnemius strength, as measured by heel raises or ankle
power generation at the times evaluated. BTX-A has been
shown to cause transient muscle weakness lasting 1 to 2 weeks
with greater than 90% functional recovery at 6 months (Elsaidi
et al. 2003). Recent studies have suggested that BTX-A pro-
duces a greater effect on intrafusal fibers than extrafusal fibers,
which reduce spasticity while maintaining voluntary muscle
activity, thus allowing for maintenance of functional muscle
strength (Fillipi et al. 1993, Rosales et al. 1996). Our findings
are similar to those of Boyd et al. (2000) and Zurcher et al.
(2001) who found that ankle power generation was not red-
uced and ankle power quotient was significantly improved
after injections of BTX-A or BTX-A/casting. Decreases in gas-
trocnemius spasticity have been hypothesized to facilitate
strengthening in the anterior muscle groups (Koman et al.
2001); however, no studies have reported changes in tibialis
anterior strength after injections of BTX-A into the gastrocne-
mius. In this study, both BTX-A and BTX-A/casting produced a
decrease, although not significant, in dorsiflexor strength as
measured by manual muscle testing at the 7.5-month assess-
ment (6 weeks after the BTX-A injection), which was not seen
after casting alone. This subtle decrease in strength may indi-
cate some diffusion of the BTX-A to the anterior muscle groups,
reducing strength at 6 weeks after injection which resolved by
the 3-month assessments. Although it is assumed that BTX-A
remains confined to the muscle injected, animal studies have
shown that there is potential for diffusion into neighboring
structures, across fascial planes, if saturation occurs at an injec-
tion site (Graham et al. 2000); however, this has not been
shown in humans.
Although neither casting nor BTX-A decreased gastrocne-
mius muscle strength in this study, objective measurement of
muscle strength would enhance our understanding of the
impact of the various treatments on both agonist and antago-
nist muscle strength. Isokinetic dynamometers can provide
a more accurate assessment of muscle strength at specific
626 Developmental Medicine & Child Neurology 2005, 47: 620–627
14698749, 2005, 9, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1469-8749.2005.tb01215.x by Nat Prov Indonesia, Wiley Online Library on [14/09/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
positions, as well as throughout the entire range, and have been
successfully used to assess strength in children with spastic
diplegia (Ayalon et al. 2000). The use of these objective mea-
surement tools over subjective measures would enable the
subtle differences between the treatments to be recognized.
It has been suggested that casting should be delayed for 2 to
3 weeks to distinguish between the effects of BTX-A and casting
and determine the need for casting (Graham et al. 2000).
Furthermore, Kim et al (2003) determined that to maximize
the muscle paralysis effect from BTX-A, it is beneficial to inc-
rease the dilution volume and perform post-injection stretch-
ing with electrical stimulation before the placement of casts;
even the simple activity of walking can increase the paralytic
effects of BTX-A. In this study, children were placed in a cast
immediately after their injection of BTX-A. Despite immediate
immobilization, the combination of BTX-A and casting resulted
in significant gains in passive and dynamic ankle motion at all
assessment times. However, if the casting had been delayed,
the effects of the BTX-A may have been greater and the advan-
tage of the combination would be maximized. Further study is
needed to determine the differences between immediate and
delayed casting to determine the optimal time to cast after an
injection of BTX-A and length of cast application, as delayed
cast application may produce an even greater effect in the BTX-
A and casting group.
SHORTCOMINGS
One variable that may have impacted the outcome of this study
is the dosage of BTX-A used. At the onset, 4U/kg was the recom-
mended number of units by Allergan and 3 to 6U/kg was the
recommendation by professionals using BTX-A clinically
(Graham et al. 2000). At the time of writing, the dosage of BTX-
A that is injected in each muscle group has increased, yet the
relation between the amount injected, the dilution volume,
and the change in ankle motion is still not well delineated.
Furthermore, the time from completion of treatment to
each evaluation was always 3 weeks longer for group B than
that of the two other groups in this study because casts
remained in place for 3 weeks. Although the children in this
study who received BTX-A did not make significant improve-
ments, changes were noticed and perhaps if they had been of
similar involvement as the other groups and evaluated at the
same post-treatment time, significant changes may have been
recognized.
Conclusions
Results of this study suggest that the efficacy of treatment
interventions for dynamic equinus in children with CP is rep-
resented by a continuum. BTX-A (4U/kg) had limited efficacy
because of the brevity of its effect (no more than 6 weeks).
Although decrements in outcomes were seen at 1 year, 6 months
after the last of the three treatments, neither the casting nor
the BTX-A/casting groups regressed to baseline values, indi-
cating some long-term benefits. Based on the results of this
study, repeated treatments of either casting or BTX-A/casting
demonstrated successive improvement and thus proved to
be effective treatments for dynamic equinus in the short and
long term for children with CP.
DOI: 10.1017/S0012162205001222
Accepted for publication 24th August 2004.

Acknowledgements
We thank the children and their families for their participation in
this study. We also thank the BTX-A Study Group personnel at each
investigative site who made significant contributions to the success
of this study: Mary Carter, Gerald F Harris, Sahar Hassani, and Kathy
Reiners (Chicago), Cecilia Concha and Kevin Cooney (Erie), Judith
Gooch, Bruce MacWilliams, and Diane Nicholson (Intermountain),
and George Gorton and Owen Kelly (Springfield). We also thank
our statisticians, David S Phillips and Gary Sexton, for contribution
to the protocol development and assistance with the statistical
analysis, respectively. This research was funded by an unrestricted
educational grant by Allergan, Inc.
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List of abbreviations
AFO Ankle–foot orthoses
BTX-A Botulinum toxin A
DFIC Dorsiflexion at initial contact
GMFCS Gross Motor Function Classification System
KE Knee extension
KF Knee flexion
PDFSt Peak dorsiflexion in stance
PDFSw Peak dorsiflexion in swing
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