日小整会誌（J Jpn Ped Orthop Ass）23（2）：416 426, 2014.
第 24 回日本小児整形外科学会学術集会 JPOA Asian Fellows

Is There Any Beneﬁt to Using Botulinum Toxin Type A
in the Treatment of Lower Limb Spasticity in Younger AgeChildren with Cerebral Palsy?
Ashok N Johari M.S., M.Ch.Orth. 1
Sidharth Vemuri BMed Sc 1, 2
3, 4, 5, 6
Roslyn N Boyd PhD（Human Bioscience）, MSc（Physiotherapy）, PDip（Biomech）
1
Ratna A Johari M.S, Dip（SICOT）

1

Children s Orthopaedic Centre, Mumbai, India

2

Faculty of Medicine, Dentistry and Health Sciences,The University of Melbourne, Australia
3

Department of Orthopaedics, Royal Children s Hospital, Melbourne, Australia

4

Department of Rehabilitation, Critical Care and Neurosciences Theme, Murdoch Children s
Research Institute, Melbourne, Australia
5

School of Physiotherapy, La Trobe University, Australia
6

Brain Research Institute, Melbourne, Australia

Abstract：This prospective comparative clinical trial examined the eﬀectiveness of Botulinum
toxin type A（BoNT-A）treatment for lower limb spasticity in younger age（＜ 3 years）children
compared with older-age children（＞ 3 years）
with cerebral palsy（CP）for improvements in spasticity, function, health-related quality of life
（HRQOL）, and parent perception of outcomes.
Method： Twenty-seven children with CP, ranging from 11 months to 8 years and 6 months,
were grouped according to age and treatment- one younger age group treated with BoNT-A andphysiotherapy（ ＝9, mean age＝2＋ 3 years SD＝ 4 months）, a second younger age group treated, and a third group of older
with physiotherapy alone（ ＝9, mean age＝ 2＋ 8 years SD＝7 months）
aged children（＞ 3 years）
treated with BoNT-A and physiotherapy（ ＝9, mean age＝ 4＋ 5 years,
SD＝15.1 months）. Outcomes were evaluated for - spasticity using the Modiﬁed Tardieu Scale,activity limitation using the Gross Motor Function Measure（GMFM）, a condition speciﬁc Pediatric Quality of Life InventoryTM and a parental questionnaire of perceived satisfaction with theirchild s performance. These measures were administered once prior to injection（baseline）, thenat one, three and six months post-injection.
Results： There was a signiﬁcant reduction in spasticity for the younger age children treatedwith BoNT-A compared to controls retained at 6 month follow up. However, this was not accompanied by greater improvements in gross motor function. For the primary outcome there were

Key words：cerebral palsy, spasticity, botulinum toxin type A, pre-school infants, gross motor function, health-related
quality of life, controlled clinical trial
Corresponding author：Dr. Ashok N Johari, Children s Orthopaedic Centre, Bobby Apartment, 2nd Floor,
Plot No. 295, TPS No. 3, L.J. Road, Mahim（West）,Mumbai, India-400 016.
Email: drashokjohari@hotmail.com
Phone: ＋91 22 24365050/＋91 22 24374040 Fax: ＋ 91 22 24445599
日本小児整形外科学会雑誌 Vol. 23, No. 2, 2014

Is There Any Benefit to Using Botulinum Toxin Type A in the Treatment of Lower Limb Spasticity in Younger Age Children with Cerebral Palsy

signiﬁcant gains in gross motor function（GMFM-66）for the younger age treated children compared to older children at one month follow up（diﬀerence in means＝7.27, 95％CI 0.05,14.49, ＝0.019）and three months（diﬀerence in means＝7.86, 95％CI 1.04,14.68, ＝0.012）
post-injection. A relationship between younger age BoNT-A treatment and improved parental perceptions was identiﬁed, attaining signiﬁcance at three（ ＝0.038）and six months（ ＝0.029）
post-injection.
Conclusions： This controlled trial suggests that there were additional benefits in treating
younger age patients with intramuscular BoNT-A. Injections were safe, well tolerated and provided additional functional beneﬁts and improvements in health related quality of life, when spasticity was treated in this younger age group compared to older children with CP.
Clinical Signiﬁcance： Botulinum toxin A may provide a useful window of opportunity to enhance functional gains, improve HRQOL and achieve functional independence when provided at
infant age.

Introduction

spasticity. This may decrease the efficacy of
BoNT-A as there is a direct correlation between

Botulinum toxin type A（BoNT-A）
has gained

the magnitude of response to treatment and thewider appreciation as a focal treatment of spas-

dynamic component of spasticity of the gastro-

ticity in children with cerebral palsy（CP）, sincesoleus10）.

the early 1990 s. There is good evidence that

This study was performed at the Children s

intramuscular injections of BoNT-A may inhibit

Orthopaedic Centre in Mumbai, India, where

the pre-synaptic release of acetylcholine, thechildren were treated with BoNT-A at younger

neurotransmitter responsible for muscle con-ages（from 11 months）since 1999. Subjective

traction, resulting in a reduction in spasticity

findings suggested improvements in gross mo-and it has been proposed that this may provide

tor function along with a reduction in spasticity.

an opportunity to facilitate eﬀective motor train-

However, beneﬁts of treating children with CP

ing. The duration of eﬀectiveness of BoNT-A ap-

at a younger age with BoNT-A have not yet

pears to be limited to three-to-six months

been quantiﬁed.

though repeated injections are possible without

Methods

serious adverse eﬀects4）. The question concerning the optimum age for the best efficacy forThis open-label study, combines data collected

use of BoNT-A in children with CP remains un-from a prospective six-month follow-up of chil-resolved.

dren with CP（younger and older groups）
and a

It is thought that younger children will bene-

matched group of retrospectively studied chil-

fit more from BoNT-A combined with physio-

dren from the medical chart review of younger

therapy than older children and that this com-age children with CP who did not receive

bined treatment may reduce or delay the need

BoNT-A for the treatment of lower limb spastic-

for surgery in ambulatory children. Treating

ity.

children with CP with BoNT-A, at younger

Participantsages, reflects the hypothesis that as the child

The list of inclusion and exclusion criteria are

matures, the incidence of muscle shortening in-summarised in Table 1a and 1b. Two sets ofcreases, reducing the dynamic component ofchildren were studied：日本小児整形外科学会雑誌 Vol. 23, No. 2, 2014

Is There Any Benefit to Using Botulinum Toxin Type A in the Treatment of Lower Limb Spasticity in Younger Age Children with Cerebral Palsy

Table 1a：- List of inclusion criteria.

However, their parents/caregivers decided

Inclusion Criteria

not to opt for this treatment option and・Diagnosis of CP with spastic motor type impairing the lower limbs, made by two clinical professionals（orthopaedic surgeon and physiotherapist）.

continued with physiotherapy alone.

・Attended physiotherapy for at least threemonths prior to the recommendation of BoNT-A
injection.

Once informed consent was obtained, themedical records of the retrospective patientswere accessed. The prospective patients completed a proforma and an appointment for base-Table 1b：- List of exclusion criteria.

line evaluation was made prior to the scheduled

Exclusion Criteria

BoNT-A injection.

・Presence of severe ﬁxed contractures.

Study Protocol This study incorporated the・Generalised athetosis and/or dystonia

domains speciﬁed in the International Classiﬁca-

・Previous BoNT-A injection（s）to the upper extremity, trunk or lower limb.

tion of Functioning, Disability and Health13）,

・Previous surgery.
・Very low cognition confirmed through clinicalobservation and anecdotal information from parents, as this would impact on the ability to co operate with physiotherapy.
Table 1c：- Patient groups.
Patient group

Description

Younger age

Prospectively studied children
with CP, younger than 3 years ofage, who received BoNT-A treatment for their spastic lower limb（s）.

Older age

Prospectively studied children
with CP, older than 3 years of age,
who received BoNT-A treatment
for their spastic lower limb（s）.

Physiotherapy Retrospectively studied children
onlywith CP, younger than 3 years ofage, who were recommended but
did not receive BoNT-A treatment
for their spastic lower limb（s）.

namely body structure（muscle impairment including spasticity）, activity limitation（function）
and Health-Related Quality of Life
（HRQOL）.
Prospectively studied children were evaluatedat baseline（pre-injection）, and post-injection atone, three and six month intervals. Evaluations
were standardised and conducted by experienced physiotherapists with at least three years
experience working in the ﬁeld. Each evaluationconsisted of measures of impairment of the lower limb and functional abilities. At six months,
the parental perception of the child s functional
status over the study period was evaluated using a parental questionnaire.
These children were separated into twogroups based on their age when receiving the
BoNT-A injection to those younger than 3 years
and those older than 3 years of age. Medical re-（i）Prospective participants were younger

cords of the retrospective group of children

than 10 years of age at the commencementwith CP younger than 3 years of age were ex-of clinical treatment, which involved theamined. Data were collected over two time peri-use of BoNT-A. These children were thenods- baseline and at six months, and included

grouped into those younger than 3 years

measures of impairment and functional abilities.

and those older than 3 years at ﬁrst BoNT-All groups were matched along similar parame-

A injection.

ters The three groups are summarised in Table（ii）The retrospective group of children with1c.

CP were younger than 3 years of age

Outcome Measureswhen recommended for BoNT-A injection.

At the level of body structure, the Modified

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Is There Any Benefit to Using Botulinum Toxin Type A in the Treatment of Lower Limb Spasticity in Younger Age Children with Cerebral Palsy

Tardieu Scale（MTS）5）was used to assesses dy-

the gastro-soleus and 1-2 U/kg of body weightnamic spasticity by measuring the catch range

for other lower limb muscle groups. Correct

5）of motion（R1）at fast velocity（Tardieu V3） . Ac12）

ceptable inter-rater reliability and validity

6）

needle placement was confirmed by observing
needle motion during movement of the joint
above or below the targeted muscle9）.

have been established.
At the level of activity limitation, the Gross

Both the retrospective and prospective

Motor Function Measure-66（GMFM-66）, a Ra-groups continued with their physiotherapy re-sch analysed version specifically for children

gime, which was standardised based on goodwith CP, was used. The GMFM-66 contains se-clinical practice. Each physiotherapy session

lected items of the GMFM-88 to improve scal-consisted of passive stretching, followed by2）

ability and is a valid and reliable measure of18）

strength training and guided functional move-the achievement of motor activities . Healthments. Each child received at least one physio-

Related Quality of Life was measured using thetherapy session per day for 30‑45 minutes, 6

toddler and young child versions of the CP mod-days per week, for 24 weeks duration post-injec-

ule of the Pediatric Quality of Life Invento-tion/recommendation. The timing of outcomery

TM 20）（PedsQL

TM, Varni et al. 2006）The par-ent-proxy report of the toddler version of themeasures for the three sample groups is illustrated in Figure 1.

PedsQL CP module was administered as a ques-

Analysistionnaire that considers daily activities, move-

The absolute amount of change was com-ment and balance, pain and hurt, fatigue andpared from baseline to each follow up interval ineating activities. The infant version additionallythe total scores of the Tardieu R1, the GMFM-

considers school activities, and parent report of66, the PedsQLTM and parental questionnaire forthe child s communication skills. Varni et al20）.

the younger and older age groups. The abso-

reported strong reliability, validity and sensitivi-lute amount of change from baseline to follow

TMty of the PedsQL

in CP.

up at six months was determined for the total

A parental questionnaire was utilised to gath-R1 and GMFM-66 score for the physiotherapy

er the parents perception of change in theiralone group. The amount of change in spastici-

child s abilities following BoNT-A treatment.

ty（Tardieu R1）, function（GMFM-66 score）,

This was adapted from a questionnaire devel-

HRQOL（PedsQLTM）and parental questionnaire

oped for a previous randomised controlled clini-

scaled scores was averaged within each sample

21）

cal trial by Wallen et al. , as there were no oth-group and compared between groups.

er relevant questionnaires that considered theAs samples were independent and of small

functional movements and transitions of chil-sizes, nonparametric tests were used to conduct

dren with CP as young as 1 year of age.

statistical analysis, using Data Analysis Plus in
Microsoft Excel（XP edition）. The Wilcoxon

Intervention
Intramuscular BoNT-A injections were ad-

Rank Sum test was used to determine（a）any

ministered, under mask anaesthesia, by a seniordiﬀerences in impairment and function between

paediatric orthopaedic surgeon whose practicethe younger age and physiotherapy only groups,

involves specifying BoNT-A doses at 1-3 U/kg

and（b）
diﬀerence in the amount of change in im-Ⓡof body weight of BOTOX （Allergan, USA）for

pairment, and HRQOL between the treated日本小児整形外科学会雑誌 Vol. 23, No. 2, 2014

Is There Any Benefit to Using Botulinum Toxin Type A in the Treatment of Lower Limb Spasticity in Younger Age Children with Cerebral Palsy

Key：MTS ＝ Modiﬁed Tardieu scale（Boyd and Graham 1999）
BoNT-A ＝ Botulinum toxin A injections
GMFM ＝ Gross Motor Function Measure
PedsQLTM＝ Pediatric Quality of Life Inventory（Cerebral Palsy module）
Fig. 1．Timing of outcome measures

younger and older age children. These compari-into three patient groups（nine in each group）.

sons were also used to test the hypothesis that

Participant demographics are included in Table

younger age children with CP have greater

2. The dosages of BoNT-A per muscle groupchanges in function compared to older children

per limb and per child by sample group are

following treatment.

summarised in Table 3.

Confidence intervals for differences between

The results of changes in Spasticity（R1）,

two means were determined for the domains ofGross Motor Function, Health Related Quality of

impairment and function in younger age andlife and parent reporting of changes in function

physiotherapy only groups and the older age

between baseline and each follow up intervalgroup, and HRQOL in younger and older age

are summarised in Table 4.

groups. Signiﬁcance was set at a p-value of lessthan 0.05.
Results

Discussion
The primary results of this comparative study
demonstrated a reduction in spasticity in theParticipant demographics

BoNT-A group when combined with physiother-

A total of 27 children with CP were enteredapy, compared to physiotherapy alone. At six

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Is There Any Benefit to Using Botulinum Toxin Type A in the Treatment of Lower Limb Spasticity in Younger Age Children with Cerebral Palsy

Table 2：- Participant demographics
Younger age group

Older age group

Physiotherapy only

＝9

＝9

＝9

M＝ 5 F＝ 4

M＝ 5 F＝ 4

M＝ 5 F＝ 4

Sample size
Male/Female Ratio
Mean age（years）

Distribution of spastic motor type

4＋ 6
2＋ 1
2＋ 3
＋ 4.23＋3
SD＝0
SD＝1
SD＝0＋ 7.33
＋8
＋9
＋6
＋6
（range 1 to 2 ） （range 3 to 7 ）（range 0＋ 11 to 2＋ 9）
7： diplegia
2： hemiplegia

8： diplegia
1： quadriplegia

6： diplegia
2： quadriplegia
1： hemiplegia

Mean baseline R2 of hamstrings（degrees ofextension, Popliteal angle）

152.5
124.38142.94
SD＝ 30.11
SD＝ 31.30
SD＝ 33.54（range 90 to 180） （range 85 to 180） （range 90 to 180）

Mean baseline R2 of gastro-soleus（degrees of
dorsiﬂexion, knee extended）

8.25
SD＝ 6.34（range 0 to 15）

6.07
SD＝ 5.61（range -5 to 15）

9.80
SD＝ 5.40（range 0 to 15）

Number of children with CP who received
concomitant casting in addition to BoNT-A
treatment

9

9

N/A

Right only： 1
Left only： 1
Bilateral： 7

Right only： 2
Left only： 0
Bilateral： 7

N/A

Limbs casted

Mean duration of casting（weeks）2
2＋ 1
SD＝ 2.60
SD＝ 2.71（range 1＋ 5 to 2＋ 6） （range 1＋ 4 to 2＋ 4）

Mean hours of physiotherapy received per
week

7.5
7.0
7.5
SD＝ 3.18
SD＝ 3.27
SD＝ 3.18（range 4.5 to 13.5） （range 4.5 to 13.5） （range 4.5 to 13.5）

N/A

Number of children with CP taking anti-spasticity medication

5

5

5

Muscle groups targeted with spasticity treatment

16： Gastro-soleus
12： Hamstrings
3： Gracilis
7： Adductors
1： Rectus Femoris

14： Gastro-soleus
16： Hamstrings
6： Gracilis

12： Gastro-soleus
15： Hamstrings
5： Gracilis
2： Adductors

Level I： 3
Level II： 4
Level III： 1
Level IV： 1
Level V： 0

Level I： 2
Level II： 3
Level III： 1
Level IV： 2
Level V： 1

Level I： 2
Level II： 0
Level III： 2
Level IV： 3
Level V： 2

Number of children in each GMFCS levelmonths, this effect was greater in the ham-In the gastro-soleus muscle, at six months,

strings, in the younger age group, compared tothere was no greater reduction in spasticity forcontrols. At one month post-injection, the older

the younger age group treated with BoNT-A

children had a greater reduction in spasticity

compared to physiotherapy alone. However, thecompared to younger treated children. However,reduction in spasticity in the physiotherapy only

this difference between groups was not sus-

treated group is thought to have occurred grad-

tained at three and six months.

ually over six months, while the BoNT-A treat日本小児整形外科学会雑誌 Vol. 23, No. 2, 2014

Is There Any Benefit to Using Botulinum Toxin Type A in the Treatment of Lower Limb Spasticity in Younger Age Children with Cerebral Palsy

Older age group

Younger age group

Table 3：- BoNT-A total dose and dosage ratio per muscle group per limb and per
kilogram of body weight for each subject.
Subject

Weight
（kg）

1
2

10.0
10.0

3

8.0

4

10.0

5

7.0

6

10.0

7

12.0

8

9.5

9

10.0

Total dose Dosage ratio per muscle Total dose per bodyadministered group（U/kg）
per limb weight（U/kg of bw）（units）60
3.0/ gastro-soleus
6100
2.0/ gastro-soleus
102.0/ hamstrings
1.0/ adductors
100
3.0 gastro-soleus
12.5
2.0/ hamstrings
100
3.0/ gastro-soleus
102.0/ hamstrings
1.0/ adductors
1003.0/ gastro-soleus
14.3
2.0/ hamstrings
1.0/ adductors
1.0/ gracilis
13.0
1303.0/ gastro-soleus
2.0/ hamstrings
1.0/ gracilis
1.0/ adductors
1.0/ rectus femoris
60
3.0/ gastro-soleus
5.0
2.0/ hamstrings
95
3.0/ gastro-soleus
10.0
2.0/ hamstrings
30
3.0/ gastro-soleus
3.0

＝

＝

1

10.0

100

2

12.0

120

3

20.0

140

4

14.3

100

5

10.0

100

6

12.0

72

7
8

20.0
15.0

120
90

9

10.0

100

＝

＝

＝
2.0/ gastro-soleus
2.0/ hamstrings
1.0/ gracilis
3.0/ gastro-soleus
2.0/ hamstrings
1.5/ hamstrings
1.0/ gracilis
1.0/ adductors
3.0/ gastro-soleus
2.0/ hamstrings
3.0/ gastro-soleus
2.0/ hamstrings
2.0/ hamstrings
1.0/ gracilis
3.0/ gastro-soleus
2.0/ hamstrings
1.0/ gastro-soleus
3.0/ gastro-soleus
2.0/ hamstrings

Footnote：- Mean dosage ratio per muscle group（U/kg）per limb
Younger age group Older age group
Gastro-soleus
2.89, SD＝ 0.33
2.57, SD＝ 0.79
Hamstring
2.0, SD＝ 0.0
1.94, SD＝ 0.18

日本小児整形外科学会雑誌 Vol. 23, No. 2, 2014

10.0

10.0
7.0

7.0
10.0
6.0
6.0
6.0
10.0

＝

＋ 3.9（SD＝5.25）
0.2（−3.58,3.98）＋ 4.1
16（SD＝4.17）
13＋ 5.28（SD＝5.76）
7.27（0.05,14.49）＋ 12.55
9（SD＝7.39）

9

Physiotherapy only

Younger age

Older age

Physiotherapy only

Younger age

Older age＋ 8.95（SD＝11.98）
3.79（−8.97,16.55）＋ 12.749（SD＝11.45）

99＋ 3.87（SD＝8.63）
6.01（−7.42,19.44）＋ 9.889（SD＝15.15）

Physiotherapy only 9Younger age

Older age

Physiotherapy only 16

Younger age

Older age

Physiotherapy only 16

Younger age

Older age

＝0.35

＝0.40

＝0.019＝0.90＋ 10.25（SD＝10.53）
4.78（1.32,28.24）＋ 25.03（SD＝13.96）＋ 7.09（SD＝7.67）
9.22（−4.99,23.43）＋ 16.31（SD＝16.78）＋ 4.24（SD＝4.46）
7.86（1.04,14.68）＋ 12.06（SD＝7.65）＝0.038＝0.27＝0.012＋ 8.59（SD＝14.77）
23.38（4.59,42.17）＋ 31.97（SD＝19.42）

9.68（SD＝7.75）
11.00（−2.91,24.91）
20.68（SD＝16.32）＋ 9.29（SD＝9.76）
7.1（−5.12,19.32）＋ 16.39（SD＝12.52）＋ 8.657.74（SD＝9.26） （−4.25,19.73）＝0.024＝0.10＝0.086

＝0.10

＝0.37

＝0.26

＋ 4.3
3.0
（SD＝5.14）（−1.99,7.99）＋ 1.3（SD＝7.42）−2.0
3.3（SD＝13.76） （−5.02,11.62）＋ 3.9（SD＝5.25）
2.0（−2.55,6.55）＋ 1.9（SD＝6.29）＝0.48

Baseline-Six months
Mean change Diﬀerence in‑value（SD）
means（95％CI）＋ 24.38（SD＝30.65）
1.04
＝0.78
（−20.94,23.02）＋ 25.42（SD＝ 22.2）＋ 5.9419.48＝0.037（SD＝26.35） （−0.74,39.7）

Baseline-Three months
Mean change Diﬀerence in‑value（SD）means（95％CI）＋ 28.13（SD＝28.22）
0.21
＝0.82
（−19.03,19.45）＋ 27.92（SD＝17.9）

Key:R1 = Catch range of motion at fast velocity
GMFM-66 = Gross Motor Function Measure (66-item)
PedsQLTM = Pediatric Quality of Life Disability Inventory (Cerebral Palsy module)

Parental
Questionnaire

PedsQLTM

GMFM-66

R1 of Gastrosoleus

R1 of Hamstrings

Sample group

Baseline-One month
Mean change Diﬀerence in‑value（SD）means（95％CI）＋ 36.8816（SD＝25.36）
19.38＝0.046（3.67,35.09）＋ 17.512（SD＝11.38）

Table 4：- Results of changes in Spasticity（R1）, Gross Motor Function, Health Related Quality of life and parent report of changes infunction between baseline and each follow up interval.

Is There Any Benefit to Using Botulinum Toxin Type A in the Treatment of Lower Limb Spasticity in Younger Age Children with Cerebral Palsy

ed group experienced the greatest reduction inafter three years of age experienced a greater

spasticity at one-month, and this eﬀect declined

reduction in spasticity with the ankle joint be-by six months. When comparing the groups

coming closer to neutral or in dorsiﬂexion range

treated with BoNT-A at younger and older

at one month, but this was not sustained atages, it was determined that children injected

three and six months post-injection when it re-

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Is There Any Benefit to Using Botulinum Toxin Type A in the Treatment of Lower Limb Spasticity in Younger Age Children with Cerebral Palsy

these issues by using the GMFM-66.

turned to an equinus posture.
The results suggest that BoNT-A was useful,

There were no differences between groups

though its eﬀect was limited in duration, in re-for improvements in the HRQOL according toducing dynamic spasticity. There were no diﬀer-

the age of ﬁrst injection. Varni et al.20）suggest-ences in amount of reduction in spasticity ac-

ed that disease-speciﬁc symptoms tested in thecording to age at initial injection. This partly

CP module of the PedsQLTM may be indicators

supports the view that the eﬀect on muscles isof HRQOL. They reported a signiﬁcant correla-

not limited by the patient s age9）16）. However, ittion between diﬃculties in gross motor function

does not provide strong evidence supporting

and lower HRQOL. However, in the present

this contention, as the age groups consideredstudy, the younger age group had signiﬁcantly

16）
14）

.

greater improvements in gross motor function

The younger age group had greater improve-when compared to the older age group but didments in gross motor function compared to old-

not demonstrate respective gains in HRQOL us-

er children at one and three months post-injec-

ing the PedsQL‒CP module. To date there aretion but this was not sustained at six months.

no studies that have reported changes inFurthermore, there were no additional beneﬁts

HRQOL due to BoNT-A nor reports of condition

for gross motor function, at six months, for the

specific measures of HRQOL that have mea-

younger group compared to the physiotherapy

sured changes in HRQOL due to spasticity man-alone group. These ﬁndings conﬁrm the results

agement.

are younger than in those previous studiesof another study in children with CP where sin-

In contrast to the HRQOL outcomes, parents

gle or two level injections did not result in func-

reported there were greater improvements intional gains at six months compared to therapy

their perception of their child s transitional

17）

alone . However, in this study, there is a new

movements, for the younger age group com-finding related to the enhanced outcome forpared to the older age children. These results,

younger age children with BoNT-A at one andhowever, may be biased by the lack of blinding

three months. The reduction in spasticity en-of the parents to their child s treatment.

abled opportunities for enhanced motor out-

It is important to acknowledge the inﬂuencecomes when combined with a comprehensiveof parental expectations prior to commencing

physiotherapy program.

treatment when reporting the results of parent

1）7）

and meta-analyses in-perceptions, in regard to clinical treatment. Set-

vestigating gross motor function outcomes inting realistic goals with parents prior to treat-

response to BoNT-A with or without physio-

ment, may be important, in order to ascertain

therapy have conﬂicting ﬁndings with some re-their level of expectations and inform them of

Systematic reviews

15）
11）

while others re-

the potential eﬀects that might be achieved. In

Some studies suggest thedoing this, more accurate data related throughporting improved outcomes
port no diﬀerence.

17）
1）

GMFM-88 may not be sensitive to changes due

proxy reports, may be collected.

to BoNT-A treatment as the effect of BoNT-A

Quantiﬁcation of severity and the distribution

may be more on quality of movement or align-of lower limb spasticity in children with cere-

ment of the task compared to attainment of thebral palsy who were younger than three years

8）task . This current study overcame some of
日本小児整形外科学会雑誌 Vol. 23, No. 2, 2014of age presented some methodological challeng-Is There Any Benefit to Using Botulinum Toxin Type A in the Treatment of Lower Limb Spasticity in Younger Age Children with Cerebral Palsy

es. The inclusion criteria, as far as possible, ad-achieved rather than how much change in spas-

dressed certain confounds, by having two inde-ticity had actually occurred. The approach ad-pendent confirmations of the diagnosis of CP

opted in the current study focussed on change

and the dosage and theoretical construct of thefrom a stable baseline. Inter-rater variability

physiotherapy was standardised. However,was minimised by having the child assessed bythere were limitations.

the same physiotherapist.

The exclusion criteria sought to ensure that
initial BoNT-A treatment of spasticity was theConclusion

main focus of the study by excluding other

There are beneﬁts to using BoNT-A in young-movement disorders（ using Sanger s defini-er age children with CP to reduce spasticity and19）

tions ）, severe ﬁxed contractures and previous

improve gross motor function. Intramuscular

BoNT-A injections. Importantly, some children

BoNT-A injections combined with a stan-with CP, included in this study, demonstrated

dardised, intensive physiotherapy regime great-some mild localised dystonia and mild to moder-ly improves gross motor function at one andate ﬁxed muscle contractures but dynamic spas-

three months follow up compared to similarticity appeared to be the main contributor totreatment in older aged children. It also reduces

their clinical presentation.

hamstring spasticity at six months compared toChildren in the present study received a sub-physiotherapy alone.

stantial duration and intensity of physiotherapy,

In this prospective study, the groups of older

as compared with many western programmes.

and younger children with CP were matched

Participants had no major cognitive difficulties

for key demographics and interventions wereas these would impact on compliance with phys-

carefully controlled for intensity and duration

iotherapy management, potentially confounding

between groups. This study provides somethe impact of BoNT-A on the development of

new data with promising ﬁndings that needs togross motor function.

be replicated in a larger clinical trial.

The brevity of the recruitment time period
meant that the number of eligible children wasrestricted and this small sample thoughmatched on some key variables（age, gender）
may lack statistical power. There may be a limitation in the potential reliability of some outcomes measures（spasticity and gross motor
function）
in younger age children due to compliance.
In the MTS, absolute changes in R1 were considered instead of proportional change, the difference between R1 and the muscle length atslow velocity（R2）. Blair et al.3）stated that the
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