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ISSN: 1751-8423 (print), 1751-8431 (electronic)
ORIGINAL ARTICLE
Abstract Keywords
Objective: To determine whether physiotherapy is more effective when applied in blocks or Cerebral palsy, en bloc, motor development,
continuously in children with cerebral palsy (CP). Methods: A prospective randomized cross-over physiotherapy, randomized clinical trial,
design study compared the effect of regular physiotherapy (baseline) with blocks of regular
physiotherapy alternating with no physiotherapy over one year. Thirty-nine institutionalized
children with CP and clinically similar syndromes (616 years old, Gross Motor Function History
Classification Scale IIIV) were included. During the first scholastic year, group A received
regular physiotherapy, group B blocks of physiotherapy and vice versa in the second year. The Received 26 January 2014
Gross Motor Function Measure 66 (GMFM-66) was the outcome measure. Results: Thirteen Revised 7 May 2014
children in each group completed the study. GMFM-66 improved (p50.05) over the study Accepted 7 May 2014
period in both groups in total; changes (p50.05) were seen only in dimension D (group B) and Published online 22 May 2014
E (both groups) during regular therapy. Conclusion: Physiotherapy may be more effective when
provided regularly rather than in blocks.
Authors Years Participants Age GMFCS Duration Intervention (PT sessions) Tests Results
Trahan and 2002 5 children Mean 45 6 months No groups four sessions/ After four and eight Improvement
Malouin 22.6 months week for four weeks weeks (GMFM 66)
eight weeks without
therapy
Tsorlakis et al. 2004 34 children 314 years 13 16 weeks Group A: basic two Before and after the Improvement
sessions/week Group B: intervention (GMFM
intervention five 66)
sessions/week
Shamir et al. 2012 10 children 1224 months 20 weeks Groups A and B Both At four weeks intervals Improvement
groups: four weeks (GMFM 66 and 88)
baseline one session/
week Group A: eight
weeks intensive four
sessions/week Cross
over for eight more
weeks
Mayo NE 1991 29 children 02 years 6 months 17 children one session/ After intervention (no Improvement
week one hour GMFM/other motor
(intensive) 12 children development tests)
one session/month one
hour (basic) Both groups
got a home program
Bower et al. 2001 56 children 312 years 35 18 months Six months baseline 12 At three-month intervals Equal
sessions/week Six (GMG 66)
months treatment five
sessions/week Six
months follow-up 12
sessions/week
Christiansen 2008 25 children 18 years 15 30 weeks Intermittent four sessions/ Before and after Equal
and Lange week for fuor weeks and intervention
six weeks without ther-
apy Continuous 12
sessions/week
development and avoiding contractures. It was deemed the co-authors who was not involved in the study during data
unethical to leave such children untreated. Thus, it was not acquisition. The parents agreed without knowing to which
possible to design a study that had an untreated group of group their child would be allocated.
children with CP, and so only treatment modalities could be Four physiotherapists assessed the children over the study
compared. Motor skills may improve with growth and period and were blinded to the physiotherapy regimen. These
increasing age, but it was impossible to identify sufficient therapists were trained in administering the GMFM-66 but
pairs of children with similar severity of CP for a matched did not work at the childrens institutions and did not know
pair study design. For these reasons, a crossover design was them beforehand or treat them at any point in the study.
chosen. Each child acted as his/her own control. All children with incomplete data were excluded from
A double-blinded study was not possible, because the statistical analyses, and the reasons for those children either
children, parents and treating physiotherapists would be aware stopping the study or with incomplete data were recorded.
of their physiotherapy schedule. The study, however, was The reasons for dropouts were impression of deterioration by
single-blinded since the physiotherapists who assessed the the parents (Group A: two and Group B: three children),
children were blinded to the physiotherapy regimen. As all change of institution (Group A: two and Group B: one child),
children already had regular physiotherapy (NDT, Bobath, change of therapy regimen, e.g. rehabilitation or surgery
Peto, Vojita and strength training) depending on each (Group A: two and Group B: one child) and incorrect
therapist and her/his training, this was taken as the baseline application of the study protocol (Group A: zero and Group
physiotherapy regimen, and the same regimen continued B: two children).
during the study. The content of each physiotherapy session
thus varied. However, this regimen was unchanged, and the
Participating children and therapists
same local therapist treated the same child during the study
period. Similarly, all other activities (sports, additional The children were recruited from 15 institutions in 10 cantons
therapies, etc.) continued unchanged over the study period. covering more than one-third of Switzerland as an outpatient
Two groups, A and B, were formed receiving the opposite setup would have been too difficult to organize for the
order of the therapy regimen. The order was randomized parents. The children were classified according to the Gross
before the baseline assessment by generating a random Motor Function Classification Scale (GMFCS) [911]. They
number in Excel (Microsoft Office Excel 2003) as a were assessed before entering the study (A1 and B1), after
discriminant (0.5). The randomization was done by one of year 1 (A2 and B2) and after year 2 at the completion of the
428 A.-L. Brunner et al. Dev Neurorehabil, 2014; 17(6): 426432
study (A3 and B3). The assessment consisted of a Gross Outcome measures
Motor Function Measure 66 (GMFM-66) assessment with
Primary outcome. The GMFM-66 test was used. It is a
five dimensions. Inclusion criteria were age 616 years,
clinical tool designed to assess gross motor function in
GMFCS IIIV and a diagnosis of CP (any type) or a syndrome
children with CP as well as to detect changes. There are five
with very similar symptoms. The children were aged 10.32
dimensions: A lying and rolling, B sitting, C crawling
years (mean, SD 2.91). Exclusion criteria were planned
and kneeling, D standing, E walking, running and jump-
surgery or changes in the rehabilitation programme
ing with numbers from 0 to 3 [9, 1214]. The GMFM-66 has
(e.g. botulinum toxin injections, casting and change of
the advantage over the original GMFM-88 of being less time
physiotherapy regimen). The study was discontinued in case
consuming and tiring out for the patients, and is thus usually
of severe illness, any prolonged hospitalization or if children
used (Table I). The items test a wide spectrum of activities in
or their carers wished to withdrew from the study. Children
lying, rolling, walking, running and jumping [15, 16].
who withdrew were excluded from statistical analysis as they
could not be followed up. The study (DRKS00004284) Data analysis
received ethical approval by all involved agencies, and parents
of the participating children gave written, informed consent. For the evaluation of the GMFM-66 scores the Gross Motor
Ability Estimator (GMAE; Can Child Center of Child
Intervention Disability Research, Ontario, 2000, Canada) software was
applied [17]. This GMAE data were used for further statistical
The children received their physiotherapy from the same analysis. For data comparison, SPSS Ver.19, 2010 (IBM
physiotherapist during the study period. Group A started with Software, Armonk, NY) was used.
regular physiotherapy and changed to blocks in the second A simple t-test was used for age distribution and a Mann
year, and Group B started with blocks of physiotherapy and Whitney U test for GMFCS level and GMFM-66 distribution.
changed to regular physiotherapy in the second year. As all For ordinal data (GMFM-66) a Friedman test for repeated
children were recruited from institutions, the physiotherapy measurements was applied and in case of significance a sign
regimens were applied over one scholastic year each running test as a post hoc test was added, which allowed for the
from mid-August to end of June, and the study ran over two differences in either study year. Effect size was evaluated with
years. Cohens d test, and confidence intervals were calculated. The
During the other year, when blocks of physiotherapy were data of groups A and B were analysed separately. The
not received, regular physiotherapy, as the baseline, con- dependent variables were the differences of the GMFM-66
tinued. Regular physiotherapy was administered one or two scores between the two groups. The independent variable was
times per week (44 or 88 sessions per year) and was a block or regular physiotherapy. Confounding variables known
continuation of the childrens standard pre-study regimen. in advance were additional therapies in case of improvement
The blocks of physiotherapy were double the frequency of the or deterioration of the children. Both these situations might
regular physiotherapy regimen (two or four times per week, have been a reason for changing the protocol as it would have
44 or 88 sessions per year) given over a quarter of the been unethical to withhold additional therapy, such as surgery,
scholastic year, alternating with the same period of no which could improve the childs condition.
physiotherapy.
Half of the children receiving blocks of physiotherapy Results
started with a break and the other half started with physio-
Flow of participants through the study
therapy. This difference was not randomized and was
arranged to avoid additional costs and to keep the work Initially, 39 children were included. Thirteen children (33%)
load for the therapists even during the study (Figure 1). did not complete the study, and the reasons for
Statistically evaluated (study completed) Statistically not evaluated (study not completed)
Total Group A Group B Total Group A Group B
Total number of children 26 13 13 13 6 7
Female (f) 10 5 5 7 3 4
Male (m) 16 8 8 6 4 2
Type of cerebral palsy
Bilateral spastic 3 3
Bilateral spastic predominantly legs 2 3
Unilateral spastic 3 3
Bilateral ataxic 1 2
Bilateral dystonic 2 2
Bilateral syndromic (diagnosis unclear, 1
poor motor control)
Trisomia 22 1 0
Additional Treatments
Hippotherapy 2 0
Occupational therapy 5 3
Hippotherapy and occupational therapy 0 1
Ankle foot orthosis/demi ankle foot orthosis 8 10
Spinal brace 0 1
Additional informations
M. perthes (7 years) 1 0
Hip reconstruction (4 years) 0 1
Botulinum toxin to calf muscles/hamstrings 1 3
GMFCS II 15 8 7 4 3 1
GMFCS III 4 2 2 4 0 4
GMFCS IV 7 3 4 5 4 1
Mean GMFCS II and III + IV 6.5 6.5
MannWhitney U test (p) 1.0
Age 69 (years) 12 5 7 6 3 3
Age 1013 (years) 8 4 4 6 3 3
Age 1416 (years) 6 4 2 1 1 0
Minimum 8 6
Maximum 15 16
Arithmetical mean 11.462 9.692
SD 2.85 2.81
t-test (p) 0.118
GMFM start (mean) 65.76 59.97
Mann-Whitney U test (p) 0.418
GMFCS: Gross Motor function Classification System and GMFM: Gross Motor Function Measurement.
discontinuation were as follows: clinical deterioration Comparing the two physiotherapy regimens, there
(five parents thought their child was deteriorating), change were only significant effects in regular physiotherapy in
of institution (three children), incomplete study protocol dimensions D and E of GMFM-66. Improvements in
(two children), surgery (two children) and significant change GMFM-66 scores were seen only after periods of regular
in physiotherapy regimen (one child). The withdrawals were therapy (Figure 3). On an average, Group A improved by 4.8
equally distributed considering the type of therapy setting: points on dimension E after regular therapy (p50.05) and
Group A first year: three, second year: three, Group B first showed no significant change after blocks of physiotherapy.
year: four and second year: three children. The number of On an average, Group B improved by 2.1 points on dimension
discontinuations was similar in both groups (six regular and D and by 2.2 points on dimension E after regular therapy
seven blocks of physiotherapy). The results for the remaining (p50.05), again with no significant changes after blocked
26 children, who completed the study, were analysed therapy.
statistically and are displayed in Table II and Figure 2.
The two groups did not differ in age (p 0.118), GMFCS Discussion
level (p 1.0) or GMFM-66 values at the initiation of the This prospective study compared regular physiotherapy
study (p 0.418). (NDT, Bobath, Peto, Vojita and strength training) with
blocks of physiotherapy, each lasting a year. The number
GMFM-66 values
of physiotherapy sessions was the same in both parts of
The GMFM-66 values for both groups improved over the two the study. The GMFM-66 parameters improved over the
years in both groups (Group A by assessment A1A3 whole study period in both groups. It is, however, not
(p 0.022, 95% CI: 2.694.31, d 0.27) and Group B by possible to ascribe this improvement to physiotherapy alone
B1B3 (p 0.039, 95% CI: 2.033.21, d 0.15). The as growth and developmental progress may also contribute.
dimensions A to C did not change statistically. On further analysis, only regular physiotherapy was
430 A.-L. Brunner et al. Dev Neurorehabil, 2014; 17(6): 426432
0.5) for the 26 children who finished the study. Nevertheless, Conclusion
differences were statistically significant. Another possible
This study has shown that regular physiotherapy was more
weakness was a lack of untreated control children,
effective than blocks of physiotherapy based on GMFM-66
and it is not possible to conclude on the efficacy of
outcomes for children in GMFCS levels IIIV.
physiotherapy in general. Physiotherapy is routine in
Switzerland for every baby at risk for CP, and it would be
Acknowledgements
impossible, and unethical, to have untreated controls.
Another weakness is possibly incomplete information about We thank the participating institutions for their cooperation.
additional therapies. Not having a long-term follow-up to
show an effect on general function of daily living and
life quality is a drawback. On the other hand, so many
Declaration of interest
factors influence the individual course of a patient that it is
impossible to follow the effect of a single factor at long-term. There were no conflicts of interest. We thank the Swiss
Two years seem to be a good compromise but as the outcome Foundation Cerebral for financial support
differences are low, a long-term prognosis can only be
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