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Summary General Discussion and Conclusions

VIEWS: 12 PAGES: 12

									Summary, General Discussion
and Conclusions




                   Leo A. van Vlimmeren
                                            Chapter 8
          Department of Physical Therapy,
             Bernhoven Hospital Veghel,
                         The Netherlands
Summary

In Chapter 1, a brief introduction is presented on the changed recommendations on prevention
of Sudden Infant Death Syndrome (back sleeping in young children), increasing prevalence of
positional preference and deformational plagiocephaly (DP), changes in motor development,
accepted interventions, as well as the implications for parents and its clinical relevance.

Since there is a great necessity for a systematic management of asymmetry in infancy, we
highlighted in Chapter 2 the different aspects of asymmetry in infancy, based on best evidence
in current literature (nomenclature, incidence, prevalence, associated variables, co-morbidity,
natural course and differential diagnostic strategies). Asymmetry in infancy is a diagnosis with a
large spectrum of features and of a multifactor aetiology. There is no consensus in definitions,
nomenclature and classifications. Data regarding the natural course are scarce. We designed a
diagnostic flow chart based on best evidence in literature. Diagnostic strategies in case of
asymmetry in infancy primarily focus on the presentation of shape, posture and movements, and
generalized or localized disorders/ diseases.

In Chapter 3, we evaluated the different therapeutic aspects of the most occurring asymmetries
in infancy: congenital muscular torticollis, positional torticollis and plagiocephaly, based on best
evidence in current literature. No randomised clinical trials have been reported concerning
therapeutic strategies while non-controlled studies hold different views towards management
on congenital muscular and positional torticollis, and plagiocephaly. This implicates both a
great need for randomised controlled trials and for a structured approach of this problem. We
presented a clinical flow chart showing different pathways in therapeutic strategies, such as
physical therapy, orthotic devices and surgery, based on best available evidence in current
literature, in order to achieve uniformity in therapeutic thinking and performance.

In Chapter 4, we investigated the intrarater and interrater reliability of plagiocephalometry
(PCM), a new, non-invasive, inexpensive instrument to assess and quantify the asymmetry of
the skull. Using a thermoplastic material to mould the outline of the infant’s skull, a
reproduction of the skull shape is performed on paper allowing for accurate cephalometric
measurements. We concluded that PCM is an easy-to-apply, non-invasive and reliable
measurement instrument to assess skull asymmetry with good clinical use and low application
costs. PCM might serve as an instrument used in all levels of care for children with DP and
might, by measurements over time, provide information concerning the natural course of DP as
well as the assessment of the effects of conservative treatment strategies. Although proposal of
cut-off points to differentiate between abnormal and normal is premature, in our opinion a
difference of more than 5 millimetres in ear deviation (ED), 4 millimetres in posterior dextra -
posterior sinistra (PDPS), 4 millimetres in oblique diameter difference (ODD) and more than
104% in oblique diameter difference index (ODDI) illustrates obvious clinical asymmetry of the
skull and seems to be clinically relevant.




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In Chapter 5, we investigated the concurrent validity of plagiocephalometry, comparing PCM
with 3D-CT scanning, being the golden standard of 3D monitoring, including correlations and
clinical agreement between the scores of both measurements. The study supports concurrent
validity of the measurements for all of the explorations: PCM fitting to the skin, retaining PCM
shape off the head and correspondence of the actual asymmetry of the skull as acquired by
PCM and CT scanning. Plagiocephalic measurements are in agreement with the measurements
from 3D-CT scanning, the present golden standard. Although only 2 dimensional measurements
are done by plagiocephalometry, the combination of simplicity, reliability and validity make it a
promising tool for daily practice.

In Chapter 6, we documented the prevalence of positional preference and DP at birth. We also
studied prevalence changes over time until the age of seven weeks, and we identified risk
factors that influence the occurrence and possible progression of DP. Three determinants were
associated with an increased risk of DP at birth: male gender, birth rank first-born and
brachycephaly. Eight factors were associated with an increased risk of DP at seven weeks of
age: male gender, birth rank first-born, positional preference when sleeping, head to the same
side on chest of drawers, only bottle feeding, positioning to the same side during bottle feeding,
tummy time when awake < 3 times per day and slow achievement of motor milestones. The
study supports the hypothesis that specific nursing habits as well as motor development and
positional preference are primarily associated with the development of DP. Earlier achievement
of motor milestones probably protects the child from developing DP. Implementation of
practices based on this new evidence of preventing and diminishing DP in child health care
centres is important.

In Chapter 7, we investigated the effectiveness of a standardized paediatric physical therapy
protocol on the occurrence and the course of positional preference and severe DP, assessed at 7
weeks after birth (entry of the study) and at the age of 6 and 12 months. A four-month
standardized paediatric physical therapy intervention program on children with positional
preference significantly reduced the prevalence of severe DP compared to care-as-usual.

In Chapter 8, we presented a summary and general discussion, conclusions on the clinical
relevance of new evidence on positional preference and DP, and directions for future research.




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General discussion

Since the early nineties, deformational plagiocephaly (DP) and positional preference in
newborns and very young children are the most occurring asymmetries in posture and
movements, and common, associated problems in daily practice. Positional preference (or
positional torticollis) and DP are exponents of asymmetry in infancy, whereas there is no
consensus in definitions, nomenclature and classifications regarding asymmetry in infancy.
Positional torticollis is the variant of torticollis with normal passive range of motion in the
cervical spine (flexion, extension, rotation and lateral flexion). The active range of motion is
almost always restricted, resulting in rotation preference of the head. The child is not able to
keep the head in the midline position1, probably caused by the existence of a muscular
imbalance2, which could easily develop when the child is always in supine position. For reasons
of clinical use and for conversations with parents, the term “positional preference” is to be
preferred.

Epidemiological studies have shown that prone and side sleeping is a major risk for Sudden
Infant Death Syndrome (SIDS).3,4 Concurrent with the increase in supine sleeping, consistent
with the American Academy of Pediatrics recommendations that healthy term infants should be
positioned on their side or back to sleep5,6, a rise in the prevalence of positional preference and
deformational plagiocephaly has been observed.1,7-10 Strong associations suggest causal
relationships between supine sleeping and the development of positional preference and
deformational plagiocephaly.11-14

Accepted measurement procedures and diagnostic thresholds for differentiating normal
variation from DP are lacking.15 Several measurement instruments and methods are reported in
studies, but have limited clinical utility due to the impossibility in obtaining accurate
measurements, to poor reliability or due to costs of CT-scans. The new instrument to quantify
asymmetry of the skull, plagiocephalometry (PCM) provides insight into the natural course of
asymmetries of the skull, as well as into the effects of conservative treatments on asymmetries
of the skull. PCM is unique in assessing the shape of the skull. Besides quantification of the
severity of cranial distortion in DP, it provides insight into the relations between transversal
shape and exact position of the ears and nose. It is the first clinical instrument with detailed
description of reliability and validity characteristics and with easy applicability in all kind of
research and clinical settings. Especially the use of PCM in recording measurements over time
makes it very suitable for randomised clinical trials on skull asymmetries. PCM proved to be a
non-invasive, inexpensive instrument to assess and quantify the asymmetry of the skull, with a
good intrarater and interrater reliability. PCM is a valid method for measuring skull asymmetry,
as was investigated by comparing PCM with 3D CT scanning, being the golden standard of 3D
monitoring in 21 children with craniosynostosis. Concurrent validity was established by three
aspects: fitting of the PCM thermoplastic tape to the skin, retained PCM form after taking it off
the infants’ head, and correspondence of measurements of asymmetry of the skull as acquired
from PCM and as acquired from 3D CT scanning.16




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A restricted passive range of motion is frequently suggested to be associated with DP. 7,8,15 We
did not find any persistent restriction of the cervical spine. The range of motion of the cervical
spine was assessed in the supine position by promoting gentle passive movements, taking into
account the physiological capabilities regarding adequate motor development, i.e. active
rotations, stability and motor control. By adequate handling of the children, end range of
motion was symmetrical and normal in every child. Our findings implicate that there is no
reason to intervene in passive range of motion of the cervical spine, since no abnormal range of
joint motion could be found. Slight muscular lengthening of the shortened cervical muscles
caused by a very persistent positional preference is rarely indicated.

We discussed that, for clinical and practical reasons, the best plagiocephaly indicator was
“oblique diameter difference index” (ODDI). By leaving out other plagiocephaly indicators, we
probably missed some children with specific head flattening: those with symmetrical oblique
diameters (low ODDI), but with a severe occipital flattening spot or a remarkable ear deviation.
The best choice of a cut-off point of the ODDI could be debatable. However, the analysis of the
continuous variables showed the same tendency in risk factors. ODDI ≥ 104% represents a
distinct visible asymmetry of the skull. Using this cut-off point, the prevalence of DP shows
much resemblance with the prevalence as determined with the slightly higher cut-off point in
the HeadsUp method of Hutchison et al.7 Choosing one clear indicator of PCM as ODDI, which
represents asymmetry of the skull in two dimensions, is most suitable for a clinical study. In our
experience, parents and observers are focused most on the asymmetry of the skull and less on
facial asymmetry.

This prospective, population-based epidemiological study established the incidence and
prevalence of DP over time, in a large cohort, with extensive assessments regarding all putative
determinants as suggested in different previous studies. PCM can provide information
concerning the natural course of DP as well as the effects of conservative treatment strategies
on DP. This prospective study also revealed information about neuromotor development
associated with changed positioning habits when asleep and when awake. There were
indications for psychomotor developmental delays in children with DP, before intervention.13,14
This trial could not find differences in motor development between children with and without
DP.
Bridgewater et al established that the time spent in positions involving greater stimulation from,
and closer interaction with, caregivers may be beneficial to motor development in early
infancy.17 The use of equipment and specific play positions was established to enhance motor
development in a trial with 60 preterm born infants, assessed at eight months corrected age.18
These findings may explain why in our trial children, treated by paediatric physical therapists,
including instruction of the parents to stimulate their child, did not increase quantitative motor
development, but certainly demonstrated a better outcome in DP. We hypothesized that the
positional preference in treated children decreased faster by sooner attaining symmetrical and
altered positions of the head spontaneously, probably facilitated by a slight improvement of
muscular strength and stability of the head, trunk and upper limbs. Nevertheless, at six months
of age, neither the treated nor the untreated children demonstrated positional preference. We




                                                                                              127
also hypothesized that the positional preference would diminish spontaneously between 2 and
6 months of age, in every child, but essentially faster and therefore more crucial on the severity
of DP, in treated children.
Paluszynska at al established that infants who are inexperienced in prone sleeping have
decreased ability to escape from asphyxiating sleep environments when sleeping prone.19
Tummy time, playing in prone positions, positively affects muscular strength of the extensors of
the cervical spine, in keeping the head upright, eventually rotating, and both decreases the risk
of development of DP and the risk of SIDS.
Regarding the prevalence figures of positional preference we established that positional
preference is a self-limiting ‘disease’. In that way, early intervention in the first months of life
could be questioned, but in the same period, DP is very progressive.

Explaining DP in young children by suggesting obstetrical factors, such as a restrictive,
intrauterine environment, premature birth, assisted vaginal delivery, prolonged labour, unusual
birth position and multiple births are frequently reported.7,20,21 Nevertheless, our study did not
support these suggestions and with additional statistical analyses, it could be concluded that DP
at birth was not a predictor for DP at 7 weeks of age.
As reported in previous DP studies, we also found that boys2,7,11,22 and first-born children7,8,20
were more frequently affected; the right occipital skull was always flattened more
frequently7,22,23 and the important role of positional preference was confirmed.1,2,8 A hypothesis
for the higher incidence of DP in first-born children is that their parents have little child rearing
experience, and can be overwhelmed by the amount of information they obtain. Once their first-
born infant has developed DP, the parents will be more likely with subsequent children to be
cognizant of head shape, and methods for preventing distortion. Another reason for the higher
prevalence of severe DP in first-born children could be the fact of over-interpretation of the
recommendations in preventing SIDS. Parents are convinced of the risks of prone and side
sleeping, but think that prone and side playing, also when awake and under supervision, is a
risky thing to do.

The study supports the hypothesis that specific nursing habits, as well as motor development
and positional preference are primarily associated with the development of DP at seven weeks
of age. Earlier achievement of motor milestones probably protects the child from developing DP
at seven weeks of age.
With this new evidence it seems obvious that one sided and less varying positioning, causing
less motor stimulation and providing constant external pressure on the same spot of the skull, is
most responsible for a transient motor developmental delay and for severity of DP. Stimulating
motor development by facilitating prone positions had at least one positive side effect. Children
positioned in prone, turned their head spontaneously to both sides, in contrast to the more
asymmetrical movements when they are positioned only supine. Especially children with
positional preference, at the moment when they were positioned in prone for the very first time,
turned their head immediately to the opposite non-preferred side. This might be one of the keys
in solving the problem.




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The Alberta Infant Motor Scale (AIMS) is a highly reliable and valid, norm-referenced,
performance-based observational measure that examines the spontaneous qualitative gross
motor movement repertoire of infants (till 18 months of age) in supine, prone, sitting and
standing positions. The motor scale described in the Bailey Scales of Infant Development 2nd
edition (BSID-II) is a highly reliable, valid and norm-referenced method of assessing the motor
and mental abilities of children up to the age of 42 months. The AIMS focused on the gross
motor functions, whereas the BSID also discriminated for other developmental aspects, like fine
motor skills and adaptation.
At 7 weeks of age, a significant adverse association between motor development and the
severity of DP could be established. Stimulating (symmetrical) motor development was one of
the goals of the paediatric physical therapy program, but there was no significant difference in
motor developmental scores between de treated and untreated children, at 6 and 12 months of
age. There might have been a notable difference for example at 4 or 5 months of age, which
could explain the better outcome in severity of DP later at 6 months of age.

Till this study, it was agreed that conservative strategies to prevent and to intervene in
positional preference and DP are parental counselling, counter positioning1,24,26, physical
therapy25,28,29 and orthotic devices.2,30-35 Studies on the effectiveness of these interventions were
of moderate to poor methodological quality and randomised controlled trials were not
found.15,23,36
A four-month standardized paediatric physical therapy intervention program on children with
positional preference significantly reduced the prevalence of severe DP compared to care-as-
usual, assessed at 6 and 12 months of age.
For children with DP and their parents, a careful multidisciplinary assessment and follow up
program in child health care centres and paediatric physical therapy practices, based on
updated protocols, clinical guidelines regarding positioning, handling and training of children
with positional preference and with or without DP, are highly recommendable.




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Conclusions

The following conclusions can be drawn from this thesis:

1. Consensus in definitions, nomenclature and classifications regarding asymmetry in infancy
   can be based upon the clear expressions of the features of asymmetry in children.
2. There are different pathways in therapeutic strategies regarding muscular and positional
   torticollis, and plagiocephaly, concerning physical therapy, orthotic devices and surgery.
3. Plagiocephalometry is a reliable and valid, non-invasive, inexpensive instrument to assess
   and quantify the asymmetry of the skull, with a good applicability for research and daily
   practice.
4. Plagiocephalometry can provide information concerning the natural course of deformational
   plagiocephaly as well as the assessment of the effects of conservative treatment strategies
   of deformational plagiocephaly.
5. Three determinants were associated with an increased risk of deformational plagiocephaly
   at birth: male gender, birth rank first-born and brachycephaly.
6. Deformational plagiocephaly at seven weeks of age was primarily caused by postnatal,
   external factors (nursing habits, positioning and care) and inversely associated with
   achievement of motor milestones. Deformational plagiocephaly at birth is not a predictor for
   deformational plagiocephaly at 7 weeks of age.
7. A four-month standardized paediatric physical therapy intervention program on children
   with positional preference, significantly reduce the prevalence of severe deformational
   plagiocephaly compared to usual care, assessed at 6 and 12 months of age.




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Directions for future research

Deformational plagiocephaly (DP) is of great concern to parents. They are worried about the
possible influence on their child’s physical appearance. Since the changed recommendation to
let children sleep supine, the heads of the children, as a result, are becoming slightly more
brachycephal.23 So, what is normal and what is perceived as being normal and what is
tolerated? Measurements and treatments focus mainly on normalizing children’s craniofacial
appearance in order to prevent social stigmata. By visiting certain websites on the Internet,
parents are confronted with messages with a non-evidence based background. In our controlled
study, we found evidence for the suggested statements in literature. Some parents may be more
vulnerable in this regard than others. Some parents who are seeking evaluations of DP, show
elevated concerns and anxiety about their child’s health and appearance in general, perhaps
related to their perceptions of responsibility for the problem.15 It was suggested that not only an
objective deformation of the skull was responsible for the worries of the parents of children with
DP. Also personal perception and coping styles could influence satisfaction of the cosmetic
presentation of the skull and face. To study these patterns we constructed an extensive
questionnaire regarding parental opinions about the appearance of the child’s head, face and
body, added with questions regarding nursing habits, observed motor skills at home and
experiences with well-baby clinics. Data of this study will be analysed and published in future.

In prone position, children turn their head spontaneously to both sides, in contrast to the
asymmetrical movements when they are positioned on their back only. Especially children with
positional preference, who were positioned prone for the very first time, turned their head
immediately to the opposite non-preferred side. This might be one of the keys in solving the
problem. We hypothesize that the suddenly changed position, immediately after a long period
of one sided head position, causes a vestibular impulse resulting in a cervical rotation activity in
the opposite direction. Nevertheless, this mechanism needs further research.
Future studies should focus on details in motor development. Positional preference as the
strongest factor to cause DP, diminished before 6 months of age in all children. In new studies
the first follow up assessment should be performed before six months of age, to elicit possible
differences between treated and not treated children, regarding positional preference
prevalence and motor development.

Delays in both mental and psychomotor development associated with DP, whether it occurs in
early life or still when these children are older, were reported several times.13,14,37,38 This study
presents the first trial with longitudinal data from birth on, starting with all healthy neonates,
exposed to all kinds of influence (nursing, positioning, pieces of advice, treatment), with or
without DP and with or without positional preference. Yet, not all data have been analysed and
follow up assessments at 24 months of age of all participating children will be performed and
presented in future publications. Regarding the (retrospectively) suggested mental and
psychomotor development problems at 6 years of age or later15,37, we may ask the parents for
follow up assessments and/or questionnaires at that age, to explore prospectively, the expected
problems in detail.



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