Babcock&perea Evidence Paper
Babcock&perea Evidence Paper
Babcock&perea Evidence Paper
PICO Question: How would the asymmetries of a clients head with deformational
plagiocephaly improve with helmet therapy versus positional treatment?
Research Question: What is the comparison of effectiveness on correcting cranial and ear
asymmetry between helmet therapy and counter positioning for deformational plagiocephaly
(DP)?
Introduction
Deformational plagiocephaly (DP) is a prevalent diagnosis which includes shape
abnormality of the head that can cause progressive issues, such as eye and ear asymmetries,
without early intervention. This asymmetry is directly related to repeated pressure on one side of
the head resulting in an imbalance of cranial fluid. There are several factors which provide
correlation to this diagnosis: torticollis, prematurity, and back sleeping. DP arises in children
and must be addressed before cranial plates converge and fuse (Stanford Childrens Health).
Two main methods of intervention are often used: helmet intervention, and counter positioning.
This paper will discuss the comparison of efficacy between the two methods based off a
quantitative research article.
Purpose
The purpose of the study was to compare the effectiveness of helmet therapy versus
counter positioning for treatment of DP. It analyzed the two methods through comparison based
upon measurements to prove which one is more effective. The researchers did not state a
hypothesis, but based their justification for this study through observation of evidence based
practice in the United States.
This study directly correlates to the original research question through comparison of the
effectiveness between helmet therapy and counter positioning for plagiocephaly. The ultimate
results will justify the utilization of one method in contrast to the other.
Justification of the Study
DP is more common in children; therefore, more studies have been done comparing the
effectiveness of helmet therapy. The incidence of DP was very minimal in the 1970s, but has
increased throughout the years. First helmet was introduced in 1979 and cranial asymmetry
improved without any serious complications. In 1998, the FDA approved the cranial orthotic
device as a medical device for infants between 3 and 18 months of age with moderate to severe
DP.
Other studies were conducted but did not show results that compared the two groups
specifically for cranial helmets and counter positioning. Therefore, justification for this study
was warranted. Further studies should assess ear shift improvements in children with DP.
Participants
There were 21 participants recruited to participate in this study. Each participant was
clinically diagnosed with DP but was excluded from the study if additional neurodevelopmental
disorders, such as cerebral palsy, autistic spectrum disorders, genetic aberrations and metabolic
diseases were present. They were split into two groups depending upon the type of intervention
prioritized by the family. The group consisted of 21 child participants receiving helmet therapy
and 6 children receiving counter positioning. The groups were similar in gender proportion and
side of occipital flattening. All of the participants were less than 10 months of age and had a
measured diagonal difference (DD) of greater than 10 millimeters. The researchers used a
convenience sample technique by recruiting children from their clinic. The 27 participants
continued the duration of the study and there were no participant drop-outs.
This small sample size greatly reduced the generalizability of this study to the greater
population. A future study would benefit from not only having a larger sample, but also creating
even groups to enhance comparison efforts. A change of sample would assist to limit bias as
well as create greater transferability.
Measurement and Variables
This was a retrospective study which analyzed medical records of patients diagnosed and
treated for DP at clinics from Korea. The time of treatment created one independent variable for
this study. The mean duration of therapy was 4.30 months in the helmet therapy group and 4.08
months in the counter positioning group. The age of the child also created an independent
variable with the mean age of 5.62 months. Age directly affects the efficacy of cranial remolding
due to progression of cranial plate convergence with age. The DD outcome measurement of the
clients head provided the dependent variable for the study. This variable changed over time and
was the source used to define the ultimate study outcomes.
Neither administrators nor participants were blind to group assignments. The
administrator role was to educate and guide the family toward goal attainment dependent upon
their chosen method. Similarly, the participants chose their assignment as assembly of groups
was based on familial preference of intervention strategy.
Intervention
There were two separate intervention methods in this study. The helmet intervention
involves full-time wear of an orthotic device to create an even balance cranial fluid. The counter
positioning method is utilized only during times of non-movement, nights and naps, and requires
the caregiver to follow specific instructions of how to reposition the head to achieve this same
cranial fluid balance. Both methods are non-invasive techniques to alleviate a DD of less than
10 millimeters. Although the two comparison groups had one communal goal, they were
measured for differences in efficacy. Familial education was a crucial component of this
intervention and guided the primarily home-based treatment.
Statistical Analyses
Statistical analysis was measured using The Statistical Package for the Social Sciences
(SPSS) ver. 21.0. Statistical significance was measured using the nonparametric Mann-Whitney
U-test. Dichotomous variable comparisons, such as gender and individual deformity, were
measured with the chi-square test. The final test used was to measure the post hoc statistical
power, the G*Power ver. 3.1. This confirmed the appropriate level of statistical power of the
study. The statistical significance was set at a p-value of <0.05.
Findings
Cranial asymmetry measurements and ear shift measurements showed significant
improvement during the study time frame in the helmet intervention group. However, in the
counter positioning group, cranial asymmetry measurement showed no significant difference
from the start to the end of the treatment period. Only ear shift showed significant improvement
during the treatment period. Due to the large outcome difference between groups, there were no
possible errors suggested. Although there was no defined hypothesis, the results evidenced
significance to the prevalent use of helmets in the United States.
Literature Review
The researchers stated after reviewing the English and Korean literature, this study is the
first report to compare the effectiveness of these two intervention methods on ear shift in patients
with DP. It is also the first Korean report to compare the general efficacy of two therapeutic
options for children with DP.
A prospective study by Meyer-Marcotty, Bohm, Kunz Stellzig-Eisenhauer et al.
compared 20 patients with DP and 20 control subjects without the condition. This study showed
the measurements before and after helmet therapy had no significant difference in ear shift
although their cranial asymmetry measurements such as DD improved significantly.
Implications
Education of the family provides a large clinical implication. This education not only
directs the family toward a preferred intervention method, but also provides them with
information and resources to ensure success. There must also be follow-up appointments to
confirm progress and make any necessary check-point alterations. It was suggested that parents
of children with more drastic deformity may choose more aggressive treatment methods. The
authors recommended a randomized control trial with a large sample to combat this obstacle.
Limitations
The study had four highlighted limitations. The small sample size of 27 participants was
in direct relation with the strict selection criteria. This limits generalizability to the greater
population. The second limitation was based on bias introduced by the method used to separate
groups. The groups were split according to the parental preference of treatment method. Uneven
sample size was another evident limitation in the study; one group was composed of 21
participants whereas the counter positioning group only consisted of 6 participants. Parental
compliance is a necessary factor in this specific intervention. Exact compliance was not
measured because it is performed in household, thus creating the final limitation.
There were no reliability and validity reports in this study. This could be another
limitation of the study that was not addressed in the article. However, there were no questions
about the outcome measures chosen which suggests reliability and validity.
Contributing Factors
Familial compliance is the greatest factor contributing to the outcome of the study.
Parental involvement is a requirement for both intervention strategies yet is not measured
because it takes place in the household. As aforementioned, this lack of measurement is a
component of the study limitations. Another factor is the affordability of helmet therapy. It
provides a greater cost to families than counter positioning if insurance is not utilized or if they
cannot access non-profit charity support.
Strengths and Weaknesses
Strengths
We identified the three greatest strengths as the following:
1. Cranial measurements such as DD, CVAI and RSI and ear shift showed significant
improvement during the study in helmet group; whereas, the counter positioning
showed no significant difference throughout the study period.
2. Children of the study underwent diagnosis of DP by 3-dimensional (3D) computed
tomography and caregivers were given the option to choose which therapy method
they wanted to pursue for their child.
3. Due to studies such as these not being prevalent in Korea, parents in this country
received state of the art treatment that is recognized in the U.S.
Weaknesses
The following are the three identified weaknesses of the study:
1. The sample size was small and children had to be 10 months of age or younger with
moderate to severe DP.
2. The therapy group was determined by parental preference which may have introduced
bias.
3. The sample size was uneven between two groups which resulted in more subjects in
the helmet therapy group and small subjects in the counter positioning group.
References
Kim, S., Park, M., Yang, J., & Yim, S. (2013). Comparison of helmet therapy and counter
positioning for deformational plagiocephaly. Ann Rehabil Med, 37(6), 785-795. Retrieved
from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3895518/
Meyer-Marcotty, P. D. P., Boehm, H., Linz, C., Kunz, F., Keil, N., Stellzig-Eisenhauer, A., &
Schweitzer, T. (2012). Head orthesis therapy in infants with unilateral positional
plagiocephaly: an interdisciplinary approach to broadening the range of orthodontic
treatment. Journal of Orofacial Orthopedics/Fortschritte der Kieferorthopdie, 73(2),
151-165.
Stanford Children's Health. (n.d.). Deformational plagiocephaly. Retrieved from
http://www.stanfordchildrens.org/en/topic/default?id=deformational-plagiocephaly-90P01834