CRITICALLY APPRAISED TOPIC (CAT) - Creighton University

P/OTD 541 Critical Analysis of Occupational Therapy Practice | OTD 601 Capstone
CRITICALLY APPRAISED TOPIC (CAT)
Focused Question:
What is the effectiveness of cranial shaping interventions on general development of infants
with deformational plagiocephaly?
Prepared By:
Clare Voigtlander, OTS (clarevoigtlander@creighton.edu)
Department of Occupational Therapy
School of Pharmacy and Health Professions
Creighton University
2500 California Plaza
Omaha, Nebraska 68178
Date Review Completed:
April 13, 2010
Clinical Scenario:
Deformational plagiocephaly, also known as positional plagiocephaly, is a condition
characterized by changes in infants skull shape due to factors applied in utero, at birth, or
postnatally (Bialocerkowski, Vladusic, & Wei Ng, 2008). The number of infants with
deformational plagiocephaly has greatly increased in the past 20 years (Biggs, 2004). In the
past, the incidence of positional plagiocephaly was estimated at 0.3% (Bruteneau & Mulliken,
1992). The current incidence of deformational plagiocephaly at 4 months is estimated to be
anywhere from 19.7% to 48% (Robinson & Proctor, 2009). This increase is assumed to be
related to the American Academy of Pediatrics recommendation of having infants sleep on their
backs to decrease the incidence of sudden infant death syndrome as well as an increased amount
of time that infants are spending in car seats and swings (Biggs, 2004; Littlefield & Kelly,
2004).
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Deformational plagiocephaly was once considered to be a purely cosmetic disorder (2008).
However, recent studies suggest that deformational plagiocephaly is more than a cosmetic
disorder by discovering a link between deformational plagiocephaly and neurodevelopmental
delays (Lekovic, 2007; Kordestani, Patel, Bard, Gurwitch, & Panchal, 2005). Infants with
deformational plagiocephaly have delays in mental and psychomotor functioning when
compared to their peers (2005). Children who were diagnosed with deformational plagiocephaly
are more likely to require special education and assistance such as physical therapy,
occupational therapy, and speech therapy during elementary school (Fowler et al., 2008).
Psychosocial implications have also appeared for children with residual asymmetry of the head.
Children who have remaining asymmetry once they are school age, may be considered
abnormal by their peers due to the asymmetry of the head (Bruner, David, Gage, & Argenta,
2004).
With an increased number of infants with deformational plagiocephaly and the possibility that
developmental delays can occur, occupational therapists should be aware of the complications
that can arise and should focus on the prevention of deformational plagiocephaly. Early
intervention and prevention decreases the severity and risk of developmental delays (Thompson
Adapted from AOTA Evidence-Based Literature Review Project

2
et al., 2009). If prevention of deformational plagiocephaly is not successful, occupational
therapists should be aware of the effectiveness of cranial shaping interventions and can educate
parents on the importance of receiving interventions for their children, as well as, provide
interventions. Treatment of deformational plagiocephaly includes the use of cranial orthotics,
repositioning, and physical or occupational therapy (Bialocerkowski, Vladusic, & Howell,
2005). Occupational therapists are able to provide comprehensive treatment for infants with
deformational plagiocephaly.
Summary of Key Findings:
Summary of Levels I, II, and III
• Cranial shaping using helmet therapy or repositioning with or without
physiotherapy improves head shape in infants with deformational plagiocephaly
(Bruner, David, Gage, & Argenta, 2004, Level III; Robinson & Proctor, 2009,
Level I; Thompson et al, 2009, Level III)
• There is a link between developmental delays or neurological injury with
deformational plagiocephaly, casual relationship has not been identified
(Leighton, 2008, Level I; Robinson & Proctor, 2009, Level I; )
• School age children who have been diagnosed with deformational plagiocephaly
showed developmental delays and required special education and therapy
services more than non-affected peers, no difference was present between the
groups treated with helmets and groups with repositioning (Leighton, 2008,
Level I; Robinson & Proctor, 2009, Level I)
• One study included in a systematic review reported no delay (Robinson &
Proctor, 2009, Level I)
• Repositioning and physiotherapy is effective for treating mild to moderate cases
in infants under 6 months of age while cranial orthoses are effective for severe
deformities, infants with mild to moderate deformities who are older than 6
months, or do not respond to repositioning and physiotherapy (Robinson &
Proctor, 2009, Level I; Xia et al., 2008, Level I)
• Orthotic therapy does not seem to confer protection against developmental
delays (Leighton, 2008, Level I)
• Two studies found that helmet therapy is more effective than repositioning
(Thompson et al, 2009, Level III; Xia et al., 2008, Level I). However the most
effective conservative intervention cannot be established due to low order of
study designs, inconsistent outcome measures, and inconsistent protocol of
therapy as well as other biases and limitations (Leighton, 2008, Level I;
Thompson et al, 2009, Level III)
• Earlier intervention results in increased improvements (Thompson et al., 2009)
• Higher compliance results in increased improvements (Burner, David, Gage, &
Argenta, 2004, Level III; Thompson et al, 2009, Level III)
Summary of Levels IV and V
Level IV – None available for review
Level V – None available for review
Contributions of Qualitative Studies:
Not included in review
Adapted from AOTA Evidence-Based Literature Review Project

Bottom Line for Occupational Therapy Practice:
There is evidence to support that cranial shaping interventions impact the general development
of infants with plagiocephaly by improving head shape (Bruner, David, Gage, & Argenta, 2004;
Robinson & Proctor, 2009; Thompson et al., 2009; Xia et al., 2008). As the incidence of
deformational plagiocephaly increases, the need for the best practice to treat these infants rises.
Results of this review indicate that repositioning is effective and should be used for infants with
mild plagiocephaly and who are under 4 months of age. Helmet therapy is effective and should
be used for infants over 4 months with moderate to severe plagiocephaly or infants who failed
to respond to repositioning. (Robinson & Proctor, 2009; Xia et al., 2008). Since improvement
was seen in head shape post intervention of infants with deformational plagiocephaly,
occupational therapy practitioners should use cranial shaping interventions and should be
reimbursed accordingly.
3
More rigorous research is needed to establish the cause of developmental delays in children
with deformational plagiocephaly. Studies have identified that there is in fact a developmental
delay present in infants who were diagnosed with deformational plagiocephaly, however it is
unclear whether the delay caused the plagiocephaly or if the plagiocephaly resulted in
developmental delays (Leighton, 2008). Although the cause of developmental delays is still
unclear, occupational therapist should be not only focus on improving head shape, but should
also focus on decreasing developmental delays. Therapists can promote development in infants
with deformational plagiocephaly by educating parents on counterpositioning and increasing the
amount of time spent in the prone position when awake. Therapists can also complete exercises
to reduce positional preference and stimulate motor development (van Vlimmeren et al., 2008;
Nuysink, J., 2009). Once the infants head shape has been corrected, parents should be advised
to watch their children throughout school age for developmental delays (Bialockerkowski,
Vladusic, & Wei Ng, 2008).
Occupational therapists have the knowledge and skills to provide comprehensive treatment to
infants with deformational plagiocephaly. Additional education and experience is needed for
therapists to safely and effectively apply cranial molding devices to infants’ heads, since the
orthosis applies pressure to certain areas of the infant’s skull. Occupational therapists have the
knowledge to educate provide education to parents, to complete repositioning and exercises that
do not involve applying pressure to the infants head without additional education.
With the increase in the prevalence of deformational plagiocephaly in the past 20 years, there is
an increase in societal need as well as a potential for program development. Occupational
therapists will have an important role in the development of new helmet clinics as well as
running the helmet clinics as the demand grows. Occupational therapists could also develop a
program that could provide education to parents about the monitoring for plagiocephaly and the
importance of repositioning to decrease the risk of plagiocephaly. Occupational therapists could
also participate in additional research to determine the causative relationship between
deformational plagiocephaly and developmental delays. Therapists should complete research to
further support treatment protocols and screening processes in order to develop the most
effective treatment plan for deformational plagiocephaly. The treatment of plagiocephaly
should be reimbursed because a reduction in plagiocephaly and developmental delays can
reduce hospitalization and rehabilitative costs.
Adapted from AOTA Evidence-Based Literature Review Project

Review Process
• Student identified focus question.
• Key terms were developed.
• Databases were searched using key terms.
• Titles and abstracts of articles were retrieved.
• Comprehensive literature search was completed.
• Articles which appeared to be of high relevance were obtained for review.
• Articles which met criteria were analyzed in the evidence table.
Procedures for the selection and appraisal of articles
Inclusion Criteria:
• No limitations was used for the year articles were published, all relevant articles were
included
• Articles written in English
• Peer review articles/journals
• Research participants with plagiocephaly
• Discussed impact of therapy on head shape or development of the child
Exclusion Criteria:
• Level V articles
• Qualitative studies
• Craniosynostosis
• Surgical Interventions
• Dissertations and Theses
Search Strategy
Categories Key Search Terms
Patient/Client Population Infants, Newborns, Children, Babies, Deformational
Plagiocephaly, Plagiocephaly, nonsynostotic, Flat Head
Syndrome, Cranial Deformities
Intervention Cranial Shaping, Helmet, Helmet Therapy, Molding Therapy,
Cranial Molding, Cranial Osteopathy, Orthotic Devices,
Repositioning, Physiotherapy
Comparison Not searched
Outcomes Developmental Delays, Cognitive Delays, Neurodevelopment,
Delays, Crawl*, Walk*, Talk*, Cognit*, Language
Developmental Disorder
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Databases and Sites Searched
MEDLINE, CINAHL, Humanities International Index, Communication & Mass Media Complete,
Health Source-Consumer Edition, International Pharmaceutical Abstracts, Academic Search Premier,
Business Source Premier, Regional Business News, EPIC, ATLA Religion Database with
ATLASerials, MAS Ultra-School Edition, Military & Government Collection, Primary Search, Funk &
Wagnalls New World Encylopedia, PsycINFO, MagillOnLiterature Plus, MLA International
Bibliography, MLA Directory of Periodicals, SPORTDiscus, Dentistry & Oral Sciences Source,
Google Scholar, ERIC, Web os Science, FirstSearch, EBSCOHost, OTsearch, SPORT, Chocrane
Library, OTCATS, Otseeker, JAMA Evidence
Adapted from AOTA Evidence-Based Literature Review Project

Quality Control/Peer Review Process:
• Occupational therapy student developed a focus question and search terms.
• Instructor and teaching assistant reviewed the focus question and search terms.
• Comprehensive literature search was completed by the student.
• Instructor and teaching assistant completed a literature search to ensure that all articles
had been included.
• Instructor and teaching assistant reviewed level of evidence and priority of article to
ensure that all articles had been located in the comprehensive literature search.
• The student then completed the evidence table for all selected articles.
• After the student completed the evidence table, the instructor and teaching assistant
reviewed the table.
• The critically appraised topic was then completed by the student and reviewed by the
instructor and teaching assistant.
Results of Search
Summary of Study Designs of Articles Selected for Appraisal
Level of Study Design/Methodology of Selected Articles Number of Articles
Evidence
Selected
I Systematic reviews, meta-analysis, randomized
controlled trials
3
II Two groups, nonrandomized studies (e.g., cohort,
case-control)
0
III One group, nonrandomized (e.g., before and after,
pretest, and posttest)
2
IV Descriptive studies that include analysis of outcomes
(single subject design, case series)
0
V Case reports and expert opinion, which include
narrative literature reviews and consensus statements
0
Qualitative Studies 0
TOTAL 5
Limitations of the Studies Appraised
Levels I, II, and III
Level I
• Comparison of interventions is difficult due to available articles having low order of
study designs, inconsistent outcome measures, inconsistent protocol of therapy
(Leighton, 2008; Robinson & Proctor, 2009; Xia et al., 2008).
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• Biases were present in many of the studies included in systematic reviews (Leighton,
2008; Xia et al., 2008).
• Systematic review was not comprehensive and missed a few articles ((Leighton,
2008).
• Higher level evidence and quality research is needed to determine the causative
relationship between deformational plagiocephaly and developmental delay
(Robinson & Proctor, 2009).
Adapted from AOTA Evidence-Based Literature Review Project

6
• Measurements without proven reliability and validity were used in the studies
included (Robinson & Proctor, 2009). This also contributes to the difficulty in
comparing interventions.
• Studies were difficult to assess due to flaws in many of the study designs (Xia et
al., 2008).
Level III
• Possible that a three dimensional volumetric correction equates to a significantly
greater clinical improvement, and thus may not fully represent the overall
clinical improvement (Bruner, David, Gage & Argenta, 2004)
• The study was a low level design, lacked randomization and lacked a control
group (Bruner, David, Gage & Argenta, 2004; Thompson et al,, 2009).
• A small sample size was used (Bruner, David, Gage & Argenta, 2004).
• There was a large drop-out rate (Bruner, David, Gage & Argenta, 2004).
• Parents reported compliance, which was a self reported outcome (Thompson et
al., 2009).
Levels IV and V
N/A
Articles Selected for Appraisal
Bruner, T. W., David, L. R., Gage, H. D., & Argenta, L. C. (2004). Objective outcome analysis
of soft shell helmet therapy in the treatment of deformational plagiocephaly. The
Journal of Carniofacial Surgery, 15, 643-650.
Leighton, J. M. (2008). Non-synostotic deformational plagiocephaly: An evidence-based case
report. Clinical Chiropractice, 11, 211-218.
Robinson, S., & Proctor, M. (2009). Diagnosis and management of deformational
plagiocephaly. Journal of Neurosurgery: Pediatrics, 3, 284-295.
Thompson, J. T., David, L. R., Wood, B., Argenta, A., Simpson, J., & Argenta, L. C. (2009).
Outcome analysis of helmet therapy for positional plagiocephaly using a threedimensional
surface scanning laser. The Journal of Craniofacial Surgery, 20, 362-365.
Xia, J. J., Kennedy K. A., Teichgraeber, J. F., Wu, K. Q., Baumgartner, J. B., & Gateno, J.
(2008). Nonsurgical treatment of deformational plagiocephaly: A systematic review.
Archives of Pediatric & Adolescent Medicine, 162, 719-727.
Adapted from AOTA Evidence-Based Literature Review Project

Other References
Bialockerkowski, A. E., Vladusic, S. l., & Howell, S. M. (2005). Conservative interventions for
positional plagiocephaly: A systematic review. Developmental Medicine & Child
Neurology, 47, 563-570.
Bialocerkowski, A. E., Vladusic, S. L., Wei Ng, C. (2008). Prevalence, risk factors, and natural
history of positional plagiocephaly: A systematic review. Developmental Medicine &
Child Neurology, 50, 57-586.
Biggs, W. S. (2004). The ‘epidemic’ of deformational plagiocephaly and the American
Academy of Pediatrics’ response. Journal of Prosthetics and Orthotics, 16, S5-S8.
Bruner, T. W., David, L. R., Gage, D., & Argenta, L. C. (2004). Objective outcome analysis of
soft shell helmet therapy in the treatment of deformational plagiocephaly. The Journal of
Craniofacial Surgery, 14, 643-650.
Bruteneau, R.., & Mulliken, J. (1992). Frontal plagiocephaly: Synostotic, compensational, or
deformational. Plastic and Reconstructive Surgery, 89, 21-31.
Fowler, E. A., Becker, D. B., Pilgram. T. K., Noetzel, M., Epstein, J., & Kane, A. A. (2008).
Neurologic finding in infants with deformational plagiocephaly. Journal of Child
Neurology¸23, 742- 747.
Lekovic, G. P., Baker, B. J., Lekovic, J. M., & Pruel, M. C. (2007). New world cranial
deformation practices: Historical implications for pathophysiology of cognitive
impairment in deformational plagiocephaly. Neurosurgery, 60, 1137-1147.
Littlefield, T. R., & Kelly, K. M. (2004). Deformational plagiocephaly: Recommendations for
future research. Journal of Prosthetics and Orthotics, 16, S59-S62.
Kordestani, R. K., Patel, S., Bard, D. E., Gurwitch, R., Panchal, J. (2006). Neurodevelopmental
delays in children with deformational plagiocephaly. Plastic and Reconstructive Surgery,
117, 207-218.
Nuysink, J. (2009). Supporting early development of infants with identified positional
plagiocephaly. Physical & Occupational Therapy in Pediatrics, 29, 236-238.
Thompson, J. T., David, L. R., Wood, B., Argenta, A., Simpson, J., & Argenta, L. C. (2009).
Outcome analysis of helmet therapy for positional plagiocephaly using a threedimensional
surface scanning lacer. The Journal of Craniofacial Surgery, 20, 362-265.
van Vlimmeren, L. A., van der Graaf, Y., Boere-Bookenkamp, M. M., L’Hoir, M. P., Helders, P.
J. M., Engelbert, R. H. H. (2008). Effect of pediatric physical therapy on deformational
plagiocephaly in children with positional preference – A randomized controlled trial.
Archives of Pediatric and Adolescent Medicine, 162, 712-718.
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Adapted from AOTA Evidence-Based Literature Review Project