The Effects of a Non-Invasive Three-Dimensional Laser Scanner

for the Treatment of Deformational Plagiocephaly When Using

Cranial Molding Orthosis

Kristin Lewis, B.S.

Orthotic Directed Research Study
April 3, 2009
Abstract
During the past 15 years, there has been a dramatic spike in the incidence of
Deformational Plagiocephaly, or asymmetrical head shapes in infants. The complete
etiology is not fully understood, but the leading cause of Deformational Plagiocephaly
can be correlated to the increased number of infants sleeping supine to prevent Sudden
Infant Death Syndrome (SIDS). Deformational Plagiocephaly is most commonly treated
conservatively with a repositioning program, physical therapy, and/or a cranial molding
orthosis. Many published studies have looked at the efficacy of these treatment
modalities, as well as the natural history of Deformational Plagiocephaly, however, few
have been able to produce reliable results. This is due in large part to the inconsistent use
of measurement devices and techniques used to document the asymmetry of the infant’s
head. Recently, a non-invasive three-dimensional laser scanner has been developed
which allows practitioners to capture an accurate, digitized image of an infant’s skull.
This study aims to look at the effects of the digitized scanner on how practitioners treat
Deformational Plagiocephaly with a cranial molding orthosis. A survey was mailed to
each of the 50 orthotic and prosthetic facilities in the United States that currently use the
Orthomerica STARscannerTM in their practice. The results showed that using the
STARscannerTM was more time efficient during the initial evaluation and fabrication than
the previous impression techniques. In addition, cranial molding orthoses fabricated
using the STARscannerTM required less modification and re-fabrication for an optimal fit.
Finally, of those practices that sent a summary report to the referring physician, the
number of referrals for cranial molding orthoses increased.

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Introduction
To decrease the risk of Sudden Infant Death Syndrome (SIDS), in 1992

pediatricians began recommending that infants sleep on their backs. With this change in

infant sleeping position came an increase in Deformational Plagiocephaly.1-9

Deformational Plagiocephaly in an asymmetry of the skull, usually observed within the

first several months after birth. Currently, Deformational Plagiocephaly is usually treated

conservatively with repositioning activities, physical therapy, and/or a cranial molding

orthosis. Only in severe cases, and when conservative treatment has been unsuccessful,

is surgery considered.

In 2004, the American Academy of Orthotics and Prosthetics (AAOP) held a

State-of-the-Science-Conference (SSC) to assess the current knowledge level of the

orthotic treatment of Deformational Plagiocephaly. Throughout the conference, there

were re-occurring reports of disappointment in the current research due to inadequate

validity and accuracy of measurement techniques used to measure an infant’s skull.

Without accurate and reliable data, it is difficult to determine the efficacy of the cranial

molding orthoses. In 2005, Bialocerkowski, et al., conducted a thorough literature review

on Deformational Plagiocephaly in Developmental Medicine & Child Neurology. This

review came to the same conclusion: it is impossible to assess the efficacy of treatment

modalities for Deformational Plagiocephaly without adequate measuring devices.6 The

literature published from the SSC stated that “without evidence that the untreated

condition persists into adulthood, third-party payers will continue to argue that

plagiocephaly spontaneously improves in time and will promote repositioning… because

it is the one treatment that costs them nothing.”10

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 Over the past couple years, the STARscannerTM, a three-dimensional non-invasive

laser head scanner manufactured by Orthomerica1, has become available to orthotic and

prosthetic facilities. It captures a three-dimensional image of the infant’s skull in a

matter of seconds, alleviating the traditional plaster cast and measurement techniques.

The STARscannerTM is a valuable tool for obtaining an objective, digitized image,

assessing the fit of the cranial molding orthoses, and tracking the progress of treatment of

Deformational Plagiocephaly. Research has shown that measurements and images

generated by the STARscannerTM system are accurate to 0.5mm and practitioners

consistently record the same measurements among each other.8

The purpose of this study is to evaluate the effects of the STARscannerTM laser on

the treatment of Deformational Plagiocephaly using a cranial molding orthosis. Expected

results from a survey of practitioners currently using the STARscannerTM system are that

less time is spent evaluating the patient and fabricating and modifying the orthosis; the

number of remakes is decreased; the end results of treatment are improved; and the

number of referrals from physicians was increased when the facility began using the

STARscannerTM as an evaluation too.

Literature Review

During the last 15 years, the incidence of Deformational Plagiocephaly has

skyrocketed, becoming the most commonly diagnosed cranial deformity.2 The 1992

spike in Deformational Plagiocephaly corresponded with the American Academy of

Pediatricians “Back to Sleep Campaign” that recommended parents place their infants

supine during sleeping.2,3,5,8 The supine position is recommended because of a

1
Orthomerica, 6333 N. Orange Blossom Trail Orlando, FL 32810, (800) 446-6770

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documented association between prone sleeping and SIDS. The “Back to Sleep

Campaign” decreased the occurrence of SIDS “from 2.6 per 1000 in 1986 to 1.0 per 1000

in 1998.”5 Unfortunately, it increased the occurrence of Deformational Plagiocephaly

from 1 in 300 live births before the “Back to Sleep Campaign” to an estimated 1 in 70

live births in 2001.2

Other less common causes of Deformational Plagiocephaly include: a primary

diagnosis of tortocolis, in-utero cramping due to multiple births and positioning.

Deformational Plagiocephaly is a change in the shape and symmetry of the skull, caused

by external forces on the skull. The most commonly observed deformation is a flattening

to the posterior of the skull, a shift in ear alignment and forehead asymmetry.11 The

increase in time infants spend supine is believed to be the leading cause of Deformational

Plagiocephaly.

Deformational Plagiocephaly is often classified by the severity of the deformity.

A mild deformity is classified as a singly asymmetry, usually to the posterior of the skull,

and is limited to the right or left side.11 Mild Deformational Plagiocephaly is usually

treated with a repositioning program at home.8 A repositioning program attempts to limit

the time pressure is applied to the flattened areas of the skull by decreasing unnecessary

time spent supine.6 Tummy time is encouraged, along with rearranging the nursery

furniture, changing feeding position, and decreasing time in baby swings and car seats.12

Moderate Deformational Plagiocephaly is characterized by ipsolateral ear shift

and forehead asymmetry secondary to the posterior flattening. Severe Deformational

Plagiocephaly affects the contralateral side of the skull, creating a parallelogram shaped

skull when viewed from the top of the head. Infants with severe Deformational

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Plagiocephaly will demonstrate significant facial asymmetry of the eyes, cheeks,

forehead, and/or ears.

Both moderate and severe Deformational Plagiocephaly are usually treated with a

combination of a repositioning program, physical therapy, and/or a cranial molding

orthosis.11 Infants with moderate to severe Deformational Plagiocephaly may also have

tortocolis, an asymmetrical tightening of the sternocleidomastoid muscle. This causes a

tilted head position, further increasing the severity of Deformational Plagiocephaly.

Physical therapy is used to stretch tight cervical musculature and promote a full range of

motion if preference to one head position is demonstrated.6 If the infant is older than

three months or does not demonstrate increased outcome with repositioning, a cranial

molding orthosis is used to increase the correction.

As evaluated at the AAOP SSC in 2004 and by Bialocerkowski, et al., using the

National Health and Medical Research Council hierarchy of evidence, it is difficult to

draw reliable conclusions regarding the effectiveness of the cranial molding orthoses.

One main reason for the poor quality of research looking at the treatment of

Deformational Plagiocephaly is the absence of appropriate measuring devices to record

tri-planar measurements of the skull. In the past, measurements used to record natural

history of Deformational Plagiocephaly and efficacy of treatment modalities have used

such devices as calipers, photographs with linear measurements delineated on them, and

even parent satisfaction scales. On the 16 studies evaluated by Bialocerkowski, et al.,

only three discussed the accuracy and reliability of their measurement techniques. “Thus,

in most cases, it was not known whether the observed change was greater than the

measurement error, therefore influencing interpretation of results.”6 Before the efficacy

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of Deformational Plagiocephaly treatment modalities can be proven or disproven,

establishing repeatable, accurate measurements of the three-dimensional skull shape are

essential.

Recently, a scanning bed with multiple vision-safe scanning lasers has become

common in orthotic and prosthetic facilities that specialize in the treatment of

Deformational Plagiocephaly. The STARscannerTM from Orthomerica creates a digital

image of the infant’s skull in seconds. The STARscannerTM reconstructs the skull on a

computer which divides the cranium into quadrants and calculates cranium capacities for

each quadrant. This digital scanner has verified accuracy to within 0.5mm.8 The file can

then be sent electronically to Orthomerica’s central fabrication where the cranial molding

orthosis is manufactured to the practitioner’s specifications. Since the STARscannerTM is

digitized, the three-dimensional reconstruction is saved on computer and can be retrieved

and overlaid on a later scan to document progression of the treatment. This is especially

valuable not only as clinical documentation and for research purposes, but also as a pre-

and post-treatment image that can then be sent to the referring physician.

Methods

Orthomerica, the manufacturer of the STARscannerTM laser data head scanner,

lists 50 individual orthotic and prosthetic facilities in the United States that have the

scanner and software to perform three-dimensional skull shape scans of infants. A cover

letter explaining the basis of the study and a one page survey was mailed to each of the

50 facilities.

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 The survey addressed previous impression techniques, the time spent evaluating

the patient, time spent fabricating and modifying the orthoses, occurrence of remakes, as

well as impact on treatment results and number of referrals for cranial molding orthoses.

See Appendix A and B for a copy of the cover letter and survey, respectively.

Responses to the survey will be analyzed by calculating percentages of each reply

within a given question.

Results

A one page survey (see Appendix B) was mailed to 50 individual orthotic and

prosthetic practices who own an Orthomerica STARscannerTM. Of the 50 practices, 62%

(31 practices) returned the completed survey via mail or fax. Of those replies, the

impression method used previous to the STARscannerTM was: 90.3% (28 of 31) plaster,

9.7% (3 of 31) fiberglass, and 12.9% (4of 31) measurements.

The impression method that is most time efficient during evaluation of the patient

is: 100% (31 of 31) the STARscannerTM over the previous impression method. The

impression method that is most time efficient during fabrication of the cranial molding

orthoses is: 0% previous impression method, 96.7% (29 of 30) STARscannerTM, and

3.3% (1 of 30) no noticeable difference. The impression method that requires less

modification to the cranial molding orthoses at the time of initial fitting is: 3.2% (1 of 31)

previous impression method, 71% (22 of 31) STARscannerTM, and 25.8% (8 of 30) no

noticeable difference. The impression method that requires less re-fabrication of the

cranial molding orthoses due to an unacceptable initial fitting of the cranial molding

orthoses is: 3.4% (1 of 29) previous impression method, 75.9% (22 of 29)

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STARscannerTM, and 20.7% (6 of 29) no noticeable difference. The impression method

that produces more correction of Deformational Plagiocephaly during treatment using a

cranial molding orthoses is: 0% previous impression method, 60% (18 of 30)

STARscannerTM, and 40% (12 of 30) no noticeable difference.

The STARscannerTM summary reports are sent to referring physicians by 80% (24

of 30) of practices, while 20% (6 of 30) do not send summary reports. The number of

referrals for cranial molding orthoses have changed since obtaining the STARscannerTM

by increasing at 83.9% (26 of 31) of practices, decreasing at 3.2% (1 of 31) of practices,

and no noticeable difference by 12.9% (4 of 31) of practices. Of those practices that send

a summary report to the referring physicians, 87% (20 of 23) have an increase in the

number of referrals, 4.3% (1 of 23) have a decrease in the number of referrals, and 8.7%

(2 of 23) have no noticeable difference in the number of referrals.

Discussion

Two observations are evident from the results of the study: (1) the

STARscannerTM decreases the amount of time needed to evaluate the infant and to

fabricate the cranial molding orthoses; and (2) cranial molding orthoses fabricated from

images obtained using the STARscannerTM fit better, leading to less time spent modifying

and re-fabricating cranial molding orthoses.

The Orthomerica STARscannerTM has previously been proven to be an important

tool for obtaining the accurate, objective impression of an infant’s skull. The findings of

this study suggest that the STARscannerTM will also be a valuable tool to increase time

efficiency for the practitioner.

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 In addition, the STARscannerTM summary report with pre- and post-treatment

images can be a useful marketing tool for the orthotic practice. Most practices that send a

STARscannerTM summary report to the referring physician saw an increase in the number

of cranial molding orthoses referrals.

Further research will be needed to determine the best impression method for

optimal correction of Deformational Plagiocephaly. Of those practitioners that returned

the survey, 60% stated that they had more correction with the STARscannerTM, while

40% of practitioners stated there was no noticeable difference in outcomes.

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Appendix A

To whom it may concern,

I am a resident at Artisan Orthotic-Prosthetic Technologies, Inc. in Tualatin, OR.
In order to complete my residency, I am conducting research on the effects of the
Orthomerica STARscanner TM on the orthotic practice. The Orthomerica STARscannerTM
is a scanner designed to allow orthotists to accurately evaluate deformational head shapes
for treatment with cranial remolding orthoses. I have obtained your name from the
Orthomerica STARscannerTM website list of available locations. I have no affiliation
with Orthomerica.
Please take a few minutes to fill out an eight question survey regarding your perceived
effects of the Orthomerica STARscannerTM on the orthotic practice. Your survey results
will be kept anonymous.
Thank you for your time.
Sincerely,

Kristin Lewis
Orthotic Resident

Artisan Orthotic-Prosthetic Technologies, Inc

19365 SW 65th Ave, Suite 210
Tualatin, OR 97062
Aoptinc.com
Phone: (503) 885-9448
Fax: (503) 885-9398

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Appendix B

Please check the most appropriate box regarding the following statements.
The survey may be returned in the enclosed envelope or faxed to (503) 885-
9398. Thank you for your participation.
1. Which impression method did you use before utilizing the
STARscannerTM?

Hand cast, plaster

Hand cast, fiberglass

Measurements

Other scanner

2. Which impression method is more time efficient during the evaluation

of the patient?

Previous method

STARscannerTM

No noticeable difference

3. Which impression method is more time efficient during fabrication of

the cranial remolding orthoses?

Previous method

STARscannerTM

No noticeable difference

4. Which impression method requires less modification to the cranial

remolding orthoses at the time of initial fitting?

Previous method

STARscannerTM

No noticeable difference

5. Which impression method requires less re-fabrication of the cranial re-

molding orthoses due to an unacceptable initial fitting of the cranial
remolding orthoses?

Previous method

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 STARscannerTM

No noticeable difference

6. Which impression method produces more correction of cranial

deformation during treatment using a cranial remolding orthoses?

Previous method

STARscannerTM

No noticeable difference

7. Do you send the STARscannerTM summary report to referring

physicians?

Yes

No

8. Has the number of referrals for cranial remolding orthoses changed

since you began utilizing the STARscannerTM?

Increased with STARscannerTM

Decreased with STARscannerTM

No noticeable difference

References

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Molding helmet therapy in the treatment of brachycephaly and plagiocephaly.
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2. Brunner TW, David LR, Gage HD, Argenta LC. Objective outcome analysis of soft
shell helmet therapy in the treatment of deformational plagiocephaly. Journal of
Craniofacial Surgery 2004 July:15(4):643-650.

3. Hutchison BL, Hutchison LAD, Thompson JMD, Mitchell EA. Plagiocephaly and
brachycephaly in the first two years of life: a prospective cohort study. Pediatrics
2004 Oct; 114(4):970-980.

4. Biggs WS. The ‘epidemic’ of deformational plagiocephaly and the American Academy
of Pediatrics’ response. Journal of Prosthetics and Orthotics 2004;16(4):S5-S8.

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Management of deformational plagiocephaly: repositioning versus orthotic therapy.
Journal of Pediatrics 2005 Feb;258-262.

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