Over the past decade, physicians, practitioners, and engineers have worked hard to establish the foundation for treating patients with deformational plagiocephaly. In 2004, a work group of the Institute for Clinical Systems Improvement (ICSI) wrote a technical assessment abstract on the subject. (The group consisted of two plastic and rehabilitative surgeons, a physical medicine and rehabilitation physician, and an orthotic/prosthetic lab manager.) By reviewing current literature and practical experience, the team concluded that cranial orthoses are safe and effective in reducing cranial asymmetries.1
The objective of this article is to present findings regarding treatment protocols for deformational plagiocephaly based on the current literature and on a comprehensive survey of 17 orthotic practitioners at various centers nationwide. The survey's 19 questions covered treatment duration, wearing schedules, frequency of follow ups, fitting and follow-up adjustments, variables affecting outcomes, and multiple orthoses.
PURPOSE AND USE OF CRANIAL ORTHOSES
The goal of a cranial remolding orthosis is to inhibit growth in some areas of an infant's skull and enable growth in others, thus improving cranial asymmetry and/or shape.2–4 Orthoses could also prevent infants from lying on the skull's flattened side, thus inhibiting further asymmetric development.4
Cranial orthoses are the only orthoses that require U.S. Food and Drug Administration (FDA) 510(k) clearance. Those in use today are designed to apply passive pressure to prominent and/or normal regions of the cranium while allowing space for growth of flattened regions.1 Cranial orthoses must be adjusted as a patient's head shape changes.1 Both helmet and band-type designs are made of varying materials and features, including closed or open top trims. The earlier an infant begins treatment, the greater the likelihood of attaining a head shape within normal limits.5
Using a cranial orthosis is contraindicated for patients with unshunted hydrocephalus and patients with craniosynostosis except in as-yet-undefined adjunctive treatment.1
LENGTH OF TREATMENT
The typical length of treatment for plagiocephaly is anywhere from 6 weeks to 6 months.2 In 1998, Littlefield et al.5 found that the mean duration for 750 patients was 4.3 months, with an average starting age of 6.9 months. Factors affecting correction include age at beginning of treatment, type and severity of deformation, and caregiver compliance with the treatment program.
Consensus indicated that the average length of treatment is 3 to 5 months (Figure 1). Some practitioners noted that treatment length could increase (to 5–6 months) when patients are 12 months and older.
AGE AT INITIATION OF TREATMENT
Cranial orthoses are approved for use on infants, aged 3 to 18 months, with moderate to severe deformational plagiocephaly who have not shown improvement after at least 6 to 8 weeks of repositioning therapy (less than 6 months of age).2 The best results have been observed in infants aged 4 to 12 months as a result of greater malleability of the skull and rapid brain growth during that period.6
The consensus range was slightly tighter than the literature with 4 to 8 months seeming to be optimal (Figure 2).
Although starting treatment at 3 months of age is not contraindicated, the practitioner could experience two challenges. The first is an increased chance that two orthoses will be necessary to achieve optimal results. This is the result of the occipitofrontal circumference being smaller, thus accommodating less growth. The second challenge is an increase in fitting issues resulting from lack of head control.
When treating patients 12 months and older, it is important to initially express realistic expectations to caregivers. Discuss the reduced chance of achieving optimal correction, the extended duration of treatment, and the higher probability that patient will try to remove the orthosis.
THE EFFECT OF TORTICOLLIS ON AVERAGE LENGTH OF TREATMENT
At present, the FDA requires that the practitioner must verify that torticollis is being treated, if diagnosed. In many craniofacial centers, torticollis is treated aggressively. Survey respondents found that if torticollis is resolved, it is unlikely to affect the duration of cranial orthosis treatment. If torticollis is unresolved, practitioners could increase the duration of cranial orthosis treatment by 2 to 4 weeks as a prophylactic measure. In contrast to plagiocephaly, as a result of the symmetric nature of brachycephaly, there is usually no associated frontal flattening, facial change, or neck involvement, including torticollis.2
FREQUENCY OF FOLLOW UP
A common schedule begins with a 1-week follow up after the initial fitting. This is an opportunity to discuss any questions the parents could have after experiencing use of the orthosis.
General consensus is every 2 weeks for patients less than 8 months of age and every 3 weeks for older patients. Infants with other underlying diagnoses and/or fitting issues could be seen on a weekly basis.
When providing caregivers with a written guide regarding treatment, it is beneficial to have a detailed wearing schedule, including the break-in period. In addition, address topics such as:
- Cleaning the orthosis;
- Donning and doffing the orthosis;
- Rash prevention; and
- When not to use, the orthosis (eg, if the child has a fever or is outside on a hot, humid day).
Typical Break-in Period
The consensus range for the break-in period went from none (orthosis worn full-time on the first day) to up to 7 days before full-time use (Figure 3). A common schedule is:
- Day 1: Wear for 1 to 2 hours, with a 30 minute- to 1-hour break between sessions; do not wear at nap time or overnight.
- Day 2: Wear for 2 to 3 hours with a 30-minute break between sessions; do not wear at nap time or overnight.
- Day 3: Wear for 3 or 4 hours with a 30-minute break between sessions; wear throughout naps and overnight.
- Day 4: Wear full-time; check the patient's head every 3 to 4 hours and provide a 30-minute break if needed during the day (breaks are not needed overnight).
AVERAGE WEARING SCHEDULE
Patients typically wear cranial orthoses 22 to 23 hours a day for 6 weeks to 6 months.2 Off-time is used for bathing and hygiene.
It is believed the orthosis is essentially correcting while the infant's head is growing. If the infant's head growth is at a plateau, the head shape is not redirecting. Although generalized data regarding head circumference exist,7 there is no way to know exactly when growth occurs. Therefore, having a full-time schedule captures the redirection of growth to the fullest.
DISCONTINUATION OF THE ORTHOSIS
In one study of 285 patients, anthropometric measurements taken 18 and 24 months after treatment showed that correction remained stable with no regression or further improvement.5
Survey respondents commonly discontinue orthosis use, without weaning, at the end of treatment (when head shape falls within normal limits). In patients with unresolved torticollis and same-side sleeping patterns, however, respondents often continued using the orthosis for 2 to 4 weeks after treatment would otherwise have ended.
FITTINGS AND FOLLOW UP
The synarthrodial joints crossed include sutures relating to growth rather than motion. The practitioner must balance appropriate trims with enough length to allow for growth. Also consider the amount of relief–void area to achieve optimal outcomes, with an ability to maintain suspension.
Common points of focus during a fit include:
- Maintenance of good suspension/purchase on the infant's cranium (<1-cm movement);
- Appropriate trim to eyebrows, following outline of ears, and as low as possible in the occiput;
- Accommodation of the trapezius if head tilt is present;
- No redness noted after wear time of 15 minutes; and
- Rotation is controlled by total contact of temporal extensions and by adding contralateral mastoid pads if needed (eg, for right frontal lobe rotation, add a left mastoid pad).
STANDARD ADJUSTMENTS DURING TREATMENT
At the initial fit, adjustments are provided to maintain suspension, eliminate red areas (if any), and provide proper clearances. As the infant grows into the orthosis, the adjustments shift to accommodating growth while still maintaining total contact for passive correction. It is the practitioner's responsibility to adjust the orthosis to the maximum of its limits, thus reducing the probability of requiring a second orthosis.
VARIABLES AFFECTING OUTCOMES
The extent of the correction that can be achieved is dependent on several factors, including the age of child when entering treatment, type of deformity, severity of initial deformity, and compliance of the treatment protocol.5
CORRELATION BETWEEN AGE AND LENGTH OF TREATMENT
The earlier an infant presents for treatment, the greater the likelihood of catching periods of rapid brain growth, resulting in a significant increase in the correction achieved.5 There was complete consensus that age at the onset of treatment had a direct correlation to the length of treatment.
CORRELATION BETWEEN SEVERITY AND LENGTH OF TREATMENT
To date, there is no clear definition of what constitutes mild, moderate, or severe plagiocephaly.6
In general, there was consensus on the severity of the head shape increasing length of treatment. Treating severe shapes at 4 to 6 months appeared to achieve a head shape within normal limits in a shorter time versus onset of treatment at older ages. A patient with severe plagiocephaly is less likely to achieve a normalized head shape and has increased chance of requiring multiple orthoses.
CORRECTION POTENTIAL AND DIFFICULTY OF FIT
Deformational plagiocephaly encompasses three head shapes: plagiocephaly (oblique), brachycephaly (short and wide), and dolichocephaly (long and narrow). A chart review of 254 diagnosed patients by Miller and Clarren8 found flat right occiput (plagiocephaly) in 63%, flat left occiput in 28%, bilaterally flat occiput (brachycephaly) in 7% and 2% unknown. Teichgraeber et al.10 found that, overall, head shapes normalized in children with posterior plagiocephaly, but not in children with brachycephaly, despite statistically significant improvements.
Survey respondents generally agreed that plagiocephaly has the best correction potential (Table 1) and is easiest to fit (Table 2). They considered brachycephaly more difficult to fit and less likely to be fully correctable. Among the practitioners who have had experience with dolichocephaly, responses showed a reduced correction potential.
Variations in head shape and other factors (eg, types of orthoses, practitioners, and modification styles) make it difficult to categorize outcomes in this area. This consensus relates only to head shapes and represents only practitioner opinion.
In the majority of cases, the parents and clinicians find the corrected head shape acceptable at the end of the first orthosis. A second orthosis is rarely required but could be used in very severe head deformations, unusual circumstances (illness-negated use or if the child has serious health and/or positioning issues), or unusually high expectations of the family.
Criteria for determining a second orthosis include:
- Despite every effort, the orthosis becomes ill-fitting or leaves little or no room for new growth;
- If age and severity indicate another orthosis and parents are willing to continue; and
- If prescribed for use as a continued postoperative adjunct or for preventative measures.
Regardless of the design, cranial orthoses are safe and effective in reducing cranial asymmetries and show no evidence of regression after treatment.5,9 Cranial orthoses are typically worn 23 hours per day for a period of 6 weeks to 6 months, with an average of 4.3 months' duration. The average age range for initiating treatment is 4 to 12 months. The optimum age range is 4 to 8 months. A common follow up is 1 week after the fit and then every 2 weeks. Goals of a fit include maintaining good suspension with room for growth, appropriate trims, no redness after 15 minutes' wear time, and control of rotation. Although not conclusive, age and severity appear to have the most significant of effect on treatment outcomes.
The author thanks those who responded to the Practitioner Consensus Survey for the purposes of informing this paper: Deanna Fish, CPO; Rob Kistenberg, CP, FAAOP; Dulcey Lima, CO, OTR/L; Joe Terpenning, CO; Tim Littlefield, MS; Bill Barringer, CPO; Paulette Hamblin, CO; Ellie Dias, CPO; Aaron Sorenson, CPO; Charles Kuffel, CO; Laura Plank, CO; Cindy Fox, CPO, FAAOP; Georgia Lallas, CO; George Gent, CO; Patti Larkin, CO; Stephen Fletcher, CPO; and Paul Richey, CPO.
Special thanks also to Robert Wood, MD; to the original cranial orthosis team at Gillette Children's Specialty Healthcare (David Ellis, CP; John Valeri, CO; Kathy Molina, orthotist; Kathy Kuykendall, technician; and Tim Matthees, RTO); and to Gillette's current team of orthotic practitioners and technicians.
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2. Neufeld S, Birkett S. What to do about flat heads: preventing and treating positional occipital flattening. Axone
3. Littlefield TR. Food and Drug Administration regulation of orthotic cranioplasty. Cleft Palate Craniofac J
4. Biggs WS. Diagnosis and management of positional head deformity. Am Fam Physician
5. Littlefield TR, Beals SP, Manwaring KH, et al. Treatment of craniofacial asymmetry with dynamic orthotic cranioplasty. J Craniofac Surg
6. Persing J, James H, Swanson J, et al. Prevention and management of positional skull deformities in infants. American Academy of Pediatrics Clinical Report. Pediatrics
7. Nellhaus G. Composite international and interracial graphs. Pediatrics
8. Miller RI, Clarren SK. Long-term developmental outcomes in patients with deformational plagiocephaly. Pediatrics
9. Wood RJ, Elwood ET, Petronio JA. Experience with a new FDA approved cranial orthosis: the craniocap. Presented at the Ninth International Congress of the International Society of Craniofacial Surgery; Visby Gotland, Sweden; June 17–20, 2001.
© 2004 American Academy of Orthotists & Prosthetists
10. Teichgraeber JF, Seymour-Dempsey K, Baumgartner JE, et al. Molding helmet therapy in the treatment of brachycephaly and plagiocephaly. J Craniofac Surg