Comparative analysis of goal attainment for helmet therapy versus conservative management for positional plagiocephaly in infants

Bjoern Vogt; Ariane Deutschle; Georg Gosheger; Adrien Frommer; Andrea Laufer; Henning Tretow; Robert Roedl; Gregor Toporowski

doi:10.3345/cep.2025.01102

Clin Exp Pediatr > Volume 68(11); 2025

Vogt, Deutschle, Gosheger, Frommer, Laufer, Tretow, Roedl, and Toporowski: Comparative analysis of goal attainment for helmet therapy versus conservative management for positional plagiocephaly in infants

Original Article

General Pediatrics

Comparative analysis of goal attainment for helmet therapy versus conservative management for positional plagiocephaly in infants

Bjoern Vogt, MD^1,^*

, Ariane Deutschle^1,^*

, Georg Gosheger, MD², Adrien Frommer, MD¹

, Andrea Laufer, MD¹

, Henning Tretow, MD¹, Robert Roedl, MD¹

, Gregor Toporowski, MD¹

¹Pediatric Orthopedics, Deformity Reconstruction and Foot Surgery, Muenster University Hospital, Muenster, Germany

²General Orthopedics and Tumor Orthopedics, Muenster University Hospital, Muenster, Germany

Corresponding author: Gregor Toporowski, MD. Pediatric Orthopedics, Deformity Reconstruction, and Foot Surgery, Albert-Schweitzer-Campus 1, 48149 Muenster, Muenster University Hospital, Germany Email: Gregor.Toporowski@uni-muenster.de

^* These authors contributed equally to this study as co-first authors.

Received May 17, 2025 Revised July 2, 2025 Accepted July 4, 2025

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Clinical and Experimental Pediatrics 2025;68(11):892-900.

Published online: October 2, 2025

DOI: https://doi.org/10.3345/cep.2025.01102

Abstract

Background

Positional plagiocephaly (PP) is a common cranial asymmetry of infancy. Its treatment options include conservative management and helmet therapy. However, the efficacy of each, particularly at achieving a normal cranial shape, remains uncertain.

Purpose

This study aimed to compare the efficacy of conservative management and helmet therapy for PP.

Methods

We retrospectively analyzed 199 infants with PP treated in 2015–2024. A total of 72 patients with a minimum treatment duration of 90 days and minimum plagiocephaly severity level of 2 (Children's Healthcare Atlanta Plagiocephaly Severity Scale) were included. Of them, 36 received conservative management and 36 received helmet therapy. Each infant underwent three-dimensional surface scanning of the cranium (StarScanner).

Results

The mean±standard deviation age at treatment initiation was 31.9±6.6 weeks in the helmet group versus 21.0±5.7 weeks in the conservative management group (P<0.001). The average treatment duration was 21.9 (interquartile range [IQR], 15.3–31.4) weeks vs. 20.6 (IQR, 14.1–26.6) weeks (P=0.171), respectively. The monthly correction speed of the cranial vault asymmetry index (CVAI) was comparable between groups (0.66±2.09 vs. 0.64±0.55, P=0.964). Plagiocephaly degree was reduced to level 1 in 9 of 36 patients (25%) who received helmet therapy versus 4 of 36 patients (11%) in the conservative management group (P=0.220), whereas a reduction in severity level was observed in 24 of 36 (67%) versus 15 of 36 (42%), respectively (P=0.058). In the helmet group, an earlier treatment initiation was significantly associated with a greater severity level reduction (r=-0.480, P=0.003). A longer treatment duration showed a trend toward a greater reduction in CVAI (r=0.331, P=0.052). In the conservative management group, both earlier treatment initiation (r=-0.537, P<0.001) and longer treatment duration (r=0.381, P=0.022) correlated significantly with improved outcomes.

Conclusion

Conservative management and helmet therapy reduced cranial asymmetry with no significant difference in correction speed. An early treatment initiation was the strongest predictor of improvement, while a longer treatment duration was associated with better outcomes. A trend toward a greater reduction in severity level was observed with helmet therapy, suggesting its potential benefits in more severe cases.

Key words: Plagiocephaly, non-synostotic; Orthotic devices; Skull abnormalities; Infant; Physical therapy modalities

Key message

Question: Is helmet therapy more effective than conservative management in treating positional plagiocephaly?

Finding: Both approaches reduced cranial asymmetry with comparable correction speed. Helmet therapy showed a trend toward greater severity reduction.

Meaning: Early treatment initiation was the strongest predictor of improvement. Helmet therapy may offer additional benefit in more severe cases.

Graphical abstract. CVAI, cranial vault asymmetry index.

Introduction

Positional plagiocephaly (PP) is a cranial deformity resulting from prolonged external pressure on the skull, leading to asymmetrical head flattening while the cranial sutures remain normally developed [1-3]. Severe plagiocephalic occipital flattening is often accompanied by ipsilateral frontal bossing, as well as an anterior displacement of the ipsilateral ear and cheek [4,5]. Key risk factors for PP include male sex, supine sleeping position, prematurity, assisted delivery, torticollis, restricted head mobility, and insufficient prone positioning ("tummy time") [6,7]. Cranial deformation is generally considered a cosmetic condition [3,8]. Although developmental delays are often reported in affected infants, current evidence suggests that cranial asymmetry serves as an indicator of underlying developmental issues rather than being the direct cause of these delays [9,10].

In light of increasing parental awareness and the growing availability of private treatment options, the management of PP has gained not only medical but also socioeconomic relevance. In recent years, the prevalence of PP has risen significantly, partly due to the "Back to Sleep" campaign promoting supine sleep positioning to prevent sudden infant death syndrome [11,12]. Consequently, there has been a notable increase in demand for treatment.

Helmet therapy (cranial orthosis) is frequently offered in private healthcare settings. In the United States, associated costs typically range from $1,000 to $4,000, with insurance coverage varying widely by provider and policy [13]. Reimbursement policies for helmet therapy in Europe are heterogeneous: in the United Kingdom, cranial orthotic treatment for PP is not funded by the National Health Service due to its classification as a cosmetic intervention [14], whereas in the Netherlands, costs are typically reimbursed when prescribed by a medical specialist [3]. This regulatory variability across healthcare systems leads to unequal access and may impose a financial burden on families, depending on national coverage policies.

This rise has led to ongoing debate regarding optimal treatment strategies. While some studies suggest that physiotherapy and repositioning are sufficient in mild to moderate cases [15,16], others highlight the advantages of helmet therapy, particularly in more severe deformities, as it may offer faster and more consistent correction [17-19].

Despite the widespread use of both approaches, a clear consensus regarding their comparative efficacy remains lacking. Some studies report similar correction outcomes between conservative and helmet therapy [3], while others suggest superior results with helmets in moderate to severe cases [20]. This study aims to provide a systematic comparison of both treatment modalities in infants with PP, focusing on correction speed, overall treatment success, and factors influencing outcome variability.

Methods

1. Study design and patient selection

This single-center retrospective cohort study was conducted on infants with PP who underwent treatment between 2015 and 2024 in the Department of Pediatric Orthopedics of Muenster University Hospital. The study was performed according to the WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects and approved by the Institutional Review Board of the University Münster (reference number: 2023-636-f-S). Since only anonymized retrospective data were analyzed and no identifiable patient information was published, informed consent for publication was not required. Inclusion criteria included: (1) a confirmed diagnosis of PP; (2) initial severity of at least level 2 according to the Children's Healthcare of Atlanta plagiocephaly severity scale [21]; (3) a treatment duration of ≥90 days; and (4) the presence of an open anterior fontanelle.

Children with congenital cranial dysplasia or early-onset craniosynostosis were not included in the study.

A total of 199 infants were initially identified, of whom 72 met the inclusion criteria (49 males, 68%). These patients were divided into 2 groups: 36 infants who underwent conservative management (physiotherapy and repositioning) and 36 who underwent helmet therapy. The study findings are reported according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines (Fig. 1) [22].

Patients with treatment duration of less than 90 days were excluded to ensure reliable outcome analysis and to avoid bias due to insufficient therapeutic exposure. In many of these cases, families discontinued treatment or follow-up after the initial consultation, as they were reassured that PP is primarily a cosmetic condition without neurological consequences in most cases [3]. For many parents, the prospect of improvement through natural skull growth and consistent repositioning was sufficient, and no further intervention was desired. The exclusion criteria were predefined and applied consistently.

All patients initially received conservative management for at least 6 weeks. Families were offered helmet therapy if asymmetry of level 2 or greater persisted, indicating insufficient improvement. Families who declined helmet therapy—due to financial aspects, aesthetic concerns, or personal preference—continued conservative management and were analyzed in that group (Fig. 2). Group allocation was therefore based on cranial shape and parental decision. The initial six-week phase was included in the total treatment duration in both groups.

2. Classification

All patients underwent clinical examination and three-dimensional stereophotogrammetrical cranial surface scanning using the StarScanner (Orthomerica, USA) (Fig. 3). The severity of PP was classified according to the Argenta classification and the Children's Healthcare of Atlanta plagiocephaly severity scale [4,21]. Age at treatment initiation, treatment duration, and correction rates were recorded. The primary treatment goal was defined as achieving level 1 severity according to the Children's Healthcare of Atlanta plagiocephaly severity scale. Additionally, changes in the cranial vault asymmetry index (CVAI) and severity levels were analyzed before and after treatment.

3. Treatment methods

All patients initially received conservative management for at least 6 weeks, consisting of structured physiotherapeutic interventions and guided repositioning strategies. Physiotherapy was delivered by certified pediatric physiotherapists using Vojta or Bobath techniques, depending on the individual motor development of the infant [23,24]. Parents were educated in positioning techniques to minimize pressure on the flattened area of the skull, increase prone positioning during wakefulness, and stimulate active head rotation. Physiotherapy sessions occurred weekly and were supplemented by daily exercises at home.

After 6 weeks, all patients underwent re-evaluation. Families were offered helmet therapy if no sufficient improvement was observed—defined as persistence of a cranial asymmetry ≥ level 2 (Fig. 2). In Germany, helmet therapy is not routinely reimbursed by statutory health insurance providers. The following protocol was applied if caregivers agreed to the proposed helmet treatment.

A custom-made remolding cranial orthosis was fabricated using three-dimensional cranial surface data obtained via the StarScanner. Scans were used by certified orthotists to generate a digital model of the infant's skull, serving as the basis for the computer-assisted design of the helmet. The orthosis consisted of a lightweight thermoplastic shell with a foam lining that permitted growth in the flattened regions while restricting expansion in areas of prominence, thereby guiding symmetrical cranial development [25].

Helmet therapy was applied for 23 hours per day. Compliance with helmet therapy was assessed at each follow-up visit by caregiver reporting. A daily wearing time of 23 hours was consistently achieved by all included patients. There were no cases of treatment discontinuation due to non-compliance. Only patients with sufficient adherence were included in the final analysis.

Adjustments to the orthosis were performed only when clinically indicated, based on physical examination findings. In such cases, additional 3-dimensional (3D) cranial surface scans were obtained to guide helmet modification and ensure optimal fit and therapeutic effectiveness. In the absence of required adjustments, follow-up evaluations were conducted every 3 months using cranial 3D scanning until the closure of the anterior fontanelle. Caregivers were instructed in hygiene management, wear schedule, and monitoring for skin pressure marks or irritation. Conservative measures such as physiotherapy and repositioning were not continued after initiation of orthotic treatment.

The conservative group received ongoing physiotherapy and positioning guidance throughout the entire treatment period. The initial six-week phase was included in the total treatment duration in both groups.

4. Outcome measures

The primary outcome measure was the correction speed of cranial asymmetry, calculated as the monthly change in the CVAI. Secondary outcomes included (1) the absolute reduction in CVAI, (2) treatment success, defined as achieving level 1 severity, and (3) any reduction in severity level, regardless of target achievement. Additional analyses examined the relationship between treatment duration, age at treatment initiation, and outcome measures. Group comparisons were conducted to assess differences in treatment effectiveness between helmet therapy and conservative management.

5. Statistical analysis

Data were analyzed using the Shapiro-Wilk normality test to assess distribution. Continuous variables were reported as mean±standard deviation or median with interquartile range (IQR) depending on normality. Group comparisons were performed using an unpaired and paired Student t test for normally distributed data and the Mann-Whitney U test and Wilcoxon signed-rank test for nonnormally distributed data. Categorical variables were analyzed using Fisher exact test (2×2). Correlations between variables were assessed using Pearson correlation coefficient. A significance level of α<0.05 was applied. Statistical analysis was conducted using Prism, v8.4.3 (GraphPad, USA).

Results

1. Treatment initiation and duration

The mean age at treatment initiation was significantly higher in the helmet group (31.9±6.6 weeks) compared to the conservative management group (21.0±5.7 weeks, P<0.001). Median treatment duration was longer in the helmet group (21.9 weeks; IQR, 15.3–31.4 weeks) than in the conservative group (20.6 weeks; IQR, 14.1–26.6 weeks), but the difference was not statistically significant (P=0.100). The mean initial severity level was 2.7±0.8 in the helmet group and 2.5±0.6 in the conservative group (P=0.084). The mean terminal severity level was 1.9±0.6 in the helmet group and 2.0±0.4 in the conservative group (P=0.256).

2. Effectiveness of treatment

Both treatment modalities resulted in significant reductions in cranial asymmetry, helmet therapy by a mean of 0.9 levels (P<0.001) and conservative management by a mean of 0.4 levels (P=0.003) (Fig. 4). Patients treated with helmet therapy showed a significantly greater reduction in mean severity level than those receiving conservative management (mean reduction, 0.89±0.73 vs. 0.39±0.66; P=0.007). The average correction speed of the CVAI per month was comparable between groups (0.66±2.09 vs. 0.64±0.55, P=0.964). The treatment goal of achieving a severity level of 1 was attained in 9 of 36 patients (25%) of the helmet therapy group and 4 of 36 patients (11%) of the conservative management group (P=0.220). A reduction in severity level occurred in 24 of 36 patients (67%) of the helmet group and 15 of 36 patients (42%) of the conservative management group (P=0.058) (Table 1).

Earlier treatment initiation was associated with a reduced severity level in the helmet group (r=-0.480, P=0.003). Longer treatment duration showed a trend toward greater CVAI correction, however, the association did not reach statistical significance (r=0.331, P=0.052). In the conservative management group, treatment duration was significantly correlated with severity level reduction (r=0.381, P=0.022), and younger age at treatment initiation was strongly associated with improved CVAI correction (r=-0.537, P<0.001) (Fig. 5).

Minor side effects such as increased sweating, mild skin irritation, or initial discomfort were reported in several cases. No major complications occurred.

Discussion

The high prevalence of PP, between 5% and 46%, has led to ongoing debate regarding the optimal treatment strategy [26-28]. This has sparked discussions regarding the necessity of intervention, with treatment strategies ranging from simple repositioning to cranial orthotic (helmet) therapy. While helmet therapy is widely used, concerns about cost, compliance, and necessity persist [13,29,30]. Furthermore, the primary focus of these treatments is often cosmetic rather than functional, raising the question of whether helmet therapy provides measurable benefits beyond aesthetic improvement [31,32]. In Germany, helmet therapy is not reimbursed by statutory health insurance. The costs must be covered by the families and typically range between 1,800 and 2,500 euros. This may influence the decision to decline helmet treatment despite clinical indication. Additionally, as the prevalence of plagiocephaly decreases significantly with age, the risk of overtreatment must be considered [33]. Despite the widespread use of both conservative and helmet therapy for PP, consensus on treatment indications remains elusive [15,17-19,21]. Our study contributes to this discussion by comparing both treatment modalities and identifying key factors influencing treatment success.

In our study, helmet therapy and conservative management effectively reduced cranial asymmetry, with no significant difference in the correction rate. The average correction rate was 0.66 CVAI per month in the helmet group and 0.64 CVAI per month in the conservative group. Similar correction rates between 0.1 and 0.2 CVAI per week were also observed by Graham et al. [34]. In this study, both methods achieved a sufficient reduction in CVAI without a significant difference between the techniques. Kim et al. [35] also confirmed similar correction rates with helmet therapy.

Nevertheless, our findings indicate a trend toward greater correction with helmet therapy compared to conservative management, both in terms of achieving the therapeutic goal — reduction to level 1 — and overall severity level reduction. Moreover, the overall reduction in severity was significantly greater with helmet therapy compared to conservative management. Although treatment duration was slightly longer in the helmet group, this difference did not reach statistical significance (P=0.100), suggesting that the observed therapeutic effect is likely attributable to the intervention. Although not statistically significant, the treatment goal was achieved more often in the helmet group (25%) than in the conservative group (11%). Given the overall low success rates in both groups, it is essential to clearly communicate the therapeutic goal and the realistic possibility of complete correction of the deformity to all families. Similarly, the rate of severity level reduction was numerically higher with helmet therapy (67%) than with conservative management (42%), but this difference also did not reach statistical significance. A possible explanation for this trend is again the slightly longer median treatment duration in the helmet group (21.9 weeks) compared to the conservative group (20.6 weeks).

Helmet therapy is generally well tolerated. Minor side effects such as sweating or skin irritation have been described and were also observed in our cohort. These effects were mild and manageable with routine care. No serious adverse events occurred.

At the same time, it is important to consider that PP tends to regress spontaneously over time, with a significant reduction in prevalence during early childhood. Therefore, the extent to which spontaneous correction contributed to the observed improvements in both groups remains unclear. Van Wijk et al. [3] demonstrated that there was no difference between the correction achieved with helmet therapy over a six-month period and the spontaneous development of cranial shape when assessed at the age of 2 years. Similarly, Akutsu et al. [36] observed that while the prevalence of cranial asymmetry decreases with growth, severe deformities tend to persist. Consequently, the study group recommends helmet therapy for the treatment of more severe cases.

However, our findings indicate that early initiation of treatment plays a crucial role in achieving favorable outcomes. In the helmet group, an earlier start of treatment was significantly correlated with a reduction in severity level, and more extended treatment duration was associated with greater CVAI correction. Similarly, in the conservative group, a more extended treatment duration correlated with a greater reduction in severity level, while an earlier treatment initiation was associated with a more substantial reduction in CVAI. Early therapy initiation following an early diagnosis—resulting in longer treatment duration and, consequently, better correction outcomes—is recommended in the literature [37,38]. Weersma et al. [39] demonstrated significantly better treatment outcomes for plagiocephaly in infants aged 4 to 6 weeks compared to older children. However, the balance between treatment duration and patient adherence should be considered, as extended treatment periods may present challenges in compliance [30].

The strengths of this study include a well-defined patient cohort and the use of objective severity grading scales to assess treatment outcomes. However, certain limitations must be acknowledged. First, the retrospective nature of the study introduces inherent biases, such as variability in treatment adherence and physician recommendations. In addition, treatment allocation was influenced not only by cranial shape at re-evaluation but also by parental preferences and financial considerations. As helmet therapy is frequently not reimbursed by statutory health insurance in Germany, some families chose to continue conservative treatment despite persistent asymmetry. This may introduce a selection bias that needs to be taken into account when interpreting the results. Second, while our sample size is comparable to similar studies, larger multicenter studies are needed to validate these findings. Due to the limited sample size, multivariate analysis was not performed. Therefore, potential confounding factors such as age at treatment initiation or duration of treatment could not be fully adjusted for. Finally, long-term follow-up data were not available, which limits our ability to assess the persistence of treatment effects over time.

Conclusion

Both helmet therapy and conservative management effectively reduce cranial asymmetry in infants with PP, with no significant difference in the correction rate between the 2 approaches. Early treatment initiation emerged as the most important predictor of improvement, emphasizing the need for timely intervention. Longer treatment duration was also associated with better outcomes, suggesting that sustained therapy supports greater cranial symmetry correction.

While both treatment modalities proved effective, a trend toward greater severity reduction was observed in the helmet therapy group, particularly in more severe cases. However, given the natural decline in plagiocephaly prevalence over time, the potential risk of overtreatment should be carefully considered. Future research should focus on refining treatment algorithms to optimize patient outcomes and establish individualized care strategies for infants with plagiocephaly.

Footnotes

Conflicts of interest

B. Vogt reports grants or contracts from NuVasive/Globus and Smith & Nephew, and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events and support for attending meetings and/or travel from NuVasive/Globus, OrthoPediatrics, Smith & Nephew, BioMarin, Orthofix, Kyowa Kirin, and Merete, all of which are unrelated to this article. A. Frommer reports grants or contracts and support for attending meetings and/or travel from NuVasive/Globus, unrelated to this article. A. Laufer reports support for attending meetings and/or travel from BioMarin, NuVasive/Globus, and Implantcast, all of which are unrelated to this article. H. Tretow reports support for attending meetings and/or travel from NuVasive/Globus, Smith & Nephew, Orthofix, Kyowa Kirin, all of which are unrelated to this article. R. Roedl reports institutional grants or contracts from NuVasive/Globus, royalties or licenses and patents planned, issued or pending from Merete, and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from NuVasive/Globus, BioMarin, Kyowa Kirin, Vereinigung für Kinderorthopädie, Forum für medizinische Fortbildung, and Infectopharm, all of which are unrelated to this article. G. Toporowski reports support for attending meetings and/or travel from NuVasive/Globus, Smith & Nephew, Orthofix, Kyowa Kirin, all of which are unrelated to this article. The other authors have nothing to disclose.

Funding

This study received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Acknowledgments

We sincerely thank all infants and their families for participating and trusting in this study. We also acknowledge the dedicated support of the nursing and clinical staff in the Department of Pediatric Orthopadics at University Hospital Münster for their assistance in patient care and data collection.

Author contribution

Conceptualization: BV, AD, AF, GT; Data curation: BV, AD, HT; Formal analysis: BV, AD, AF, AL, HT, RR, GT; Methodology: BV, AD, AF, AL, RR, GT; Project administration: GG, AF, AL, HT, RR, GT; Visualization: BV, AD, AL; Writing - original draft: BV, AD, GT; Writing - review & editing: BV, AD, AF, AL, HT, RR, GT

Fig. 1.

STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) diagram detailing the study inclusion and exclusion criteria.

Fig. 2.

Treatment algorithm and decision process. All patients received an initial 6-week phase of conservative management. In cases of persistent cranial asymmetry (level ≥2), helmet therapy was offered. Families who declined helmet therapy continued conservative treatment. The end of treatment was defined as closure of the anterior fontanelle.

Fig. 3.

Sample stereophotogrammetric cranial surface scan using the StarScanner (Orthomerica, USA) (left); the corresponding examination results are displayed on the right.

Fig. 4.

Violin plots of severity levels before versus after treatment in the helmet therapy and conservative management groups. Significant reductions were observed in both groups after treatment (hatched areas). Medians are indicated by dashed lines. **P<0.01; ***P<0.001

Fig. 5.

Correlations among severity reduction, treatment initiation, treatment duration, and CVAI in helmet therapy and conservative management (Pearson r). CVAI, cranial vault asymmetry index.

Table 1.

Treatment parameters and outcomes of helmet therapy versus conservative management for positional plagiocephaly

Variable	Helmet therapy	Conservative management	P value
Treatment initiation (wk)	31.9±6.6	21.0±5.7	<0.001
Treatment duration (wk)	21.9 (15.3–31.4)	20.6 (14.1–26.6)	0.100
Initial severity level	2.7±0.8	2.5±0.6	0.084
Terminal severity level	1.9±0.6	2.0±0.4	0.256
Severity level reduction	0.89±0.73	0.39± 0.66	0.007
Goal achieved	9/25 (25)	4/36 (11)	0.220
Reduction in severity level	24/36 (67)	15/36 (42)	0.058

Values are presented as mean±standard deviation, median (interquartile range), or number (%).

Boldface indicates a statistically significant difference with P<0.05.

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