Plagiocephaly is an asymmetrical moulding of the head caused by external forces. It can be caused by a number of factors involving positioning such as extended time spent in a neonatal unit, the birth process, position in the womb and often the infant's preferred sleeping position. It can also be caused by a condition called torticollis. In this case, there is an asymmetry in the muscles on either side of the neck that flex the head, tip it toward the affected side and rotate the face to the opposite side. When one of these muscles is tight, it causes the baby to sleep primarily on one side, and the back of the head tends to flatten there. The entire side, including the ear, moves forward as the head assumes a parallelogram shape. In many cases, there is bulging of the forehead on the same side.

There is another condition called craniosynostosis that creates head shape deformation that can resemble deformational plagiocephaly. However, this condition is caused by premature fusion of the sutures of the skull. The skull can assume a very unusual shape if one or more of these sutures close before the child's brain achieves full growth. Neurosurgeons or plastic surgeons differentiate these two conditions based on physical examination, but more definitive tests like CT scan or MRI can clarify the diagnosis. If a child has craniosynostosis, surgery will be necessary to realign the plates of the skull and allow normal growth to occur. Infants with craniosynostosis should be seen by a specialist for this condition.

Deformational plagiocephaly does not affect the brain, and is not the cause of mental retardation, cerebral palsy, or seizures if not treated. Many ancient people including the Egyptians, Peruvian Indians, and Pacific Northwest Indian tribes used various methods to shape their baby's skulls. The infant skull is thin and malleable, and if babies spend extended time in one position the head can become deformed and asymmetrical. If the baby is less than 3-4 months of age and the asymmetry is mild, alternative positioning is recommended to get the baby to sleep with his/her head to the other side. Ways to achieve this include having the infant respond to toys and stimulation toward the opposite direction and "tummy time" during the day. Your doctor may also recommend stretching exercises if your child has torticollis. If repositioning and exercises are not effective, your physician may recommend a STARband™ cranial remolding orthosis.
If the plagiocephaly is accompanied by torticollis, the torticollis must be treated in conjunction with the orthotic treatment program.

The STARband™ is a lightweight, plastic and foam orthosis made from a 3-D scan of your infant's head. It is made of a plastic flexible shell lined with polyethylene foam, The foam can be modified over time to allow for growth and will provide a pathway for your infant's head to grow into a more symmetrical shape. The STARband™ allows your baby to sleep in any position he/she wants yet keeps pressure off the flat spots and constrains head growth along the axis of the prominent parts. It offers a simple and direct solution to the problem of deformational plagiocephaly and brachycephaly. Correction usually occurs within 2-3 months with patients beginning STARband™ treatment between 4 and 7 months of age. In older patients, longer treatment time is necessary.

We accept referrals in 3 ways.

1. Formal hospital referrals from consultant doctors or therapists with an official order to allow payment by the hospital.

2. Informal or private referrals from doctors or therapists.

3. Self referrals from the baby’s parents.

In all cases, initial and final scan reports will be sent to the baby’s doctor or consultant to allow referral back to the baby’s healthcare provider if necessary.

If your baby’s consultant agrees to the treatment he/she will sign a requisition or order for a STARband™ cranial remoulding orthosis.

Generally UK insurers do not reimburse for any orthosis unless it is part of an acute medical treatment or operation, however they have been known to pay for the clinical time associated with management of the orthosis. Each insurance company has different coverage and medical policy guidelines. It is best to contact your insurance company and/or employer benefits coordinator to determine the type and level of coverage for orthotics.

This varies, but some parents have seen improvement after only 2 weeks of STARband™ use. Correction continues over time, and requires complete compliance to achieve the greatest degree of symmetry. Although there is often early visible improvement, the STARband™ must be worn by the baby for the full length of the treatment to gain the maximum benefit.

In most cases children adapt quite easily to the orthosis. As your infant begins to wear the orthosis, any concerns you may have can be addressed by your orthotist.

The STARband™ is cleaned with isopropyl alcohol (rubbing alcohol) on a soft cloth or small toothbrush. In some cases, a mild unpleasant scalp odour may develop. It is easily controlled with daily washing of the baby’s head with a mild shampoo. You may also remove the STARband™ for a couple of minutes during the day to towel or blow-dry your baby’s head and band. The STARband™ may also have a mild chemical smell that dissipates within a day or two.

Yes. In most cases, your child will need frequent STARband™ adjustments by the orthotist. Contact your orthotist sooner if the STARband™ seems tight or you notice any problems. The referring physician may wish to see the child periodically during STARband™ treatment to evaluate progress.

The decision to discontinue wearing the STARband™ should be made by the physician in conjunction with the orthotist. The orthosis has done its job when the head rounds into the symmetrical shape of the STARband™, or when the head shape has changed to an acceptable degree of symmetry and has outgrown the STARband™.

Most infants complete the STARband program with a single orthosis. In cases of moderate to severe deformational plagiocephaly it is possible to outgrow the STARband™ before all possible correction may be achieved. If this happens, the physician, orthotist and parents play an active role in determining if another orthosis is appropriate. Any additional orthosis will require new order/payment before proceeding.

It is not common for the head shape to revert back to its original shape. As children get older, they spend more time sitting, crawling and walking which minimizes the amount of time they spend on their backs. In fact, further skull shape improvement may occur over time. If your child was diagnosed with torticollis it may be necessary to continue the stretching program to maintain correction achieved by the STARband™.

Yes. The STARband™ is produced by Orthomerica Products Inc. which received its FDA clearance to market and manufacture STARband™ cranial remoulding orthoses in July 2000. The STARband™ is regulated as a Class II orthotic product which regulates the manufacturing methods, materials, record keeping, caregiver information and medical professional information requirements.

Orthotists are medical professionals in their own right. All orthotists are dual trained as
prosthetist /orthotists and are educated for 4 years at degree level in all aspects of anatomy, physiology, biomechanics and orthotic manufacturing and application. After qualification there is a one year internship before an orthotist / prosthetist is fully prepared to work independently. All cranial remoulding orthoses are regarded as highly complex orthoses.

Other professional groups may be able to advise on and fit the more simple orthotic device, but their training does not specifically cover any aspect of orthotic management. In the UK it is very unusual for example for a doctor or surgeon to be involved in orthotic management. Doctors prescribe, surgeons operate, orthotists manage orthoses.

Yes, there are about 30 STARscanner sites. All except for the 3 that are in the UK and associated with Technology in Motion are in the USA. All scanner sites and orthotists keep in contact and compare their experiences. There is an annual scanner seminar at which all orthotists who are involved in STARband™ cranial remoulding are invited to share experience and develop their skills. The STARscannner™ is a CE marked electronic device licensed for safe use in the EU.

The ideal age to start treatment is 4 to 7 months, but remoulding can be started up to about the age of 14 months. Generally, better results are achieved within a shorter time if started as soon as possible as the head is growing faster and the bones and sutures are more flexible when the baby is younger.

We will see you for a no obligation assessment free of charge. If you decide to enter treatment the total cost is £1950.

If you would like us to give you an indication of whether we think that your baby would benefit from STARband treatment, please Email them to smottram@ossur.com and we will answer by return.

Each type of helmet is made by a different manufacturer, to its own specification, to work to redirect growth to improve head shape. They all use different thickness and strengths of material, and different modifications to the original head mould or scan to achieve this. When we specify the desired modifications for STARband treatment, we are working not only to improve asymmetry, but also to improve the width to length ratio to bring about greater normality in the overall head shape. Unlike other orthoses available, every STARband has a thicker 10 to 12mm liner, which we modify to allow continuation of correction as treatment progresses. We also often specify that additional liner material is added to give us room for greater improvement where we need it. With these two unique attributes, we make sure that the majority of babies treated only require a single STARband to achieve the correction required for a more normal head shape.

Unlike cranial remoulding orthoses manufactured in the UK and Europe, the American FDA (Food and Drug Administration) has recognised that cranial remoulding must be safe and requires strict regulation. When assessing a supplier, the FDA is tough in its requirements and policing before granting approval to manufacture an orthosis. All aspects of research, development, recommended treatment regimes, and all aspects of manufacture and outcomes by way of improvement in head shape are assessed and monitored. Scans and records must also be kept for several years. If any area is not to standard, they will close the manufacturer down without warning. We are happy to be working with one of the largest and most highly respected orthotic manufacturers in the USA and follow the regulations and guidelines laid down by the FDA, even though we do not need to here in the UK. We do this because we know that these regulations are put into place for the safety and assurance of parents and their babies. We are active in seeking similar regulation in the UK and are dismayed that such regulation is not forthcoming here.

There are two main types of scanner, the fixed type (the STARscanner) which uses four Class 1 lasers and eight cameras and the hand held type which uses a higher strength single, Class 2 laser with a single or double camera unit.

The STARscanner is verified to an accuracy of 0.5mm which allows a very accurate model to be fabricated. The STARscanners are maintained and checked regularly to ensure that this accuracy does not deteriorate and these checks are part of our ongoing protocols. This ensures that we work within the standards that the United states FDA demands (even though we don’t have to in the UK) knowing that in America these standards are rigorously policed for the safety of those using cranial remoulding. We do not know the working accuracy or the protocols surrounding the use of the hand held type.,

Because there are more cameras recording the data, the fixed type (STARscanner) can use a lower strength Class 1 laser light which is safer for the baby’s eyes than the stronger Class 2 laser used in the hand held type. The extra cameras in the fixed type also allow a faster scan and because it operates automatically, (with an integral safety cut out as standard) there is no danger from operator error or concerns from the baby turning to look into the light causing the laser light to dwell on the baby’s eyes.

We do not treat babies older than 14 to 16 months as by then the majority of head growth has occurred and the treatment requires growth to bring about change. We do occasionally continue a treatment to continue up to the age of 24 months if the baby is already with us and correction is continuing. We understand that there are other clinics in the UK which treat older infants but we regard this as unethical practice as we believe that parents are given false hopes that correction will occur.

STARband treatment is highly regulated by the FDA and because of the inability to gain correction at an older age treatment is not permitted within these regulations. Although the other clinics claim to be offering a service which complies with FDA regulations, they are essentially self regulating and not working within any external reference protocols which have been laid down for the safety of infants and to ensure that treatment is effective.