While STARband (Side-Opening Band) helmets are used in patients with brachycephaly and plagiocephaly, the STARband (Bi-Valve) is mainly preferred for the treatment of craniosynostosis-related head shape abnormalities. These include sagittal suture synostosis (scaphocephaly), metopic suture synostosis (trigonocephaly), coronal suture synostosis (anterior plagiocephaly), and for the treatment of deformational scaphocephaly. While the STARlight series is preferred in patients with plagiocephaly, the STARlight PRO is specifically used after endoscopic strip craniectomy.
Each active STARband cranial remolding orthosis is designed to meet the infant’s specific needs. The 3D head shape measurements taken with the STARscanner and the SmartSoc data acquisition system with 0.1% accuracy is sent to Orthomerica. Orthomerica is the world leader and pioneer in developing and manufacturing STARband helmets in the US since 2001.
STARband helmets are designed specifically to restore each infant’s head shape deformity to its normal shape. The goal of STARband treatment is to ensure that your baby's head grows in normal symmetry and proportion. It accomplishes this by pausing the growth in the prominent places of the babies' heads.
STARband helmets are designed to direct the rapidly growing head of the baby into the desired areas. STARband helmets are frequently controlled and modified when needed to support growth only in the void areas. Throughout the treatment, our technicians continuously monitor the baby's development and make necessary modifications to the STARband.
Besides corrective needs, STARband helmets can also be used for protection purposes. The Protective STARband Helmet is less expensive than standard corrective STARband family helmets. There is no age restriction for use of Protective STARband helmets manufactured by Orthomerica. Infants are not the only users of protective helmets. Children and adults who have undergone skull surgery, such as trauma, epilepsy or open (cranial vault remodeling) craniosynostosis also benefit from wearing protective helmets.
Active STARband cranial remolding orthoses is approved by the FDA (American Food and Drug Administration). The FDA gives its approval to the STARband family cranial remolding orthoses because of the effectiveness. In addition, these orthoses must be closely monitored in strict accordance with FDA regulations.
The first and perhaps most important condition that the FDA requires is that parents try traditional repositioning methods in the presence of deformities. In cases that show no response to repositioning, treatment with STARband family helmets is recommended. Several studies using STARband show that STARband is effective for the treatment of head shape abnormalities. With its superior design and manufacturing, STARband has a 95% success rate in correcting all kinds of head shape abnormalities with only one helmet.
The second condition required by the FDA is that no harm should be done to the neurological development of rapidly growing babies. STARband helmets do absolutely no harm to the normal head growth and development of infants. In research done with STARband, normal development of head circumference and neurological development were seen.
The FDA also requires that there should be no harm to the skin of babies caused by the material used, the measurements, the design, the manufacturing, or user error. The materials used in STARband helmets are hypoallergenic. Moreover, STARband is designed based on careful calculations of each baby’s head circumference, growth, and asymmetry. In addition, STARband ensures that babies will receive comfortable treatment without pressure or irritation to their skin with the accurate measurements taken by the STARscanner and SmartSoc scanning systems.
The FDA considers it necessary to estimate and control the skin and growth development with comparative reports throughout the treatment.
STARband helmet treatment is FDA approved since it meets the strict requirements and controls mentioned above.
With the STARband treatment, deformities can be corrected even if they are extremely severe. Moreover, this is achieved with only one helmet. There is no need for a second helmet. STARband starts working to correct the overall asymmetry of the head immediately. Thanks to its unique design, the STARband begins the correction process as soon as it is fitted on the very first day. The correction of asymmetry is clearly seen on the STARscanner or the SmartSoc scan report.
STARband can only be fitted to patients less than 3 months old who have undergone surgery.
Patients with hydrocephaly cannot be fitted with the STARband unless the infant is stabilized with a shunt. After the growth is stable with a working shunt, the STARband can be fitted.
Babies with craniosynostosis cannot be fitted with STARband prior to having surgery. The closed suture must be opened with endoscopic-assisted strip craniectomy surgery. After surgery, these infants may be fitted with STARband.
General criteria to initiate STARband treatment;
It can be fitted in infants between 3-18 months.
It is ideal to start between 4-6 months.
It is not ideal to start after 12 months.
If the severity of the deformity is moderate, first exercises, prone activities and repositioning should be exhausted for 1-2 months until 6 months of age.
If the deformity is severe, STARband treatment should be started immediately.
The STARband helmets are not used for infants less than 3 months old and older than 18 months.
Before 3 months of age, infants do not have enough neck control to wear STARband. That is why one of the most important conditions for infants with deformational head shape abnormalities is to begin treatment with STARband at 3 months of age. Use of the STARband helmet is only allowed for babies younger than 3 months of age if they have undergone surgery due to craniosynostosis. STARband is required after endoscopic-km, assisted strip craniectomy.
STARband can be worn until 18 months of age. This is because no significant growth is seen in the skull after 18 months. The brain has completed almost 90% of its growth at this age. The sutures between the bones in the skull are almost closed. Due to these reasons, after 18 months, there is no significant correction obtained from STARband treatment.
Regardless of the severity of the head shape deformity, helmet therapy for infants should be initiated between 4-6 months. As stated previously, helmet therapy should be started at 3 months at the earliest. In research, it is emphasized that helmet treatment should be started before the 6th month to obtain the expected results. Since babies begin to spend less time lying on their backs or turning around and sitting on their own after their 4-6th month, activities such as repositioning are no longer effective. When there is no response or insufficient response from these activities prior to 6 months, helmet treatment is the last resort to correct head shape deformities.
To achieve the targeted improvement, it is important to start the treatment sometime between 4-6 months, depending on the severity of the deformation. In the following section, the relationship between severity and age, in months, is described in a more detailed way.
The response from helmet treatment is limited when it is started after the 10th month, and especially when it is started after the 12th month. Therefore, no target can be set especially for severe head shape abnormalities. Also, the duration of helmet treatment is prolonged.
Waiting for a head shape deformity to correct on its own by the 12th month will result in time wasted for the helmet treatment. Every day that passes after the 6th month results in moving away from the expected correction and prolonging the treatment, especially with severe deformations. Therefore, it is recommended to monitor the progression of the deformation with objective, comparative screening reports as soon as the skull deformity is recognized.
When skull deformities are first noticed by parents or doctors, infants should be scanned for severity. As a follow up, additional scans should be taken for comparison. After determining the severity with the STARscanner or the SmartSoc scanning systems, if the deformity is moderate, the priority is to monitor it up to 6 months of age. Research recommendations are to try methods such as repositioning, tummy time activities and stretching exercises for infants with skull deformities for about 1 or 2 months. According to research and articles in pediatric publications, the help of a physiotherapist is needed to relieve tight neck muscles, which should be initiated at the age of 2 months.
If diagnosed in the early months, a moderate head shape deformity is likely to be corrected with the above methods. As the months go by and the closer you get to the 6th month, it becomes more difficult to see enough improvement. Babies who reach their 6th month can no longer be positioned because they start to roll over on their own and sit without any support. Therefore, methods such as repositioning are not beneficial. Although it is thought that the deformity will get better when a baby starts to sit, on the contrary, it will not. After this point, the severity of the deformity generally does not improve.
The deformity of infants' heads mainly starts in the earlier weeks. In time, it graduality increases. Head shape deformities are caused due to the malleability of the bones of the skull, prolonged lying on the same side in the supine position, the force of gravity, and the growth of the brain. The deformity can also be corrected the same way by the force of gravity and brain growth. This time the supine position of the head in the opposite direction helps to fix the deformity. In this way, gravity, which caused the head shape deformity in the first place, helps to eliminate the deformation of the head in the opposite direction this time. This can only be achieved if the baby is positioned on its back. Gravity has no effect on the head of a baby who starts to roll over and can sit down on its own. That is why the deformity does not change after about 4-6 months of age. The skull and the brain inside continue to grow globally.
If no response is obtained from repositioning, from doing prone activities and from doing other exercises in the 6th month, helmet treatment remains the only solution to correct the head shape deformity.
Helmet treatment should be started immediately in infants with severe head shape deformities without attempting to do repositioning. Studies have shown that it is extremely difficult to get the deformity down from severe to below moderate through repositioning. Babies who have severe deformities, especially after 3 months of age, must start helmet treatment at the earliest time. If started early, the success of correcting a head shape deformity is high, almost guaranteed. It is even possible with very severe deformities. In addition to this, the duration of the treatment is also significantly reduced.