KidCap and Plagiocephaly FAQs

KidCap and Plagiocephaly FAQs

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Questions for Physicians and Parents

Yes. The cranial molding orthosis designed and manufactured by Infinite Technologies (formerly Infinite Technologies and Eastern Cranial Affiliates) has received 510(k) clearance from the FDA . Our clearance number is K020448 and we have recently named our device the KidCap™ for Helmet Therapy.

The 2-Dimensional Cranial Mapping Analysis is an innovative assessment tool designed by the practitioners at Infinite Technologies. This system utilizes geometric principles to assess specific regions of the skull for asymmetry. Using this hand measurement system, asymmetry can be identified and quantified within 2mm.

The measurements from the 2-Dimensional Cranial Mapping Analysis are combined with the 3-dimensional image to create the most accurate and effective KidCap for each patient. Each KidCap is customized to meet the patient’s specific and unique goals for correction; a main reason it is in the forefront of cranial molding technologies.

No they are not.  The key to correction is providing an adequate counterforce to direct the growth of the expanding cranium.

Infinite Technologies uses one of the most advanced technologies in body capture and imaging, the Omega Scanner by Ohio Willow Wood. The Omega is an FDA cleared handheld scanner, which captures a 3-dimensional model of the patient, which can be analyzed and modified on the computer.

Questions for Parents

We are all asymmetrical somewhere. But like our teeth, some may be more misaligned than others. The asymmetry may or may not affect our functioning. Regardless, we may wish we could alter the appearance.

It helps to ask yourself these questions:

  • If I had my child’s head shape now or when I was a teenager, would I want it changed?
  • If the change was comfortable, would I do it?
  • Have I ever had orthodonture or laser eye correction? If so, how did I feel about those procedures?
  • If I wouldn’t remember the treatment, would that alter my feelings?
  • If I wanted something changed but missed the chance, how would I feel?

Some helmet therapy providers tout a 2-dimensional self-evaluation system for plagiocephaly. It is our belief that you should visit a professional for a complete evaluation if you believe there may be an issue. Our evaluations are scientific with the use of our cranial mapping analysis and 3D imagery. Best of all, they are free of charge.

As mentioned in “Treatment Options,” positional plagiocephaly therapy has a place in defense against plagiocephaly. However, it has a varying affect and relies on aggressive “treatment” from the parents from near birth to 6 months of age. The result ultimately depends on the severity of the asymmetry in conjunction with timely treatment. The baby must be constantly repositioned during key growth spurts in order to produce corrective results.

Plagiocephaly results from consistent force over a long duration to the same part of the head. Therefore repositioning is necessary every few hours while a baby sleeps, naps, or is in a seat. As the child learns to sit and roll, and as the head toughens and becomes more resistant, treatment will be less affective.

Studies have shown that 20-25% of babies below six months will experience some correction in this manner, but near total self-correction may occur in only 5% of children younger than 4 months and only in approximately 3% of children older than 6 months.

The treatment timeline depends on two key factors: the age of the child entering treatment and the amount of correction required. The earlier a child begins treatment, the faster the correction will occur, and the shorter the overall treatment timeline.

Age of Child Length of Treatment
3-5 Months 2-4 Months
5-7 Months 3-5 Months
7-9 Months 4-7 Months
10 Months 6-9 Months

*These are estimates based on past averages and a more precise estimate will be provided at the initial appointment.

On your first visit, the practitioner will take a series of anthropometric measurements. Next, the practitioner will use a completely non-invasive laser scanner to capture a 3-dimensial model of your child’s head.

While you are holding your child on your lap, the practitioner will first place a stockinette hood over your child’s head with an opening for the full face. The practitioner will then place reflective dots on your child’s face and head to register the facial features and record the image. Last, the orthotist will conduct the scan with the handheld device. After reviewing the scan, the practitioner will consult with you to make recommendations and discuss next steps.

Normally, the KidCap is ready approximately one week from the day of the scan evaluation. Once the scan has been conducted, a board certified orthotist will take some time to review and cross-reference the hand measurements in comparison with the visual data from the 3-dimensional scan. The practitioner will make adjustments to the scan to render a corrected model. Thus file will be sent to a carver which yields a model of your child’s head within a 0.5 mm degree of accuracy. Your child’s KidCap is fabricated from this model in our FDA registered on-site fabrication lab.

The standard return time is one week from the day of your scan evaluation. This may be altered to suit the patient’s specific needs.

You will be seen one week after the scan evaluation for the fitting and delivery of the KidCap, and then one week following the fitting for fine adjustments.

  • Below 6.5 months of age = every two weeks
  • Older than 6.5 months = every month

This follow-up protocol is the minimum recommended schedule for the practice. We may recommend more frequent appointments if your child warrants special attention. If at any time you want to be seen, we will accommodate any request.

Each routine follow-up appointment will consist of a 3-dimensional image of your child, a detailed skin and fitting assessment, and adjustments as needed to allow for growth. Any worn components will be refurbished or replaced.

Yes. It is our policy to forward an initial and final report to the parents as well as all members of the clinical team treating each patient. By request, we will also provide reports to other appropriate parties. In many cases, we routinely discuss the treatment and target goals with the physicians, and co-design therapy protocols with physical therapists.

The practitioners of Infinite Technologies are very accessible to parents. Questions and concerns can be addresses by phone and email. We maintain an on-call status for weekend emergencies and check our emails daily.

As with everything, it depends on the insurance company you are with and the type of coverage you have. We work very hard to get every patient some level of reimbursement. Our expert benefits and claims consultants will educate and assist your with your questions.

Please call in and see if you are eligible for a consultation. We are proud to have corrected many failed treatments, but each case is handled on an individual basis.