About the MiracleFeet Brace
A brace worn primarily at night for up to 5 years is a critical part of clubfoot treatment. Poor compliance can lead to relapses.
Brace-wearing is the longest phase of clubfoot treatment.
A lot of work goes into successful clubfoot treatment, from identification, to casting, to the tenotomy. However, the stage of treatment most likely to determine long-term success is bracing.
A key part of the Ponseti Method, children wear an abduction brace consisting of shoes and a bar which maintain the feet in the proper position as they grow. The brace phase of treatment is multifaceted, so let’s break it down.
Half of children in treatment do not wear their brace as prescribed, which often results in relapse. In addition, most braces are either high-quality but unaffordable ($200 – $1,000) or inexpensive ($8 – $40) but hard to use, uncomfortable for the child, and not easily scalable to manufacture.
MiracleFeet partners reported the lack of an easy-to-use affordable brace was the single biggest impediment to scaling Ponseti treatment in their countries. Since braces are worn for up to four years after the completion of active treatment, and they are critical to long-term patient outcomes, MiracleFeet knew that scaling clubfoot treatment in low- and middle-income countries required a high-quality, low-cost solution.
Did you know?
Clubfoot braces are among 26 essential assistive products that the World Health Organization guidelines say health systems need for inclusive health services. Guide: Assistive Product Specifications (WHO, 2021)
MiracleFeet recognized that there was a need to fill when it came to clubfoot braces. In 2013 we set out to design a brace that would be affordable, easy to use, and durable.
How it Started
4-5 YearsLength of time that braces are worn, primarily while sleeping.
The MiracleFeet brace was an idea formed by MiracleFeet in response to feedback from our partners, who claimed that the lack of an easy-to-use affordable brace was the single biggest barrier to scaling Ponseti treatment in their countries. Bracing is a critical part of Ponseti treatment. Following the casting phase of treatment and the tenotomy, braces are worn for 4-5 years primarily while sleeping. Poor brace compliance can lead to relapses.
While there are several existing braces available (Mitchell, Dobbs, Dennis-Browne, Steenbeek) none meet the needs of low resource settings very well. MiracleFeet decided that it should be possible to develop a high quality, easy-to-use brace at costs that would make it affordable in low resource countries.
The MiracleFeet Difference
MiracleFeet has been fortunate to have been able to collaborate with an extraordinary group of partners, and together has developed an affordable, comfortable, practical, and easy-to-use brace. MiracleFeet provides the brace to MiracleFeet-supported clinics through our local partners free of charge. Additionally, we provide braces to doctors, hospitals, rehabilitation facilities, NGOs, and other organizations needing technical support in the form of assistive technology. The brace is also available for purchase for organizations treating higher-income patients with the ability to pay. All revenue from the sale of the MiracleFeet brace goes back into supporting our work in low-income countries.
To date, over 60,000 pairs of shoes and 38,000 bars have been distributed to 39 countries, with demand increasing exponentially every year. In the next 12 months, MiracleFeet anticipates sending another 20,000 pairs of shoes and 15,000 bars around the world.
The MiracleFeet Brace comes with all the functionality of the $350-$1,000 braces used in the U.S. It features a wider, more stable base, allowing kids to stand while wearing it; detachable shoes, making it easier for parents to put on a moving toddler; and sturdy, colorful plastic – making the brace look more like a toy than a medical device.
The end product achieved our initial vision: ease of use for the parent, comfort for the child, and improved treatment outcomes for clinicians. Providers and families alike are extremely satisfied with the MiracleFeet brace and early reports from clinical studies show that it is at least as effective as currently-available models.
In 2015, we sent our first major shipment out into the clubfoot world. To date, over 60,000 pairs of shoes and 38,000 bars have been distributed to 39 countries,
The MiracleFeet brace consists of:
The canvas part of the shoe
The plastic part of the shoe
The purple plastic part of the device
We believe the ease-of-use and comfort of the brace will increase compliance, which will result in better outcomes for the children as well as reduced treatment costs. The MiracleFeet brace system (3 bar sizes and 7 shoe sizes) will also reduce the average cost of bracing for each child. Fewer bars are needed throughout the course of treatment and the plastic bars and shoes are reusable.
- ease of use The shoes clip on and off the bar, making it much easier to put the brace on a child. This feature is available in the $360+ US braces and has been received very enthusiastically.
- kid-friendly look The bar, which is made of purple plastic, is lightweight, child-friendly, and looks almost toy-like making it appealing to children and their parents.
- comfortable material The shoes are made of soft canvas and are washable, making them comfortable and practical.
- adjustable design The braces are adjustable to work for unilateral (one foot at 35 degrees and one at 65 degrees) and bilateral (both feet at 65 degrees) clubfoot. The unique wedge design under the shoe keeps the foot at 10 degrees of dorsiflexion. These are the specifications laid out in the Ponseti manual.
- flexible sizing There are 7 sizes of shoes and 3 sizes of bar which is sufficient to fit children aged 1 month to 5-6 years. Any shoes can fit on any brace to provide maximum flexibility.
MiracleFeet is fortunate to collaborate with an extraordinary group of partners.
Stanford University’s Hasso Plattner School of Design (commonly known as the d.school), through the Design for Extreme Affordability course, partnered with MiracleFeet to develop the MiracleFeet brace. The highly-regarded Design for Extreme Affordability course brings together students from the medicine, engineering and business schools. By applying “design thinking” they work to design products that solve social needs primarily for use in less developed countries. Stanford University owns the patent (final patent applied for Sept 2014 and received in June 2019). MiracleFeet has a contract with Stanford that gives it exclusive rights to use the technology for the life of the patent.
Suncast is a world-class, highly efficient, injection molding plastics manufacturer based just outside Chicago, Illinois. Suncast primarily produces items used outside such as plastic sheds, storage lockers, and play and gardening equipment sold at outlets such as Walmart and Home Depot. Suncast have provided, and continue to provide, extensive pro bono design and technical expertise throughout the brace project and generously produce the shoe plates and bars, and riveting the shoes to the shoe plates in Batavia, Illinois. They are doing this at cost and frequently provide design changes, manufacturing expertise as pro bono gifts in kind to MiracleFeet.
Clarks Shoes, based in the UK, is a global shoe manufacturer and retailer who have 200 years of experience making children’s shoes. Clarks provided extensive pro bono technical and design support for the brace in the early stages of the brace design. Clarks Shoes is also a major donor to MiracleFeet, supporting programs in the Philippines and Brazil.
King and Spalding
King and Spalding
King and Spalding is a full-service, international law firm with offices in the United States, Europe, the Middle East and Asia. King and Spalding have generously provided pro bono legal services, in the area of intellectual property, for the brace project. Tim Smith, partner in King & Spalding’s Houston office, was born with clubfoot. He has worked on the patents filings and on ensuring that the design does not infringe upon any existing patents.