miraclefeet

The miraclefeet Clubfoot Bracing Compliance Kit functions to revolutionize the clubfoot treatment system with cost-effective and easily scalable wearable technology that caters to children and families in low resource settings globally.

What is it?

One in every 750 children worldwide is born with clubfoot. This disability causes one or both feet to point inward and upward, making it difficult and painful to walk. Currently, one million children around the world lack access to treatment, and cannot walk properly due to untreated clubfoot. Children with disabilities are often stigmatized, abused or neglected (1). They are less likely to go to school and obtain employment, often driving them into poverty. miraclefeet increases access to proper treatment for children born with clubfoot in developing countries, through partnerships with local healthcare providers. miraclefeet envisions a world in which all children born with clubfoot receive treatment, enabling them to live productive, active, and healthy lives. Our work impacts 11,000 children in 14 countries. According to our Net Present Value analysis, this translates to a potential addition of $170 million of future earnings by treated patients.

The Ponseti method, the gold-standard for clubfoot treatment, is low-cost, non-surgical, and effective in 97% of cases if followed properly. The treatment consists of serial casting for 4 to 8 weeks. The child then has to wear a foot abduction brace (two shoes attached to a bar) at night for four years, to prevent the feet from relapsing back into the clubfoot position. If the child does not wear the brace at night, he or she has a 95% chance of relapse. Existing clubfoot braces are either expensive ($400- $1,000) or cheap ($8-60) and uncomfortable. Treating clubfoot is easy, but the lack of an affordable, practical brace is preventing 200,000 children a year from getting treatment.

miraclefeet has been working with corporate, university, and in-country clinical partners since 2012 to design a low-cost, and comfortable brace for clubfoot. miraclefeet first collaborated with a team of students and professors from Stanford University’s Design School’s class “Design for Extreme Affordability” to invent a new low-cost brace for clubfoot. Students spent time in miraclefeet-partnering clinics in Brazil, speaking to clinicians and parents of children with clubfoot, to understand what they wanted from a brace. Clarks Shoes, CJ Shoes, and Suncast, a leading plastics company, joined the team in 2013 to design of the brace pro-bono, and continue to produce the brace at cost. Clinicians from 5 partnering countries gave feedback on the brace. After three years of rapid prototyping and feedback from the field, the team came up with a $20 brace that is so user-friendly it boosts long-term compliance. We believe that this award winning brace is a game-changer for clubfoot treatment in low resource settings.

To encourage compliance of treatment during the bracing phase, miraclefeet has implemented the use of tailored SMS-texting to increase communication between parents and clinicians, reducing dropouts. This system provides timed messaging to families to encourage compliance, offering tips, emotional support, and educational reminders about bracing. This program provides the voice of the doctor and clinical assistants at parents’ fingertips, for consistent support at home between appointments. This system is currently available in English, Spanish, and Hindi.

To document and evaluate bracing compliance, miraclefeet maintains a free, secure, web-based patient database for our partners, the International Clubfoot Registry (ICR). This allows for standardized record-keeping. miraclefeet uses this tool to manage programs, monitor treatment quality and evaluate impact. The ICR encourages data collection and information sharing to continue to improve treatment practices within clinics.

The miraclefeet Clubfoot Bracing Compliance Kit functions to revolutionize the clubfoot treatment system with cost-effective and easily scalable wearable technology that caters to children and families in low resource settings globally.

1. United Nations Children’s Fund (UNICEF). “The State of the World’s Children 2013.” May 2013: 1
2. Save the Children UK & Handicap International. “Out from the Shadows: Sexual Violence Against Children with Disabilities.” 2011. vi

How is it used?

• The miraclefeet brace is worn on the feet of children receiving treatment for clubfoot. The sturdy bracing bar can be used again after one child has completed treatment.
• The SMS system is a service provided to families via a mobile device
• The International Clubfoot Registry is a web-based database that can be accessed from anywhere in the world by registered partners.

What technologies does it incorporate?

• Currently, the SMS system incorporates mHealth technology. The SMS system sends messages and is implemented primarily as a communication device between providers and families. The SMS system also has the capacity to capture data by issuing surveys to users. This data would be anonymous and track information about the compliance, barriers, and access to the brace wearable technology and service. Surveys through the SMS system would also allow treatment and messaging to be improved by assessing specific barriers, such as transportation to care, messaging appropriateness, and stigma within communities.
• The ICR incorporates database technology initially established in conjunction with Ponseti International Association and the International Clubfoot Registry. miraclefeet was the leader in developing the ICR from its initial form to the current state, which enables greater functionality in low bandwidth settings. The platform was modified and the technology improved to ensure user-friendly designs in the high pressure clinic setting of a low resource country. miraclefeet partners face barriers to using the ICR, such as unreliable internet connectivity, limited human resources and low computer literacy, so miraclefeet will pilot the use of tablets at remote clinics to determine if this will facilitate regular use the ICR. We hope that this offline method will reduce barriers to use, improve reporting, and allow for a greater depth of data collection and analysis. miraclefeet constantly seeks out opportunities to improve monitoring, evaluation, and reporting through innovative measurement tools.
• miraclefeet is also in discussion to improve the brace through the use of pressure sensors to best understand usage of the brace by families. Self-report of brace usage can often be misleading and pressure sensors could increase accuracy in data collection and insight to barriers to usage(1). This would help miraclefeet to understand at what ages and times during treatment drop outs occur and assist in understanding barriers to compliance with brace treatment.
1 – Morgenstein, Aaron, Rebecca Davis, Vishwas Talwalkar, Henry Iwinski, Janet Walker, and Todd A. Milbrandt. “A Randomized Clinical Trial Comparing Reported and Measured Wear Rates in Clubfoot Bracing Using a Novel Pressure Sensor.” Journal of Pediatric Orthopaedics 00.00 (2014): 185-91. Print.

How does it work?

• Brace – The brace is utilized to complete clubfoot treatment following the casting phase. The shoes on the brace clip on and off for ease of use and are made of comfortable soft canvas. They resemble conventional shoes and are appealing to the eye. The bar is made of very sturdy plastic, and children can stand in the brace. There are seven sizes of shoes, produced for $10 a pair, and 3 sizes of bar, produced for $10. The bars can be recycled, further reducing the cost of treatment.
• SMS System – Each child is enrolled into the program during their first visit. A bank of messages are then tailored and timed specifically to match with the bracing phase of the child. These continue throughout the continuum of bracing treatment.
• ICR – miraclefeet partners use the ICR to track patients and patient progress, identify trends in treatment, and ultimately to achieve better bracing outcomes through losing fewer patients to follow-up. Through the ICR and reports, miraclefeet will measure the actual number of new children enrolled, the number of children served, the number of patients completing casting phase and bracing phase, the number of new clinics, the number of providers trained, and specific accomplishments in.

Who uses it?

• Brace – Used by the child and put on the child by parents and medical providers
• SMS system – Used by the family, miraclefeet, and the implementing partners. Medic Mobile and Telerivet (service providers)p
• ICR – Used by partners in clinics, miraclefeet

Why does it help?

Brace – So far, 1,700 shoes and 1,200 bars were manufactured at cost in collaboration with Clarks and Suncast and provided to miraclefeet. A portion of these were distributed and tested at five of miraclefeet’s partner clinics in Nicaragua, the Philippines, South Africa, Brazil, and India. Feedback from parents and clinicians alike was extremely positive, which makes us believe parents will use the miraclefeet brace more than other braces. Parents thought the brace was more comfortable and practical than other braces. Testing has also indicated that the brace is durable, recyclable, and less fragile than the current market braces. It is also more medically compliant with the Ponseti method in comparison to current low-resource braces, providing a higher quality of consistent care to children.

By getting the brace into 50% of miraclefeet-supported clinics, we will assess brace performance on a broader scale, measuring its impact on brace compliance and clubfoot relapse rates compared to those within clinics using other braces (eg. Steenbeek, Mitchell, Dennis Brown). miraclefeet will run a trial with two partnering clinics in Nicaragua, two in India, and two in Tanzania, working with 40 children in each clinic, in order to compare the relapse rate of the miraclefeet brace and the Steenbeek brace. Other organizations such as ICRC have also committed to testing the brace. We have extensive data on brace cost and the cost of treating relapsed cases by country, enabling us to compare the cost savings associated with the new braces.

SMS system – The use of this system allows for sharing, forwarding of messages, and ability to re-read information, creating a sense of community. In pilot tests in India and Nicaragua, mothers at the clinics like getting the messaging because they can share it with family. Tailoring resources to be culturally appropriate and cater to the family structure of our patient families in developing countries. We are in the process of studying whether this system directly increases compliance and thus reduces relapses and dropouts. Our preliminary qualitative research indicates that the SMS system provides a comprehensive pipeline to encourage adherence to bracing treatment.

ICR – The ICR provides a formalized, accessible, and comprehensive method to store and share data relating to clubfoot patients. This database encourages data capture relating to the bracing phase and evaluation. It directly enables patient, clinic, and program management.

The impact of the miraclefeet Clubfoot Bracing Compliance kit has enormous indirect and direct benefits globally. This kit directly contributes to our ‘Eradicate Untreated Clubfoot Plan’, which scales over 10 years to provide the greatest access to care for children born with clubfoot. We anticipate that this impact to progress as follows:

Year 1 – 200,000 cumulative number of children born with clubfoot – 2% in the bracing market – 4,000 direct beneficiaries – 16,000 indirect beneficiaries
Year 3 – 600,000 cumulative number of children born with clubfoot – 10% in the bracing market – 60,000 direct beneficiaries – 240,000 indirect beneficiaries
Year 5 – 1,000,000 cumulative number of children born with clubfoot – 20% in the bracing market – 200,000 direct beneficiaries – 800,000 indirect beneficiaries
Year 10 – 2,000,000 cumulative number of children born with clubfoot – 50% in the bracing market – 1,000,000 direct beneficiaries – 4,000,000 indirect beneficiaries

The numbers calculated above are based on the following assumptions: Direct beneficiaries: children born with clubfoot, Indirect beneficiaries = 4: 2 adults/parents and 2 siblings. Braces will be provided to 50% of miraclefeet-supported clinics in Year 1 (4,000). This will build an evidence base to expand to other clinics, NGOs, and private clinics in following years. In Year 3, the brace will expand to all other miraclefeet clinics, and scale up to other NGOs, Ministries of Health, and private clinics, and will have reached 10% of all children born with clubfoot from years 1 to 3. By the end of Year 5, the brace will have reached 20% of all children born with clubfoot from years 1 to 5. By the end of year 10, the brace will have reached 80% of all children born with clubfoot.


Team

Team's Location

USA

Team's Occupation

Entrepreneurs

Team Members

Lucy Topaloff, Lauren Wall, Ian Connolly, Jeffrey Yang

Focus Area(s)

Diagnosis/Treatment/Referral, Behavior Change, Data Collection/Data Insight

UNICEF Pillar(s)

Health



These pages have been pulled directly from applications submitted to the Wearables for Good Challenge in 2015. They represent the work of the individual teams and have subsequently not been edited.

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