Case study
The Challenge
Foot drop is a symptom of different conditions, such as a stroke, head injury, nerve injury, or genetics, and is a muscular weakness that makes it difficult to lift the front part of your foot, making walking harder. Around 30 million people around the world live with foot drop and it affects over 46,000 children in the UK alone.
Frustrated by the current commercial splints used to treat foot drop today, Claire Narborough, a Chartered Physiotherapist, set up OrthoPed. The company first started making off-the-shelf splints for children who could adjust them with one hand and now makes splints for both adults and children.
One woman on a mission to help children and adults lead better lives.
Back in 2020, OrthoPed worked with NPL to test a splint prototype made by Claire’s mother-in-law. Following an Innovate UK grant, OrthoPed first worked with NPL on a Measurement 4 Recovery (M4R) project. This project tested the best potential materials for the cords and neoprene in the splint, leading to a final design that was eventually taken through to clinical tests with the NHS. These showed good patient outcomes, including patients stating that it was easier to put on than their current splints, that they found it more comfortable when walking, and they could better navigate over obstacles and uneven ground while wearing the splint. The original project also fatigue-tested the splint to make sure that it was safe for the clinical tests.
A few years later, OrthoPed enlisted the help of NPL again, this time through the Measurement 4 Business (M4B) programme, for a product that has been sold on the market, not a prototype.
In the M4B project, OrthoPed focused on testing the splint with three attachments with different functions for the wearer, including a barefoot attachment, one that allowed the wearer to attach the splint to a thicker shoelace, and one for people with milder foot drop symptoms.
The Solution
The splints with attachments were tested at NPL using mechanical testing systems that pull, push, and bend materials in a controlled manner to measure the response of the splint. To see how much ‘stretching’ it could handle, static machines pulled the splint from either end until it failed. Fatigue machines repeatedly applied and removed stress to the splint to see how it would behave after regular use, as a patient repeatedly puts it on and takes it off.
During the M4B project, some of the cords were also tested and design tweaks were made, such as different clasps and tightening the cords. One of the main design changes was the choice to use a crimp tool―a device used to join materials or components by pressing them together―to connect the cords to the attachment. To simulate the real-world usage of the splint and attachments, they were attached to a 3D printed foot, printed by NPL.
The Impact
Two out of the three accessories passed testing and are moving on to human trials. While the third failed, with the attachment’s cord snapping, the physical testing provided a lot of useful information for developing a new iteration of this attachment.
Because of the two projects with the NPL, OrthoPed are already making direct-to-consumer sales and have had patents approved in 39 countries, with more pending. OrthoPed are now talking to large orthotics and physiotherapy websites who supply the NHS, with some companies already agreeing to stock OrthoPed’s products. If the products are sold at scale to the NHS, this will improve patient outcomes for many people and could also reduce NHS waiting times. Children usually need multiple appointments for leg casting and fitting of the splints, but because no casting of the leg needs to be done with OrthoPed’s products, the number of required appointments could be significantly reduced for the average patient.
After the success of the first two projects, OrthoPed are looking collaborate with NPL on a new M4B project. OrthoPed is wanting to work with NPL to tweak the design and retest the attachment that failed physical testing in this project. This is an adapter that allows patients to wear the splint without shoes, or with slip-on shoes.
What the customer says
We’ve had so much fantastic feedback on the splints; children saying they can run again and be more independent, and one lady burst into tears because she doesn’t have to think about walking anymore. We make the products, but NPL is helping us check they do what we want, and show when they are ready for patients, which is the only way to turn products into real patient benefits.
Claire Narborough - Founder of OrthoPed