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Insoles for Neuropathy and Balance Issues

Periodic Reporting for period 4 - Path Feel (Insoles for Neuropathy and Balance Issues)

Reporting period: 2021-05-01 to 2021-10-31

An aging population and diseases related to aging (Parkinson’s disease, diabetes, neuropathy) increase feet numbness, balance and mobility issues. Affected people stop feeling the ground properly, which makes them lose balance and increases the risk of falls and injuries, which in turn lead to devastating consequences. Patients and families lose their independence and public healthcare costs are rising as a result – now the European population aged 65+ uses 60% of
healthcare resources. One of the ways to reduce the costs of care for the elderly and chronic patients relates to fall prevention.

At Walk With Path, we invented Path Feel – an insole that provides vibrational feedback to the feet in real time to help people feel the ground again. It increased the balance and mobility of 92% of users and reduces their risk of falls by 50%. We have proven that it works in a number of pre-clinical studies, and further studies are taking place as part of this project to validate the product in a diabetic population. By bringing mobility back, Path Feel gives more freedom to the patient and the family.

The elderly population in the EU is projected to increase, reaching 75 million by the end of 2020 and 88 million in 2030. Over 220 million people worldwide suffer from balance and sensory issues, and the global walking aids market is estimated to surpass €1 billion by 2023, growing at an estimated CAGR of 4.3% from 2018 to 2023.

Within the project we will finish our existing prototype and make it ready for manufacture, validate it based on clinical and usability testing, certify it according to the required regulations, and introduce it to the market after the project ends.
During months 19-24 we have made significant progress on product development and within phase 1 of the clinical study, although our recruitment has still experienced difficulties. Algorithms that calculate gait parameters are working and validation with the Vicon system in Manchester has been completed. Implementation into the insoles firmware has nearly completed, and only smaller updates are happening now in parallel with app, dashboard and electronics finalisation. End user testing has also advanced as we now have full prototypes of the user app and dashboard for healthcare professionals, so several surveys and user testing groups have happened.

We have a new updated version of the insole with enhanced comfort and use of safety. Path Feel design for manufacturing documentation is ready for mass production, and production is currently taking place, aiming to complete at the end of February, 2022. We have had several pilot discussions with hospitals, and are currently planning a pilot in South West Thames Hospital from March 2022. We won the EIT ‘Startups meets Pharma’, we have also started discussions with pharma. We were also accepted onto EIT Ulabs where we can conduct user testing. We have chosen to work with IBV, Spain for this, in order to compare our insole data with that of common smart watches like Fitbit or Apple Watch.
We expect Path Feel to make a significant impact on society and people living with chronic conditions affecting their mobility and many other aspects of their lives, including psychosocial health. Path Feel will contribute improved quality of life for individuals and their families and a reduction in cost to healthcare systems and society. In terms of the technology, we have progressed beyond the state of the art by providing haptic feedback to alleviate symptoms of diabetes (and other potential conditions, including neuropathy caused by aging). Other potential solutions such as insoles with sensors are passive and do not provide a therapeutic benefit in real-time. This is a significant improvement over the state of the art.
Images of the insole prototype (from left to right) from the bottom, from the top and with a side vi
Interview in Medical Futurist, April 2020
App visualisation
Interview with Expresso
Insole prototype in use in the clinical study
Latest insole prototype in use for Manchaster for Phase 2
Latest insole prototype exploration in sizing and fit
Design of the layers of the Path Feel insole
Interview with Polidea, April 2020
Healthtech Digital article, April 2020
Interview with Medwatch