FP-00018

Section 1 - Basic information about you and your application:

Title of research project
SoleSense Research and Development

Grant Type
The Ronald Furlong Fund

Research area
Treatment

Duration
12

Start date
January 1, 2024

Have you previously received funding from ORUK?
No.

Profession
Entrepreneur

Your current job title/position
Founding CEO

Are you an early-career researcher (ECR)? (definition of ECR)
no

Section 2 - Lay summary

Lay summary:

Improving physiotherapy provision is vital to increase the quality of life and alleviate negative health impacts for individuals experiencing falls and/or fractures. 

Hip fractures constitute one of the most serious consequences of falls, since they are a major cause of morbidity and mortality in the elderly. In 2021, over 76,000 people suffered a hip fracture in the UK, with 1 in 45 hospital beds taken up by hip injuries due to falls. The annual cost of frailty fractures is £4.4Bn. Hip fractures account for ~£2Bn of this, with costs estimated to rise to £5.6Bn by 2033.

Proper rehabilitation after surgery has been shown to shorten hospital stays, improve physical function, help maintain independence and reduce care costs. In May, 2023, the World Health Assembly affirmed rehabilitation as an essential health strategy that should be delivered as part of universal health coverage. 

The UK national guidelines recommend that patients are assisted to get up and walk on the first day after surgery for a hip fracture. Daily therapy as a minimum should be provided to achieve rehabilitation goals in a timely way. Evidence suggests however that patients completing three sessions of therapy a day get better faster and could leave hospital sooner. 

Post operative therapy is often limited however due to an under-resourced health service. The National Hip Fracture Database audit of therapy provision showed only 2 hrs a week was delivered, with only 68% being mobilised on day one in some areas.

SoleSense is a digital rehabilitation system designed to increase the amount of therapy that can be provided to patients with orthopaedic or neurological conditions.  Independent exercise is facilitated through sensor insoles and a real-time biofeedback app that measures the weight going through each foot in real time, provides games for balance rehabilitation, and shows performance outcomes. It has been shown that this kind of feedback can improve walking ability and speed up recovery from surgery. It can be tailored to individual ability for the first time at a price point appropriate for an NHS market.

SoleSense is a revolution in therapy diagnostics and treatment for all those learning how to stand and walk again after injury. Physiotherapists can deliver better treatment outcomes to patients, improving their quality of life and independence, whilst relieving the burden on the NHS. In the next 12 months the company seeks to grow the team, raise finance and build out its minimum product for market release.

This project will assist the company to improve the measurement capacity of the insoles to include useful data for the orthopaedic market. It will also allow a software build and validation phase which will achieve the necessary milestones for further funding and more formal clinical research.

Section 3 - Purpose of research

Purpose of research:

SoleSense is a digital rehabilitation platform that enhances the provision of physical therapy to individuals within the orthopaedic and stroke market, alleviating pressure on the NHS. Pressure sensors in the insoles of the shoe detect weight shift in real time to re-educate balance and walking performance, forging better recovery of weight bearing through weak and painful limbs and expediting discharge. Accessing just 10% of the stroke and hip fracture market could save the NHS £14.6 Million annually through reduced length of stay alone. 

This project will develop Solesense’s prototype to MVP stage. Current development for a stroke market has used the Centre of Pressure (CoP) metric to track movement over the base of support. We now aim to expand into the orthopaedic market, developing the loading as a percentage of body weight metric required for accurate quantification weight bearing. We will then build out the current software functions.

Our core objective is then to achieve validation against gold standard pressure measurement equipment, complete usability testing in a clinical setting, and collect data through a community test bed program.  This will inform an onward clinical pilot study which we aim to raise grant funds for.

SoleSense is at TRL level 3 having achieved proof of concept for software gamification, audio feedback, and centre of pressure metrics. This project allows us to expand our offering to a broader rehabilitation market, further define IP, and clarify route to market through exploration of in-house development of the technology vs external partnerships with insole providers.

Study Deliverables: 

1. Thirty insole prototypes complete with bluetooth connection
2. Software MVP for two measurement metrics, games and performance  analysis.
3. Validation reports for metrics from force plate comparison
4. Clinical usability report and co-design worksheets from therapists and patients
5. Patent applications for software algorithms

Section 4 - Background to investigation

Background to investigation:

Improving physiotherapy provision is vital to increase the quality of life and alleviate negative health impacts for individuals experiencing falls and/or fractures. 

Hip fractures constitute one of the most serious consequences of falls, since they are a major cause of morbidity and mortality in the elderly [1]. In 2021, over 76,000 people suffered a hip fracture in the UK, with 1 in 45 hospital beds taken up by hip injuries due to falls. The annual cost of frailty fractures is £4.4Bn. Hip fractures account for ~£2Bn of this, with costs estimated to rise to £5.6Bn by 2033 [2].

Proper rehabilitation after surgery has been shown to shorten hospital stays, improve physical function, help maintain independence and reduce care costs [3]. In May, 2023, the World Health Assembly affirmed rehabilitation as an essential health strategy that should be delivered as part of universal health coverage [4]. 

The NICE guidelines recommend mobilisation on day one post operatively and daily therapy as a minimum to achieve functional rehabilitation goals. Evidence suggests however that patients completing three daily sessions in the acute phase on average reached functional discharge criteria 10 days earlier than with one daily session [5].

Post operative therapy is often limited however due to an under-resourced health service. The National Hip Fracture Database audit of therapy provision showed only 2 hrs a week was delivered, with only 68% being mobilised on day one, with a wait of over 2 weeks for community therapy provision to start post discharge [6]. 

SoleSense is a digital rehabilitation system designed to increase the intensity of therapy that can be provided to patients with orthopaedic or neurological conditions.  Independent exercise is facilitated through sensor insoles and a real-time biofeedback app that quantifies weight bearing, provides games for balance rehabilitation, and shows performance outcomes. It is supported by evidence that visual biofeedback can improve accuracy of weight bearing and therapy compliance post operatively, and can improve motor learning [7].

SoleSense is a revolution in therapy diagnostics and treatment for all those learning how to stand and walk again after injury, employing the latest digital technologies to enable NHS physiotherapists to deliver enhanced treatment outcomes to patients, improving their quality of life and independence, whilst relieving the burden on the NHS. In the next 12 months the company seeks to grow the team, raise finance and build out its MVP.

MARKET SIZE

The potential market size for this type of product is large and will continue to grow due to an increasing prevalence of bone disorders, medical technology and an ageing society. The home rehabilitation market is set to increase to just under £200 billion by 2029, with the musculoskeletal rehabilitation market reaching over £10 billion for hospitals and clinics by 2032.

Specifically, SoleSense aims to leverage the hip fracture, elective joint replacement and stroke market. The accessible UK market is 100,000 (30,000 for hip fracture, 40,000 stroke, 30,000 elective hip replacements) annually. The accessible global market equates to 9.3million annually (4.3 million for stroke, 3.3 million for hip fracture, and 1.2million for joint replacements).

At £200 per pair of insoles and with an average subscription of £200 over 2-6 months, the acute UK market alone could be as much as £28 million in orthopaedic and stroke pathways.

We aim to licence our software to commercialised insole companies in the first three years in order to expedite the point of revenue generation. We will operate a mixed funding stream, with a subscription model for the software at an affordable price paid for by the patient, and the hardware procured within an NHS orthotics budget that allows for £200 per patient. We will also look to leverage the private market while we gain traction in the NHS. 

PERSONAL TRACK RECORD

Caz Icke, SoleSense founding CEO is a senior physiotherapist with 15 years clinical and research experience and is currently a senior therapist at Southmead Hospital in Bristol. SoleSense was developed to provide simple affordable technology to empower independent rehabilitation to address the unmet clinical need for greater rehabilitation provision throughout the NHS. She has received one of the nationally recognised Women in Innovation Awards in 2021 for her work in this field, was recognized in the South West Business Insider’s Top 42 under 42, and is a member of the Clinical Entrepreneur Program run by NHS England. Caz is a member of the SETSquared incubator, winning their prestigious Tech Xpo award for best Elevator Pitch this year, as well as the Medilink SouthWest Best Advancement in Digital Health Award 2023.

 

PRELIMINARY DATA

Prototype Proof Of Concept: 

• Hardware: Tracking CoP with soundscape and visual representation of CoP across the base of support: Validation with FootScan pressure plate shows weight distribution to within 3% for static conditions but slow temporal parameters.
• Software:  Calibration and gamified app with the ability to tailor a balance game to each individual’s ability.
• Minimum specification requirement for insoles identified: 16 sensors and 100-200 Hz

Future development requirements for Orthopaedic market;

• Software development to include loading as a function of body weight; required in addition to CoP due to the dependence on walking aids which skews CoP. THis delivers  quantification of weight bearing that informs compliance with post op instruction.
• Platform build-out to include extra game, refine audio feedback, performance analysis graphics.

SoleSense vs current state-of-the-art

• Current products focussed on gait re-education for clinics, not sit to stand and standing balance re-education in hospital settings for low level ability. 
• Current price points are prohibitive to NHS
• SoleSense repurposes sports insoles that are cost-effective for NHS. Our initial validation shows a 16 sensor insole (sports grade) is suitable.
• SoleSense is suitable for hospital and community settings as it can be tailored to an individual’s ability for the first time.
• Quantified falls risk metric to facilitate confidence in physiotherapists to set independent standing exercise earlier than is current normal practice. 

Section 5 - Plan of investigation

Plan of investigation:

This project is focussed on two areas:

1. Technical development:
   1. Build out the current hardware prototype: make a smaller electronics unit and produce 6 different sizes.  
   2. Build out the current software metrics to ISO 13485 and ISO 9001:2015. 
   3. Verify and Validate the prototype incrementally against force plates with 10 healthy subjects
2. Research/PPIE: 
   1. Complete co-design with 5 acute orthopaedic patients using 1:1 interviews.
   2. Assess our prototype with 10 patients in a clinical environment for usability post development. This will inform a clinical feasibility trial which will require further funding and ethical approval.  
   3. Place 20 insoles into ECareWell community test bed for real-world technology assessment, collecting real world feasibility data 

 

Technical development: Work packages 1-3

The technical development for the prototype will be led by Pointer Consultancy Group (Pointer), who have extensive experience in managing concept and technology development projects and are experienced in managing agile software development. Both Pointer Directors are chartered project professionals and bring a depth of project management expertise. Pointer will manage Work Packages 1 – 3 (outlined below) according to the SoleSense QMS and will liaise with the Regulatory consultant for compliance adherence.

Hardware development will be documented with appropriate technical files that allow us to track progress and decision making and manage configuration control and quality assurance. This will enable the technical files to be built into ISO regulatory compliance documentation at a later date as needed. As a primary route to market we will look to partner with an insole company that have already validated the product to ISO standards, but in developing the correct technical files we will future proof further pivots into developing our own hardware.

The software work package will also be led by Pointer who will manage the software development team. The MVP will be developed according to ISO regulation within the required timescales to maximise the benefit of the lab review sessions in informing the software development. 

Research and IP: Work packages 4 and 5

The PPIE, clinical usability testing  and community test bed research will be led by the Solesense CEO who has clinical expertise as a physiotherapist and currently works as a senior clinician at North Bristol NHS Trust where the usability testing could be undertaken. The CEO has a large network of clinicians, academics and advisors in the southwest and Northern Ireland that will support decision making. Formal research ethics will be applied for through Ulster University by Professor Joan Condell who manages the ECareWell programme. Further funding will be required for a formal feasibility study at Plymouth University but they have expressed interest. 

A patent application was made in 2019 with broad spectrum definition covering the hardware prototype and software function. We are going through substantive examination with regard to the audio feedback that tracks CoP directly as this is considered novel. We have completed an IP Audit in 2021 and will apply for an IPO Access Fund to complete the recommendations around patenting software algorithms from this project. 

 

Overall Project Governance 

Pointer will be responsible for the overall project management throughout the entirety of the project’s duration. An effective project governance structure will be put in place, consisting of weekly and monthly meetings.  

The tactical level weekly meetings will review the previous week’s progress against all work packages with key project personnel, confirm the plan for the next week and identify any blockers or risks that need to be managed to ensure delivery.   

The operational level monthly project meetings will involve the wider team and will review:

• The high-level work package status dashboard;
• Progress against project schedule.
• Project spend against plan.
• Risks, issues and opportunities. 
• Key delivery dependencies on 3rd parties.

The owners of the respective work packages will be responsible for meeting the project deadlines and delivering milestones according to timescale and budgets. We will track changes against our baseline documents to ensure delivery is informed at all times and collaborate across the various work package owners throughout the project duration. Trello task manager software will be used to oversee all deliverables and their milestones. 

Agile approach 

Where appropriate, work packages will be delivered using an agile approach. This approach is appropriate where the overall outcome, budget and duration of a work package is understood, but the detailed requirements for achieving these may not initially be as well defined. Additionally, the nature of this project will require the project delivery team to recast and mature their delivery approach as the work packages progress and the product development evolves. Utilising this iterative approach allows the project team to be flexible, and ensure the conditions for go/no-go decision making are well defined.  

Relevant work packages will follow a consistent tasking and reporting drumbeat, typically fortnightly, with key project stakeholders in order to agree the activities to take place during the next period, report completion/progress on previously tasked activities and discuss risks and opportunities identified. 

 

WP 1: Hardware Procurement

Owner: Pointer

M1 – M2

Milestones: 30 prototypes in 6 different sizes

• Procurement of hardware x 30 units
• Create integrated hardware solution
• Test phase with all units

 

WP 2: Software Development

Owner: Pointer

M1 – M6

Milestones: Software verification report as per specification

• UX Design
• Calibration Assessment and development 
• Develop Audio output
• Second game development
• Develop progress report graphics
• Objective measurement mode for therapists
• Gait parameters – stance time

 

WP 3:  Validation

Owner: Pointer and SoleSense

M5-M8

Milestones: Validation report for all metrics

• Validation of software functions for all 30 insoles: Bath University force plate comparison. Loading metric and CoP metric during quiet standing, sit to stand, single leg stand and gait for temporal and spatial parameters.
• 10 healthy subjects

 

WP 4: Research 

Owner: SoleSense

M1-M3, M5-M12

• 20x insoles to ECareWell program run by Ulster University Intelligent: Community based test bed overseen by Professor Joan Condell. Ethical approval from University and fast turn around of recruitment due to a well established programme. 
• Clinical Patient and Public Involvement

 

WP 5: Intellectual Property

Owner: SoleSense

M4-M12

• Apply for IPO access grant (dates currently unknown)
• IP application and submission

Section 6 - Research environment and resources

Research environment and resources:

Solesense CEO, Caz Icke will act as the Project Director, with day-to-day project management lead by Charles Ross-Smith from partner Pointer Group. This R&D project will develop partnerships with Bath University, UWE Physiotherapy department and Ulster University. The consortium brings together academics in biomechanics, physiotherapy and community research projects across three universities to provide third-party assurance and validation of the outputs, and the clinical expertise from the CEO of SoleSense. The consortium has worked together on similar projects and the working relationships are expected to continue beyond this application to validate further technical and regulatory aspects of the design.

The Biomechanics Lab at Bath Spa University has world class equipment for plantar pressure analysis, including high end motion capture systems and multiple force plate technology. Their extensive experience developing Nurvv Run sensor insoles, the leading UK smart insole company for sports applications, makes them the go-to choice for development partners. The physiotherapy department at UWE has been supporting the project since inception, running comparator investigation with the current state of the art software used in therapy gait labs. All laboratory space and equipment required for this project is contained within the three university partners and Ignitec.

The expertise of Ignitec has been demonstrated to date with successful validation of the current prototype and CoP metrics against force plate equipment. They bring together engineering expertise and software development to produce high end products. Further software development may be outsourced. 

The CEO of SoleSense holds a clinical position at a large Foundation Trust and has links to both orthopaedic and neurological patient caseloads. This clinical resource will be fundamental in designing and delivering a successful health technology into the market and gaining rapid traction. Membership of NHS England’s Clinical Entrepreneur Program has provided 1:1 business planning with Professor Tony Young OBE (Clinical Lead for Innovation NHSE) and access to pitching events and presentation opportunities to the C-Suite of the NHS. 

A diverse advisory board is in place to ensure successful project delivery, including clinical, academic, and commercial expertise. Aaron Torrens has been the commercial advisor for the project for the last 12 months, bringing a wealth of experience from his role as commercial lead for IBM Watson Health. 

 

Additional Funding:

The milestones achieved during this project will allow us to become eligible for large grant funds from NIHR and Innovate UK in the future. During the course of this project we will apply for smaller grant funds and the Qantx Innovation Prize, which  is designed to assist products to get to commercialisation through research. This onward research will be a clinical pilot study which will require MHRA approval but will provide clinical data used as the basis for regulatory compliance. 

Section 7: Research impact

Who will benefit from this research?

Our vision is to improve quality of life for all those with a movement disorder who need rehabilitation, starting with 105,000 stroke and orthopaedic patients every year.  Those who can stand independently (Clinical Frailty Score of 6 or less) and have the potential to progress their functional ability to weight-bear can use SoleSense to improve their physical ability. There is an urgent priority to improve the rehabilitation process and facilitate better patient outcomes for all those suffering disability worldwide.

This product will support the NHS by delivering a potential net saving of £146 million per year for acute stroke and hip fracture alone. Regular exercise in the community with the SoleSense solution will further reduce the falls risk for the 250,000 over 65’s that are at risk each year, delivering further cost savings to an over stretched health service. 

How can your research be translated in real-life?

Our solution lends itself to the following areas: prehabilitation, rehabilitation, remote monitoring and telerehabilitation. Future addition of AI algorithms that can diagnose health conditions through plantar pressure analysis and quantify falls risk due to physical impairment will allow a person centred, tailored digital physiotherapy to be available for everyone that needs it.  

We will initially target the UK market, primarily the NHS acute and community settings, alongside the private UK market due to complexities in NHS procurement. We aim to expand into the global market in year three. 

Preliminary work has identified possible procurement routes into the NHS that can bring this product to consumers rapidly. The orthotics department at Southmead Hospital have expressed interest in providing SoleSense if the price point is £200 per unit or under,  meaning no additional budget needs to be allocated. This reduces the barriers to adoptions within the NHS.

How will your research be beneficial for ORUK and its purpose?

This research will directly support the goals of ORUK to “reduce the burden of poor musculoskeletal health on individuals, workplaces and our health system”. The SoleSense product directly drives forward these goals by providing a digital solution to enable independent rehabilitation. It improves post-operative outcomes as well as positively impacts conditions that influence orthopaedic and musculoskeletal conditions such as osteoporosis and sarcopenia through exercise. We are addressing the grand challenge to achieve a “healthy ageing society” which aligns with ORUK’s goals and purpose. 

Revenue generated from this project will be financially aligned with the strategic direction of ORUK and will serve to diversify the ORUK portfolio with the use of tech gamification and AI algorithms for diagnostic and therapeutic purposes. 

We aim to be an internationally operating company and in a position to promote the values of ORUK on a global stage.

Section 8: Outreach and engagement

The founder of SoleSense has a history of commitment to reaching wider audiences through various outreach activities and public engagement initiatives. Within educational settings, we have been involved with Founders for Schools and spoken at career pathway talks for students to promote the importance of STEM. Recently the founder of SoleSense spoke on the Entrepreneurship Panel as part of the Creative Tuition Collective series at Bristol College, to promote innovative and inclusive education for individuals with diverse backgrounds. We will continue to strive to engage students and engage with the non-academic public to drive interest within the digital health tech space. An example of this will be displaying our Women in Innovation award in a local primary school to encourage and inspire younger people, especially females, to enter the tech innovation sector.

The founder of SoleSense is a part of various networks and memberships to connect industry leaders and professionals enabling knowledge sharing across the tech and digital space. For example, the founder is a member of One Health Tech, a global, distributed, volunteer-led community that exists to drive better equality, diversity, inclusion, and accessibility in health innovation. Alongside this, the founder was a panelist on ‘Tech Brekkie’, a university-lead event dedicated to connecting individuals with the South West tech community. Other network memberships include: The SetSquared Business Incubator Programme and the Natwest Enterprising Women Programme for female founders which gives opportunity for pitching and speaking at events. In 2024 the founder will attend the Bath Digital Festival and the Bristol Technology Festival, to engage with the non-academic public within the digital health space with regard to this project.

A range of academic conferences have already been attended including: speaking at the MiNT conference in Neurotechnology (2023) alongside eminent speakers in the field, the Association of Chartered Physiotherapists interested in Neurology (ACPIN) annual AGM and the ‘Bridging The Gap’ event in 2023 hosted by UWE that aimed to bring together clinicians, industry and academic and local policy makers within the Bristol area to problem solve barriers to innovation in the NHS. To disseminate the findings of the project in question we will attend the following: the CSP conference 2024, the British Orthopaedic Association Annual Congress 2024, Association of Trauma and Orthopaedics Chartered Physiotherapists (ATOCP) Conference 2024 and the Neurorehabilitation and Neural Repair Conference in Spring 2025.

A significant outreach component of this project will involve disseminating the findings on social media, namely LinkedIn. The award winning CEO of SoleSense has an online presence on LinkedIn who has the ability to connect and interact with a wide range of audiences via her platform. We will create a number of LinkedIn posts to translate our findings to the wider public.

Section 9: Research budget

Requested funding from ORUK

University fees (if any)
£15000

Salary
£27000

Consumables
£16000

Publications
£0

Conference attendance
£1500

Other items
£40500

Total 'requested fund'
£100000



Other items
Product Development: Firmware Application interface build: £2,500 Software development: £ 34,650 PPIE costs: £100 Insurance for usability testing: £3,250



Other secured funds

Internal funding
£0

Partner (University)
£0

Partner (Commercial)
£0

Partner (Charity)
£0

Other sources
£0

Total 'other funds)
£0

Section 10: Intellectual property and testing on animal

Is there an IP linked to this research?
Yes

Who owns and maintains this patent?

SoleSense submitted a patent application with braod description in 2019 which is undergoing substantive examination at present.  Prior art demonstrated by the IPO has similar hardware and software with regard to CoP. As a company we are looking to innovate in the software field and are not looking to patent a hardware design at this time. The novel aspect of the software is around the audio feedback that is continuous and directly proportional to the weight going through each foot. This has not been done before and is important for those that have visual and sensory deficits.

An IP Audit was undertaken in 2021 which identified that there would be patentable algorithms with regard to:

1. audio feedback which will use 3d sound,
2. how the games are tailored to individual ability,
3. how we calibrate the sensors.

We will apply for those patents as a milestone from this project. The Access Fund of £5,000 from the IPO is likely to be released again in March 2024 which we plan to apply for early given the limited allocation. Patents will allow us to license software in the future, and we may look to white label our technology.

Does your research include procedures to be carried out on animals in the UK under the Animals (Scientific Procedures) Act?
No

If yes, have the following necessary approvals been given by:

The Home office(in relation to personal, project and establishment licences)?


Animal Welfare and Ethical Review Body?


Does your research involve the use of animals or animal tissue outside the UK?
No

Does the proposed research involve a protected species? (If yes, state which)



Does the proposed research involve genetically modified animals?


Include details of sample size calculations and statistical advice sought. Please use the ARRIVE guidelines when designing and describing your experiments.


There should be sufficient information to allow for a robust review of any applications involving animals. Further guidance is available from the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), including an online experimental design assistant to guide researchers through the design of animal experiments.

Please provide details of any moderate or severe procedures


Why is animal use necessary, are there any other possible approaches?


Why is the species/model to be used the most appropriate?