Smart wearable device that helps people with Parkinson's walk better

Background Parkinson's disease is a progressive neurodegenerative disorder.

Approximately half of people with Parkinson's (PwP) suffer from debilitating gait symptoms such as festination (FSG - increased step frequency, shortened stride length) and freezing (FOG - inability to initiate/continue movement). Both FOG and FSG contribute to the two-fold increased risk of falling in PwP.

Fear of falling and balance concerns are number one concern in the James Lind Alliance top ten priorities for patients, families and clinicians.

Cueing is an established method to initiate and maintain gait by providing an external stimulus to activate alternative motor pathways in the brain that bypass the regions affected by Parkinson's. Use of cueing by PwP is endorsed by the Royal College of Occupational Therapists.

However, there are several practical challenges to bring cueing to PwP s daily lives: Difficulty in multi-tasking limits self-cueing by PwP. Existing basic rhythmic cueing methods, do not adapt to changes in gait quality or activities undertaken.

PwP can become habituated to repetitive cuing, reducing efficacy. gaitQ has been developing a smart cueing system that comprises two wearable devices, worn on the upper calves, to automatically deliver vibrational cues when needed and adapt to the user s walking characteristics. Research question To what extent does gaitQ s smart cueing system improve PwP s gait?

Is it effective in PwP s everyday environment?

Aims and objectives To complete the final phase of product development comprising (1) algorithm refinement and (2) monitoring system development. To evaluate the efficacy of the gaitQ product using gait data collected in laboratory and real-world environments.

To prepare for market entry and NHS adoption: early economic modelling, pricing, marketing strategies, early adopter partnerships.

Methods Clinical workstream: collect clinical efficacy data using the gaitQ system and investigate its usability and performance in the everyday environment.

This will involve a statistically significant cohort of PwP in a type I hybrid randomised trial in laboratory and home environments (Trials 1&2). Additional patient groups will be investigated including stroke, hip/knee injury (Trial 3). Timelines for delivery Ethical approval, MHRA, Trust R&D approval: 6 months Trial 1: 12 months.

Product iteration: 3 months Trial 2: 12 months. Trial 3: 9 months (undertaken in parallel with Trial 2).

Reporting/dissemination: 3 months R&D workstream: develop core algorithms enabling the delivery of smart, adaptive cueing.

This will involve a cross-section of PwP whose gait is measured and analysed in a controlled gait laboratory, followed by walking data collected from the clinical workstream.

Commercial workstream: investigate pricing and marketing strategies for the UK market entry and investigate clinical pathway and cost benefits brought by the technology to in-clinic and future tele-health settings. Regulatory workstream: undertake quality management and regulatory compliance throughout the project.

Clinical evidences will be added to regulatory claims as the clinical workstream progresses.

Anticipated impact and dissemination gaitQ aims to help PwP maintain a more fluid and stable gait, reducing the risk of falls and associated injuries.

The study outcomes will be disseminated to professionals though peer-reviewed journals, conference presentations (ICPDMD), and to patient groups through patient organisations.