Title: F.R.A.M.E. (facial remote activity monitoring eyewear) An inconspicuous, non-invasive, mobile sensor device for real-time control of assistive technologies through facial expression.
Funder: Department of Health and Social Care

Abstract: See Workflow Diagram App1 Fig.9 WP1. Define patient/stakeholder hardware/software requirements (M1&ndash;24) Leader: Nduka Quarterly PPI groups to tailor hardware/software design in-line with patient requirements. Deliverables: &bull; User hardware/software design needs defined &bull; PPI feedback supporting iterative design and user-centred optimisation WP2. Development of First Generation FRAME prototype (M2-8) Leader: Skinner Optimum sensor placement for tracking frontalis, corrugator supercilli, orbicularis oculi and auricular muscles identified (Fig. 4). Glasses incorporate: optimised sensors; Bluetooth data transmission; battery; analogue to digital conversion electronics; and accelerometer. Signal processing optimised to ensure repeatable, selective, specific signal acquisition and processing. Variations in signal amplitudes across selected facial expressions will be assessed (healthy volunteers) ensuring sensor positioning is adaptable across different facial morphologies, allowing accurate facial expression mapping to underlying muscle activities and facilitating hardware calibration with different wearers. Deliverables: Define optimal sensor locations for selected muscles, expressions and gestures. Prototype sensor, data acquisition and wireless data transmission system. Glasses mechanical design adaptable across different facial morphologies. A First Generation Glasses Prototype (sensing platform). WP3: Development of Second Generation FRAME Prototype (M2-18) Leader: Skinner A biofeedback mechanism (bone conduction or vibrating actuator) integrated. Signal amplitudes for each facial expression to calibrate &ldquo;normal&rdquo; ranges for biofeedback. Prototype tested - small group of unilateral facial palsy patients - determining parameters for activating biofeedback and incorporate appropriate physiotherapy parameters. Deliverables: Qualitative assessment of the biofeedback mechanisms Second Generation Glasses Prototype (sensing and biofeedback platform) 40 sensing and biofeedback glasses for patient trials WP4. Conduct Clinical Study Using Second FRAME Prototype (M2-20) Leader: Study 1: Nduka; Study 2: Breedon Study 1: Trial of 20 healthy adult volunteers and 20 unilateral facial palsy patients will evaluate the prototype for comfort, wearability, appearance and acceptability. Selected facial expressions tracked across a range of intensities videoed to adjustment form factor and biofeedback mechanism. Study 2: Real-world testing with 10 healthy subjects over 2-weeks assessing impact on data acquisition. Using volunteer diaries, feedback includes device integration into daily life. Deliverables: &bull; Healthy and facial palsy subjects: qualitative data on user-acceptability; quantitative data on accuracy and repeatability WP5. User Interface Development (M12&ndash;24) Leader: Breedon A cross-platform user interface for patients and therapists developed (Fig. 2) enabling: baseline capture of facial function; deconvolution and real-time signal analysis; tracking of device use and patient exercise progress; amending biofeedback ranges; infographic representation of data to enhance motivation and therapist monitoring. Deliverables: Firmware algorithms for detecting facial expression and asymmetry (Sense Innovation) Creation of an engaging, effective user interface in-line with PPI feedback Qualitative data on integrated hardware/software system and acceptability Device trialled with 10 patients to evaluate patient and therapist experience. WP6. Health Economic Modelling (M1-24) Leader: Szczepura Economic modelling comparing current treatment options versus FRAME through surveys of rehabilitation uptake; service costs; patient compliance rates; and clinical outcomes. Excel-based modelling will compare therapy uptake, percentage patient outcomes and associated costs of current treatments versus FRAME, with outputs subject to sensitivity analysis. Deliverables: &bull; Cost comparison of status quo vs. FRAME, including NHS capital, staffing, consumables and patient costs &bull; Identify dominant technology for patient s health-related benefits (reduced disability/ improved quality-of-life) and cost to the health service WP7. Commercial viability and NHS adoption (M1-24) Leader: Fielding Market research including industry expert feedback on device use and impact; establishing potential market size and commercial viability plus exploration of NHS stroke and facial palsy markets. IP value evaluated, with plans developed for protection, management and exploitation. Deliverables: Potential NHS economic payback (cost savings and clinical benefits) Estimated break-even price Business plan: inc. market research, projected market size, IP created and commercialisation plan.

Lay abstract: We take for granted the ability to smile, kiss, or close our eyes at night, all of which can be affected by facial paralysis. This condition may strike anyone at any time, regardless of age or gender. The project aims to develop a pair of glasses that discreetly provides real-time feedback to the wearer about their facial muscle function, helping them practice their rehabilitative exercises regularly and correctly, thereby speeding recovery of normal, symmetric facial expressions. Facial paralysis results in weakness of the facial muscles, typically on one side of the face, affecting the facial function, appearance and communication of emotions. Patients experience issues with speech, swallowing and blinking, plus significant psychological difficulties (anxiety, depression and significantly impaired social interactions). Bell s Palsy represents 60% of facial palsy cases, resulting in up to 25,640 new cases in the UK annually. Approximately 8,000 of these new Bell s Palsy cases are left with a permanent disability each year &ndash; estimated figures of over 100,000 people living in the UK with permanent facial problems are likely to significantly underestimate the problem. There are approximately 152,000 new strokes per year in the UK, with an estimated 26,000 of these patients suffering from residual facial problems after their stroke. The benefits for these patients of 45 minutes daily physiotherapy in the early recovery period are well known but the costs to the NHS of providing such therapy are large (around &pound;2,600 per patient or &pound;62,400,000 per year). Biofeedback is a long-established medical technique whereby control of bodily processes are improved by providing the user with real-time feedback (auditory, visual or tactile) on their performance. Until recently the technology was bulky and limited to hospital usage. Recent Cochrane reviews have reported benefits of biofeedback in a number of conditions including limb rehabilitation after stroke. Studies show that following facial paralysis rehabilitative exercises speeds recovery and improves the end result. However, patients usually have limited awareness of the abnormal movements their faces display so, without feedback about these movements, their facial function may worsen, developing permanently abnormal movements. Currently, patients are shown their exercises in clinic and then are expected to practice alone at home using only a mirror for feedback. Many patients dislike having to work with their own reflection as it reminds them of their condition. Most get discouraged and stop exercising which limits their recovery and may worsen psychological issues. Wearable technology that provides real-time facial muscle information to patients and therapists promises a significant improvement in the rehabilitation of facial paralysis, allowing wearers to practice their exercises discreetly and correctly whilst completing other daily activities. The objective is to develop a working prototype and trial (through proof-of-concept clinical studies) an inconspicuous, non-invasive wearable device (indistinguishable from normal spectacles) that provides discreet feedback on facial muscle movement and helps patients to continuously practise facial muscle exercises. This will speed patient recovery, provide direct NHS costs and time benefits and offer patients significant improvements in their facial function and quality of life.

Research activity codes: 5.3 MEDICAL DEVICES
Health categories: NEUROLOGICAL