Title: GLOVED (Generation and evaLuation Of hand therapy deVices for Epidermolysis bullosa and Dupuytrens) project: Adjustable Splint Glove manufacturing and commercialisation
Funder: Department of Health and Social Care

Abstract: Background The Project addresses the lack of an acceptable splint to manage finger and hand contractures for people with long-term requirements, for example Epidermolysis Bullosa, Dupuytrens and Paediatric Contractures. The Adjustable Splint Glove is a seamless knitted glove with detachable splinting, monitoring and measurement technologies. Hand therapists attach caterpillar tubules and sensors to individual fingers and hands. The tubules are inflated individually by a standard inflation bulb to the level prescribed by hand therapists. Pressure sensors display readings on a laptop to guide the user when to stop inflating. The digital data are discharged to the Hand Therapy-Online system. This research uses advanced engineering and digital technologies to provide the adjustable splinting system required to maintain hand function and data on patient outcomes and cost offsets, which is currently lacking. Aim: To finalise the Adjustable Splint Glove prototype for patient use, manufacturing, commercialisation and adoption into health services. Objectives: 1. To finalise the sensor technology to measure range of movement (digital goniometer) with performance equivalence to a manually operated clinical goniometer (&plusmn;5 degrees); and the soft pressure splint technology 2. To manufacture demonstrator Adjustable Splint Gloves for pre-patient/patient tests 3. To conduct patient proof-of-concept studies 4. To conduct a cost analysis 5. To secure manufacturing and commercial partners Methods A non-randomised n-of-1 crossover design to evaluate individual and group level experiences of the Adjustable Splint Glove. Timelines for Delivery This is a 36-month project with a detailed Gantt Chart, timed Work Packages and Deliverables. Anticipated impact and dissemination The impact is a novel Adjustable Splint Glove, which addresses the discomfort, and lack of patient acceptance of fixed splints. The devices are consistent with the aspirations of NHS Digital and the NHS 10-year plan. Dissemination is via the commercialisation plans, patient networks including international patient support groups, publications and conference papers.

Lay abstract: Numerous conditions result in hand deformities, including Epidermolysis Bullosa (EB), Dupuytren s Contracture and contractures occurring in childhood conditions such as Cerebral Palsy. EB is an inherited, disabling, lifelong condition characterised by fragile skin, recurring painful blisters, wounds and scar tissue. Disabling complications of scar tissue include fused and bent fingers, requiring repeat, painful and expensive surgery to restore hand function. Between surgery hands are managed with dressings and splints. Dupuytren's contracture is a common condition where small hard nodules in the palm of the hand cause one or more fingers to become permanently bent. EB and Dupuytren s patients find current fixed splints so uncomfortable they stop wearing them. In our previous project, EB patients, clinicians, engineers and a knitwear manufacturer developed and evaluated new devices for their hands: &bull; A disposable dressing glove to manage blisters &bull; A glove to keep fingers separated (web-spacer glove) &bull; A Hand Therapy-Online system for routine recording and monitoring treatment, patient-recorded outcomes, and costs. Patients and clinicians can consult each other online without needing to be face-to-face, thereby avoiding long journeys to specialist treatment centres. A prototype Adjustable Splint Glove was also developed with detachable, tubules inflated with air (to straighten fingers), wrist supports, and sensors to measure range of movement. The Adjustable Splint Glove was developed because patients told us fixed splints are uncomfortable, sweaty, inflexible, and can increase blisters. It is a novel seamless, knitted glove. The splint tubules and measurement sensors are detachable to provide a versatile, integrated, adjustable splinting system. Hand therapists can customise the splint actions for individual patients' fingers and hands. Patients can put the glove onto their hand and inflate the tubules to the level set by the hand therapists, enabling them to self-manage the comfort of their splint. Measurements from the sensors, including the amount of stretch applied, can be downloaded onto the Hand Therapy-Online system, for remote hand monitoring and splint adjustment. Patients and carers can self-report their outcomes developed by patients in our previous project. The information recorded on the Online system can enable hand therapists to pick up and reverse deteriorating changes in hand function. In this project patients and hand therapists will refine the Adjustable Splint Glove with the engineers and test it to make sure it suitable for routine use. The Adjustable Splint Glove actions, which gradually stretch joints and tendons to support hand function, may be applicable to other conditions which require splinting. The sensors measuring range of movement provide accurate,consistent measurements, advancing current methods, in routine hand therapy clinics. We will identify more patients that can benefit from the Adjustable Splint Glove and the measurement tool in the commercialisation plan for sustainable NHS and other health services supplies.

Research activity codes: 5.3 MEDICAL DEVICES;6.3 MEDICAL DEVICES
Health categories: SKIN