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GLOVED (Generation and evaLuation Of hand therapy deVices for Epidermolysis bullosa and Dupuytrens) project: Adjustable Splint Glove manufacturing and commercialisation
A knitted glove with inflatable plastic tubules could replace the rigid, painful splints that people with hand contractures currently endure. The problem is that existing fixed splints are so uncomfortable that many patients stop using them, allowing their fingers to curl permanently inward. This affects people with Epidermolysis Bullosa (a severe skin condition), Dupuytren’s disease, and children with contractures. The Adjustable Splint Glove uses a seamless knit with detachable caterpillar-shaped tubes that a hand therapist inflates individually using a standard bulb. Pressure sensors display readings on a laptop, telling the user when to stop inflating. The project will finalise the prototype, test its digital goniometer (which must match a manual goniometer’s accuracy to within ±5 degrees), run patient proof-of-concept studies, conduct a cost analysis, and secure manufacturing partners. If successful, the glove could replace a system that currently fails many patients, offering adjustable, data-driven splinting that patients will actually wear. The data would feed into the NHS Digital system, supporting the NHS 10-year plan for remote monitoring and personalised care.
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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 (±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.
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