People with epidermolysis bullosa (EB) — a condition that makes skin as fragile as butterfly wings — will co-design new hand therapy devices to prevent their fingers from fusing together into useless fists. The problem is stark: EB causes painful blisters and scarring on the hands, and existing splints and dressings are often uncomfortable, ineffective, or simply not worn. This project directly tackles that gap by involving patients from the start. Over six work packages, researchers will first run workshops to capture exactly what users need from hand therapy. They will then develop two key devices: a dressing glove lining that manages moisture and protects wounds, and a novel knitted splint glove that can reversibly stiffen using hydraulic technology. Sensors built into the splint glove will measure stiffness levels and feed data into a new online system called Hand Therapy-online. If successful, this research could transform daily life for people with EB. Instead of ill-fitting, rigid splints, they would have comfortable, custom-knitted gloves that actively prevent finger webbing and contractures. The devices would be CE-marked as Class IIa medical products, ready for NHS use, and the digital platform could streamline hand therapy monitoring for clinicians. This is applied medical device development with immediate, tangible impact on a rare disease community.
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Project Plan There are six interrelated work packages with discrete objectives, milestones and deliverables. Work Package 1 User needs Objective: Determine user experiences Milestone Four audio-recorded workshops determining user experiences, device shortfalls, feedback on data capture systems Deliverables Report on user requirements Work Package 2 Technical specification of hand therapy devices Objective: Validate hand measurement data collection Milestones 3D hand measurement; data transfer protocols EB hand deficit index, webbing/contraction indicators; consensus validation with user/TELER groups Version 1 Hand Therapy-online system alongside NHS IT governance procedures Deliverables Hand measurement protocol Data informing device designs Version 1 Hand Therapy-online service Objective: Develop dressing glove lining Milestones Investigate candidate yarns Conduct knitting tests; iteratively refine Design glove linings from hand measurements Deliverables Dressing glove lining specification Glove designs Objective: Research technical feasibility of a knitted splint glove Milestones Materials and methods for the reversible hydraulic/stiffening function Deliverable Report on the design and technical components of a knitted reversible splint glove Objective: Research inclusion of sensors into splint glove, signal acquisition, actuation, determining stiffness levels Milestones Sensor materials to measure glove stiffness Signal acquisition systems, actuation, file storage, file format for data export to Hand Therapy-online service Deliverable Report on sensor materials, incorporation into knitted material of splint glove, electrical signal acquisition, file export to Hand Therapy-online web service Work Package 3 Prototyping Objective: Dressing glove lining Milestones Knit prototype glove linings with candidate yarns Iteratively refine prototypes with user group Deliverable Prototype glove linings Objective: Splint glove and sensor technology Milestones Technical specifications of splint glove stiffening and sensory functions Knit prototype splint gloves Iteratively refine prototypes with user group Deliverable Prototype demonstrator of splint glove Objective: Research systems for electrical signal acquisition from splint glove sensors, actuation processing, data display, interoperability with the Hand Therapy-online service Milestones Electrical signal acquisition, actuation, processing, data display systems Test signal acquisition and file export to Hand Therapy-online service Integrate splint glove, signal acquisition, actuation, processing and data display, as a prototype Deliverables Splint glove prototype Work Package 4 Bench and clinical testing of prototypes Objective: in vitro tests of dressing glove lining. Milestones Test glove lining material: fluid handling; heat/moisture wicking; waterproof barrier Deliverable Medical grade dressing glove lining Objective: Surrogate test glove linings with Skinnies WEB™ web-spacer glove Milestones Objective performance criteria for glove linings and web-spacer gloves Surrogate tests of the glove lining and web-spacer glove together; iteratively refine Package and sterilise the gloves as Class IIa medical devices CE mark; MHRA Classification Class IIa medical Deliverables Objective performance criteria for dressing glove lining with web-spacer glove Surrogates tests, iterative refinements CE marked glove linings Objective: Clinical proof-of-concept tests; dressing glove linings with web-spacer gloves Milestones Develop and validate (consensus with user group; TELER users ) clinical indicators of device performance and hand deficits Training for Hand Therapy-online service. Proof-of-concept tests Automated data analysis via Hand Therapy-online service Deliverables Measures to cha
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