Title: Co-design of hand therapy devices for Epidermolysis Bullosa
Funder: Department of Health (England)

Abstract: 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 chart hand deformity and device performance Trained users of Hand Therapy-online service Clinical proof-of-concept data and analysis Report Work Package 5 Implementation of Hand Therapy-online service Objective: Hand Therapy- online service Milestones User tests: data capture systems Signed-off Information Governance Project Requirements Deliverable NHS compatible Hand Therapy-online service Work Package 6 EB Hand Therapy Cost Benefit Ratio Objective: NHS costs of Hand Therapy devices Milestones Unit device costs Staff time/contact frequency Estimated device usage, unit costs/patient/12 months Deliverable Analysed hand therapy device costs relative to benefits Analysed Hand Therapy-online service implementation costs Objective: Monetise benefits Milestones Frequency of surgery Hand surgery episode costs Partial cost benefit analysis Deliverables Benefits of the devices and cost-benefit calculation. EB hand therapy cost benefit ratio (NHS)


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: SKIN