Generation and evaluation of hand therapy devices for Epidermolysis Bullosa and Dupuytrens

Health

Generation and evaluation of hand therapy devices for Epidermolysis Bullosa and Dupuytrens

Generation and evaluation of hand therapy devices for Epidermolysis Bullosa and Dupuytrens: Adjustable Splint Glove manufacturing and commercialisation (GLOVED)

In our previous GLOVE project, people living with Epidermolysis Bullosa, clinicians, engineers and a knitwear manufacturer developed and evaluated novel hand devices:

A disposable dressing glove to manage blisters
A glove to keep fingers separated (reinforced web-spacer glove)
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 with a digital system for measuring range of movement (digital goniometry).

The Adjustable Splint is being advanced in the GLOVED project. The aim is for clinicians to customise the splint actions for individual patients' fingers and hands and for patients to be able to adjust their splint within safe limits for comfort, also to keep pace with changes in the hand because of splinting. Digital measurements can be taken by patients and downloaded onto the Hand Therapy-Online system, for remote hand monitoring and splint adjustment.

Aims

To finalise the Adjustable Splint Glove prototype for patient use, manufacturing, commercialisation, and adoption into health services.

Objectives
1. To refine and finalise the hand measurement sensor technology (digital goniometer) with performance equivalence to a current manually operated goniometer (±5 degrees)
2. To refine the splint technology
3. To manufacture demonstrator Adjustable Splints for pre-patient/patient tests
4. To conduct patient proof-of-concept studies
5. To conduct a cost analysis
6. To secure manufacturing and commercial partners.

Methods

Qualitative online audio-recorded interviews. Workshops to demonstrate prototypes to clinicians and people living with Dupuytren’s Contracture

Trials Design

A model of user engagement in medical device co-design.

Summary of Findings

With the academic engineers, various splinting technologies were developed, tested, and rejected. The current adjustable splint and digital goniometer are being translated into commercially viable and manufacturable devices for hand splinting and digital measurement.

Impact

Patients with incurable, progressive conditions need medical devices to mitigate condition-related deformities. The project is enabling people living with Dupuytren’s Contracture to co-design and revise an adjustable splint so that it can be worn comfortably overnight to manage their hand contractures, improve hand function, and improve independence. The device may be appropriate for people living with hand contractures, which arise form other underlying conditions.

Related projects

Generation and evaluation of hand therapy devices for Epidermolysis Bullosa (GLOVE)

Xeroderma Pigmentosum: Codesign and testing of a specialised visor for ultraviolet radiation protection

Publications

Grocott P, Weir H, Bridgelal Ram M. A Model of User Engagement in Medical Device Development International Journal for Health Care Quality Assurance 2007; 20(6):484-93. https://pubmed.ncbi.nlm.nih.gov/18030966/.

Browne N, Grocott P, Cowley S, Cameron J, Dealey C, Keogh A, Lovatt A, Vowden K, Vowden P. Woundcare Research for Appropriate Products (WRAP): validation of the TELER method involving users. International Journal of Nursing Studies 2004; 41(5):559-71. https://pubmed.ncbi.nlm.nih.gov/15120984/.

Grocott P, Graham, T, Blackwell R, Currie C, Pillay E, Clapham J, Graham-King P, Hon J, Snelson K (2013) Individualising wound care research: The wound care for epidermolysis Bullosa project. Wounds UK Vol 9 (3) 23-32. https://www.wounds-uk.com/journals/issue/35/article-details/individualising-wound-care-research-the-woundcare-for-epidermolysis-bullosa-project

Grocott P. Blackwell R, Currie C, Pillay E, Clapham J, Graham-King P, Hon J, Snelson K. Woundcare research for epidermolysis bullosa: designing products with users. Dermatological Nursing 2013;12(1):30-5. https://www.ingentaconnect.com/contentone/bdng/dn/2013/00000012/00000001/art00003.

Graham T, Sooriah S, Giampieri S, Box R, Grocott P. Iterative co-design and testing of a novel dressing glove for Epidermolysis Bullosa. Journal of Wound Care 2019; 28(1): 5-14. DOI: 10.12968/jowc.2019.28.1.5. https://www.ingentaconnect.com/contentone/bdng/dn/2013/00000012/00000001/art00003.

Graham T, Sooriah S, Box R, Gage H, Williams P, Clemett V Grocott P. Participatory co-design of patient-reported outcome indicators and N-of-1 evaluation of a dressing glove for Epidermolysis bullosa. Journal of Wound Care 2020; 29(12): 751-62. https://doi.org/10.12968/jowc.2020.29.12.751

Conferences

2021 Graham, T, Sooriah, S, Box, R, Grocott, P International Forum on Quality and Safety Conference Europe, 2021 Poster title: Advancing quality improvement through codesign with patients and carers.

2020 Graham, T, Sooriah, S, Box, R., Grocott, P, Meydan, T, Williams, P. & Hashimdeen, S, Jul 2020, Proof of concept and clinical follow up of a disposable dressing glove and reinforced web spacer glove for Epidermolysis Bullosa In: Acta Dermato-Venereologica. 100, Supplement 220, p. 49 1 p., P45. DEBRA International 2020 poster presentation

2020 Box, R, Sooriah, S, Graham, T. & Grocott, P, Jul 2020, Service Evaluation of a hand therapy online system - initial findings In: Acta Dermato-Venereologica. 100, Supplement 220, p. 54 1 p., P54. DEBRA International 2020 poster presentation