Clinical usability evaluation of an ATFS for socket design
Research type
Research Study
Full title
An evaluation of clinical usability-related safety of an Adaptive Templates Fitting System (ATFS) to support prosthetic socket design
IRAS ID
317901
Contact name
Shigong Guo
Contact email
Sponsor organisation
Radii Devices Ltd.
Clinicaltrials.gov Identifier
MUSC 57956, NIHR Clinical Research Network (CRN) Portfolio
Duration of Study in the UK
0 years, 6 months, 3 days
Research summary
This study will be carried out over 6 months at Bristol, Norwich and Cambridge Opcare NHS prosthetic services. Prosthetists at these services and patients with a below-knee amputation will be eligible to participate if they are interested.
Participation will be split into two stages:
- Stage One consists of iterative usability testing of the Adaptive Template Fitting System (ATFS) software to inform its further development.
After assessment appointments, prosthetist participants will upload the 3D shape capture of participating patients’ limbs to the ATFS and use it to support socket design for their patients. Prosthetists will think aloud and be recorded while using the software with the researcher available to help where required. The designs will be transferred for manufacture into sockets for patients’ fitting appointments as per the clinical normal process.
At fitting appointments patient participants will try the socket as per normal clinical practice. Prosthetists will discuss the socket fit with the patients and make socket adjustments as required as per normal clinical practice, using the ATFS Software where digital adjustments are needed, leading to delivering the definitive sockets for the patients.
Finally, the prosthetist participants will be asked about their experiences creating socket with the aid of the ATFS in semi-structured interviews. Training materials on using the software will also be evaluated through these interviews.- Stage Two consists of summative usability testing of the fully developed ATFS.
Identical to Stage One except for the following changes:
i. The prosthetist participants will use the ATFS Software independently while being screen recorded but without thinking aloud.
ii. After delivery of the definitive sockets to participating patients, the prosthetist participants will be asked about their experiences independently creating sockets with the aid of the ATFS, plus their views on comparisons against their standard CAD/CAM design workflow in semi-structured interviews.REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0126
Date of REC Opinion
15 Apr 2024
REC opinion
Further Information Favourable Opinion