Prosthetic socket design Other
Conditions
Interventions
Group A – Prosthetists
Prosthetists participating in Stage One (the iterative usability testing phase) are first informed about the study via their clinic lead and invited to participate. If intereste
Sponsors
Radii Devices Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Group A: Prosthetists: 1. Prosthetists working with patients recruited as participants in the study 2. Are willing to design a socket using the ATFS Group B – Adults with limb loss: 1. Over the age of 18 years 2. Have had a transtibial amputation 3. Deemed ready to cast for a new prosthesis by the clinical team as per usual care at the prosthetic centre 4. Able to understand verbal and written English and give informed consent
Exclusion criteria
Exclusion criteria: Group A: Prosthetists 1. Not familiar with using CAD software technologies for socket design 2. Unwilling to design a socket using the ATFS Group B – Adults with limb loss: 1. Contraindication to be fitted for a prosthetic socket 2. Unwilling for their prosthetist to design their socket using the ATFS 3. Unable to answer verbal questions (as per normal fitting appointment) on their socket fitting and comfort
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Usability of the ATFS is measured using a semi-structured interview with the prosthetist at post-definitive socket delivery (per patient case) 2. Prosthetist confidence and experience with the ATFS is measured using a semi-structured interview conducted by the study researcher at post-definitive socket delivery 3. Perceived usability and clarity of ATFS training materials is measured using a semi-structured interview conducted by the study researcher at post-definitive socket delivery 4. Socket comfort is measured using the Socket Comfort Score (SCS) at the definitive socket fitting appointment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time taken for initial rectification and socket design using the ATFS is measured using direct observation and meeting recording at the assessment appointment in Stage One 2. Time taken for initial rectification and socket design using the ATFS is measured using system log data at the assessment appointment in Stage Two 3. Prosthetist-reported typical design time using standard CAD/CAM software is measured using self-report at the assessment appointment | — |
Countries
England, United Kingdom
Contacts
Public ContactJoshua Steer
Outcome results
None listed