STEPFORWARD: Patient acceptability of a novel prosthetic device
Research type
Research Study
Full title
STEPFORWARD: Patient acceptability of a novel prosthetic device: A randomised feasibility study in older patients with vascular-related amputations and multimorbidities
IRAS ID
232950
Contact name
Natalie Vanicek
Contact email
Sponsor organisation
Hull and East Yorkshire NHS Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Background: Annually, 6,000 people in the UK are referred for fitting of an artificial lower leg (known as a prosthesis) following the surgical removal of their limb (lower-limb amputation). These are mostly patients over 50 years and usually with diabetes and/or blood vessel (vascular) problems. Older patients are often prescribed standard foot-ankle prostheses which are rigid at the “ankle”, unlike those often given to younger people which can adjust to slopes and stairs. It is unknown which is the best prosthesis for older patients.\n\nThe aim of this study is to see if it is possible to do a large randomised controlled trial comparing the standard foot-ankle prosthesis to a new version. We will do this by first carrying out a smaller study.\n\nMethods: We will look at the randomisation process, recruitment and whether patients found the study processes acceptable. Over two years, we want to recruit 90 older people with a below-knee amputation because of vascular problems and who find walking difficult. We will invite patients from three prosthetics centres across England to participate and they will be placed randomly into one of two groups by a computer: wearing 1) their existing prosthesis; or 2) a new prosthesis for 12 weeks. We will hold one-to-one interviews to ask how patients felt about participating in the study. We will measure how far patients can walk, how long they wear their prosthesis daily, and ask them to score their pain, health and well-being. We will do this with questionnaires, simple exercise tests and a wearable device which measures activity.\n\nPublic involvement: We have already spoken to fifteen patients with a lower-limb amputation and their input has been valuable in developing the research questions around what is important to them, including walking ability, managing daily activities and measuring pain.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
18/YH/0089
Date of REC Opinion
4 May 2018
REC opinion
Further Information Favourable Opinion