Background: Almost 6,000 people have a leg amputated in the UK annually. These are mostly patients over 50 years and usually with diabetes and/or blood vessel problems. Older patients are often prescribed standard ankle-foot prostheses, unlike those given to younger people. New types of prostheses can help improve someone’s walking, but older patients are seldom offered the new types.
Aim: We want to see if it is possible to do a large randomised control trial across the UK comparing a standard below-the-knee prosthesis to a new version. We will do this by first carrying out a much smaller study.
Methods: This 2-year study will look at all the different stages involved including the randomisation process, recruitment and whether patients found the process acceptable. We want to recruit 90 older people who have a below-the-knee amputation because of problems with their blood vessels and find walking difficult. We will invite patients from three prosthetics centres across England to participate and a computer will put them into one of two groups: 1)wearing their existing prosthesis; or 2)a new prosthesis for 3 months. We will hold focus groups to ask how patients felt about the computer deciding whether they got to try a new prosthesis or not. We will measure how far patients can walk, how long they wear their prosthesis daily, and ask them to score their pain, health and wellbeing. We will do this with questionnaires, simple exercise tests and a wearable device which measures their activity. Because of the way the study design, any differences should be due to the new prosthesis.
Public involvement: We have already spoken to some patients and their comments helped design this study. Members of that group will be invited to sit on the steering committee and asked to share the findings with fellow patients