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2018-2020 Patient acceptability of a novel prosthetic device: A randomised feasibility study in older patients with vascular-related amputations and multimorbidities - NIHR

The aim of this feasibility study is to establish if it is possible to conduct a large randomised controlled trial comparing standard ankle-foot prostheses to a non-standard version. Over two years, 90 trans-tibial amputees will be recruited who are at least 50 years of age, lost their limb due to vascular problems and find walking difficult. These will come from three prosthetics centres across England and will be randomly placed into one of two groups: wearing for 12 weeks 1) their existing (standard) prosthesis; or 2) a non-standard prosthesis. They will be asked how they felt about the study; to score their pain, health and well-being; and be measured to establish their daily walking distances and the amount of time per day during which they wear their prosthesis. A Patient Advisory Group (PAG), Trial Management Group (TMG) and Trial Steering Group (TSG) will be established to help guide the focus of this study.

Lead organisations University of Hull / HEY NHS Trust

Principal Investigator Vanicek N

Co-investigators Barnett C, Twiste M (Salford), Mitchell N, Salawu A, Jepson F, Watson J, McDaid C, Bell K, Brisco S

Funding body: National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) (PB-PG-0816-20029) for £248,894