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STEPFORWARD: Patient acceptability of a novel prosthetic device: A randomised feasibility study in older patients with vascular-related amputations and multi-morbidities

Background

Annually, 6,000 people are referred for prosthetics treatment following a lower-limb amputation in the UK. These are mostly patients over 50 years and usually with diabetes and/or vascular problems. Older patients are often prescribed standard ankle-foot prostheses, unlike those given to younger people. Standard prostheses are designed for walking on level ground, and do not adjust to other surfaces such as stairs and slopes. New types of ankle-foot prostheses that are more functional can help improve someone’s walking, but older patients are seldom offered these prostheses. 

The Study

STEPFORWARD is a multi-centre, randomised controlled, open feasibility study to:

1. Evaluate the acceptability to patients and limb centres of randomisation to the two arms;
2. Assess the acceptability of, and adherence to, the intervention in a group of older patients with vascular-related amputations. 

Participants with a below-knee amputation will be randomised into one of two trial arms: standard prosthesis (standard treatment) vs. hydraulic self-aligning prosthesis (novel treatment). Participants will be individually randomised and stratified according to prosthetics centre on a 1:1 basis. They will be followed up over 12 weeks after randomisation.

The primary objective is to assess whether it is feasible to conduct a future, full scale RCT into the effectiveness and cost-effectiveness of a novel prosthesis for older patients with vascular-related amputations and other health issues compared to a standard rigid prosthesis.

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