STEPFORWARD

• Research type

  Research Study

• Full title

  STEPFORWARD: A randomised controlled trial and economic evaluation of the impact of a hydraulic self-aligning ankle-foot on quality of life for patients with a below-knee amputation who have limited mobility

• IRAS ID

  346857

• Contact name

  Natalie Vanicek

• Contact email

  n.vanicek@hull.ac.uk

• Sponsor organisation

  Hull University Teaching Hospitals NHS Trust

• Duration of Study in the UK

  3 years, 11 months, 31 days

• Research summary

  BACKGROUND
  In the UK, most amputations are below-the-knee in adults aged over 50 years because of problems with blood vessels &/or diabetes. These patients are often categorised as having limited mobility and usually prescribed an artificial leg with a rigid foot that does not self-adjust to sloped surfaces. Artificial legs with self-adjusting feet are available and often prescribed to patients who are active. They are seldom prescribed to those with limited mobility on the NHS because of a lack of evidence about benefits in this patient group and they have a higher cost. These feet are likely to help these patients become more active long-term.

  IMPORTANCE
  Patients said that a rigid artificial foot makes walking difficult, uncomfortable, exhausting and is likely to stop them using their artificial leg, leading to worse quality of life and poorer health.

  AIM
  We want to know whether an artificial leg with a self-adjusting foot improves quality-of-life and health status for below-knee amputee patients with limited mobility and is value for money for the NHS.

  STUDY DESIGN
  We will compare a self-adjusting foot with a more rigid foot usually prescribed on the NHS. 266 below-knee amputees, who have limited mobility and use a rigid artificial foot, will be recruited across 10 NHS prosthetics centres in England and Scotland. Patients will be placed into one of two groups by random chance so that they either keep their existing foot or receive the self-adjusting foot. Only their foot will be different. All patients will be able to access their usual care during the study. We will compare quality-of-life, balance, falls, patient satisfaction and use of the artificial limb between patients with rigid and self-adjusting feet every 3 months for 1 year.

  This study is being funded by the NIHR Health Technology Assessment programme.
  

• REC name

  West of Scotland REC 4

• REC reference

  26/WS/0035

• Date of REC Opinion

  20 Apr 2026

• REC opinion

  Further Information Favourable Opinion