STEPFORWARD: A comparison between usual care “rigid” prosthetic feet and hydraulic “flexible” feet for quality of life in patients with a below-knee amputation who have limited mobility

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30060279

Enrollment

266

Registered

2026-03-16

Start date

2026-08-01

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a below-knee amputation categorised as having limited mobility Musculoskeletal Diseases

Interventions

People taking part in this study will be randomly assigned by the research team, using a secure computer system, to one of two groups. One group will continue using their usual rigid prosthetic foot,

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years and over. 2. Have a major unilateral below-knee amputation, of any aetiology. 3. Are prosthesis users categorised as having limited mobility in the community. 4. Have an MFCL K2-level classification. 5. Have a SIGAM mobility grade of C (can walk on level ground only, less than or up to 50 metres, with or without walking aids) or D (can walk outdoors on level ground only and in good weather, more than 50 metres, with or without walking aids). 6. Are using a usual care rigid, non-hydraulic, non-self-aligning prosthetic foot (for example: solid ankle cushioned heel, uniaxial, multiaxial, or multiflex). 7. Have completed initial prosthetic rehabilitation. 8. Have an appropriately fitting socket and/or a socket comfort score (SCS) of 7 or higher. 9. Are deemed suitable to use a flexible foot based on multidisciplinary team (MDT) clinical decision-making. 10. Are willing to trial the hydraulic self-aligning flexible foot if randomised to the intervention group.

Exclusion criteria

Exclusion criteria: 1. Have a contraindication to wearing their current prosthesis (e.g., open wound, infection on residual limb)** 2. Have a contraindication to the intervention flexible hydraulic self-aligning foot (this relates to body mass > 100 kg, long residual limb) 3. Have a clinical diagnosis of disease affecting memory or score =3 on the Abbreviated Mental Test indicating severe cognitive impairment ** If a patient is undergoing initial prosthetic rehabilitation or has an inappropriately fitting socket or contraindication to wearing their prosthesis, they can be reconsidered for inclusion once they satisfy the eligibility criteria (i.e., they complete initial prosthetic rehabilitation, or have their socket modified/remanufactured to fit correctly and/or have no contraindication, respectively).

Countries

England, Scotland, United Kingdom

Contacts

Public ContactAmy Wilkinson

amy.wilkinson@hyms.ac.uk+44 1482 464897

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 29, 2026