Clinical Trial

Personalisation of Prosthetic Care for Lower- Limb Amputees

Active, Not Recruiting
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Record status
This record was last updated March 27, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
Summary
The global rise in lower-limb amputations is mainly due to diabetes and vascular complications. Amputations cause serious physical and psycho-social disabilities which impair locomotion and compromise patients quality of life. Biopsychosocial factors such as altered gait parameters, poor prosthetic fit, depression, fear avoidance behaviours and stigma increase the risk of individuals incurring lower back pain; the leading cause of secondary disability amongst persons with lower-limb amputation. Exploring the potential mechanistic pathways of lower back pain development is important to inform timely patient-centred programmes of care. Currently, limited information exists to inform the design of such programmes. Thus, there is a pressing need to understand the bio-behavioural, psychological, and social features of individuals with lower-limb amputation in the presence of lower back pain.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-02-04.
Status change: Recruiting → Active, Not Recruiting 2025-03-24
Trial Details
NCT Number NCT06243549
Lead Sponsor University of Bath
Collaborators: University Hospitals Bristol and Weston NHS Foundation Trust, Portsmouth Hospitals NHS Trust
Conditions Low Back Pain
Enrollment 30 participants
Start Date 2023-09-01
Primary Completion 2025-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-03-27