Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised...

Area of Science:

• Rehabilitation Medicine
• Biomedical Engineering
• Clinical Trials

Background:

• Older adults with transtibial amputations often receive rigid prostheses, limiting mobility on varied terrain.
• Current prostheses can be energy-inefficient and lead to disuse due to difficulties with uneven surfaces.
• Evidence for optimal prosthetic ankle-foot mechanisms in this population is limited.

Purpose of the Study:

• To determine the feasibility of a large-scale randomized controlled trial (RCT).
• To assess the effectiveness and cost-effectiveness of self-aligning prostheses compared to standard prostheses.
• To gather patient and staff perspectives on prosthesis use and trial delivery.

Main Methods:

• A pragmatic, parallel-group, randomized controlled trial (RCT) design.
• Recruitment of 90 patients aged 50+ with transtibial amputations (primarily vascular-related).
• Feasibility measured by consent/retention rates, projected sample size, and outcome completeness; qualitative interviews and focus groups conducted.

Main Results:

• Feasibility metrics (consent, retention, recruitment rate, data completeness) will be reported.
• Qualitative data will provide insights into patient experience and implementation barriers.
• Results will inform the design of a definitive, full-scale RCT.

Conclusions:

• This feasibility study is crucial for designing a robust RCT on prosthetic interventions.
• Findings will guide the development of more effective and user-friendly prostheses for older amputees.
• The study aims to improve mobility and quality of life for individuals with transtibial amputations.