Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation

Abstract

<p><a>In research on lower limb prostheses, safety during testing and training is paramount. Lower limb prosthetic users risk unintentional loss of balance that can result in injury, fear of falling, and overall decreased confidence in their prosthetic leg. Here, we present a protocol for managing the risks during evaluation of active prosthetic legs with modifiable control systems. We propose graded safety levels, each of which must be achieved before advancing to the next one, from laboratory bench testing to independent ambulation in real-world environments. This ensures safety for the research participant and staff.</a></p>

Investigating the Association of Quantitative Gait Stability Metrics With User Perception of Gait Interruption Due to Control Faults During Human-Prosthesis Interaction

“…Subjective perception of the robotic assistive device's functionality and its impact on walking gait stability directly affect users' psychosocial conditions, such as fear of falling and reduced physical activity [13], [14], [15]. These subjective perceptions are widely applied to guide prosthesis tuning in clinics and even used to directly tune control parameters of robotic assistive devices [8], [16], [17].…”