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