Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation v14.pdf (556.25 kB)

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

preprint

posted on 02.05.2021, 05:25 by Alexander ThesleffAlexander Thesleff, Bahareh Ahkami, Jenna Anderson, Kerstin Hagberg, Max Ortiz-CatalanMax Ortiz-Catalan

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.

Funding

Swedish Innovation Agency (VINNOVA)

Swedish Research Council (Vetenskapsrådet)

Promobilia Foundation

IngaBritt och Arne Lundbergs Foundation

Swedish state under the agreement between the Swedish government and the county councils, the ALF agreement (ALFGBG-76480 and ALFGBG-725641).

History

Email Address of Submitting Author

thesleff@chalmers.se

ORCID of Submitting Author

0000-0003-0384-9205

Submitting Author's Institution

Chalmers University of Technology

Submitting Author's Country

Sweden

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Categories

Bioengineering

Keywords

Lower Limb Prostheses Neuromuscular Control Safety Protocol Rehabilitation Amputation

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