MyLeg System: The functional evaluation of a powered knee-ankle prosthesis prototype for osseointegrated transfemural amputees

People with a transfemoral amputation experience a higher metabolic cost and
cognitive load during walking. This is mainly due to the absence of an active
knee and ankle. To resolve these challenges, a fully active, and intuitive
prototype prosthesis has been developed using new materials with a higher
energy storage capacity, a smart control system, and EMG to identify intent.
The prototype prosthesis is able to generate power during highly active daily
activities (i.e. climbing stairs), making knee power generation approximate the
knee power generation of able-bodied people and a prosthesis which is more
intuitive to use during daily life. Measurements will be done to confirm if the
design of the prototype is adequate and attains the pre-set goals.

To evaluate the functioning of and experience using the newly-developed
prototype prosthesis (MyLeg System) during daily activities in people with a
transfemoral osseointegration implant.

Explorative observational cross-sectional study.

An introduction and practice with the MyLeg System inside the Radboudumc under
supervision of a physiotherapist, researcher, orthopaedic technician, and the
manufacturer.

The participants are asked to visit 4 days of maximal 8 hours, with a
compensation in minimal wage. During the day, participants are asked to perform
activities like standing, sitting, level and hill walking, and stepping on a
step, whereof the risk and burden for the subjects are minimal. During this
day, participants are asked to use newly-developed knee-ankle prosthesis. The
use of this prosthesis prototype can cause discomfort. Walking with the new
prototype can feel uncomfortable, mostly at the beginning of practice with the
prototype. The use and getting used to a new prosthesis, like this prototype,
may also cause muscle strain. Although the prosthetic prototype has been
extensively tested for safety and use, the unlikely event that the prototype
may break could cause a participant to fall. However when using the prototype,
the participants will always wear a safety-harness, which will prevent them
from harm in the event of a fall. In addition, the researcher and physical
therapist will always be present and next to the participant during the day to
prevent a fall from happening.
This research has the potential to provide an objective evaluation of the
design and build of the newly-developed prosthesis in relation to the former
prototypes (MyLeg P1, register number NL2019-5920 & MyLeg P2). This knowledge
will be used to further develop and improve the prosthesis prototypes within
and outside the MyLeg project (ERC-H2020 n.780871).