PROSTHETIC: Prosthesis Training for Humans: Educational-games vs. Traditional-care and Innovative control vs. Classic-control

In the field of myoelectric upper limb prostheses, a huge gap exists between
the mechanical/electrical functions of prosthetic hands and the possibilities
of the user to control those (i.e. the human-machine interface). Traditional
control (called *direct control*, DC) has shown to be highly non-intuitive,
resulting in device abandonment rates in the range of up to 28%, even with
state-of-the-art prosthetic hands. To overcome the non-intuitiveness of DC, a
form of control based on machine learning algorithms (ML) has been developed.
However, until now it remains unproven whether ML control is superior to DC.
Moreover, no well-grounded training scheme exists for neither DC nor for ML
control, even though it is widely known that quality of training highly affects
the satisfaction with prostheses and thus the risk of device abandonment.
Serious games (e.g. video games that are fun/engaging to play and at the same
time teach the user specific skills), have often been suggested in the
literature for myoelectric training with DC and ML control, but controlled
studies with patients are lacking.

The aim of this experiment is to collect preliminary data to guide future
studies to assess whether training based on serious gaming and conventional
methods lead to different functional outcomes for DC and ML control. Moreover,
the aim is to find out whether ML control and DC control lead to different
functional outcomes.

Explorative intervention study with pre-posttest design.

Four groups will undergo a different training paradigm: Two groups will undergo
standard clinical training for DC and ML, respectively. The other two groups
will undergo training based on a serious game for DC and ML, respectively. A
fifth group will establish a baseline and will not undergo any interventions.

All participants (except for the reference group) will start with a fitting
session. During this session all participants will be fitted with a plaster
custom-made socket. After the socket is fitted a 20 minute introductory session
with the control mechanism will take place. In the next session the pre-test
will be conducted. This session will last around 120 minutes of which 60
minutes consists of resting periods to not fatigue the muscles producing the
control signals. In the seven sessions after the pre-test participants will
partake in 7 training sessions of 45 minutes where they will use the muscles in
the stump to practice myoelectric control. After these training sessions one
last session containing the post-test will take place. This day is similar to
the pre-test. The pre- and post-test will be held on days separate from any
training session.

The risk associated with participating in this study are negligible, with
muscle fatigue as the only risk. The burden is minimal since all sessions will
take place under supervision within a month at a place chosen by the
participant such as the participants home or at a clinic.