Clinical investigation on the safety and performance of the ABLE Daily to assist people with spinal cord injury in home and community settings

A spinal cord injury can affect the patients' ability to walk and maintain
balance. As a result, paraplegic patients are often dependent on the wheelchair
to move around, which means they sit a lot during the day. This results in less
physical movement each day, which might have negative consequences for the
mental and physical health.

With the emerging technologies, an exoskeleton could perhaps (partly) replace
the wheelchair and increase the amount of physical movement in a day. At the
moment, exoskeletons are only used in clinics and not yet in the home
environment. To date, only one study has been published that has investigated
the effect of home use the Rewalk exoskeleton. This research has shown
improvements on the mental and physical health in spinal cord injury patients
after only two weeks of using an exoskeleton in the home environment, but it is
still unknown what the consequences are for mental and physical health after an
installed period in the home environment .

The primary objective of this study is to assess the safety and performance of
the ABLE Daily to perform ambulatory functions in home and community settings
for people with spinal cord injury.

The secondary objectives are to assess the impact of the ABLE Daily use on the
perceived general health of the participants, the gait performance with the
ABLE Daily using data collected from the exoskeleton, and the level of user
satisfaction from participants, companions, and therapists.


Additionally, exploratory endpoints are selected to observe the effect of using
the ABLE Daily for ambulatory functions in home and community settings on
health promotion. The change from baseline to final assessment of participant*s
parameters in the following domains will be quantified:
- Cardiovascular
- Respiratory
- Muscle spasms and spasticity
- Bowel function
- Bladder function
- Body composition
- Insulin sensitivity
- Sleep quality
- Mental health and quality of life

Intervention study with 10 spinal cord injury patients.

ABLE Daily exoskeleton use in the home and community settings.

The research is quite time-intensive. We ask the participant to practice with
the exoskeleton in the clinic three times a week during the clinical period of
three weeks. Once the participants have received the exoskeleton home, we
expect them to walk with the exoskeleton at least three times a week for 30
minutes.

The exoskeleton can create pressure points on the skin. In addition to the
pressure points, the participant may experience joint pain or swelling because
the participant is moved by the exoskeleton or because the exoskeleton has not
been fitted properly. To reduce the risk of pressure points and joint pain or
swelling, the skin will be examined before and after training by the therapist
and at home by the buddy. In addition, the ABLE Daily has cushions at the
various contact points.

When the participant moves from sitting position to standing position, a sudden
difference in blood pressure can cause dizziness. This physical response is
reduced when this movement is repeated more often.

Because the participant is not used to walking in an exoskeleton, the
participant can easily lose balance. The participant is therefore required to
use crutches or a walker that help maintain balance. In addition, the buddy
must always be present when the exoskeleton is used. Despite these measures,
there is still a chance that the participant will fall.

Previous research has shown that in rare cases bone fractures occur due to the
use of the exoskeleton. In this study, there will be a preliminary screening to
confirm that the participants have healthy, strong bones. Despite this measure,
it cannot be ruled out that there is a risk of bone fractures during this
study.

Exoskeletons could be suitable for improving the mobility and independence of
people with physical disabilities. Previous research with a different
exoskeleton has shown that there may be health benefits to walking with an
exoskeleton. Reduced spasticity in the muscles was observed, less pain,
improved bowel function, improved fitness and less fatigue and thus an improved
quality of life. However, we cannot guarantee that participants will experience
these benefits. By participating in the study, we can gain more knowledge about
the application of the exoskeleton in rehabilitation, which could possibly help
people who are in a similar situation as the participant.