Feasibility of exoskeleton training for home use for patient with motor complete spinal cord injury.

Due to Spinal Cord Injury (SCI) in the Netherlands every year +/- 450 people
become wheelchair bounded. A lifetime of sitting leads to multiple secondary
complications, such as muscle atrophy, muscle shortening, decubitus,
spasticity, and worsened bladder and bowel function. Standing devices can
prevent these complications. However, they are not always convenient for
functional purposes because they are stationary. Exoskeletons (external active
orthosis) provide an opportunity for people with SCI to stand and walk (again).
Previous research has shown that in hospital exoskeleton training in feasible.
In hospital training with an exoskelet is safe, the average startup time is
less than 20 minutes, the level of assistance the physical therapistcontributed
decreased over the training period, and the patients tolerated the exoskeleton
well. For the users of the exoskeleton, it is important that the exoskeleton is
not only applicable in a hospital, but also in the home situation.
At the moment, the Sint Maartenskliniek offers SCI patient a 10 week
exoskeleton training program. In this intensive training program (three
training sessions each week, for eight weeks) patients learn to use an
exoskeleton safe and independent. Because of the independent use of the
exoskeleton, these exoskeletons might be able to be implemented in patients
daily life activities. In the present study, the feasibility of the training
program with an exoskeleton for home use for people with motor complete SCI
(ASIA A and B) will be examined. The possible changes on health parameters,
such as spasticity, bladder and bowel function, and range of motion of the hip
and knee, are also monitored during the training program. The main aim is to
examine the feasibility of training with an exoskeleton for home use.

In the present study, the feasibility of a training program with an exoskeleton
for home use for people with motor complete SCI (ASIA A and B) will be
examined. Participant will also be evaluated based on individual goal setting,
patient satisfaction, and health changes.

The following questions are answered through an evaluative cohort study:

1. The main feasibility questions are:
- Which skills can be performed after a training period of three times a week
for 8 weeks in the hospital?
- What is the amount of usage (duration and number of steps) of the exoskeleton
at home?
- What kind of activities are performed by the patients when using the
exoskeleton at home and are these in correspondence with the expectations of
the patient and the physical therapists?

2. What is the effect of three times per week for 8 weeks gait training with an
exoskeleton on health parameters such as bladder and bowel function,
(neuropathic) pain, spasticity, range of motion (ROM) of the hip, ROM of the
knee, body experience and quality of life of patients with motor complete
spinal cord injury?

The study will be conducted in a controlled trial.

Twenty-five patients, who are interested in testing the potential of the
exoskeleton training program in the Sint Maartenkliniek, are included in the
present study. The patients will receive eight weeks of exoskeleton training
(aimed at learning to use the exoskeleton independent and safe), three times a
week, for 1.5 hours per session. If a patient can use the exoskeleton
independent and safe after the eight week training period, the patient has the
opportunity to use the exoskeleton in home for two weeks.

The study will be performed mainly during the exoskeleton treatment in the Sint
Maartenskliniek. Gait training is a common therapy during rehabilitation for
patients with incomplete SCI, but not for motor complete SCI (ASIA A and B).
The frequency of the given interventions is not exceeding the frequency of gait
training during the inpatient rehabilitation program (of patient with
incomplete SCI). The gait training with the exoskeleton (ReWalk) is safe,
although some participants may experience small irritations of the skin due to
the attachment to the exoskeleton.

Treatment exoskeleton
This study is designed around the training program with the exoskeleton. To
check if the participant is eligible for the training program, the participant
visits the rehabilitation center prior to the treatment (inclusion). The
exoskeleton training program consists of two parts (1) the in clinic period and
(2) the in home period. During the in clinic part of the training, the
participant receives three session of 1.5 hours training a week for a period of
eight weeks in the Sint Maartenskliniek. These training sessions are under the
supervision of physical therapists who are qualified exoskeleton instructors
The aim of the training sessions is to learn to use the exoskeleton
independently and safe. The participants are allowed to take rest during the
training. Before the participants have the opportunity to use the exoskeleton
at home they (1) have to show that they master sufficient skills independently,
(2) the participant has to take a *buddy* to the clinic, who receives
instructions for guidance in the home setting, and (3) in a brief medical
examination the professionals check if there are no skin lesions or other
adverse events which increase the risk of in home use. If these requirements
are met, the participant is given the opportunity to use the exoskeleton two
weeks at home (in home period). There is a small risk that, despite the
frequent training, the participant falls with the exoskeleton during the in
home period. This could cause moderate damage.


Research
To answer the research questions, the participants fill out a questionnaire
(M1) prior to the training and after the in clinic training period. Filling out
these questionnaire takes +/- 45 minutes, which can be done at home and does
not require a visit to the rehabilitation center.
During the in clinic training period, the participant keeps a logbook (M2).
Completing this logbook takes +/- 3 minutes each time, and will be done
directly after the training session. During the training, the heart rate will
be monitored (M2) to assess the level of physical activity. Once every two
weeks the skills a participant acquires will be assessed with a skill-test (M3)
during the training session. The participants are allowed to take rest between
the various skill-tests. In the last training session the achieved skills and
safety for home use is tested in a parkour (M4). This parkour exists of 20
tasks, which mimics the activities required in a home situation such as short
turns and passing a door. The measurements (M2, M3 and M4) will take place
during the training sessions, and therefore do not require an extra visit to
the rehabilitation center.
If the use of the exoskeleton is considered safe, the treatment continues with
a two-week home period. During this home period the participants will be
keeping a logbook (M5), which will take +/- 5 minutes each day. After the home
period the participant visits the rehabilitation center to return the
exoskeleton and fill out a user satisfaction questionnaire (M6) (duration of
+/- 10 minutes).