The effect of GRAIL training on functional walking capacity and social participation in patients with incomplete spinal cord injury.

Approximately 60% of the patients with a spinal cord injury (SCI) suffer an
incomplete lesion (Nijendijk et al., 2014). In the chronic phase of an
incomplete SCI (iSCI) many patients experience problems such as a reduced
functional ambulation (Hedel van, 2009) which can negatively influence social
participation (Lund et al., 2005). Frequently, an important goal of
rehabilitation is to improve functional ambulation. Various interventions and
training approaches aiming to improve walking performance in iSCI patients have
been introduced and all approaches show some improvement without supremacy of
one intervention over others (Morawietz & Moffat, 2013). A promising training
approach in rehabilitation is GRAIL (Gait Real-time Analysis Interactive Lab)
training. The GRAIL is a training device where people train on a treadmill in a
virtual environment. During GRAIL training the focus is on adjustment of the
gait pattern, which is referred to as *gait adaptability training*. Results
from our own (pilot) study show that a short period of GRAIL training led to an
improved walking and balance capacity during treadmill walking in ambulatory
iSCI patients. After 6 weeks of GRAIL training iSCI patients increased their
walking speed, stride length, and gait stability in anterior-posterior
direction while walking on a self-paced treadmill (van Dijsseldonk et al.,
2018). This effect was remained at 6 months follow-up. However, it is unknown
whether the effect of GRAIL training also extends to functional walking and to
social participation in ambulatory iSCI patients. Moreover, we do not know the
effect size of GRAIL training compared to other gait interventions.

The main objective of this study was to evaluate the effect of 6 weeks of GRAIL
training on functional walking capacity compared to endurance and strength
training (control intervention) in ambulatory patients with chronic iSCI. In
addition the effect of GRAIL training on social participation will be assessed.

The proposed study is a randomized controlled trial with parallel groups
design.

The GRAIL intervention consist of twelve one-hour training sessions spread over
a six-week period. During the GRAIL intervention the focus is on training gait
adaptability on a treadmill using a virtual reality training device.
The control intervention also consist of twelve one-hour training sessions
spread over a six-week period. During the control intervention the focus is on
training endurance and lower body strength. As a contrast to the GRAIL
intervention, participants will not train their gait adaptability during the
control intervention.

The study will be performed with chronic iSCI subjects. Participants will
receive either the control intervention or the GRAIL intervention twice a week
for one hour each time. After a 6-weeks rest period, participants will
cross-over to the other intervention. Therefore, each participants will receive
both interventions. The frequency and duration of the interventions are part of
the rehabilitation process and are based on actual care pathways that match the
inclusion criteria of the study population. This category of patients is
generally well tolerable to training. The GRAIL is a safe training device,
which will not expose participants at risk. The trainings frequency (of both
interventions) does not exceed the normal frequency during rehabilitation.
Most of the measurements for the study are already part of the rehabilitation
trajectory and are used for the clinical evaluation of the intervention. The
clinical evaluation consists of four measurements. For the study we add extra
tests to these (clinical) measurements and we ask participants to participate
in one extra (fifth) measurement. The additional tests for the study consist of
questionnaires and functional tests. The functional tests (2MWT and SCI-FAP)
reflect tasks in daily life and do not involve extra risks. Participants are
allowed to take rest in between the tests. The total extra time/burden for the
study is 2 hours and 45 minutes (of which 1 hour and 10 minutes for
questionnaires (USER-P, rehabilitation goals, patients* experience and ABC) and
1 hour and 35 minutes for functional tests (2MWT and SCI-FAP)).
The training and the measurements will be accompanied by experienced
physiotherapists who will take care of the patient. Any additional (physical)
therapy aimed at improving the walking or balance capacity will be temporarily
stopped during the study duration in consultation with the patient.