Project CAPARE: Cueing-assisted Personalised Augmented-Reality Exergaming for Parkinson*s rehabilitation

Reality DTx® is a potentially effective and clinically feasible medical device
with two core modules -movement assistance and movement training- that applies
the existing proven principles of sensory cueing and home-based exercise for
people with Parkinson*s disease (PD) onto augmented-reality (AR) headsets.

The primary objective of this study in people with PD is to examine the
clinical feasibility, in terms of safety, adherence, performance and user
experience (i.e., patient and physiotherapist), and effectiveness of home-based
gamified cueing-assisted personalized AR gait-and-balance exercises with
Reality DTx®. In order to achieve this, several (sub)studies will be conducted.
First, it will be determined if the AR headset data can be used to reliably and
validly calculate outcomes of clinical tests and exergames for remote
monitoring of gait-and-balance outcomes and to personalize exergame content
(data quality study). Subsequently, the intensity of the AR gait-and-balance
exercises of Reality DTx® will systematically be evaluated (intensity study).
Finally, a clinical feasibility study will be conducted to test the cueing
protocol and assess the feasibility and effectiveness in a clinical setting of
home-based gamified cueing-assisted personalized AR gait-and-balance exercises
with Reality DTx®.

This study is a clinical feasibility study with two substudies, namely a data
quality study and an intensity study. The substudies will be performed first to
be able to better interpret the results of the clinical feasibility study.

To validate gamified gait-and-balance monitoring outcomes (data quality study),
1 session in the laboratory will be performed.

To systematically evaluate the intensity of the gait-and-balance exercises
(intensity study), 1-2 home visits will be performed depending on the fitness
level of the participant.

The clinical feasibility study is a concealed two-arm Randomized Controlled
Trial and consists of three in-clinic assessments. After a baseline assessment
of standard clinical tests, participants will start with an 6-week usual care
control period. After 6 weeks, participants undergo the midterm assessments.
Then, participants will start with the 8-week Reality DTx® intervention and
will receive a final assessment hereafter. A predefined two-armed
block-randomisation will determine which participants will be allocated to the
control group and which participants will be allocated to the intervention
group.

Reality DTx®, a class I CE marked medical device, is a software application for
AR headsets, such as HoloLens 2 and Magic Leap 2. The intended use of the
Reality DTx® software is to provide visual and auditory cues to assist walking
and modify gait and to provide gamified AR exercise programs for the
therapeutic treatment of gait and balance in PD.

The risks of this study are minimal and the burden on the participants is low
to medium considering the clinical assessments and daily exercise and likely
outweighs the benefits associated with physical activity promotion in people
with PD in general, such as slowing down the progression of motor symptoms, and
boosting their gait-and-balance skills through the offered home-based gamified
AR exercises program as an addition to usual care.