The primary objective of this clinical feasibility study in people with PD is to evaluate the feasibility and potential efficacy of home-based gamified AR gait-and-balance exercises with Cue X. Secondary objectives of this study are to validate the…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters to evaluate clinical feasibility of home-based
gamified AR gait-and-balance exercises with Cue X are usability (e.g., system
usability scale), safety (e.g., adverse events, side effects), adherence (e.g.,
compliance to the prescribed exercises, withdrawal, hours exercising, number of
days exercising minimally 30 min), and patient-reported experience measures and
patient-reported outcome measures (e.g., perceived effectiveness through Likert
scale reporting, quality of life questionnaire).
The main study parameters to evaluate the potential effect of the Cue X
gamified AR gait-and-balance exercise program are gait-and-balance outcome
measures from standard clinical tests as well as from laboratory based
Interactive Walkway gait-and-balance tests.
Secondary outcome
Secondary study parameters to evaluate the potential effect of the Cue X
gamified AR gait-and-balance exercise program are gait-and-balance outcome
measures.
For the secondary objectives 1 (gait-modifying ability) and 2 (data quality),
study parameters are spatiotemporal gait parameters (speed, cadence, step
length, step time) derived from Interactive Walkway and AR headsets during the
8-meter walking test (with or without visual/auditory cues) and standard
clinical tests of gait and balance derived from AR headsets and stopwatch
scores.
Background summary
Cue X is a new product 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.
Study objective
The primary objective of this clinical feasibility study in people with PD is
to evaluate the feasibility and potential efficacy of home-based gamified AR
gait-and-balance exercises with Cue X. Secondary objectives of this study are
to validate the gait-modifying effects of Cue X AR cueing and to quantify the
test-retest reliability and concurrent validity of (clinical) outcome measures
of gait and balance, as derived from AR headset data.
With these primary and secondary objectives, the study will give insight into
1) the feasibility and potential efficacy of Cue X for home-based gamified AR
gait-and-balance exercises, 2) the most effective type of AR cueing and 3) the
best parameters for feedback, reporting and sample-size calculations for a
subsequent effect study with Cue X. Furthermore, the study will inform about
the best AR headset for these purposes.
Study design
(Single-arm) clinical feasibility study
The study consists of four visits to the gait laboratory, one home visit. In
between laboratory visits 2 and 4, participants will use Cue X to train their
gait and balance with gamified AR gait-and-balance exercises in their own home
environment as intervention above usual care. The exercise content will be
evaluated on a weekly basis, as well as safety and usability.
Intervention
Cue X, 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 Cue X
software is to provide visual and auditory cues to assist walking and modify
gait and to provide gamified AR exercise programs to improve gait and balance
in PD.
Study burden and risks
The risks of this study are minimal and the burden on the participants is low
to medium considering the laboratory visits 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.
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Have command of the Dutch language
- Diagnosed with Parkinson's disease according to the UK PD Brain Bank criteria
(stages 2-4 on the Hoehn and Yahr scale)
- Bothersome gait or balance impairments (i.e., negatively affecting their
ability to perform their usual daily activities)
Exclusion criteria
- Inability to comply with the protocol, i.e. additional neurological diseases
and/or orthopaedic problems seriously interfering with gait function,
insufficient physical capacity or cognitive/communicative inability (as
observed by the researcher or clinician) to understand instructions and
participate in the tests
- (Severe) visual or hearing impairments (after corrective aids)
- (Severe) visual hallucinations or illusions
- Inability to walk independently for 30 minutes
- No stable dosage of medication
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05605249 |
| CCMO | NL82441.100.22 |