The primary objective of this study is to investigate the effect of visual turning-cues presented in augmented reality on the severity of freezing of gait evoked during turning in patients with Parkinson*s disease. This effect is compared to that of…
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Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is FOG severity, as defined by the parameters: fraction of
time spent with freezing; number of freezing episodes; duration of freezing.
The occurrence of FOG is determined by evaluation of the video recordings by
two independent trained raters. The FOG severity will be compared amongst the
different cueing conditions.
Secondary outcome
A secondary endpoint is quantification of the turns with parameters of
interest: lateral weight shifting; turn duration; cadence; step time; step
height; footstep latency; motor initiation and stopping performance. Another
secondary endpoint is the association of FOG severity parameters obtained from
the video recordings, with FOG detection parameters calculated using data from
the accelerometers.
Background summary
Freezing of gait (FOG) is a particularly disturbing and potentially harmful
symptom occurring in a majority of people with Parkinson*s disease (PD) over
the course of the disease. FOG symptoms are predominantly evoked by turning
around and remain difficult to treat with pharmacological management and/or
surgical treatment.
External cues, such as auditory, tactile or visual stimuli, aid in scaling and
timing of automatized movement. Cueing is thought to enforce goal directed
movement and to increase attention to gait.
There is preliminary evidence that visual cueing is effective for preventing
FOG during turning. Visual cues might be more effective than auditory cues in
reducing FOG. However, few studies investigated the effect of visual cueing
during turning. Comparative studies investigating the effect of auditory and
visual cues on FOG are scarce, and specifically for an effect during turning
not available.
In the current study we use the Microsoft HoloLens, a commercially available
brand of smart glasses, to present cues to investigate the feasibility of
visual cueing in augmented reality aiding in turning around. We compare 4
cueing conditions (visual cues; auditory cues; a combination of visual and
auditory cues; and no cues) to determine optimal ambulant management of
freezing symptoms.
Study objective
The primary objective of this study is to investigate the effect of visual
turning-cues presented in augmented reality on the severity of freezing of gait
evoked during turning in patients with Parkinson*s disease. This effect is
compared to that of conventional auditory cueing strategies; that of a
combination of visual and auditory cueing; and lastly, to a control condition
without cueing.
A secondary objective of this study is to investigate the effect of visual cues
in augmented reality on different gait parameters such as lateral weight
shifting, turn duration, cadence, step time, step height, footstep latency,
motor initiation and stopping performance.
Another secondary objective of this study is to investigate the feasibility of
using accelerometers for ambulant FOG detection.
Study design
This is an explorative behavioral study. All procedures are non-invasive. The
experiments require a single 2,5 to 3-hour visit to our laboratory in Enschede.
This visit includes a 45 minutes session for questionnaires; 30 minutes
practice and preparation session; ca. 70 minutes of turning tasks (including
breaks); and an exit interview, lasting around 15 minutes. The questionnaires
are relevant for obtaining clinical characteristics of the patients and to
check whether participants comply with the inclusion criteria. The purpose of
the practice session is to get the subjects acquainted with the HoloLens cueing
system. The turning tasks are performed to obtain measurements related to FOG
severity and response to the visual cues in AR.
The turning experiments are split in two sessions, consisting of 4 blocks each.
In each block, lasting maximally 4.5 minutes, the subject performs 15 trials.
In every trial, the participant is required to make 180-degree turns *on the
spot*. There will be a different cueing condition per block: participants will
receive either auditory cues; visual cues in AR; both auditory and visual cues;
or no cues. Within each block, the cueing condition is held constant. The order
of the blocks within each session (i.e. the order of the different cueing
conditions) will be pseudo-randomized to control for the influence of training
or tiredness.
Intervention
The HoloLens cueing system provides visual and auditory external cues to aid
the participant during turning around. The visual and auditory cues will be
displayed by the Microsoft HoloLens, using an application that we developed for
this purpose.
Study burden and risks
All procedures are non-invasive. Experiments are conducted while participants
are in the *end of dose* * state, i.e. at the end of their regular dopaminergic
medication cycle. This requires the participant to delay (but not skip) normal
intake of medication and is expected to increase PD symptoms and FOG severity.
This increases the power of the study, thereby reducing the number of
participants to be tested. Furthermore, the end-of-dose state is most
representative of the dopaminergic state in which persons with PD-FOG
experience the most FOG in daily life. The increase of PD symptoms and FOG
severity is completely reversible upon medication intake after the experiments.
Studies in the *end of dose* * state are common in PD research and do not pose
a risk to participants. Physical tiredness which might occur during the turning
sessions is minimalized by allowing participants to rest as often and long as
needed. Persons with PD, and especially those with FOG, are, due to the nature
of their disease, at risk for falling. To reduce this risk of falling, a
researcher will continuously accompany the participant during walking and
during the turning tasks. There are no risks associated with the use of smart
glasses and presentation of AR reality stimuli, and the burden is considered
low. The questionnaires are widely used in medical research and are considered
to place little burden on the participants.
Drienerlolaan 5
Enschede 7522NB
NL
Drienerlolaan 5
Enschede 7522NB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Age > 18 years
* Diagnosed with idiopathic Parkinson*s disease according to the UK Brain Bank Criteria [29]
* Written informed consent
* Presence of FOG (defined as a score of 1 on question 1 from the NFOGQ[30]: *have you ever experienced FOG in the past month?*)
* Disabling/regular FOG (defined as a score of 3 *Very often, more than one time a day* on question 2 from the NFOGQ: *How often do you experience FOG?*)
* Normal or corrected to normal vision.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Comorbidities that cause severe gait impairment (e.g. severe arthrosis or neuropathy)
* Comorbidities that cause severe vision impairment (e.g. severe maculopathy)
* Severe cognitive impairments (MMSE <24) or or a score on the frontal assessment battery (FAB) of equal to or smaller than 13.
* Inability to perform a 180 degree turn around the axis unaided (e.g.: without the help of a walking aid or the direct help of a person).
* Severe uncorrected bilateral hearing impairment, preventing the participant to hear the metronome.
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL66241.044.18 |
| OMON | NL-OMON27339 |