To develop a FOG prediction algorithm under free-living conditions, and to test evaluate the use of the Parkinson*s Vibrating socks under the same conditions
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective:
• To create and evaluate a FOG prediction algorithm using IMU sensors,
physiological sensors, and a wearable camera in a house-like
environment.
• To quantitatively and qualitatively evaluate the use of Parkinson*s vibrating
socks in a house-like environment.
Primary study parameters:
Study parameters to answer the first study's main objective will be collected
by the 15 movement sensors attached to different body positions (collecting
body position, body acceleration, and body rate of rotation), one smartwatch
with GSR and PPG sensors, one wearable ECG sensor and one wearable GSR sensor
for monitoring the stress levels, and one eye tracker to retrieve the pupil
diameters and the point of fixation of the subject in the environment in front
of him/her, and eHealth house*s cameras (for labeling purposes). The primary
endpoint will then be the prediction model.
Study parameters to answer the second study's main objective will be the same
as the first study*s main objective, adding the questionnaires that the
participants will fill out at the end of the day about the Parkinson*s
Vibrating Socks.
Secondary outcome
Secondary objective:
• To investigate how stress levels change before FOG.
• To investigate how the environment influences FOG.
• To investigate if there is any correlation between abnormal posture and the
onset of FOG.
• To assess the effectiveness of monitoring skin conductance and heart rate by
using a smartwatch on the wrist, compared to standard ECG and
Skin conductance measures.
Secondary study parameters:
The study*s secondary objective will be answered using the same outcome
parameters as the first objective, except for the questionnaires about the
usability of the investigated device.
Background summary
Freezing of Gait (FOG) is one of the most bothersome gait difficulty
experienced by people with Parkinson*s disease (PD). Cueing systems can be
promising in reducing the number of freezing episodes. Cues can be auditory,
visual, or tactile stimuli. Developing a minimally invasive tactile system
(Parkinson*s Vibrating Socks) could overcome the usability limits of both
visual and auditory cues. Cues can be provided in two different ways:
continuously or *on-demand*. *On-demand* cueing can prevent cue dependency and
fatigue, and maintain more effectiveness over time. To provide *on-demand*
cues, it*s important to predict freezing before it happens.
Study objective
To develop a FOG prediction algorithm under free-living conditions, and to test
evaluate the use of the Parkinson*s Vibrating socks under the same conditions
Study design
Data will be collected at the University of Twente (eHealth house) for one day.
All participants will be asked to skip their morning levodopa intake on the day
of the visit. By doing so, in the morning, participants will be acquired in a
clinically defined OFF state in which FOG happens more often. If they do not
want to participate under this condition, they will be invited following their
regular levodopa intake in the morning (ON state), as the main objective of the
data collection is to collect as many FOG events as possible, without regard to
the medication condition. Upon arrival, participants will be instrumented with
different wearable motion and physiological (e.g. ECG) sensors on their bodies.
Next, participants will proceed to a laboratory with a home-like environment
(the eHealth house). During the first part of the visit (in OFF state),
participants will perform activities resembling their morning routine
(semi-free-living condition). After that, participants will be asked to follow
a trail inside the house (semi-controlled condition).
In the afternoon, in ON state, participants will follow the same trail in 3
different conditions: without any cueing system, and wearing the Parkinson*s
Vibrating socks, activated in two different conditions: continuous cueing and
on-demand cueing (simulated). Lastly, questionnaires regarding the usability of
the socks will be presented to the participants. The entire study visit will be
registered by video (gold standard to FOG detection). The study visit is
expected to last no more than 7 hours (including at least 1.5-hour break), with
less than 2 hours in the OFF state.
Study burden and risks
All procedures are non-invasive. The study visit will begin at an OFF status
because FOG happens more predominantly when participants are without medication
(if the participants will accept this condition). The study visit is expected
to last no more than 7 hours in total, with less than 2 hours in OFF state. In
OFF condition, there is a small risk of participants feeling overwhelmed or,
for instance, experiencing a fall episode. To diminish the risk, we have
minimized the activities performed in an OFF state. In addition, participants
will be advised to take about 1.5-hour break between the morning and the
afternoon sessions. Moreover, 5-minute breaks will be present between two
consecutive phases in the afternoon. Finally, to ensure safety and efficiency,
the assessments will be performed by a trained researcher. In any case, if the
participant wishes so, the study visit can be stopped or canceled at any time.
Participants are not expected to directly benefit from the study. However,
under their request, clinical and technical data collected during the study can
be made available to them.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis of Parkinson*s disease;
2. Use of Parkinson*s disease medications, and/or usage of advanced therapies
such as Deep Brain Stimulation that can be deactivated;
3. 18 years or older;
4. At least 3 Freezing of gait episodes of any type experienced daily (on
average)
5. Able to provide informed consent.
6. Able to understand verbal instructions.
Exclusion criteria
1. Incapacitating dyskinesia or dystonia;
2. Comorbidities that cause severe gait impairment (e.g. severe arthrosis or
neuropathy);
3. Constant use of any gait aid.
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 |
|---|---|
| CCMO | NL86905.091.24 |