To evaluate the validity of the peak frequency values and the amplitude at the peak frequency obtained from power spectral densities from the consumer product accelerometers and the laboratory-grade accelerometer following simultaneous tremor…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Validity of the peak frequency values and the amplitude at the peak frequency
obtained from power spectral densities from the consumer product accelerometers
and the laboratory-grade accelerometer will be described by agreement and
reproducibility statistics for the norm of the 3-axes, and if needed for each
axis separately.
Secondary outcome
N.A.
Background summary
Accelerometer advancements resulted in accelerometers being integrated into
different consumer products, such as widely available smartphones. These
sensors improved over the years in structure, sensitivity, resolution, g range,
and working principle. Subsequently, medical applications (here forth indicated
as apps) increasingly use the generated data from consumer product
accelerometers to describe movement. Therefore, they may offer a cost-efficient
and better accessible alternative for tremography and dyskinesia assessment
compared to the laboratory-grade accelerometers.
There are several disadvantages to use the gold standard of tremor assessment,
i.e. the laboratory-grade accelerometer. This method requires a research
facility and trained clinical staff, thereby limiting the amount of assessments
per day. The capacity to upscale the volume and ease of the assessments is
small.
Several solutions can be found to circumvent the disadvantages of assessment
with laboratory-grade accelerometers. In some studies, new devices were built
to assess tremor at home in patients with essential tremor (ET) or Parkinson
disease (PD). Other studies used apps on smartphones to measure various
patients with tremor.
Although these studies described tremor assessment by means of a smartphone,
the methodology can be optimised, and new, improved, smartphones have entered
the market. In a proof of principle study, only 1 PD and 2 ET patients were
tested with an app developed for earthquake detection. Also, the iPhone type
was not defined, the tremor assessment was not compared to laboratory-based
accelerometer but to electromyography, and it did not represent daily use of a
smartphone as the iPhone was strapped to a body part (either forearm or leg).
Another proof of principle study only tested 4 patients (2 psychogenic tremor,
2 organic tremor), without describing the smartphone and app used or
incorporating a control group or control measurement. In a different study the
methodology was superior as tremor was compared between 21 PD patients and 21
healthy volunteers using the Samsung Galaxy SII with the Android Mobile app
(Sensor UDP). However, the smartphone tremor assessment was not comparted with
the gold standard laboratorium-grade accelerometer.
It remains unclear whether the data generated by these consumer products are
comparable to data from the gold standard of laboratory-grade accelerometers
such as used by de Haas et al. This is essential to investigate, as holding the
consumer product with its specific shape and weight may affect the
tremor(assessment) in patients with ET or PD. Thus, it is necessary to
determine if and to what extent the tremor(assessment) is affected.
In this study we aim to obtain and compare data from accelerometers used in
consumer products and laboratory-grade accelerometers. Data of both assessment
types will be sampled simultaneously in 10 ET patients, and in 10 PD patients.
The acquired data will enable validation and evaluation of the technical
feasibility of the accelerometers in consumer products and improve the
development of (multi-platform) tremography apps.
Study objective
To evaluate the validity of the peak frequency values and the amplitude at the
peak frequency obtained from power spectral densities from the consumer product
accelerometers and the laboratory-grade accelerometer following simultaneous
tremor assessment in patients with ET or PD.
Study design
This is a validation study to compare consumer product accelerometers to
laboratory-grade accelerometers in patients with ET or PD.
Study burden and risks
The potential risk associated with the repeated assessments including the
movements to be executed (rest position with arms and hands horizontal, while
elbows rest on chair, and with extended horizontal arms in frontal plane) is
muscle fatigue. These movements will last for 30 seconds. In total there will
be 3.25 hours of measurements, including breaks. To limit the occurrence of
muscle fatigue, subjects will have mandatory breaks of 2 minutes between each
assessment. Around halfway during the study, a break of up to 1 hour is
allowed, if needed.
All accelerometers are commercially available and will be used for their
intended use: measuring acceleration.
There is no benefit for the subjects to participate in this study.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
Inclusion criteria
1. Signed informed consent prior to any study-mandated procedure;
2. Male or female subject, 18 to 80 years of age (inclusive);
a. Female participation is not limited to childbearing potential, or pregnancy or breast-feeding status;
3. A diagnosis of either ET or PD according to the following criteria:
a. ET diagnosis must fit the *classic ET* criteria, as describe by Deuschl et al. (Deuschl et al., 1998);
b. PD diagnosis must fit the *established PD* or *probable PD* level, as defined by Postuma et al. (Postuma et al., 2015);
i. Hoehn and Yahr stage must be * III;
4. Tremor must be present in at least 1 hand, regardless of the current therapy;
5. Otherwise healthy as is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, and physical examination;
6. Body mass index between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg;
7. Ability to communicate well with the investigator in the Dutch language.
Exclusion criteria
1. Any known factor, concomitant diagnose(s) or disease(s) or condition(s), as judged by the investigator, that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in this study;
2. Unacceptable non-pharmacological therapies at screening, e.g., radiotherapy in a cancer study;
3. Unacceptable non-pharmacological use of substances at screening known or likely to interact with the study assessments (e.g., nicotine, alcohol, caffeine);
4. Positive test for alcohol or drugs of abuse at screening;
5. Participated in a clinical trial within 90 days of screening or more than 4 times in the previous year;
6. Unwillingness or inability to comply with the study protocol for any other reason, as judged by the investigator.
Design
Recruitment
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 | NL60672.058.17 |