The main objective of this study is to evaluate whether the PowerGlove is a valid instrument that can be used for the assessment of hand motor symptoms in patients with Parkinson*s disease. Sensitivity, specificity, intra-examiner reliability and…
ID
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Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters in this study are the sensitivity, specificity and
reliability of the PowerGlove system in measuring the Parkinson symptoms
rigidity, bradykinesia and tremor.
These are derived from the relations between:
- moment of force and range of motion generated in passive wrist flexion,
measured by the PowerGlove system,
- speed and amplitude of hand and finger kinematics in different active hand
movement tasks, measured by the PowerGlove system,
- frequency characteristics and amplitude of hand movement in rest, measured by
the PowerGlove system,
and
- UPDRS scores for rigidity, bradykinesia and tremor, assessed by an
experienced clinician (UPDRS part III, items 20-25)
in different points over time, ON- and OFF-medication, and executed by
different experienced clinicians.
Secondary outcome
Secondary study parameters of interest are:
- EMG activity recorded during passive wrist flexion.
- Gender
- Age
- Disease duration
- Medication use
- Dominant left of right hand
- Body weight
- Body length
- Hand size
Background summary
Parkinson*s disease (PD) is an age-related neurodegenerative disorder. It is
estimated that in 2030, the 10 most populated nations in the world will have
between 8.7 and 9.3 million PD patients. Deep Brain Stimulation (DBS) of the
subthalamic nucleus (STN), one of the nuclei of the Basal Ganglia, has proven
to be an effective treatment of the various motor symptoms and reduces
medication needs. The goal of the iDBS-project is to automatically estimate the
clinical condition of the PD patient and use this information to automatically
control the stimulation parameters. Clinically, motor symptoms of a PD patient
prior, during and after DBS implantation are scored during a standard
neurological examination using parts of the Unified Parkinson*s Disease Rating
Scale (UPDRS), estimating rigidity, bradykinesia, and tremor.
However, the assessment often varies per physician and highly depends on
experience. The subjective nature makes it hard to interpret the UPDRS
correctly and the current clinical exam may be too abbreviated to detect small
changes. Recently, the University of Twente developed a PowerGlove that
consists of miniature inertial (accelerometers and gyroscopes) and magnetic
sensors on each finger segment and the back of the hand that enable accurate
and ambulant measurement of hand and finger movements. Application of the
PowerGlove before, during and after DBS surgery might enable more accurate
measure of hand motor function and objective quantification of the Parkinson*s
disease motor symptoms.
Study objective
The main objective of this study is to evaluate whether the PowerGlove is a
valid instrument that can be used for the assessment of hand motor symptoms in
patients with Parkinson*s disease. Sensitivity, specificity, intra-examiner
reliability and inter-examiner reliability will be tested.
Study design
In this observational study, measurements with PowerGlove system * consisting
of the PowerGlove, force sensor, and EMG measurement setup * will be performed
to examine the PD motor symptoms during a patient*s standard clinical
examination. The patient will be admitted to the hospital one day prior to the
clinical examination for withdrawal from medication. The next morning the
patient will be in OFF state and a Parkinson nurse will do the screening of
motor symptoms using, amongst others, the UPDRS. Next, the patient will get PD
medication and the patient will be screened a one hour later in medication ON
state. During both these clinical examinations, the PowerGlove system will also
be used to measure rigidity, bradykinesia and tremor using the same simple hand
movement tests as are used in the UPDRS.
The first measurement with the PowerGlove will consist of three sessions to
test intra-examiner and inter-examiner reliability and will take around 30
minutes. The second measurement will only consist of a single session and will
take around 15 minutes.
Study burden and risks
The burden and risks associated with participation are minimal. Because the
measurement is scheduled together with the patient*s standard clinical
examination before DBS, there are no extra travel burden or costs involved. The
measurement is not invasive, the PowerGlove is comfortable to wear and for the
measurement only six simple hand movement tasks have to be performed by the
patient. The whole study will take approximately 45 minutes extra on top of the
standard clinical examination. The greatest burden for the patient will be that
he will be withdrawn from medication for 30 minutes longer than usual during
the testing in OFF phase.
The patient has no direct benefit from this study, but an easy-to-use
instrument that can measure PD motor symptoms objectively can benefit the
patient group by making the examination of motor symptoms simple and accurate.
This way, deterioration of symptoms over time can be identified in a better
way. The same is true for the improvement of motor functions by medication or
DBS. This will benefit the whole patient group and can, in the future, benefit
the participating patient as well.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- The patient has had Parkinson's symptoms for more than five years.
- The patient has a good response to dopaminergic medication.
- The patient is selected to undergo preoperative screening for Parkinson DBS surgery in the Academic Medical Center, Amsterdam.
- The patient is able to communicate adequately in Dutch or English.
- The patient is between the age of 18 and 80.
Exclusion criteria
- The patient has a medical (or other) history other than Parkinson's disease which restricts hand movement (e.g. a complicated wrist fracture of severe arthritis).
- Inability to correctly place the PowerGlove on the patient's hand or to correctly perform the necessary calibration.
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 | NL48811.018.14 |