Tactile cueing as a means to oppose gait impairments deriving from Parkinson*s disease

Parkinson's disease (PD) is the second most widespread progressive neurological
ailment. PD imposes a heavy burden on quality of life (QOL). Motor symptoms
that contribute most to a decline in QOL are medication related impediments and
gait impairments. Additionally, gait deficiencies are widely associated with
loss of independence and an increased chance of falls. Therefore, the
improvement of these features can bring about enormous enhancement in quality
of life for Parkinson*s patients, and may postpone patient dependency on
continuous care or heavy medication.

Cueing is a relatively novel technique to improve gait in PD patients, and is
based on the phenomenon kinesia paradoxa (KP). Kinesia paradoxa is an abrupt
and temporary loss of akinesia or other walking inhibitions, both continuous
and episodic. Even though PD is a progressive disorder, its patients are
susceptible to this phenomenon. Patients with severe walking impairments can
exhibit sudden increases in mobility when stimulated suitably.
Research has shown that external sensory cues can help the patient retain a
regular gait

Primary Objective:

To establish whether it is feasible to oppose slowness caused by gait
impairments deriving from Parkinson*s disease effectively by using a
tactile-based cueing device.



Secondary Objective(s):

To establish if the device influences other Parkinson related gait symptoms,
including number of freezing episodes and step length.

To establish whether patient*s characteristics influence the effectiveness of
the device.

To establish the patient*s experience when using the device.

The study is in a single-centre intervention study in which the proof of
principle method will be leading. This study will recruit patients suffering
from gait deficiencies caused by Parkinson*s disease.
All patients will be asked to perform three short, minimally taxing tests.
First off, a short anamnesis will be performed in order to form a comprehensive
image of the disease progression and the extent of walking disabilities. This
anamnesis will consider patient privacy by omitting personal references.

Then the standardized timed up and go (TUG) test will be performed. This test
will be executed thrice.
a) Once to establish the patients regular gait performance.
b) Then once to determine whether the inactive device influences regular gait
performance.
c) Lastly to ascertain if the device has an impact on gait deficiencies.

Lastly the patient will be asked to perform the 10-meter walk test. This test
is divided into two phases.
During the first phase
a) Once to establish the patients regular gait performance.
b) Then once to ascertain if the device has an impact on gait deficiencies.
c) Lastly to determine whether the inactive device influences regular gait.
Secondly, the trajectory will be traversed thrice again to establish the effect
of the device when deliberate concentration in targeted and minimalized by
adding a manual component. The subject is asked to balance a cup filled with
water while walking the allotted distance. This extension to the test is
performed to ensure possible gait fluctuations are not solely attributable to
the patients focussed attention to the walking tests.
a) One to establish the patients regular gait.
b) Then once to determine whether the inactive device influences regular gait.
c) Lastly to ascertain if the device has in impact ton gait deficiencies.

In the both walking tests, value will be allotted not only based on interval
measurements, but also on number of freezing episodes and step count. Video
footage of the test will be acquired and number of steps will and number of
freezing episodes will be evaluated by two researchers separately. The cycle
sequence will be changed throughout to avoid operant conditioning.

The intended intervention is described as follows:
A prompt will be offered by providing an alternating vibration underneath
either foot of the subject by using the prototype. The frequency of the rhythm
will be adjusted to the desired walking cadence of the patient, therefore
adjusting the walking pattern.

Study population, exclusion criteria and additional safety measured are all
adjusted to minimize the overall risk associated with this study.
Furthermore, the risks associated with the non-invasive tactile cueing device
are minimal. The incidence of side effects due to either the product or the
testing method are negligible and almost exclusively mild.
The medical device used during testing is designed in such a way as to ensure
accompanying risks are negligible. For example, the inclusion of a fast way to
deactivate the device and the addition of a plug connection to ensure the
patient does not get caught on the wire.
Moreover, the intended testing methods are selected on their minimally
burdensome character and the fact that safety measures can be implemented. For
example, the patient is allowed to use habitual walking support devices and the
researcher will walk along the patient in order to catch the subject in the
unlikely case of a fall.
Lastly, the intended effect associated with the device is improbable to cause
any walking difficulties or other complications, for it gently stimulates the
patient to move, but does not force any actions.
The remaining risks are minimal and therefore acceptable to the subjects who
will willfully consent to participation in this study.

This study has the potential to drastically improve quality of life and
independence of patients and may lower the risks of falls and associating
(crippling) injuries. Therefore, the risk and burden for the participating
capacitated adults are in proportion with the potential value of the study.