To evaluate the usability of vibrating socks as a home-based tactile cueing device in PD.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the device usability measured by the system
usability scale.
Secondary outcome
- To evaluate patient satisfaction about the vibrating socks as a home-based
cueing device measured by a patient satisfaction questionnaire on a 5-point
Likert scale.
- To evaluate the effect of the vibrating socks in the home environment on the
physical activity levels of the patient measured by the built-in accelerometer
of the socks.
- To evaluate the effect of the vibrating socks in the home environment on
freezing severity measured by the NFOGQ (weekly instead of monthly).
- To evaluate the long-term effect of the vibrating socks on several gait
parameters in the home environment measured by a 3D accelerometer (velocity,
step time, step time asymmetry, and cadence).
Background summary
Freezing of gait (FOG) is one of the disabling motor symptoms of Parkinson*s
disease (PD). Non-pharmacological approaches, including external cueing, are
generating growing interest. However, it remains difficult to translate such
cueing strategies into an efficient ambulatory device that is effective, but at
the same time socially acceptable (i.e. *invisible* to outsiders). In this
regard, tactile cueing holds great promise. Here, we propose rhythmically
vibrating socks as a home-based ambulatory device to improve gait in PD. This
research concerns a follow-up of the clinical study on the vibrating socks
(NL68729.044.19). The vibrating socks will offer tactile cueing in a fixed
frequency. We expect vibrating socks to be usable as a cueing device for
applying prolonged tactile cueing in the home environment.
Study objective
To evaluate the usability of vibrating socks as a home-based tactile cueing
device in PD.
Study design
Using a within-subject design, we will measure device usability by the system
usability scale. The study will be performed at the patients* home.
Intervention
The vibrating socks, a new home-based tactile cueing device.
Study burden and risks
Measurements while wearing the vibrating socks will be conducted for two
consecutive weeks (week A without cueing and week B with cueing (in which
patients can turn cueing manually on/off)) at the patients* home, in which they
can perform their normal daily living. The order of starting with week A or
week B, will be balanced between patients.
In the beginning of the first week the motor (MDS-UPDRS part III) and cognitive
status (MoCA) will be tested and baseline measurements to determine FOG
severity will be performed.
In week A will the socks be turned on, however no cueing will be given. At the
third day of this week there will be a contact moment to hear if the patient
experiences any problems using the device. At the end of the week the NFOGQ en
PDQ-39 will be filled in.
In week B the socks will be in cueing mode. At the third day of this week
there will be a contact moment to hear if the patient experiences any problems
using the device. At the end of the week the NFOGQ, PDQ-39 and SUS will be
filled in. The participant will then also perform a task known to elicit
freezing (rapid full turns), with and without cueing. This is done to compare
the golden standard for freeze detection to accelerometer data.
At the end of the measurement period participants will fill in the patient
satisfaction questionnaire and the patient feedback questionnaire.
The potential risks of the investigational product are considered negligible.
The chance of worsening of symptoms is minimal, since the subject is gently
stimulated to walk and no movements are forced.
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
Idiopathic Parkinson*s disease.
Recent history of disabling/regular freezing of gait (defined as presence of
FOG several times a day in the past month and lasting longer than 1 second and
verified objectively by an experienced neurologist).
Patients who previously displayed alleviation of gait disturbances when using
the vibrating socks tested in the ongoing study (NL68729.044.19).
Patients who show or expect a benefit of the vibrating socks during a screening
test.
Exclusion criteria
Gait impairments as a result of any other factor than Parkinson*s disease.
Sensory impairments (e.g. due to polyneuropathy) hampering patients to perceive
vibration of the socks.
Cognitive impairments that cause the patient to be unable to understand the
research purpose and accompanying instructions.
Patients who already use devices that aim to reduce FOG (e.g. Parkinson*s
walker) and cannot participate without using these devices. Such devices may
interfere with the study results.
Patients who wear compression stockings.
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 | NL76285.100.21 |
| OMON | NL-OMON24575 |