Vibrating socks at home for Parkinson’s Disease

Rationale: 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 prolonged tactile cueing to be feasible in the home environment.

Using a within-subject design, we will measure device usability by the system usability scale. We will include 21 PD patient with a recent history of disabling/regular FOG and who respond well to the vibrating socks in a clinical setting or during a screening test. The study will be performed at the patients’ home.

Measurements while wearing the vibrating socks will be conducted for three consecutive weeks ((1) without cueing, (2) with cueing (in which patients can turn cueing manually on/off), (3) follow-up without cueing) at the patients’ home, in which they can perform their normal daily living. In addition to the vibrating socks, which contain a 3D accelerometer and gyroscope, patients will also wear an ECG sensor and Smart Insoles to determine gait parameters and heart rate. 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 the beginning of the second week patients will 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 combined with heart rate data. Additionally, at the third day of the second week there will be an extra contact moment to hear if the patient experiences any problems using the device. At the end of every week, four different questionnaires ((1) System Usability Scale (SUS), (2), Patient satisfaction questionnaire, (3) New Freezing of Gait Questionnaire (NFOGQ), (4) 39-item Parkinson’s Disease Questionnaire (PDQ-39)) will be filled in by the patient. And at the end of week three the last questionnaire about patient feedback will be filled in.

The primary outcome measure will be device usability measured by the SUS, measured for three consecutive weeks (without cueing, with cueing and follow-up).

Secondary outcome parameters are patient satisfaction will be measured by a patient satisfaction questionnaire on a 5-point Likert scale, measured for three consecutive weeks (without cueing, with cueing and follow-up). Furthermore, the levels of physical activity will be calculated by using the accelerometers of the socks. Additionally, the occurrence of self-reported falls/near falls will be determined. Next, the freezing severity will be determined using the NFOGQ. The NFOGQ is a commonly used questionnaire during clinical assessments of gait in Parkinson’s disease patients, for it is notoriously difficult to score FOG in a clinical setting. Lastly, the spatiotemporal gait parameters will be calculated as obtained by the 3D accelerometer and gyroscope, the ECG sensor and smart insoles, including velocity, step time, step time asymmetry, cadence and relative durations of single and double limb support phases.

We expect prolonged tactile cueing to be usable in the home environment.

33 Months

Vibrating socks, a new home-based tactile cueing device.