Usability of a Novel Cueing Device for Patients With Parkinson's Disease

Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study

Hypokinetic gait disorder and Freezing of Gait (FOG) are frequent symptoms in the advanced stage of Parkinson's disease (PD). These impair quality of life and significantly increase the risk of falls. External movement pacemakers have been developed to improve gait and avert FOG by cueing strategies. The investigators developed a smart, small and lightweight, easy-to-handle wearable tactile cueing device (TCD), consisting of a control unit, two pulse generators and a battery-driven power supply. The device is programmed via a Graphical User Interface (GUI).

Inclusion Criteria:

• Include patients who suffer from advanced PD. Characteristic symptoms of parkinsonian gait like hypokinetic movements and/or FOG have to be present.
• Parkinsonian gait is measured by the following items of the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS): item 2.12, item 2.13, item 3.10 and item 3.11. The Hoehn and Yahr (HY) stage during ON is 1-4/5.
• MoCA ≥ 22/30.
• Participant has signed the informed consent.

Exclusion Criteria:

• Inability of the participant to understand the IC or to follow the procedures of the study (as judged by the Qualified Physician).
• Significantly, impaired cognitive skills render the participant unable to use the TCD.
• Presence of severe motor fluctuations and severely impaired walking ability as defined by HY stage V during ON.
• Clinically relevant skin lesions on the wrist or fixation points (usually the thighs).