Freezing of Gait in Parkinson's Disease
Conditions
Interventions
Parkinson's Vibrating Socks (prototype only)
Sponsors
University of Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Parkinson*s disease; 2. Use of Parkinson*s disease medications, and/or usage of advanced therapies such as Deep Brain Stimulation that can be deactivated; 3. 18 years or older; 4. At least 3 Freezing of gait episodes of any type experienced daily (on average) 5. Able to provide informed consent. 6. Able to understand verbal instructions.
Exclusion criteria
Exclusion criteria: 1. Incapacitating dyskinesia or dystonia; 2. Comorbidities that cause severe gait impairment (e.g. severe arthrosis or neuropathy); 3. Constant use of any gait aid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: • To create and evaluate a FOG prediction algorithm using IMU sensors, physiological sensors, and a wearable camera in a house-like environment. • To quantitatively and qualitatively evaluate the use of Parkinson*s vibrating socks in a house-like environment. Primary study parameters: Study parameters to answer the first study's main objective will be collected by the 15 movement sensors attached to different body positions (collecting body position, body acceleration, and body rate of rotation), one smartwatch with GSR and PPG sensors, one wearable ECG sensor and one wearable GSR sensor for monitoring the stress levels, and one eye tracker to retrieve the pupil diameters and the point of fixation of the subject in the environment in front of him/her, and eHealth house*s cameras (for labeling purposes). The primary endpoint will then be the prediction model. Study parameters to answer the second study's main objective will be the same as the first study*s main objective, adding the questionnaires that the participants will fill out at the end of the day about the Parkinson*s Vibrating Socks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective: • To investigate how stress levels change before FOG. • To investigate how the environment influences FOG. • To investigate if there is any correlation between abnormal posture and the onset of FOG. • To assess the effectiveness of monitoring skin conductance and heart rate by using a smartwatch on the wrist, compared to standard ECG and Skin conductance measures. Secondary study parameters: The study*s secondary objective will be answered using the same outcome parameters as the first objective, except for the questionnaires about the usability of the investigated device. | — |
Countries
Netherlands
Contacts
Public ContactL.G. Centamore
University of Twente
Outcome results
None listed