Parkinson’s disease (PD) Nervous System Diseases Parkinson’s disease
Conditions
Interventions
A total of 55 people with Parkinson's (PD) will be recruited as part of the Mobilise-D: Clinical Validation Study* (sub-study) and if necessary as an independent study.
*Mobilise-D Clinical Validation
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or over 2. Able to walk 4 meters independently with or without walking aids 3. Ability to consent and comply with any study-specific procedures 4. Willingness to wear the wearable device, a smartwatch and use a smartphone 5. Able to read and write in first language in the respective country 6. Patients with the clinical diagnosis of PD according to the recent criteria of the Movement Disorder Society 7. Hoehn & Yahr stage I-III 8. On stable Parkinson’s disease medication doses
Exclusion criteria
Exclusion criteria: 1. Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse 2. History consistent with Dementia with Lewy Bodies (DLB), atypical parkinsonian syndromes (including multiple system atrophy or progressive supranuclear palsy, diagnosed according to accepted criteria) 3. Repeated strokes or stepwise progression of symptoms, leading to a diagnosis of ‘vascular parkinsonism’ 4. Drug-induced Parkinsonism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured continuously for 7 days: 1. Medication intake using smartwatch acknowledged medication intake time events 2. Real walking speed using (walking speed determined in real-world settings (Real walking speed) collected using the mobility monitoring device | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Obtained from the mobility monitoring device continuously for 7 days: 1.1. Volume (e.g. step count) 1.2. Pattern and variability of walking activity 1.3. Other gait pace (e.g. step length) 1.4. Rhythm (e.g. step time) 1.5. Variability (e.g. step time variability) 1.6. Asymmetry (e.g. step time asymmetry) 2. Obtained from the smartphone continuously for 7 days: 2.1. Probability of being indoor/outdoor 2.2. Stay-points 2.3. Common paths 2.4. Weather condition | — |
Countries
England, United Kingdom
Outcome results
None listed