Mobilise-D: Extension Study
NCT05874739
Summary
The goal of this observational study is to investigate the ability of a mobility monitor to measure and predict outcomes in Parkinson's disease (PD). It is an extension of a previous study (the Mobilise-D Clinical Validation Study) and consists of an additional follow-up visit for PD participants and the recruitment of age matched control participants. The data will inform researchers about PD disease progression and normal changes in mobility associated with aging.
Eligibility
Control Cohort: Inclusion Criteria: * Aged 50 years or over * Able to walk 4 meters independently without walking aids * Anticipated availability for 12 months. * Ability to consent and comply with any study specific procedures. * Willingness to wear a wearable sensor for mobility monitoring * Able to read and write in first language in the respective country Exclusion Criteria: * 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, other neurological or orthopaedic impairment that significantly impacts on gait * Patients with a clinical diagnosis of PD, COPD, proximal hip fracture or MS * History of dementia/significant cognitive impairment, or movement disorder (including essential tremor) PD Cohort Inclusion Criteria: * Participant in the Mobilise-D Clinical Validation Study (CVS) PD Cohort - see below. CVS PD Cohort: Inclusion criteria: * Aged 18 or over * Patients with the clinical diagnosis of PD according to the recent criteria of the Movement Disorder Society * Hoehn \& Yahr stage I-III Exclusion Criteria: * History consistent with Dementia with Lewy Bodies (DLB), atypical parkinsonian syndromes (including multiple system atrophy or progressive supranuclear palsy, diagnosed according to accepted criteria) * Repeated strokes or stepwise progression of symptoms, leading to a diagnosis of 'vascular parkinsonism' * Drug-induced Parkinsonism
Conditions3
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NCT05874739