|

Mobilise-D: Extension Study

RECRUITINGSponsored by Newcastle-upon-Tyne Hospitals NHS Trust
Actively Recruiting
SponsorNewcastle-upon-Tyne Hospitals NHS Trust
Started2023-05-17
Est. completion2025-07-28
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

AgingParkinson DiseaseParkinson's Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.