Monitoring mobility in Parkinson's disease and aging
Validating a Digital Mobility Assessment in Parkinson's Disease Using Wearable Technology - the Mobilise-D Extension Study.
This study is testing a mobility monitor to see how well it can track movement in people with Parkinson's disease and understand how aging affects mobility.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 651 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Newcastle-upon-Tyne Hospitals NHS Trust Academic / other |
| Locations | 1 site (Newcastle upon Tyne) |
| Trial ID | NCT05874739 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of a mobility monitor in measuring and predicting outcomes for individuals with Parkinson's disease (PD) and to understand normal mobility changes associated with aging. It extends a previous study by including a follow-up visit for PD participants and recruiting age-matched control participants. Participants will wear a body-worn sensor for continuous monitoring over seven days, and data collected will include clinical, physical, and neuropsychological assessments. Additionally, a qualitative sub-study will explore participants' experiences with PD symptoms and their impact on mobility.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 50 years or older who can walk independently and are willing to participate in mobility monitoring.
Not a fit: Patients with a clinical diagnosis of Parkinson's disease or significant neurological or orthopedic impairments affecting gait may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of mobility changes in Parkinson's disease and aging, potentially leading to improved patient care and management strategies.
How similar studies have performed: Previous studies have shown promise in using digital assessments for mobility in Parkinson's disease, making this approach a continuation of established research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Newcastle upon Tyne
- The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alison Yarnall, PhD — Newcastle University
- Study coordinator: Isabel K Neatrour, MSc
- Email: isabel.neatrour@newcastle.ac.uk
- Phone: +44 (0) 191 2081406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.