Actively Recruiting
Mobilise-D: Extension Study
Led by Newcastle-upon-Tyne Hospitals NHS Trust · Updated on 2024-07-08
651
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
Sponsors
N
Newcastle-upon-Tyne Hospitals NHS Trust
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mobilise-D: Extension Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Control participants must be aged 50 years or older.
- Control participants must be able to walk 4 meters independently without walking aids.
- Control participants must be available for 12 months follow-up.
- Control participants must be able to consent and comply with study procedures.
- Control participants must be willing to wear a wearable sensor for mobility monitoring.
- Control participants must be able to read and write in their first language in the respective country.
- Parkinson's disease participants must have participated in the Mobilise-D Clinical Validation Study PD cohort.
- Parkinson's disease participants must be aged 18 years or older.
- Parkinson's disease participants must have a clinical diagnosis of Parkinson's disease according to Movement Disorder Society criteria.
- Parkinson's disease participants must be at Hoehn & Yahr stage I-III.
You will not qualify if you...
- Control participants must not have had myocardial infarction, unstable angina hospitalization, stroke, coronary artery bypass graft, percutaneous coronary intervention, or cardiac resynchronization device implantation within 3 months before consent.
- Control participants must not be under active treatment for cancer or other malignant diseases.
- Control participants must not have uncontrolled congestive heart disease (NYHA class >3).
- Control participants must not have acute psychosis, major psychiatric disorders, or ongoing substance abuse.
- Control participants must not have neurological or orthopedic impairments significantly affecting gait.
- Control participants must not have clinical diagnosis of Parkinson's disease, COPD, proximal hip fracture, or multiple sclerosis.
- Control participants must not have history of dementia, significant cognitive impairment, or movement disorders including essential tremor.
- Parkinson's disease participants must not have history consistent with Dementia with Lewy Bodies or atypical parkinsonian syndromes including multiple system atrophy or progressive supranuclear palsy.
- Parkinson's disease participants must not have repeated strokes or vascular parkinsonism.
- Parkinson's disease participants must not have drug-induced Parkinsonism.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Actively Recruiting
Research Team
I
Isabel K Neatrour, MSc
CONTACT
A
Alison Yarnall, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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