| NCT ID | NCT05874739 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Newcastle-upon-Tyne Hospitals NHS Trust |
| Condition | Parkinson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 651 participants |
| Start Date | 2023-05-17 |
| Primary Completion | 2025-07-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 651 participants in total. It began in 2023-05-17 with a primary completion date of 2025-07-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Alison Yarnall, PhD
PRINCIPAL INVESTIGATOR
Newcastle University
Frequently Asked Questions
Who can join the NCT05874739 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05874739 currently recruiting?
Yes, NCT05874739 is actively recruiting participants. Contact the research team at isabel.neatrour@newcastle.ac.uk for enrollment information.
Where is the NCT05874739 trial being conducted?
This trial is being conducted at Newcastle upon Tyne, United Kingdom.
Who is sponsoring the NCT05874739 clinical trial?
NCT05874739 is sponsored by Newcastle-upon-Tyne Hospitals NHS Trust. The principal investigator is Alison Yarnall, PhD at Newcastle University. The trial plans to enroll 651 participants.
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