Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
651 participants
OBSERVATIONAL
2023-05-17
2025-07-28
Brief Summary
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Detailed Description
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The Mobilise-D Extension Study is an observational cohort study taking place at five clinical sites across four different countries. The study will recruit up to 411 PD participants from the CVS PD cohort and 240 age and gender matched control participants.
The PD participants will attend a single follow-up visit 36 months after their initial CVS baseline visit. The control participants will attend a baseline visit and a 12-month follow-up visit. All study visits consist of the collection of descriptive, clinical, physical, neuropsychological data. Following each visit, participants are required to wear a body worn sensor for seven days continual monitoring.
A small sample of participants will be invited to take part in a semi-structured interview (Qualitative Sub Study) to better understand participants' experiences of PD symptoms and the impact they have on mobility. The investigators also want to know if the aspects of mobility that are being measured are relevant to people with PD. These interviews will take place face to face or remotely, depending on preference.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control Cohort
Control participants who are age- and gender-matched to the PD cohort
No interventions assigned to this group
PD Cohort
PD Patients who have completed their participation in the Mobilise-D Clinical Validation Study
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Participant in the Mobilise-D Clinical Validation Study (CVS) PD Cohort - see below.
CVS PD Cohort:
* 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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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KU Leuven
OTHER
University of Kiel
OTHER
University Hospital Erlangen
OTHER
Tel-Aviv Sourasky Medical Center
OTHER_GOV
University College Dublin
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Alison Yarnall, PhD
Role: PRINCIPAL_INVESTIGATOR
Newcastle University
Locations
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The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Philip Brown
Role: primary
Other Identifiers
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MJFF-022735
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MJFF-022736
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
323855
Identifier Type: OTHER
Identifier Source: secondary_id
10402
Identifier Type: -
Identifier Source: org_study_id
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