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Mobilise-D: Extension Study

Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

NCT ID: NCT05874739

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 26 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
651
Started
2023-05-17
Last checked
2024-07

Plain English Summary

What is this study?

  • • Testing a new treatment for parkinson disease
  • • Clinical study - 651 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with parkinson disease

Where?

  • • Newcastle upon Tyne - The Newcastle upon Tyne Hospitals NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This study is an extension to the Mobilise-D project which aims to develop a real world digital assessment of mobility. This Extension Study will build on the work of the Clinical Validation Study (CVS) to extend the follow-up period of the Parkinson's disease (PD) cohort and to recruit an age matched control cohort. The additional data will for allow for modelling of disease progression in PD over a longer time period and inform on progression in normal ageing. 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.

Parkinson DiseaseAging

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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

Who cannot take part

  • ✗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.
See the full 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 Is This Study? (1 UK site)

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Recruiting
Site contact (verified)
Alison Yarnall, PhDPrincipal Investigator

How to Get in Touch

Isabel K Neatrour, MSc

Sponsor contact

CONTACT

+44 (0) 191 2081406 isabel.neatrour@newcastle.ac.uk

Alison Yarnall, PhD

Sponsor contact

CONTACT

+44 (0)191 2081279 alison.yarnall@newcastle.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-07