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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (1 UK site)
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
How to Get in Touch
Isabel K Neatrour, MSc
Sponsor contactCONTACT
Alison Yarnall, PhD
Sponsor contactCONTACT
