Mobilise-D: Extension Study
Research type
Research Study
Full title
Validating a digital mobility assessment in Parkinson’s disease using wearable technology – the Mobilise-D Extension study
IRAS ID
323855
Contact name
Alison Yarnall
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
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 551 PD participants from the CVS PD cohort and 200 age 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) so that we can better understand participants’ experiences of PD symptoms and the impact they have on mobility. We also want to know if we are measuring aspects of mobility that are relevant to people with PD. These interviews will take place face to face or remotely, depending on preference.
REC name
HSC REC B
REC reference
23/NI/0046
Date of REC Opinion
21 Mar 2023
REC opinion
Favourable Opinion