Mobilise-D CVS MS extension
Research type
Research Study
Full title
Validating a digital mobility assessment in Multiple Sclerosis using wearable technology – the Mobilise-D MS Extension study
IRAS ID
333264
Contact name
Basil Sharrack
Contact email
Sponsor organisation
Sheffield Teaching Hospitals Clinical Research and Innovation Office
Clinicaltrials.gov Identifier
STH22791, STH Number
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
This study is an extension to the Mobilise-D project which aims to develop a real world digital assessment of mobility. A novel approach to measure mobility is needed that is low cost, simple, accurate and capable of use in the real world. The data will complement a wider set of contexts of use for future digital endpoint validation and use in drug development.
This Extension Study will build on the work of the Clinical Validation Study (CVS) to extend the follow-up period of the Multiple Sclerosis (MS) cohort. The additional data will allow for modelling disease progression across a range of MS severities and enhance validation of Digital Mobility Outcomes (DMOs).
The Mobilise-D Extension Study is an observational cohort study taking place at four clinical sites across three different countries. The study will recruit up to 557 MS participants from the CVS MS cohort.
The MS participants will be invited to attend two additional follow-up visits at 30 months and 36 months after their baseline visit (final CVS follow-up visit is 24 months after baseline). 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 of their walking.
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 MS 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 MS. These interviews will take place face to face or remotely, depending on preference.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
23/YH/0285
Date of REC Opinion
6 Dec 2023
REC opinion
Favourable Opinion