Mobilise-D - Clinical Validation Study
Research type
Research Study
Full title
Validating digital mobility assessment using wearable technology – The Mobilise-D Clinical Validation Study.
IRAS ID
289543
Contact name
Lynn Rochester
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 10 months, 1 days
Research summary
The Mobilise-D Clinical Validation Study is the second study to be undertaken by the Mobilise-D project. The overall aim of this project is to develop a real world digital assessment of mobility. This Clinical Validation Study will use a technically validated body worn sensor to measure digital mobility outcomes and to predict relevant clinical outcomes. This assessment will obtain regulatory approval for future drug development and clinical practise.
The Mobilise-D Clinical Validation study is a longitudinal observational cohort study conducted in ten different countries across 16 different sites. The study will enrol 2400 participants from four different disease cohorts; Chronic Obstructive Pulmonary Disease (COPD), Parkinson’s disease (PD), Multiple Sclerosis (MS) and Proximal femoral fracture (PFF).
The study consists of a baseline visit, followed by four follow-up visits every six months. Each visit consists of the collection of descriptive, clinical, physical, neuropsychological and disease specific outcome measures. Following each visit, the participant is required to wear the body worn sensor for seven days continual monitoring. Falls and other clinical events will also be recorded between study visits.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/PR/0792
Date of REC Opinion
15 Jan 2021
REC opinion
Further Information Favourable Opinion