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
Newcastle upon Tyne Hospitals NHS Foundation Trust (NuTH)
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.
Lay Summary of the results: 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.
The Mobilise-D Clinical Validation Study was the world’s largest study of real-world digital mobility assessment.
Who carried out the research?
The Mobilise-D Clinical Validation Study was part of a larger project of work called Mobilise-D, an EU-funded consortium of many of the world’s leading scientists, clinicians, and companies specialising in digital mobility assessment.
The Clinical Validation Study was carried out at 17 clinical sites across Europe. Newcastle University was the co-ordinating site and was responsible for the day-to-day management and supervision of the study. The Newcastle upon Tyne Hospitals NHS Foundation Trust (NuTH) was the study sponsor and provided overall oversight. The study received input from expert individuals involved in data management and statistical analysis. 12 patient and public advisors were also involved in the study design, management and sharing of results.Why was the research needed?
The ability to move is an indicator of health and well-being. Measuring change in mobility can help measure and predict disease progression or improvement in many health conditions. Current measures of mobility are based on patient or clinician reporting and one-off tests. These only provide a snapshot of an individual’s mobility, and do not reflect day-to-day movement in the home. Wearable digital technology, using a small device worn on the body, can provide a low-cost, simple and accurate measure of how people move. The Mobilise-D method transforms signals detected by the device into Digital Mobility Outcomes (DMOs) such as walking amount, speed and rhythm.What did study aim to do?
This study aimed to investigate whether Mobilise-D Digital Mobility Outcomes (DMOs) can be used to detect, measure and predict meaningful change in patient health status in chronic conditions.Who was included?
The study recruited 2388 participants diagnosed with a condition which affects their mobility; 602 people with Parkinson’s Disease (PD), 612 people with Chronic Obstructive Pulmonary Disease (COPD), 602 people with Multiple Sclerosis (MS), and 572 who had suffered a recent hip fracture. Participants were recruited from 17 clinical sites across 10 countries in Europe. This ensured diversity in terms of health systems, culture, weather, and language.
The average age and gender of participants with each condition matched that of individuals in the wider population.What did the study involve?
Each participant attended up to 5 study visits over a period of 24 months (every 6 months). Visits consisted of questionnaires and assessments to assess the severity of the participants’ condition, as well as their general physical and mental health. The visits also involved physical tests, such as how far and fast people could walk, muscle strength and balance.
At the end of each visit, participants were asked to wear a digital device attached to their lower back for seven days, including at night. Participants were asked to continue with their normal daily activities.
At the end of study, participants were asked about their experience of wearing the digital device and their views on wearable technology.What did the study find?
We observed very strong adherence with the study protocol (>90%). Study participants followed the device wear instructions well and provided positive feedback of their experience.
The 24 Mobilise-D DMOs were compared to established methods of measuring patient health status (such as patient reported outcomes or clinician measured performance) to establish their ability to identify important differences. These comparisons are expressed in terms of a quality known as ‘construct validity’, which is a measure of how well the DMOs correlate with established methods of measurement, as well as their ability to identify between known groups of patients. The analysis to date has demonstrated that the vast majority of the DMOs meet or exceed the expected thresholds for construct validity. This indicates that they are effective at measuring important and meaningful aspects of health status across all four conditions. Ongoing research will look at the ability of DMOs to predict change in health.
This study therefore supports the use of the Mobilise-D DMOs in future clinical research and clinical care.What do the results mean for patients and researchers?
Use of the Mobilise-D DMOs provide a more accurate and meaningful measure of mobility which can be used in clinical research and care. The ability to measure mobility in the home environment, without requiring a hospital or clinic visit, also widens patient access to research and care.What further research is being undertaken:
Further funding was secured to follow-up the PD participants for an additional year and to recruit a control group. This data will allow us to look at longer term changes in mobility, and to compare these changes to normal aging. This study will also further explore the patient experience of digital mobility assessment.
A network of pharmaceutical companies have provided funding for a follow-on consortium called SUSTAIN Mobilise-D. This consortium will seek to further advance the case for using DMOs in clinical trials and clinical practice through additional analyses, dissemination of results, and provision of support to regulatory approval initiatives.
In late 2025 we expect to see the Mobilise-D DMOs being used in at least one high profile clinical trial sponsored by one of the pharmaceutical companies in the consortium.Where can I find out more?
The study website will continue to be updated with study results and findings (mobilise-d.eu).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