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
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.
Summary of Results
Who carried out the research?
The Mobilise-D Extension Study was sponsored by The Newcastle upon Tyne Hospitals NHS Foundation Trust and was funded by The Michael J. Fox Foundation for Parkinson's Research.The research was carried out at the five clinical sites which had recruited people with Parkinson's to the Mobilise-D study: Newcastle upon Tyne (UK), Erlangen (Germany), Kiel (Germany), Leuven (Belgium) and Tel Aviv (Israel).
The Mobilise-D Extension Study took place between July 2023 and July 2025.
Why was the research needed?
Difficulty with walking is regularly highlighted by people with Parkinson's as one of their most troublesome symptoms. Researchers need a method to track changes to mobility in a way that is accurate and meaningful to people with Parkinson's. Currently, many measures used often provide only a snapshot. This does not reflect how fluctuations in mobility from day-to-day can affect people. One promising method is using wearable devices that monitor how people move during their daily lives.The Mobilise-D study investigated the ability of body-worn devices to measure and predict changes in mobility across multiple health conditions. The data collected from was used to develop new digital measures of movement, or digital mobility outcomes (DMOs), such as walking speed, stride length and steps per day, which represent different aspects of real-world walking and mobility. This Extension Study was undertaken to provide insight into how changes in mobility in people with Parkinson's compare to changes associated with normal ageing.
What did study aim to do?
The Mobilise-D Extension Study looked at whether DMOs collected using wearable devices can reliably track changes in walking and mobility in people with Parkinson's. These measures were compared with those from people without Parkinson's to understand what "normal" aging looks like and how Parkinson's affects it.A key goal was to see if these digital tools can pick up small but meaningful changes over time. This is important because Parkinson's progresses gradually, and traditional assessments may miss subtle changes. By following people over a longer period, the study aimed to determine how long it takes to detect progression. This will help to identify useful targets for measuring treatment effects in clinical trials.
The study also explored whether people, especially those with more advanced Parkinson's symptoms, are willing and able to use wearable devices in their daily lives.
Who was included?
A total of 387 Mobilise-D participants agreed to attend an additional 36-months follow-up visit.A comparison group of 232 healthy older adults aged 50 years and over, who did not have Parkinson's or any other movement disorder also took part. These individuals were recruited from the same clinical centres, using volunteer databases as well as friends and family members of the participants with Parkinson's.
The comparison group was similar to the Parkinson's group in terms of age and sex.
The comparison group showed greater physical strength, walking ability, and mental processing. They also reported less fatigue and fewer difficulties with everyday activities.
What did the study involve?
Participants with Parkinson's attended a follow-up visit 36 months after their first Mobilise-D study visit. The control participants attended a baseline visit and a 12-month follow-up visit.The study visits consisted of questionnaires and clinical assessments to assess general health and mental well-being. Participants completed physical tests to measure how far and fast they could walk, muscle strength and balance. Participants with Parkinson's also completed Parkinson's-specific assessments to measure their disease severity.
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. This tracked their walking patterns and activity during this period. Participants were asked to undertake their normal daily activities.
The digital device data was processed into DMOs such as walking speed, number of steps and stride length.
Participants were asked about their experience of wearing the digital device and their views on wearable technology.What did the study find?
The results showed clear differences in how people with Parkinson's moved compared to those without the disease. For example, people with Parkinson's walked less, took fewer steps, and had different walking rhythms. These differences generally became more noticeable as the disease became more advanced.Over time, people with Parkinson's who showed a decrease in their walking speed were more likely to also show a decline in their ability to perform daily tasks and were more likely to experience a fall. These associations were not found in people without Parkinson's.
Participants were happy to wear the devices and followed the study instructions well.
What do the results mean for patients and researchers?
This results of this study have shown that data collected using wearable digital devices can show differences in mobility between people with and without Parkinson's and reflect the difference stages of disease progression. This supports the use of digital devices as a suitable tool to measure changes in mobility in Parkinson's disease. This may be a useful tool for improving the development and real-world testing of new Parkinson's treatments.The association between changes in DMOs, changes in daily functioning and fall risk suggest that these outcomes could be used to predict disease progression in people with Parkinson's. This may be useful to plan personalised future clinical care.
Participant feedback indicates that people with Parkinson's would be willing to wear device both for research and their clinical care, suggesting this method is acceptable for future use.
This study has built on the findings of the Mobilise-D study and provides further support for use of digital devices to provide an accurate and reliable measure of real-life mobility.
What further research is being undertaken?
Digital mobility data is now being collected as part of the world's biggest clinical trial of disease modification in Parkinson's, the Edmond J Safra ACT-PD Trial. The DMOs will be compared to traditional outcome measures in their ability to accurately measure response to the trial treatments.Where can I find out more?
The Mobilise-D website (https://mobilise-d.eu/) contains information about the development of the DMOs used in this study and their implementation in multiple movement related conditions.If you are interested in participating in the EJS ACT-PD study or other future clinical studies, please consider signing up to the Join Parkinson's Research (JPR) registry (Join Parkinson's Research - Research+Me).
REC name
HSC REC B
REC reference
23/NI/0046
Date of REC Opinion
21 Mar 2023
REC opinion
Favourable Opinion