Mobility - how well someone walks - is considered the ‘sixth vital sign’ of health. This is because poor gait, especially walking slowly, is associated with earlier death, greater risk of disease, cognitive decline, dementia and an increased risk of falls.

Funded by the European Innovative Medicines Initiative 2 Joint Undertaking, the project, called MOBILISE-D, aims to revolutionise assessment of mobility loss using digital technology to lead to enhanced clinical trials and better clinical management.

Clinicians and scientists from academic centres across Europe will collaborate with companies from the European Federation of Pharmaceutical Industries and Associations (EFPIA) - the goal is to develop, validate, and ensure regulation of better mobility outcomes.

The results of the project will directly lead to drug development and establish a roadmap for clinical implementation of new, complementary tools which will identify, categorize and monitor disability in patients. This will enable widespread, cost-effective access to managing conditions clinically through personalised healthcare.

The €50 million project includes 34 international research partners based at leading international universities and some of the world’s largest pharmaceutical and technical companies. The project is led by Newcastle University, working closely with the lead EFPIA partner, Novartis.

Professor Lynn Rochester, Professor of Human Movement Science at Newcastle University is co-ordinating the MOBILISE-D consortium.  She said: “Digital technology, including sensors worn on the body, have the potential to transform how we assess mobility and identify life-changing conditions. This will enable medical teams to intervene earlier and offer treatment to extend healthy life.”

Growing problem

In the EU, people over the age of 65 make up more than 19% of the population, a figure projected to rise significantly. Increasing life expectancy, coupled with the number of people living with chronic health conditions, means that more people are coping with mobility loss.

Better treatment of impaired mobility resulting from ageing and chronic disease is one of the 21st century's greatest challenges facing patients, society, governments, healthcare services, and science.

New interventions are a key focus but, to accelerate their development, better methods are needed to predict, detect and measure mobility loss.

MOBILISE-D will focus on digital mobility assessment being recognized for the analysis and treatment of Chronic Obstructive Pulmonary Disease (COPD), Parkinson’s disease, multiple sclerosis, hip fracture recovery, (Proximal Femoral Fracture, PFF), and congestive heart failure.

Professor Rochester added: “Digital tools that consistently and accurately measure the extent and nature of mobility loss are now within our technological reach. Once implemented, they will become a new and powerful driver for innovation in intervention, leading to an important and fundamental shift in the quality of healthcare that will extend well beyond MOBILISE-D.

“MOBILISE-D will build an all-encompassing, clinically-valid digital mobility assessment system capable of use across all conditions where mobility loss is relevant and bring with it a personalised approach to healthcare for the benefit of citizens in the EU and globally.

 “Our ultimate goal is to provide a validated, robust set of algorithms to measure digital mobility outcomes and in turn, inform therapeutic development, clinical practice, precision medicine, industrial development and stakeholder approval.”

Ronenn Roubenoff, Global Translational Medicine Head, Musculoskeletal Disease at Novartis Institutes for Biomedical Research, who serves as the industry project lead for MOBILISE-D, said: “The results of MOBILISE-D will facilitate drug development, develop a roadmap for clinical implementation of innovative tools to identify, stratify, and monitor disability in patients, and enable cost effective, wide access to clinical management and personalised healthcare.

”A key immediate impact will be on the design of clinical trials for novel treatment development, supporting better patient inclusion & stratification, more sensitive clinical outcomes, a potential correlation of real-world patient reported outcome for evidence-based healthcare.

“MOBILISE-D will also bring the key ingredient needed for any medical technology to blossom: standardization, in turn stimulating development of novel solutions.”

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 820820. The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

A patient’s perspective: Val

After a successful career in science and business, Val Argent, 68, from Stocksfield in Northumberland was diagnosed with Parkinson’s Disease nine years ago.

Soon after, she became involved with a number of clinical trials including the ICICLE-gait trial led by Professor Lynn Rochester which examines whether gait - the way you walk - can help predict increasing difficulties with brain function. 

Val says: “There is no cure for Parkinson’s Disease, and not even a treatment which can slow its progression. The best medicine is regular exercise, which helps the brain as well as the body.  So, I’ve remained really active going horse riding, caring for the grandchildren, just keeping busy in the house and garden, looking after my sheep. I even returned to work part time for several years.

“Like many with Parkinson’s I find that one side is more severely affected than another and my left side is weaker. This means I have a tremor in my left hand and I tend to drag my left foot sometimes. The condition progresses very slowly, but after 9 years I find that Parkinson’s Disease slows down every aspect of my life. Getting money out of my purse takes time or finding the right word to complete a sentence takes me longer than it used to.

“Taking part in the clinical trials is one way of fighting back. I volunteer for every trial I can because we can’t expect the doctors and scientists to come up with a better treatment if we do not help. It means that every 18 months I am assessed and as part of that a monitor, about the size of a stamp is stuck to the small of my back and I carry on with normal life. You forget the monitor’s there and the only difference is remembering to take it off if you want a bath.

“It records all my actions whether I’m walking, sleeping, standing and the number of steps I’ve taken. I wonder how the input from when I am horse riding is interpreted by the research team?

“At the end of the week, I take it off, pop it in the post and then the research team are able to use the data to help them analyse any changes.

“I do not expect taking part in clinical trials to offer any personal health benefit, but maybe that will come to our children and future generations. One thing I can say, the Research teams are always welcoming, and make each visit a pleasant experience. They are also very knowledgeable about your condition, and have more time to answer questions than busy doctors.  

“The sensors are so easy to wear, I would encourage everyone to take part and do what they can. We have nothing to lose and someday there will be a breakthrough.”