Clario joins forces with Mobilise-D to advance Digital Mobility Outcomes in clinical trials

Clario integrates Mobilise-D’s algorithms into Clario’s Opal^®️ wearable sensor system to enable real-world mobility assessments that generate accurate and reliable Digital Mobility Outcomes (DMOs) for enhancing patient outcomes.

• Clario, a long-standing member of the Mobilise-D consortium, provided essential technology and expertise for the e-clinical outcome assessments (eCOA) data capture during both the technical and clinical validation studies that developed the Mobilise-D algorithms.
• The validated Mobilise-D algorithms integrate into Clario’s Opal® wearable sensor system, allowing the capture of precise movement measurements in the patients’ daily lives to deliver objective, reliable, accurate, and sensitive Digital Mobility Outcomes (DMOs).
• This collaboration enhances clinical outcomes, notably in neuroscience, by pairing reliable digital mobility performance measurements with e-clinical outcome assessments (eCOAs) for a holistic quality-of-life evaluation.

PHILADELPHIA – August 13, 2024 – Clario, a leading provider of technologies and endpoint data solutions for clinical trials, today announced the enhancement of its digital capture of patient mobility data through the Mobilise-D consortium partnership. This collaboration integrates the recently validated Mobilise-D Digital Mobility Outcomes (DMOs) with Clario’s Opal® wearable sensor system, allowing clinicians to measure the way patients move in their daily life versus a single timepoint when they visit a clinic. DMOs deliver multiple advantages over conventional clinical scales when capturing information about human movement — they are more objective, reliable, accurate, and sensitive.

As a member of the Mobilise-D consortium, Clario provided essential technology and expertise for the e-clinical outcome assessments (eCOA) data capture, during both the technical and clinical validation studies that developed the algorithms. Leveraging this experience, Clario offers advanced solutions that integrate the validated Mobilise-D algorithms with its wearable sensors to assess mobility performance and deliver DMOs.

“It has been a privilege to contribute to the Mobilise-D consortium and advance digital mobility data for use in clinical trials,” said Kristen Sowalsky, Ph.D., D.C., VP, Product Management and Scientific Affairs, Precision Motion at Clario. “These developments are integral for demonstrating real-world patient outcomes, particularly in neuroscience where mobility insights outside of clinical settings are essential to assess treatment efficacy and quality-of-life.”

Clario is implementing these algorithms in a study with multiple sclerosis (MS) patients to establish the technical equivalence of its Precision Motion wearable device, Opal®️. In addition, Clario can provide the mobility performance data from wearable sensors along with e-clinical outcome assessments (eCOA), enhancing clinical outcomes. This, alongside Clario’s offerings in medical imaging, cardiac, and respiratory endpoints, meets a broad scope of clinical trial solutions addressing diverse needs.

Lynn Rochester, Ph.D., Professor of Human Movement Science at the Translational and Clinical Research Institute, Newcastle University in the United Kingdom co-led the Mobilise-D consortium. On the Clario partnership, Dr. Rochester said, “Working with Clario has been instrumental in our clinical studies to validate our DMO algorithms and ensuring their quality in clinical settings. Their expertise in data capture and analysis will contribute significantly to the success of our work, and we are excited about the future applications of this technology.”

To learn more about Clario and its wearable sensor technologies, please visit Clario.com.

About IMI Mobilise-D

Mobilise-D is a consortium funded under the EU Innovative Medicines Initiative comprised of experts from 22 academic institutions, 12 industry partners from pharmaceutical, technology, and clinical research organisations, and people with diverse health conditions and mobility impairments. The primary objective of Mobilise-D was to develop a novel method to accurately and reliability assess change in one’s mobility in the real-world environment using digital technologies, including a single body worn device. The project focused on conditions which affect mobility, including chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis, hip fracture recovery, and congestive heart failure. It has delivered a systematic approach to real-world mobility assessment that is standardised, validated and free. The Mobilise-D results will help to improve accurate assessment of daily life mobility in clinical trials and patient treatment, thereby contributing to improved and more personalised care.