Objective: To validate and support widespread adoption of real-world digital mobility outcomes (DMOs) to monitor mobility performance, disease progression and predict falls in patients with PD.

Background: DMOs that remotely monitor Parkinson’s disease (PD) remain an area of unmet need for research and clinical care. Mobility loss is a priority area for people with PD and its valid assessment relevant for patients. Supporting evidence also shows that DMOs may be used to monitor mobility performance, indicate changes in motor disease severity and falls risk.  Robust evidence of clinical validity, however, is still lacking [1] and remains a barrier to widespread adoption. Mobilise-D (https://www.mobilise-d.eu/) is a large consortium comprising 34 partners based at leading international universities and some of the world’s largest pharmaceutical and technical companies aiming to validate DMOs that measure what matters to patients [2].

Method: The Clinical Validation Study, a longitudinal cohort study of 600 PD (commenced April 12, 2021) is underway in 5 clinical sites in UK, Germany, Belgium and Israel. Participants with mild to moderate disease severity (H&Y I-III) are being followed every 6 months for 24 months (5 assessments). Participants are asked to wear a lower-back body-worn device continuously for 7 days, undergo a series of clinical tests, and, complete monthly falls diaries. Data analysis will establish construct validity, ability to detect change, predictive capacity and clinical meaningfulness of DMOs. Here we describe the protocol and population.

Results: To date x participants have completed baseline assessment (T1) and x and x have completed T2 (6 months) and T3 (12 months), respectively. x have been lost to follow up.  Demographic and clinical data demonstrate a diverse and representative cohort.

Conclusion: Results indicate compliance with and feasibility of remotely recorded digital mobility outcomes. The final results of the Mobilise-D Clinical Validation Study will provide supporting evidence for the use of DMOs as complementary tools in clinical research and healthcare.

References: [1] Polhemus A, Ortiz LD, Brittain G, Chynkiamis N, Salis F, Gaßner H, Gross M, Kirk C, Rossanigo R, Taraldsen K, Balta D, Breuls S, Buttery S, Cardenas G, Endress C, Gugenhan J, Keogh A, Kluge F, Koch S, Micó-Amigo ME, Nerz C, Sieber C, Williams P, Bergquist R, Bosch de Basea M, Buckley E, Hansen C, Mikolaizak AS, Schwickert L, Scott K, Stallforth S, van Uem J, Vereijken B, Cereatti A, Demeyer H, Hopkinson N, Maetzler W, Troosters T, Vogiatzis I, Yarnall A, Becker C, Garcia-Aymerich J, Leocani L, Mazzà C, Rochester L, Sharrack B, Frei A, Puhan M; Mobilise-D. Walking on common ground: a cross-disciplinary scoping review on the clinical utility of digital mobility outcomes. NPJ Digit Med. 2021 Oct 14;4(1):149. doi: 10.1038/s41746-021-00513-5. PMID: 34650191; PMCID: PMC8516969.
[2] Rochester L et.al. on behalf of the Mobilise-D Consortium. A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach. Digit Biomark 2020;4 (suppl 1):13–27.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/measuring-what-matters-in-parkinsons-disease-validating-real-world-digital-mobility-outcomes-for-widespread-adoption/