Digital Mobility Outcomes are the Next Step in Advancing Neurological Care and Trials
Basil Sharrack1, Gavin Brittain1, Mike Long2, Ellen Buckley2, Giancarlo Comi3, Letizia Leocani4, Gloria Dallas Costa4, Veit Rothhammer5, Klarissa Stürner6, Clint Hansen6, Giampaolo Brichetto7, Clemens Becker8, Brian Caulfield9, Alice Nieuwboer10, Christian Schlenstedt11, Anat Mirelman12, Jeff Hausdorff13, Heiko Gassner14, Pieter Ginis15, Lisa Alcock16, Dan Rooks17, Lynn Rochester16, Walter Maetzler18, Alison Yarnall16, Judith Garcia19
1Sheffield Teaching Hospitals NHS Foundation Trust and The University of Sheffield, 2University of Sheffield, 3Department of Neurorehabilitation, 4University Vita-Salute San Raffaele, INSPE, 5Universität Erlangen-Nuernberg, 6Department of Neurology, UKSH Kiel, Kiel University, 7AISM Rehabilitation Service, Italian MS Society, 8Unit of Digital Geriatric Medicine, University Hospital Heidelberg, 9School of Public Health Physiotherapy and Sports Science, University College Dublin, 10KU Leuven, Department of Rehabilitation Sciences, 11MSH Medical School Hamburg, The University of Kiel, 12Sackler School of Medicine and Sagol School of Neuroscience, 13Tel Aviv Medical Center, Tel Aviv University, 14University Hospital Erlangen, 15KU Leuven, 16University of Newcastle upon Tyne, 17Novartis, 18Kiel University, 19ISGlobal
Objective:

Examine the construct validity and acceptance of digital mobility outcomes (DMOs) in the largest study of unsupervised walking in people with neurological disease, Mobilise-D.

Background:

There is a rapidly growing number of digital health outcome measures. The unsupervised measurement of real-world mobility produces DMOs that represent a patient's gait and walking behaviour, which are not limited to typically used measures, such as step count. 

Design/Methods:

600 people with Parkinson’s disease (PD) and 602 with multiple sclerosis (MS) were recruited across Europe. Clinical assessments were followed by 7 days of unsupervised mobility monitoring using a body-worn sensor. Valid data was considered as ≥3 days with ≥12 hours wear time per day. A variety of DMOs were extracted from walking bouts >10s duration, and segmented by walking bout duration. Construct validity was assessed by testing correlations based on an a priori hypothesis.

Results:

531 PD (mean age 66 years, 64% male, mean Movement Disorder Society-Unified Parkinson’s Disease Rating Scale total score of 48) and 556 MS (mean age 52 years, 65% female, median expanded disability status scale score of 5) participants had a valid assessment. Construct validity was met for 12 and 21 of 24 DMOs in PD and MS, respectively. Irrespective of disease, DMOs worsen as disease severity states increases. The most consistent results were seen in DMOs reflecting the amount and pace of walking.

Acceptance to being monitored was similar in both groups with ≥92% accepting of being remotely monitored during the study and ≥79% willing to wear the device as part of clinical care.

Conclusions:

Real-world mobility monitoring is a comprehensive method of gait assessment and a valid construct in people with MS and PD. Patients are ready and accepting of its potential use. Further analysis will help to establish the place of DMOs in future clinical care and trials.

10.1212/WNL.0000000000212188
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