Abstract Details

Title Reliability and External Validity of Digital Passive Gait Tracking in MS

Topic Multiple Sclerosis

Presentation(s) P6 - Poster Session 6 (8:00 AM-9:00 AM)

Poster/Presentation
Number 6-008

Objective

To validate the feasibility and reliability of digital outcomes derived from wearable Digital Health Technology (wDHT) that measure real-life ambulation in people with Multiple Sclerosis (pwMS). We investigated several ambulation digital outcomes, and their correlation with MS gold standard outcome measures including Expanded Disability Status Scale (EDSS) and timed 25-foot walk (T25FW).

Background The wDHT is a magneto-inertial device specifically designed for continuous assessment of patients with neurological diseases (ActiMyo®). We had previously demonstrated accuracy of the measurements (with centimetric precision) in MS. One of the measures studied, 95th centile of stride velocity (SV95C), is the first digital clinical outcome measure qualified as a primary endpoint by the European Medicines Agency (for Duchenne Muscular Dystrophy).

Design/Methods

Participants were included in a longitudinal multisite study and were asked to wear the wDHT device for an initial period of three months then after 1 year. EDSS, 9-hole peg test (9HPT), T25FW, 6-minute-walking-test (6MWT) and Berg-Balance Scale (BBS) were performed at both timepoints. Reliability was assessed by comparing first and second half the recording period using inter-class correlation (ICC). Correlations were estimated using Spearman's correlation coefficient. We studied the SV95C and the maximal distance covered by patients (WD90C).

Results We included pwMS aged from 22 to 65 years (median 48 years), with mild to moderate impairment (EDSS range 0-5.5, median 3). 74/78 patients (95%) provided at least 50 hours of recording during the initial period. ICC for SV95C and SD90C was 0.99 and 0.83, respectively. Correlations of SV95C and WD90C with EDSS (-0.66 -and -0.53 respectively) and T25FW (-0.66 -and -0.57 respectively) at baseline were moderate. Other correlations and the 1-year evolution will be presented.

Conclusions

The results demonstrate the feasibility and reliability of recording using wDHT and the internal and external consistency of SV95C, and WD90C as potential digital outcome measures in MS.

Authors/Disclosures
Laurent Servais (John Radcliffe Hospital) PRESENTER	Laurent Servais has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Laurent Servais has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Laurent Servais has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astellas. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sarepta. The institution of Laurent Servais has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Evox. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PTC. Laurent Servais has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sysnav. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BioHaven. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dyne. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zentech. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MitoRx. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lupin. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Fibrogen. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alltrana. Laurent Servais has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Illumina. Laurent Servais has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Laurent Servais has received research support from Roche. The institution of Laurent Servais has received research support from Novartis. The institution of Laurent Servais has received research support from Biogen. The institution of Laurent Servais has received research support from Zentech. The institution of Laurent Servais has received research support from BioHaven. The institution of Laurent Servais has received research support from PerkinHalmers. The institution of Laurent Servais has received research support from Scholar Rock.
Margaux Poleur (Reference Center for Neuromuscular Diseases)	No disclosure on file
Barbara Willekens, MD, PhD, FAAN (Antwerp University Hospital)	The institution of Dr. Willekens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. The institution of Dr. Willekens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. The institution of Dr. Willekens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. The institution of Dr. Willekens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. The institution of Dr. Willekens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. Willekens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. The institution of Dr. Willekens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. The institution of Dr. Willekens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Almirall . The institution of Dr. Willekens has received research support from Roche. The institution of Dr. Willekens has received research support from Janssen. Dr. Willekens has a non-compensated relationship as a Co-chair scientific panel of neuroimmunology with European Academy of Neurology that is relevant to AAN interests or activities.
Bertrand Degos (Avicenne University Hospital (APHP, Sorbonne Paris Nord))	No disclosure on file
Damien Ricard, MD (Hopital Du Val De Grace)	No disclosure on file
Vincent Van Pesch, MD, PhD (Cliniques Universitaires Saint-Luc)	Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Vincent Van Pesch, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. The institution of Vincent Van Pesch, MD, PhD has received research support from Biogen.
Alexis Tricot (Sysnav)	No disclosure on file
Laurie Medard (CRMN-Citadelle)	No disclosure on file
Hui Li	No disclosure on file
Emilie Lommers (CHU of Liège)	No disclosure on file
Mona Michaud (Sysnav)	No disclosure on file
Paul Strijbos (F. Hoffmann-La Roche Ltd)	No disclosure on file
James Overell, MD, MBBS (Roche)	Dr. Overell has received personal compensation for serving as an employee of Roche. Dr. Overell has stock in Roche.
Celine Cluzeau (Sysnav)	No disclosure on file
Damien Eggenspieler (Sysnav)	No disclosure on file

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