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Background <p>Description of disease progression in MS lack sensitive clinical outcomes. Digital motor outcomes (DMO) offer potential but require thorough validation.</p> Objective <p>This 2-year observational study explores the sensitivity of 26 DMO derived from a task-based assessment protocol via RGB-D camera.</p> Methods <p>One-hundred people with MS (pwMS) were enrolled, 96 completed follow-up. Expanded Disability Status Scale (EDSS) and 12-Item MS Walking Scale (MSWS-12) served as anchors for sensitivity by classifying progression, improvement or stable at 2&#xa0;years, irrespective of intercurrent relapses. Primary analysis applied linear mixed modeling. Distribution-based thresholds (MDC) were calculated from stable subgroups.</p> Results <p>Six DMO showed a significant increase over time in relation to stand-up/sit-movement (<i>β</i> = 0.01; <i>β</i> = 0.02), stepping asymmetry (<i>β</i> = 0.02; <i>β</i> = 0.02), trunk deflection while walking (<i>β</i> = 0.02) and trunk sway in closed-eyes stance (<i>β</i> = 0.02) (95% CI 0.001–0.038; all <i>p</i> &lt; 0.05). EDSS (<i>n</i> = 22) and MSWS-12 (<i>n</i> = 11) progression groups were distinct. Time effects differed by anchor. For the EDSS progression group, the change in step width and sway velocity in closed-feet/open-eyes stance exceeded measurement error.</p> Conclusions <p>Our findings yield a well-applicable set of DMO that may support definitions of disability accumulation in (early) pwMS. Establishing patient relevance remains challenging due to expectedly low clinical progression rates. The distinct patterns captured by EDSS and MSWS-12 definitions underline the need for multiple anchors when validating new biomarkers.</p> <p><i>Trial registration</i> ClinicalTrials.gov, NCT04993274, 2021-03-09 retrospectively registered.</p>

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Anchor-based evaluation of digital motor biomarkers from a 2-year observation in 100 patients with multiple sclerosis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月4日

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  • Carla A. Ellinghaus,
  • Hanna M. Röhling,
  • Eva-Maria Dorsch,
  • Pia S. Sperber,
  • Radina Arsenova,
  • Gilberto Solorza Buenrostro,
  • Sophia Rekers,
  • Tatiana Usnich,
  • Patrick Schindler,
  • Daniel Kroneberg,
  • Judith Bellmann-Strobl,
  • Frederike C. Oertel,
  • Alexander U. Brandt,
  • Martin Weygandt,
  • Friedemann Paul,
  • Sophie K. Piper,
  • Tanja Schmitz-Hübsch

摘要

Background

Description of disease progression in MS lack sensitive clinical outcomes. Digital motor outcomes (DMO) offer potential but require thorough validation.

Objective

This 2-year observational study explores the sensitivity of 26 DMO derived from a task-based assessment protocol via RGB-D camera.

Methods

One-hundred people with MS (pwMS) were enrolled, 96 completed follow-up. Expanded Disability Status Scale (EDSS) and 12-Item MS Walking Scale (MSWS-12) served as anchors for sensitivity by classifying progression, improvement or stable at 2 years, irrespective of intercurrent relapses. Primary analysis applied linear mixed modeling. Distribution-based thresholds (MDC) were calculated from stable subgroups.

Results

Six DMO showed a significant increase over time in relation to stand-up/sit-movement (β = 0.01; β = 0.02), stepping asymmetry (β = 0.02; β = 0.02), trunk deflection while walking (β = 0.02) and trunk sway in closed-eyes stance (β = 0.02) (95% CI 0.001–0.038; all p < 0.05). EDSS (n = 22) and MSWS-12 (n = 11) progression groups were distinct. Time effects differed by anchor. For the EDSS progression group, the change in step width and sway velocity in closed-feet/open-eyes stance exceeded measurement error.

Conclusions

Our findings yield a well-applicable set of DMO that may support definitions of disability accumulation in (early) pwMS. Establishing patient relevance remains challenging due to expectedly low clinical progression rates. The distinct patterns captured by EDSS and MSWS-12 definitions underline the need for multiple anchors when validating new biomarkers.

Trial registration ClinicalTrials.gov, NCT04993274, 2021-03-09 retrospectively registered.