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Background <p>Digital biomarkers show significant potential and are emerging as outcome measures in clinical trials in spastic ataxias (SPAX). Research on the performances of digital biomarkers in home environments remains limited.</p> Objectives <p>To evaluate feasibility, user adherence, time-of-day and learning effects, and consistency across settings of the SPAX-app for home monitoring in clinical trials. The app contains four tasks assessing gait, standing balance, and finger and hand movements, along with a patient-reported outcome measure (PROM).</p> Methods <p>We conducted an 8-week long-term study in 38 SPAX patients and 10 healthy controls. Subjects first answered the SPAX-app PROM and performed tasks during one in-clinic session. Severity of ataxia and spasticity were assessed by clinician-reported outcome measures (ClinROs). Subjects then performed the tasks and answered the PROM twice a week in the morning and evening at home.</p> Results <p>The SPAX-app showed high feasibility for finger and hand movement tasks (92%), but limited feasibility for gait (47%) and stance (63%) tasks. Among those able to perform the tasks, adherence was high (81%). A significant difference (<i>p</i> &lt; 0.01) was found between morning and evening assessments by PROMs in SPAX. Results remained stable across the day and repeated assessments, except for the inter-onset interval in finger tapping (<i>p</i> = 0.002 and <i>p</i> = 0.020, respectively). Strong correlations were observed between tasks performed at home and in the clinic. Motor outcome measures correlated well with ClinROs, but not with PROMs.</p> Conclusion <p>The SPAX-app is a feasible tool for remote assessment in SPAX, showing high feasibility for finger and hand movement tasks, but limited feasibility for gait and stance tasks at home. Time-of-day and learning effects were minimal. Longer-term studies are needed to assess clinical relevance.</p>

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Feasibility of a smartphone application for remote use in spastic ataxias: an 8-week long-term PROSPAX study

  • 期刊论文

  • 发表日期：

    2025年12月4日

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  • Ilse H. J. Willemse,
  • Sabato Mellone,
  • Carlo Tacconi,
  • Filippo M. Santorelli,
  • Ivana Ricca,
  • Sara Satolli,
  • Stephan Klebe,
  • Nicole Jeschonneck,
  • Winfried Ilg,
  • Rebecca Schüle,
  • Matthis Synofzik,
  • Jorik Nonnekes,
  • Bart P. C. van de Warrenburg

摘要

Background

Digital biomarkers show significant potential and are emerging as outcome measures in clinical trials in spastic ataxias (SPAX). Research on the performances of digital biomarkers in home environments remains limited.

Objectives

To evaluate feasibility, user adherence, time-of-day and learning effects, and consistency across settings of the SPAX-app for home monitoring in clinical trials. The app contains four tasks assessing gait, standing balance, and finger and hand movements, along with a patient-reported outcome measure (PROM).

Methods

We conducted an 8-week long-term study in 38 SPAX patients and 10 healthy controls. Subjects first answered the SPAX-app PROM and performed tasks during one in-clinic session. Severity of ataxia and spasticity were assessed by clinician-reported outcome measures (ClinROs). Subjects then performed the tasks and answered the PROM twice a week in the morning and evening at home.

Results

The SPAX-app showed high feasibility for finger and hand movement tasks (92%), but limited feasibility for gait (47%) and stance (63%) tasks. Among those able to perform the tasks, adherence was high (81%). A significant difference (p < 0.01) was found between morning and evening assessments by PROMs in SPAX. Results remained stable across the day and repeated assessments, except for the inter-onset interval in finger tapping (p = 0.002 and p = 0.020, respectively). Strong correlations were observed between tasks performed at home and in the clinic. Motor outcome measures correlated well with ClinROs, but not with PROMs.

Conclusion

The SPAX-app is a feasible tool for remote assessment in SPAX, showing high feasibility for finger and hand movement tasks, but limited feasibility for gait and stance tasks at home. Time-of-day and learning effects were minimal. Longer-term studies are needed to assess clinical relevance.