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Article Abstract
Background: Clinical trials in spinocerebellar ataxias (SCA) require objective, quantifiable outcome measures sensitive to changes in disease severity.
Objectives: The objective was to study the sensitivity to change of digital gait biomarkers in SCA1 over a 1-year period.
Methods: Seventeen SCA1 patients and 15 controls walked 30 seconds wearing 3 sensors at 3 walking speeds (preferred, slow, fast) at baseline and 1-year follow-up. Relationship between gait and clinical measures was analyzed, and standardized response means (SRMs) were calculated.
Results: Toe-off angle (TOA), variability in TOA, speed, and stride length showed significant responsiveness (SRM = -1.15, 0.61, -0.77, and -0.85). TOA, which correlated most strongly with ataxia severity and patient-reported outcomes, demonstrated higher sensitivity to change than Scale for Assessment and Rating of Ataxia (SARA) in early-stage disease at preferred walking speed. Gait variability measures lacked sensitivity, possibly due to the short recording period.
Conclusions: Digital gait biomarkers are promising outcomes in future clinical trials in SCA1, but their sensitivity to change appears stage dependent.
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| http://dx.doi.org/10.1002/mdc3.70124 | DOI Listing |
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