Minimal Clinically Important Difference of Average Daily Steps Measured Through a Consumer Smartwatch in People With Mild-to-Moderate Parkinson Disease: Cross-Sectional Study.

Background: Recent studies demonstrated the validity, reliability, and accuracy of consumer smartwatches for measuring daily steps in people with Parkinson disease (PD). However, no study to date has estimated the minimal clinically important difference (MCID) for average daily steps (avDS), measured through a consumer smartwatch in people with PD.

Objective: This study aimed to calculate the MCID of avDS, measured through a commercial smartwatch (Garmin Vivosmart 4) in people with PD.

Methods: People with PD with a disease stage <4, without cognitive impairment, and who were able to walk unaided, wore a Garmin Vivosmart 4 smartwatch for 5 consecutive days on the wrist least affected by the disease, allowing the computation of avDS. To define the 3 levels of MCID for avDS, we used an anchor-based method linked to: (1) scales capturing subtle changes in global mobility and motor functions, (2) clinical and health-related measures, and (3) disease-related patient-reported outcomes. Linear regressions, Student t test, and ANOVA were used to estimate the minimal change in avDS based on anchors relevant change. For each level, the overall MCID was calculated as the average of the variables included, and the range was reported.

Results: A total of 100 people with PD were enrolled. Participants took on average 5949 (SD 3034) daily steps, ranging from 357 to 12,620. The MCID of avDS anchored to standardized measures of motor symptoms and mobility was 581 steps/day (range  554-608) or around 10% of mean avDS in our population. The MCID of avDS anchored to clinical and health-related variables was 1200 steps/day (range  350-1683), or around 20% of mean avDS in our population. Finally, the MCID of avDS anchored to disease-related patient-reported outcomes was 1592 steps/day (range 594-2589), or around 27% of the mean avDS in our population.

Conclusions: These findings could be relevant for designing future clinical trials involving avDS as a digital mobility outcome in daily life for people with PD and evaluating the effectiveness of the intervention promoting free-living walking in this population.