Bianchini Edoardo, Rinaldi Domiziana, De Carolis Lanfranco, Galli Silvia, Alborghetti Marika, Hansen Clint, Suppa Antonio, Salvetti Marco, Pontieri Francesco Ernesto, Vuillerme Nicolas
Department of Neuroscience, Mental Health and Sensory Organs (NESMOS), Sapienza University of Rome, Rome, Italy.
AGEIS, Université Grenoble Alpes, Grenoble, France.
JMIR Form Res. 2025 Mar 18;9:e63153. doi: 10.2196/63153.
Average daily steps (avDS) could be a valuable indicator of real-world ambulation in people with Parkinson disease (PD), and previous studies have reported the validity and reliability of this measure. Nonetheless, no study has considered disease phenotype, stage, and severity when assessing the reliability of consumer wrist-worn devices to estimate daily step count in unsupervised, free-living conditions in PD.
This study aims to assess and compare the reliability of a consumer wrist-worn smartwatch (Garmin Vivosmart 4) in counting avDS in people with PD in unsupervised, free-living conditions among disease phenotypes, stages, and severity groups.
A total of 104 people with PD were monitored through Garmin Vivosmart 4 for 5 consecutive days. Total daily steps were recorded and avDS were calculated. Participants were dichotomized into tremor dominant (TD; n=39) or postural instability and gait disorder (PIGD; n=65), presence (n=57) or absence (n=47) of tremor, and mild (n=65) or moderate (n=39) disease severity. Based on the modified Hoehn and Yahr scale (mHY), participants were further dichotomized into earlier (mHY 1-2; n=68) or intermediate (mHY 2.5-3; n=36) disease stages. Intraclass correlation coefficient (ICC; 3,k), standard error of measurement (SEM), and minimal detectable change (MDC) were used to evaluate the reliability of avDS for each subgroup. The threshold for acceptability was set at an ICC ≥0.8 with a lower bound of 95% CI ≥0.75. The 2-tailed Student t tests for independent groups and analysis of 83.4% CI overlap were used to compare ICC between each group pair.
Reliability of avDS measured through Garmin Vivosmart 4 for 5 consecutive days in unsupervised, free-living conditions was acceptable in the overall population with an ICC of 0.89 (95% CI 0.85-0.92), SEM below 10%, and an MDC of 1580 steps per day (27% of criterion). In all investigated subgroups, the reliability of avDS was also acceptable (ICC range 0.84-0.94). However, ICCs were significantly lower in participants with tremor (P=.03), with mild severity (P=.04), and earlier stage (P=.003). Moreover, SEM was below 10% in participants with PIGD phenotype, without tremor, moderate disease severity, and intermediate disease stage, with an MDC ranging from 1148 to 1687 steps per day (18%-25% of criterion). Conversely, in participants with TD phenotype, tremor, mild disease severity, and earlier disease stage, SEM was >10% of the criterion and MDC values ranged from 1401 to 2263 steps per day (30%-33% of the criterion).
In mild-to-moderate PD, avDS measured through a consumer smartwatch in unsupervised, free-living conditions for 5 consecutive days are reliable irrespective of disease phenotype, stage, and severity. However, in individuals with TD phenotype, tremor, mild disease severity, and earlier disease stages, reliability could be lower. These findings could facilitate a broader and informed implementation of avDS as an index of ambulatory activity in PD.
平均每日步数（avDS）可能是帕金森病（PD）患者现实世界中步行活动的一个重要指标，以往研究报告了该指标的有效性和可靠性。然而，在评估消费级腕戴设备在无监督、自由生活条件下估计PD患者每日步数的可靠性时，尚无研究考虑疾病表型、分期和严重程度。
本研究旨在评估和比较一款消费级腕戴智能手表（佳明Vivosmart 4）在无监督、自由生活条件下，对不同疾病表型、分期和严重程度组的PD患者计算avDS的可靠性。
共有104例PD患者通过佳明Vivosmart 4连续监测5天。记录每日总步数并计算avDS。参与者被分为震颤为主型（TD；n = 39）或姿势不稳和步态障碍型（PIGD；n = 65），存在震颤（n = 57）或无震颤（n = 47），以及轻度（n = 65）或中度（n = 39）疾病严重程度。根据改良的Hoehn和Yahr量表（mHY），参与者进一步分为疾病早期（mHY 1 - 2；n = 68）或中期（mHY 2.5 - 3；n = 36）。组内相关系数（ICC；3，k）、测量标准误（SEM）和最小可检测变化（MDC）用于评估各亚组avDS的可靠性。可接受性阈值设定为ICC≥0.8，95%CI下限≥0.75。采用独立组的双尾Student t检验和83.4%CI重叠分析比较每组之间的ICC。
在无监督、自由生活条件下，通过佳明Vivosmart 4连续5天测量的avDS在总体人群中的可靠性是可接受的，ICC为0.89（95%CI 0.85 - 0.92），SEM低于10%，MDC为每天1580步（标准的27%）。在所有调查的亚组中，avDS的可靠性也是可接受的（ICC范围为0.84 - 0.94）。然而，有震颤的参与者（P = 0.03）、轻度严重程度的参与者（P = 0.04）和疾病早期的参与者（P = 0.003）的ICC显著较低。此外，PIGD表型、无震颤、中度疾病严重程度和疾病中期的参与者的SEM低于10%，MDC范围为每天1148至1687步（标准的18% - 25%）。相反，在TD表型、有震颤、轻度疾病严重程度和疾病早期的参与者中，SEM大于标准的10%，MDC值范围为每天1401至2263步（标准的30% - 33%）。
在轻度至中度PD患者中，通过消费级智能手表在无监督、自由生活条件下连续5天测量的avDS是可靠的，与疾病表型、分期和严重程度无关。然而，在TD表型、有震颤、轻度疾病严重程度和疾病早期的个体中，可靠性可能较低。这些发现有助于更广泛、更明智地将avDS作为PD患者步行活动的指标来应用。
