GAIT-CKD (Gait Analysis using Artificial Intelligence for digital Therapeutics of patients with Chronic Kidney Disease): design and methods.

Background: Digital therapeutics are emerging as treatments for diseases and disabilities. In chronic kidney disease (CKD), gait is a potential biomarker for health status and intervention effectiveness. This study aims to analyze gait characteristics in CKD patients, providing baseline data for digital therapeutics development.

Methods: At baseline and after an 8-week intervention, we performed bioimpedance analysis measurements, the Timed Up and Go, Tinetti, and grip strength tests, and gait analysis in 217 healthy individuals and 276 patients with CKD. Demographic and clinical information was collected, including underlying diseases and medications, laboratory tests, and quality of life satisfaction surveys. Gait analysis was performed using skeleton data, which involved acquiring three-dimensional skeleton data of a walker using a single Kinect sensor. The performance of an artificial intelligence-based classification model in distinguishing between healthy individuals and those with CKD was then investigated. Simultaneously, inertia measurement unit analysis was conducted using measurements taken from the wrist and waist.

Results: Most subjects received a health intervention via an app, and their gait was assessed for improvements after an 8-week period. Incidents such as falls, fractures, hospitalizations, and deaths will be investigated in years 1 and 3.

Conclusion: This study confirmed that the gaits of healthy individuals and CKD patients were different, and the effect of the 8-week app-based health intervention will be analyzed. The study will yield important baseline data for creating digital therapeutics for CKD patients' diet/exercise in the future.