Using Foot Sensors to Identify Walking Patterns and Monitor Changes Over Time in Children and Adults with Spinal Muscular Atrophy and Duchenne Muscular Dystrophy

What this Trial Is About

This research focuses on two rare childhood-onset progressive neuromuscular disorders spinal muscular atrophy SMA and Duchenne muscular dystrophy DMD. The study aims to identify walking-related digital biomarkers that reflect disease severity and to monitor changes over time in natural settings. These disorders cause progressive muscle weakness and functional decline, and the study seeks to better understand real-world walking function in affected children and adults. Participants will wear specially developed instrumented insoles that collect walking data both in the lab and during daily life. The study groups include ambulatory children and adults aged 5 years and older with genetically confirmed SMA or DMD, as well as a healthy control group matched by age and gender. The sensors data will be analyzed using machine-learning models to derive accurate gait parameters that may serve as functional biomarkers. Throughout the study, participants will undergo several physical assessments such as the Six Minute Walk Test, 10 Meter WalkRun, Time Up and Go Test, muscle strength testing, and joint range of motion measurements on a single day. Additionally, free-living activity will be monitored for one month using the instrumented insoles and an Actigraph accelerometer. Questionnaires on physical activity will also be completed. These measures will help researchers track disease progression and real-world mobility over an extended period. The study is expected to continue until April 2028.

Establishing Walking-related Digital Biomarkers in Rare Childhood Onset Progressive Neuromuscular Disorders