Actively Recruiting
Establishing Walking-related Digital Biomarkers in Rare Childhood Onset Progressive Neuromuscular Disorders
Led by Columbia University · Updated on 2026-04-09
106
Participants Needed
3
Research Sites
13 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
S
Stevens Institute of Technology
Collaborating Sponsor
AI-Summary
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 Walk/Run, 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.
CONDITIONS
Brief Title
Establishing Walking-related Digital Biomarkers in Rare Childhood Onset Progressive Neuromuscular Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Genetic confirmation of Duchenne muscular dystrophy, spinal muscular atrophy, or healthy control
- Able to walk independently at least 25 meters
- For DMD: ongoing corticosteroid therapy or started corticosteroids within the past 3 months
- For SMA: stable dose of FDA-approved SMN up-regulator therapy for at least 6 months, or in an open-label extension study, or gene replacement therapy at enrollment
You will not qualify if you...
- Use of foot orthoses, assistive devices for walking in the community, or mobility devices for community navigation
- Use of investigational medications for neuromuscular disorders within 30 days
- Injury or surgery impacting gait within the previous 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete walking and muscle function tests while wearing instrumented insoles to assess gait parameters.
1 visit (in-person)
Duration - 1 month
Participants wear instrumented insoles and accelerometers in real-life environments to collect walking and physical activity data.
Continuous monitoring over 1 month with periodic data collection
Trial Site Locations
Total: 3 locations
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
J
Jacqueline Montes, PT, EdD
C
Cara Kanner, DPT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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