Linking walking patterns to bone strength in ambulatory SMA
Official title: Identification of Gait-related Digital Biomarkers of Bone Health in Spinal Muscular Atrophy
Run by Columbia University · NCT07400198 · Data updated 2026-11-12
This will try to see if wearable insole gait data can predict bone density and fracture risk in ambulatory people with spinal muscular atrophy who are on disease-modifying therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 8 Years to 50 Years |
| Sex | All |
| Enrollment | 22 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | March 5, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT07400198 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ambulatory people with genetically confirmed 5q SMA, aged 8 to 50, who can walk 10 meters without an assistive device are ideal candidates.
✕Probably not a fit
Non-ambulatory individuals, people younger than 8 or older than 50, or those with recent injuries or surgeries that affect walking are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cross-sectional study collects detailed gait data and bone health information from ambulatory children and adults with 5q SMA who are receiving disease-modifying therapy. Participants attend one in-clinic visit (about 3 hours) for instrumented insole gait testing, clinical exams, and bone health measurements, then complete brief remote follow-ups every three months for one year to record fractures and medical history. Researchers will apply machine learning to spatiotemporal and kinetic gait parameters to identify digital biomarkers that differentiate people with and without prior fractures and to build risk profiles for prospective fractures. The protocol is non-interventional and aims to move bone health management from reactive to proactive by improving fracture risk prediction.
Why it matters
Potential benefit: If successful, this could enable earlier detection of fracture risk so clinicians can take steps to protect bone health before fractures occur.
How similar studies have gone: Wearable gait sensors and machine-learning approaches have shown promise in other neuromuscular and bone-health research, but applying these digital biomarkers specifically to SMA remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of 5qSMA * Between 8 and 50 years of age * Able to walk 10 meters without support or an assistive device * All participants who meet the inclusion criteria regardless of treatment status will be included, including those on adjuvant therapies, whether investigational or approved Exclusion Criteria: * Injury or surgery within previous 3 months that would impact ability to perform in-clinic gait assessments * Unwilling or unable to comply with all study procedures * Age less than 8 or over 50 years
Where it's running
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Columbia University Irving Medical Center
New York, New York, United States Recruiting
Study contacts
- Study coordinator: Cara Kanner, PT, DPT, EdD
- Email: chy2112@cumc.columbia.edu
- Phone: 516-581-8150
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Apitegromab for infants under 2 with spinal muscular atrophy
This trial will test whether adding apitegromab to approved SMA therapy helps infants under 2 with 5q SMA reach better motor milestones.
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Identifying walking-related digital biomarkers in rare childhood neuromuscular disorders
This study is testing if special insoles with sensors can help track walking patterns in kids with spinal muscular atrophy or Duchenne muscular dystrophy to better understand their mobility.
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Gene therapy for treating spinal muscular atrophy type 3
This study is testing a new gene therapy for people with spinal muscular atrophy type 3 to see if it is safe and helps improve their movement over time.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.