Linking walking patterns to bone strength in ambulatory SMA
Identification of Gait-related Digital Biomarkers of Bone Health in Spinal Muscular Atrophy
Columbia University · NCT07400198
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 |
|---|---|
| Enrollment | 22 (estimated) |
| Ages | 8 Years to 50 Years |
| Sex | All |
| Sponsor | Columbia University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07400198 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Muscular Atrophy Type 3, Ambulatory Spinal Muscular Atrophy, spinal muscular atrophy, SMA, instrumented insole, bone health, fracture, bone mineral density