Actively Recruiting
Identification of Gait-related Digital Biomarkers of Bone Health in Spinal Muscular Atrophy
Led by Jacqueline Montes · Updated on 2026-03-18
22
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Jacqueline Montes
Lead Sponsor
B
Biogen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how walking patterns relate to bone health in people with spinal muscular atrophy (SMA) who are receiving disease-modifying treatments (DMT). The study aims to understand if gait characteristics can indicate bone density and predict fracture risk in this group. This observational study focuses on ambulatory children and adults with SMA and uses advanced wearable technology along with machine learning to identify digital markers linked to bone health and fracture risk. Participants will have one in-clinic visit lasting about three hours, during which various non-interventional assessments will be conducted. These include measuring bone density with Dual X-Ray Absorptiometry (DXA), blood collection, gait analysis using instrumented insoles, and physical function tests like the Six Minute Walk Test. After the initial visit, participants will have remote follow-up visits every three months for one year to collect fracture and medical history. During the study, researchers will gather data on fractures, falls, and gait parameters, as well as physical activity levels using questionnaires. The main outcomes involve assessing bone density and fracture history over time. This study does not involve any treatment or change to standard care, and participants' bone health will be monitored through these detailed assessments across the one-year follow-up period.
CONDITIONS
Brief Title
Gait and Bone Health in SMA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of 5q spinal muscular atrophy (SMA)
- Age between 8 and 50 years
- Able to walk 10 meters without support or an assistive device
- Participants on any treatment status, including investigational or approved therapies, are eligible
You will not qualify if you...
- Injury or surgery within the previous 3 months that affects ability to perform gait assessments
- Unwilling or unable to comply with all study procedures
- Age less than 8 years or over 50 years
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 undergo baseline assessments including gait analysis, bone density scans, blood collection, and functional walking tests to identify digital biomarkers related to bone health.
1 visit (in-person)
Duration - 12 months
Participants are observed over one year to track fracture and fall history and assess risk profiles using digital biomarkers.
Visits at baseline, 3, 6, 9, and 12 months (in-person or remote depending on assessment)
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
C
Cara Kanner, PT, DPT, EdD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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