Actively Recruiting

Age: 5Years +
All Genders
Healthy Volunteers
NCT06839469

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

204 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

The purpose of this research is (1) to identify disease specific walking-related digital biomarkers of disease severity, and (2) monitor longitudinal changes in natural environments, for extended periods of time, in DMD and SMA.

CONDITIONS

Official Title

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

Who Can Participate

Age: 5Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Genetic confirmation of Duchenne muscular dystrophy, spinal muscular atrophy type 3, or healthy control status
  • Ability to walk independently for at least 25 meters
  • For Duchenne muscular dystrophy: ongoing corticosteroid therapy or started corticosteroid therapy within the previous 3 months
  • For spinal muscular atrophy: stable dose of FDA approved SMN up-regulator therapy or participation in an open-label extension phase of a study treatment for at least 6 months, or gene replacement therapy at enrollment
Not Eligible

You will not qualify if you...

  • Use of foot orthoses or assistive devices for walking in the community, or use of mobility devices for navigation
  • Use of investigational medications intended to treat neuromuscular diseases within 30 days before study entry
  • Injury or surgery affecting gait within 3 months prior to study entry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

J

Jacqueline Montes, PT, EdD

CONTACT

C

Cara Kanner, DPT

CONTACT

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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