Establishing Walking-related Digital Biomarkers in Rare Childhood Onset Progressive Neuromuscular Disorders
NCT ID: NCT06839469
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
106 participants
OBSERVATIONAL
2024-05-01
2028-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Spinal Muscular Atrophy
Ambulatory children and adults at least 5 years old by the time of enrollment with genetically confirmed SMA.
No interventions assigned to this group
Duchenne Muscular Dystrophy
Ambulatory children and adults ages at least 5 years old by the time of enrollment with genetically confirmed Duchenne or Becker muscular dystrophy or evidence on muscle biopsy with a clinical presentation consistent with DMD/BMD.
No interventions assigned to this group
Healthy Control
The healthy control group will be ambulatory children and adults at least 5 years of age, age- and gender-matched to the SMA and DMD groups as best as possible.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Able to walk independently at least 25 meters
* Ongoing corticosteroids therapy or initiation of corticosteroid therapy in the previous 3 months for DMD
* Stable dose of FDA approved SMN up-regulator therapy or in an open-label extension phase of a study treatment for at least 6 months for SMA or gene replacement at enrollment for SMA or DMD participants.
Exclusion Criteria
* Use investigational medications intended for treatment of NMD within 30 days
* Prior to study entry had an injury or surgery that would impact gait within the previous 3 months
5 Years
ALL
Yes
Sponsors
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Stevens Institute of Technology
OTHER
Stanford University
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Boston Children's Hospital, Boston, MA, USA
OTHER
Columbia University
OTHER
Responsible Party
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Jacqueline Montes
Principal Investigator
Locations
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Stanford University
Palo Alto, California, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Columbia University Irving Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AAAU9807
Identifier Type: -
Identifier Source: org_study_id
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