Establishing Walking-related Digital Biomarkers in Rare Childhood Onset Progressive Neuromuscular Disorders
Sponsor: Columbia University
Trial Details
| Condition | Spinal Muscular Atrophy Type 3, Duchenne Muscular Dystrophy (DMD) |
| Status | Recruiting |
| Participants | 106 |
| Est. Completion | 30 Dec 2027 |
| Last Updated | 9 Apr 2026 |
Primary Outcome
Six Minute Walk Test; 10 Meter Walk/Run; Time Up and Go Test (TUG); Muscle Strength Testing with Hand-held Dynamometry (HHD); 30 Second Sit to Stand Test (30STS); Ankle Range of Motion; Knee Extension Range of Motion; Hip Extension Range of Motion
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * Genetic confirmation of disease (DMD, SMA) or healthy control * 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 foot orthoses or assistive devices for community ambulation or a mobility device for community navigation * 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
Trial Sites
Countries
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