Gait and Bone Health in SMA

Study Identifier:
AAAV3667
ClinicalTrials.gov Identifier:
NCT07400198
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
Jacqueline Montes
Recruiting

Study Details

Medical Condition
  • Spinal Muscular Atrophy Type III
Study Drug
    Date
    Mar 2026 - Jun 2027
    Patient Requirements
    Sex: Female & Male
    Age: 8 - 50 Years
    Requirements Information
    Inclusion and 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

    Protocol Summary

    The objective of this study is to understand how spatiotemporal and kinetic gait parameters are associated with bone health in pwSMA who are receiving DMT. We hypothesize that gait parameters are associated with BMD and can determine fracture risk in pwSMA. This is an observational study that involves one in-clinic visit (approximately 3 hours) with remote follow-up visits (approximately 15 minutes) every 3 months for 1 year to collect fracture and medical history. Each of the assessments included in this study are non-interventional and are not intended as a treatment nor are they at the level of standard of care.

    Trial Locations

    Location
    Status
    Location
    Columbia University Irving Medical Center
    New York, New York, United States, 10032
    Status
    Recruiting

    Contact Cure SMA

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