Wearable Technology to Assess Gait Function in SMA and DMD

Study Identifier:
AAAS5641
ClinicalTrials.gov Identifier:
NCT04193085
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
Columbia University
Study Complete

Study Details

Medical Condition
  • Spinal Muscular Atrophy Type III
  • All Spinal Muscular Atrophies
Study Drug
    Date
    Nov 2019 - Aug 2023
    Patient Requirements
    Sex: Female & Male
    Age: 5+ years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • One of the following categories:
    • Genetic confirmation of spinal muscular atrophy
    • Genetic confirmation of Duchenne or Becker muscular dystrophy or evidence on muscle biopsy with a clinical presentation consistent with DMD/BMD
    • Healthy individuals.
    • Able to walk independently at least 25 meters
    Exclusion Criteria
    • Unable to walk 25 meters independently.
    • Use of investigational medications intended for the treatment of SMA or DMD/BMD within 30 days prior to study entry.

    Protocol Summary

    The purpose of this project is to devise instrumented insoles capable of accurately measuring gait at each footfall, over multiple hours in any environment. To achieve high accuracy, the investigators will develop a new learning-based calibration framework. Features will be tested in controlled lab settings 39 during a single visit in people with SMA (13), DMD (13) and healthy controls (13) and in 15 participants in real-life environments.

    Trial Locations

    Location
    Status
    Location
    Columbia University Medical Center
    New York, New York, United States, 10032
    Status
    N/A

    Contact Cure SMA

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