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NCT Number: NCT04193085

Wearable Technology to Assess Gait Function in SMA and DMD

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.

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Key information

Conditions

Spinal Muscular Atrophy Type 3 Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Duchenne Muscular Dystrophy Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Motor Neuron Disease Muscular Atrophy, Spinal Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases Spinal Muscular Atrophies of Childhood

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

Spinal muscular atrophy (SMA) and Duchenne muscular dystrophy (DMD) are genetic disorders that often result in progressive weakness and impaired function. Results from this study will help characterize how gait is affected in SMA and DMD. This novel device can serve as a more affordable and versatile measurement instrument for neuromuscular disorders that affect gait and balance. All participants will be observed and measured while wearing the instrumented insoles in the lab and in real-life environments.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Other

Observational

Primary outcomes

  1. Validation of Instrumented Insoles: Six Minute Walk Test

    Time frame: Baseline

    To measure spatial parameters, kinetic parameters, temporal parameters, and metrics of cumulative activity in order to compare against the gold standard instrumented walkway participants will complete the Six Minute Walk Test. This test is an objective evaluation of functional exercise capacity, measures the maximum distance a person can walk in six minutes over a 25 meter course. This will be performed in a corridor and include the instrumented walkway.

  2. Validation of Instrumented Insoles: 10 Meter Walk/Run

    Time frame: Baseline

    To measure spatial parameters, kinetic parameters, temporal parameters, and metrics of cumulative activity in order to compare against the gold standard instrumented walkway, participants will walk, or run if able to, for 10 meters on the instrumented walkway.

  3. Validation of Instrumented Insoles: Time Up and Go Test (TUG)

    Time frame: Baseline

    To measure spatial parameters, kinetic parameters, temporal parameters, and metrics of cumulative activity in order to compare against the gold standard instrumented walkway, participants will complete the TUG test. This test is designed to test mobility after a person stands up from a seated position. This will be completed on the instrumented walkway.

  4. Validation of Instrumented Insoles: Straight Line Walking

    Time frame: Baseline

    To measure spatial parameters, kinetic parameters, temporal parameters, and metrics of cumulative activity in order to compare against the gold standard instrumented walkway, participants will be asked to walk in a straight line multiple times over the instrumented walkway.

  5. Validation of Instrumented Insoles: Circle Walking

    Time frame: Baseline

    To measure spatial parameters, kinetic parameters, temporal parameters, and metrics of cumulative activity in order to compare against the gold standard instrumented walkway participants will be asked to walk a series of half-circles on the instrumented walkway.

  6. Muscle Strength Testing with Hand-held Dynamometry (HHD)

    Time frame: Baseline

    HHD is used to assess strength of selected muscles.

Secondary outcomes

  1. Free-living Testing of Instrumented Insoles

    Time frame: One week

    To determine spatial parameters, kinetic parameters, temporal parameters, and metrics of cumulative activity using instrumented insoles, 5 participants with SMA, 5 participants with DMD, and 5 healthy controls will be asked to wear the insoles along with a validated activity tracker. Participants will be asked to wear the insoles during a visit to the lab, and then for one week at home in a real-life environment. Participants will be asked to wear the insoles and activity tracker for at least 4 hours per day when at home.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Muscular Dystrophy Association
  • Stevens Institute of Technology

Registry information

Official study title

Wearable Technology to Assess Gait Function in Spinal Muscle Atrophy and Duchenne Muscular Dystrophy

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2019
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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