Wearable Technology to Assess Gait Function in SMA and DMD

study id #: NCT04193085

condition: Spinal Muscular Atrophy Type 3, Duchenne Muscular Dystrophy

status: Recruiting

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.

results: https://clinicaltrials.gov/ct2/show/results/NCT04193085

last updated: February 04, 2022

start date: November 25, 2019

estimated completion: August 1, 2022

last updated: January 26, 2021

size / enrollment: 39

study description: 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.

primary outcomes:

• Validation of Instrumented Insoles: Six Minute Walk Test
  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.
• Baseline
  Validation of Instrumented Insoles: 10 Meter Walk/Run
  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.
• Baseline
  Validation of Instrumented Insoles: Time Up and Go Test (TUG)
  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.
• Baseline
  Validation of Instrumented Insoles: Straight Line Walking
  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.
• Baseline
  Validation of Instrumented Insoles: Circle Walking
  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.
• Baseline
  Muscle Strength Testing with Hand-held Dynamometry (HHD)
  HHD is used to assess strength of selected muscles.
• Baseline
  

secondary outcomes:

• Free-living Testing of Instrumented Insoles
  One week

inclusion criteria:

exclusion criteria: 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.

sponsor: Columbia University

contacts: David Uher, MS, 2123058916, [email protected]

investigators: Jacqueline Montes, PT, EdD,Columbia University

trial center locations: United States

• Wearable Technology to Assess Gait Function in SMA and DMD
  Jacqueline Montes, PT, EdD, 212-305-8916, [email protected]