Wearable Technology to Assess Gait Function in Spinal Muscle Atrophy and Duchenne Muscular Dystrophy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Muscular Atrophy Type 3
- Sponsor
- Columbia University
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Validation of Instrumented Insoles: Circle Walking
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Jacqueline Montes
Assistant Professor of Rehabilitation and Regenerative Medicine , Rehab & Regenerative Med PT
Columbia University
Eligibility 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.
Outcomes
Primary Outcomes
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.
Muscle Strength Testing with Hand-held Dynamometry (HHD)
Time Frame: Baseline
HHD is used to assess strength of selected muscles.
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.
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.
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.
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.
Secondary Outcomes
- Free-living Testing of Instrumented Insoles(One week)