Wearable Technology to Assess Gait Function in SMA and DMD

Duchenne Muscular Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193085
• Other study ID #: AAAS5641
• Status: Completed
• Start date: November 25, 2019
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Able to walk independently at least 25 meters

Exclusion Criteria:

1. Unable to walk 25 meters independently.

2. Use of investigational medications intended for the treatment of SMA or DMD/BMD within 30 days prior to study entry.

Related Conditions & MeSH terms

• Atrophy
• Duchenne Muscular Dystrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Spinal Muscular Atrophy Type 3

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Muscular Dystrophy Association, Stevens Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Muscle Strength Testing with Hand-held Dynamometry (HHD)	HHD is used to assess strength of selected muscles.	Baseline
Secondary	Free-living Testing of Instrumented Insoles	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.	One week