Wearable Technology to Assess Gait Function in SMA and DMD

Columbia University

Status: Completed

Conditions: Spinal Muscular Atrophy Type 3; Duchenne Muscular Dystrophy

Treatments: Other: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT04193085

AAAS5641

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

39 participants in 3 patient groups

Spinal Muscular Atrophy (SMA)

Description:

ambulatory children and adults at least 5 years old by the time of enrollment with genetically confirmed SMA

Treatment:

Other: Observational

Duchenne / Becker Muscular Dystrophy (DMD/BMD)

Description:

ambulatory children and adults ages at least 5 years old by the time of enrollment with genetically confirmed Duchenne or Becker muscular dystrophy or evidence on muscle biopsy with a clinical presentation consistent with DMD /BMD.

Treatment:

Other: Observational

Healthy Control

Description:

The healthy control group will be age and gender-matched to the SMA and DMD groups as best as possible

Treatment:

Other: Observational