Wearable Technology to Assess Gait Function in SMA and DMD

Completed

• Conditions: Duchenne Muscular Dystrophy; Spinal Muscular Atrophy Type 3
• Interventions: Other: Observational

• Registration Number: NCT04193085
• Lead Sponsor: Columbia University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-11
• Study Start: 2019-11-25
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spinal Muscular Atrophy (SMA)	Observational	ambulatory children and adults at least 5 years old by the time of enrollment with genetically confirmed SMA
Duchenne / Becker Muscular Dystrophy (DMD/BMD)	Observational	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.
Healthy Control	Observational	The healthy control group will be age and gender-matched to the SMA and DMD groups as best as possible

Primary Outcome Measures

Name	Time	Method
Validation of Instrumented Insoles: Circle Walking	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)	Baseline	HHD is used to assess strength of selected muscles.
Validation of Instrumented Insoles: Six Minute Walk Test	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	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)	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	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 Outcome Measures

Name	Time	Method
Free-living Testing of Instrumented Insoles	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States