Wearable Technology to Assess Gait Function in SMA and DMD

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

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.

Study Overview

• Status: Completed
• Conditions: Duchenne Muscular Dystrophy; Spinal Muscular Atrophy Type 3

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.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

• Study Contact: Name: David Uher, MS; Phone Number: 2123058916; Email: dtu2102@cumc.columbia.edu
• Study Contact Backup: Name: Jacqueline Montes, PT, EdD; Phone Number: 2123058916; Email: jm598@columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study sample will include 13 ambulatory SMA participants, 13 ambulatory DMD participants, and 13 healthy controls.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Muscular Dystrophy Association; Stevens Institute of Technology
• Investigators: Principal Investigator: Jacqueline Montes, PT, EdD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: wearable; Duchenne Muscular Dystrophy; DMD; ambulatory; gait analysis; Spinal Muscular Atrophy; SMA; neuromuscular disease; six minute walk test; instrumented insole; machine learning model; stride; foot-worn
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Cord Diseases; Muscular Disorders, Atrophic; Motor Neuron Disease; Muscular Dystrophies; Muscular Atrophy; Atrophy; Muscular Dystrophy, Duchenne; Muscular Atrophy, Spinal
• Other Study ID Numbers: AAAS5641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No