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Wearable Technology to Assess Gait Function in SMA and DMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193085
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : December 11, 2019
Sponsor:
Collaborators:
Muscular Dystrophy Association
Stevens Institute of Technology
Information provided by (Responsible Party):
Jacqueline Montes, 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.

Condition or disease
Spinal Muscular Atrophy Type 3 Duchenne Muscular Dystrophy

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.

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Study Type : Observational
Estimated Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wearable Technology to Assess Gait Function in Spinal Muscle Atrophy and Duchenne Muscular Dystrophy
Actual Study Start Date : November 25, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Muscle Strength Testing with Hand-held Dynamometry (HHD) [ Time Frame: Baseline ]
    HHD is used to assess strength of selected muscles.


Secondary Outcome Measures :
  1. Free-living Testing of Instrumented Insoles [ Time Frame: 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.



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193085


Contacts
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Contact: David Uher, MS 2123058916 dtu2102@cumc.columbia.edu
Contact: Jacqueline Montes, PT, EdD 2123058916 jm598@columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Jacqueline Montes, PT, EdD    212-305-8916    jm598@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Muscular Dystrophy Association
Stevens Institute of Technology
Investigators
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Principal Investigator: Jacqueline Montes, PT, EdD Columbia University
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Responsible Party: Jacqueline Montes, Assistant Professor of Rehabilitation and Regenerative Medicine , Rehab & Regenerative Med PT, Columbia University
ClinicalTrials.gov Identifier: NCT04193085    
Other Study ID Numbers: AAAS5641
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacqueline Montes, Columbia University:
Spinal Muscular Atrophy
SMA
Duchenne Muscular Dystrophy
DMD
instrumented insole
neuromuscular disease
six minute walk test
machine learning model
gait analysis
wearable
ambulatory
stride
foot-worn
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Atrophy
Muscular Atrophy, Spinal
Atrophy
Pathological Conditions, Anatomical
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Neuromuscular Manifestations
Neurologic Manifestations
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases