Duchenne Muscular Dystrophy Clinical Trial
Official title:
Wearable Technology to Assess Gait Function in Spinal Muscle Atrophy and Duchenne Muscular Dystrophy
NCT number | NCT04193085 |
Other study ID # | AAAS5641 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 25, 2019 |
Est. completion date | August 31, 2023 |
Verified date | February 2024 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Muscular Dystrophy Association, Stevens Institute of Technology |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05575648 -
Dual Task in Duchenne Muscular Dystrophy
|
N/A | |
Terminated |
NCT03907072 -
Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06450639 -
An Open-label Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy
|
Phase 2 | |
Completed |
NCT04335942 -
Characterization of the Postural Habits of Wheelchair Users Analysis of the Acceptability of International Recommendations in the Prevention of Pressure Sores Risk by Using a Connected Textile Sensor
|
N/A | |
Active, not recruiting |
NCT04906460 -
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02500381 -
Study of SRP-4045 (Casimersen) and SRP-4053 (Golodirsen) in Participants With Duchenne Muscular Dystrophy (DMD)
|
Phase 3 | |
Enrolling by invitation |
NCT05967351 -
A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study
|
Phase 3 | |
Recruiting |
NCT03067831 -
Bone Marrow-Derived Autologous Stem Cells for the Treatment of Duchenne Muscular Dystrophy
|
Phase 1/Phase 2 | |
Recruiting |
NCT01834040 -
Study Safety and Efficacy of BMMNC for the Patient With Duchenne Muscular Dystrophy
|
Phase 1/Phase 2 | |
Completed |
NCT02246478 -
A Study of TAS-205 for Duchenne Muscular Dystrophy
|
Phase 1 | |
Active, not recruiting |
NCT01772043 -
Duchenne Muscular Dystrophy Tissue Bank for Exon Skipping
|
N/A | |
Terminated |
NCT01168908 -
Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy
|
Phase 2 | |
Completed |
NCT00758225 -
Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension)
|
Phase 2 | |
Completed |
NCT03680365 -
Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families
|
||
Recruiting |
NCT03513367 -
The Validation Process for Confirmation of the French Version of the Pediatric Quality of Life Inventory :PedsQLTM.
|
||
Recruiting |
NCT05712447 -
Duchenne Muscular Dystrophy Video Assessment Registry
|
||
Recruiting |
NCT01484678 -
Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy
|
||
Completed |
NCT03319030 -
Aerobic Exercise in Boys With Duchenne Muscular Dystrophy (DMD)
|
||
Terminated |
NCT01753804 -
A Prospective Natural History Study of Progression of Subjects With Duchenne Muscular Dystrophy.
|
N/A | |
Completed |
NCT02530905 -
Dose-Titration and Open-label Extension Study of SRP-4045 in Advanced Stage Duchenne Muscular Dystrophy (DMD) Patients
|
Phase 1 |