Wearable Technology to Assess Gait Function in SMA and DMD (NCT04193085) | Clinical Trial Compass
CompletedNot Applicable
Wearable Technology to Assess Gait Function in SMA and DMD
United States39 participantsStarted 2019-11-25
Plain-language 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.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. One of the following categories:
. Able to walk independently at least 25 meters
Exclusion criteria
. Unable to walk 25 meters independently.
. Use of investigational medications intended for the treatment of SMA or DMD/BMD within 30 days prior to study entry.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Validation of Instrumented Insoles: Six Minute Walk Test
Timeframe: Baseline
2
Validation of Instrumented Insoles: 10 Meter Walk/Run
Timeframe: Baseline
3
Validation of Instrumented Insoles: Time Up and Go Test (TUG)
Timeframe: Baseline
4
Validation of Instrumented Insoles: Straight Line Walking
Timeframe: Baseline
5
Validation of Instrumented Insoles: Circle Walking
Timeframe: Baseline
6
Muscle Strength Testing with Hand-held Dynamometry (HHD)