Digital Monitoring of Upper Limb Function in Non-Ambulant DMD (NCT07664124) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Digital Monitoring of Upper Limb Function in Non-Ambulant DMD
Belgium50 participantsStarted 2026-07-30
Plain-language summary
Duchenne Muscular Dystrophy (DMD) is a rare genetic disorder caused by the absence of dystrophin, leading to progressive muscle degeneration. Symptoms typically begin in early childhood and result in loss of ambulation by early adolescence, followed by cardiorespiratory complications. Although early treatment, including corticosteroids and emerging therapies, can slow disease progression, sensitive tools to monitor functional decline-particularly in non-ambulant patients-remain limited.
Current assessments rely primarily on clinical scales and hospital-based evaluations, which may not detect subtle changes or reflect real-life function. Digital outcome measures derived from wearable sensors offer a promising approach for continuous, objective monitoring in daily life. This study aims to evaluate the feasibility, reliability, clinical validity, and sensitivity of digital measures to assess upper limb function in non-ambulant patients with genetically confirmed DMD. The Syde device, previously validated in ambulant DMD patients, will be investigated for its applicability in this population.
Who can participate
Sex
MALE
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:
* Patient with genetically confirmed Duchenne Muscular Dystrophy (DMD).
* Non-ambulant at the time of inclusion (not able to walk 10m without external aid).
* A legal guardian willing and able to provide written informed consent for participation in the study if \< 18 years old.
Exclusion Criteria:
* Any acute or chronic condition that, in the opinion of the investigator, may significantly interfere with the assessments and/or motor function progression.
* Participation in an interventional clinical trial.
* No access to internet connection or alternatively no capacity to come on-site to bring the Syde every 6 months after the recording periods for data retrieval by Liège team
* Scoliosis surgery within the previous 6 months or planned within the next year
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
Device usage (recording time)
Timeframe: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24
2
Patient compliance (Min)
Timeframe: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24
3
Patient compliance (Max)
Timeframe: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24