International Federated Wearable Motor Monitoring in Young Children With Spinal Muscular Atrophy: Active-NBS Study
Summary
NIH registered NCT07543003, an international observational study evaluating wearable-derived remote motor monitoring in young children with spinal muscular atrophy (SMA). The study will recruit up to 60 SMA patients and 30 healthy controls over a maximum of 30 months using the Syde and MAIJU wearable devices worn at home, without additional hospital visits. The federated data model enables collaborative sites across the UK and internationally to collect harmonised motor development data.
“The investigators will track the progress of up to 60 patients over a maximum of 30 months using wearable technologies which are worn at home.”
What changed
NIH registered a new observational clinical trial (NCT07543003) on ClinicalTrials.gov describing a protocol to evaluate wearable-derived remote longitudinal motor monitoring in young children with spinal muscular atrophy versus healthy controls. The study uses the Syde and MAIJU devices worn at home at regular intervals over up to 30 months, with no additional hospital visits required.
Affected parties — clinical investigators, healthcare providers, and public health authorities involved in SMA care — may encounter federated data-sharing protocols under this study design. The study does not create new compliance obligations but documents a methodology that may influence future decentralised clinical monitoring approaches for neuromuscular conditions.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
An International Federated Model for Wearable-derived Remote Longitudinal Motor Monitoring in Young Children With Spinal Muscular Atrophy Compared With Healthy Controls: Active-NBS Study (UK)
Observational NCT07543003 Kind: OBSERVATIONAL Apr 21, 2026
Abstract
Active-NBS is a study to evaluate the muscle development of patients with spinal muscular atrophy (SMA) who are diagnosed at birth.
Medicines have become available in the last decade, and many patients are treated very early. Treatments are most effective if used before the patient develops symptoms. However, some patients may show symptoms by the time they receive treatment. This means that even with early diagnosis, they might still develop muscle weakness despite treatment. The investigators want to see when the movements of patients diagnosed at birth differ from normal development. This information will help identify the best time to give additional medicines currently being developed to support the muscle.
The investigators will track the progress of up to 60 patients over a maximum of 30 months using wearable technologies which are worn at home. The investigators aim to validate their outcomes for use in this age group. The wearable devices are called Syde and Motor Assessment of an Infant in a Jumpsuit (MAIJU).
They will be worn at regular intervals during the study and will not involve extra hospital visits for patients. The study will also recruit up to 30 healthy control participants and follow them for up to 30 months. This will help define normal development with use of the Syde device.
Active-NBS will be conducted in the UK and internationally using a federated data model. Collaborative sites will collect harmonised data in accordance with the Active-NBS ...
Conditions: Spinal Muscular Atrophy (SMA)
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.