An interventional study of wearable sensors in Spinal Amyotrophy, sponsored by Centre Hospitalier Universitaire de Liege. Recruiting at 1 site in Belgium. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Centre Hospitalier Universitaire de Liege · Not applicable, Interventional, and Diagnostic
Spinal muscular atrophy (SMA) is a rare neuromuscular disease causing progressive muscle weakness related to degeneration of motor neurons. With the arrival of new treatments, the natural history of SMA is changing significantly, and treatments in adults have been associated with disease stabilization and a reduction in fatigue. However, functional assessment of adult patients remains difficult: their motor performance is highly fluctuating and hospital-based tests incompletely capture these daily variations.
Wearable devices, such as Syde®, now allow continuous monitoring in real life. The Syde® device, already used in Duchenne muscular dystrophy, provides digital measures describing gait and overall motor activity. However, no fully validated digital measure currently exists in adults with SMA.
The SMAdult study aims to address this gap through a precise, longitudinal, and fully decentralized follow-up of adults with SMA.
Objectives
Methodology Study type Academic, monocentric, prospective, fully decentralized study. Total duration: 36 months (24 months of inclusion, and between 12 and 30 months of follow-up).
Target population 60 adults aged over 15 years with genetically confirmed SMA. With a minimum of 20 ambulatory patients and 20 non-ambulatory patients.
On stable treatment for more than 1 year.
Procedure:
Benefits and risks
Ethical aspects
This clinical study aims to evaluate motor function in adolescents aged 15 years and older and adults with spinal muscular atrophy (SMA). The objective is to identify and quantify motor impairments associated with different forms of the disease. No direct clinical benefit is expected for participants.
SMA is a rare neuromuscular disorder characterized by progressive muscle weakness due to degeneration of motor neurons. With the advent of disease-modifying therapies, the natural history of SMA is changing significantly. In adults, treatment has been associated with disease stabilization and reduced fatigue. However, functional assessment in adult patients remains challenging, as motor performance is highly variable and standard hospital-based evaluations do not fully capture daily fluctuations.
Wearable devices, such as the Syde® system, now enable continuous real-world monitoring. The Syde® device, already used in Duchenne muscular dystrophy, provides digital measures of gait and overall motor activity. However, no fully validated digital outcome measures are currently available in adults with SMA.
The SMAdult study aims to address this gap through a precise, longitudinal, and fully decentralized follow-up of individuals with SMA.
This is an academic, monocentric, prospective, fully decentralized study with an overall duration of 36 months, including a 24-month inclusion period and 12 to 30 months of follow-up.
The study will include approximately 60 participants aged 15 years and older with genetically confirmed SMA, including a minimum of 20 ambulatory and 20 non-ambulatory participants. All participants must have been on a stable treatment regimen for more than one year and must not be enrolled in a therapeutic clinical trial.
Remote inclusion is performed using electronic informed consent. Follow-up assessments are conducted every six months via secure videoconference and electronic questionnaires. Participants use a connected wearable device (Syde®) at home to continuously collect motor activity data during defined recording periods. No hospital visits are required.
Data collected include motor activity parameters, routine clinical information, validated questionnaires (including swallowing and quality of life assessments), and patient-reported outcomes regarding disease perception and progression. Clinical data are complemented by standardized reports and genetic confirmation collected through a secure electronic platform.
As part of regulatory requirements, information on ethnic background is collected to allow stratified analyses across population groups. These data are pseudonymized, treated confidentially, and used exclusively for research purposes. Participation in this component is optional and does not affect study participation or clinical care.
The Syde® system consists of two wearable sensors, a docking station for data transfer and charging, and dedicated analysis software. The device records three-dimensional movement in daily life in a non-invasive manner. Recording periods include an initial four-week phase for reliability assessment, followed by repeated four-week monitoring periods every six months.
The study is conducted in accordance with Good Clinical Practice (GCP), applicable ethical regulations, and GDPR requirements. Data are pseudonymized and securely stored. The study is sponsored by CHU de Liège, with appropriate insurance coverage.
295 studies on the registry are indexed under Muscular Atrophy, Spinal; 77 are open to participants now.
This study's planned enrollment of 60 is above the median of 27 across 165 interventional studies indexed under Muscular Atrophy, Spinal.
Browse Muscular Atrophy, Spinal studies →Centre Hospitalier Universitaire de Liege is the lead sponsor of 40 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: wearable sensors
Syde® wearable devices will be shipped directly to participants' homes. Each participant will wear two sensors, using the "ankle-wrist" configuration for both ambulant and non-ambulant individuals. Initial recording period: continuous wear for 4 weeks Longitudinal follow-up: continuous wear for 4 weeks every 6 months Participants will receive detailed instructions and remote technical support if needed.
Device usage (recording time)
Total recording time per recording period (hours)
Time frame: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Patient compliance (Min)
Percentage of participants achieving minimal threshold (expected 50h) of recording time per period
Time frame: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Patient compliance (Max)
Percentage of participants achieving optimal threshold (expected 180h) of recording time per period
Time frame: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24, month 30, Month 36
Reliability
Intraclass Correlation Coefficient (ICC) for two distinct consecutive half-periods
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Clinical validity of digital outcome vs functional scale scores.
Correlation between digital outcomes and functional scale scores obtained from the functional assessments available for each patient during follow-up, including the Hammersmith Functional Motor Scale - Expanded (HFMSE; 0-66, higher scores indicate better motor function), Revised Upper Limb Module (RULM; 0-37, higher scores indicate better upper limb function), 4-Stair Climb (4SC; time in seconds, lower times indicate better functional performance), Brooke Upper Extremity Functional Rating Scale (1-6, lower scores indicate better upper limb function), Hammersmith Functional Motor Scale - Short Module (Hammersmith Short Module; \[score range\], higher scores indicate better motor function), and Motor Function Measure - 32 items (MFM-32; 0-96, higher scores indicate better motor function). Only functional scales available for a given patient will be included in the correlation analyses.
Time frame: Day 1, 1 year, 2 years
Syde® digital motor outcomes according to SMN2 copy number and patient/control group.
Comparison of digital motor outcomes assessed using the Syde® system between SMA participants with different SMN2 copy numbers and ACTI-CONTROL participants.
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Changes in digital motor outcomes assessed using the Syde® system from baseline to each follow-up assessment.
Change from baseline in digital motor outcome measurements assessed using the Syde® system at Month 6, Month 12, Month 18, Month 24, Month 30 and Month 36. Multiple parameters generated by the Syde® system will be analysed and reported separately, where applicable.
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Longitudinal analysis of digital motor outcomes assessed using the Syde® system.
Analysis of changes in digital motor outcome measurements assessed using the Syde® system across follow-up assessments to characterize disease progression, stabilization, or improvement over time.
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Patient perception of disease progression.
Assessment of patient-perceived disease progression, including changes in mobility, functional capacity, and disease stability, using qualitative interviews and the Patient Global Impression of Change (PGI-C). Results will be compared with digital motor outcomes assessed using the Syde® system to evaluate concordance between patient perceptions and digital biomarkers.
Time frame: 1 day, 1 year, 2 years
Qualitative data on swallowing and its association with different genotypes.
DHI or other validated bulbar tests (cf appendix), and correlation with other parameters (genotype and treatment)
Time frame: 1 day, 1 year, 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Mar 2028, 20 months after the start.
Of 51 non-industry interventional studies with no phase under Muscular Atrophy, Spinal, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 51. This study's planned 20 months is below that.
Counting every sponsor, half of 60 studies reached it within 26 months; a quarter within 17 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre Hospitalier Universitaire de Liege