ClinicalTrials.gov record NCT07136844
Gait Analysis Parameter and Upper Limb Evaluation in Adult Patients With Neurological or Metabolic Pathology
Gait Analysis Parameter and Upper Limb Evaluation in Adult Patients With Neurological or Metabolic Pathology
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This study plans to enroll about 300 ambulant adults with neurological or metabolic conditions that affect movement. Participants will wear the Syde® wrist/ankle device at home and attend clinic visits every six months for standardized walking and upper-limb tests, up to two years (six months for some neuromuscular junction conditions). The main aim is to evaluate a digital walking measure (the 95th centile of stride velocity, SV95C) and compare wearable data with routine clinical tests.
What it is studying. Whether continuous data from the Syde® wearable (including the SV95C stride-velocity metric) can serve as objective digital mobility endpoints, how the device performs in real life (acceptability and adherence), and how wearable measures correlate with standard clinical walking and upper-limb tests.
What the researchers hope to learn. Generate real-world data to support development of objective digital endpoints for future clinical trials; evaluate SV95C as a candidate digital mobility outcome; assess device acceptability, adherence, and correlations with standard clinical tests.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The ActiLiège-Adult study is a prospective, longitudinal, observational study designed to collect natural history data on adult patients with neurological or metabolic diseases affecting movement. Conducted at the Centre de Référence Liégeois des Maladies Neuromusculaires in Liège, Belgium, the study will enroll 300 ambulant patients, including individuals with neuromuscular disorders and obesity. Using the Syde® wearable device, the study aims to continuously monitor motor function in real-life settings over a period of up to two years. The primary objective is to evaluate the utility of digital mobility outcomes, such as the 95th centile of stride velocity (SV95C), as reliable and objective endpoints for future clinical trials.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Device
- Syde
- Diagnostic test
- Dynamometric measurements of muscle strength
- The 6-minute walk test (6MWT)
- The 10-meter test (10MWT)
- The 4 stair-climbing test (4SC)
- Test of rising from the floor (TRF)
- The Timed up and go test (TUG)
- The Progressive Supranuclear Palsy Rating Scale (PSP-RS)
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Ambulant patients (i.e. able to walk 10 meters without assistance)
- Confirmed diagnosis by the investigator based on current gold standard in his/her disease (genetic testing, clinical criteria, etc.)
- Myotonic dystrophy type 1 (DM1) and Charcot-Marie-Tooth (CMT) patients should present sensitive of motor signs on physical examination.
- Myasthenic patients should be seropositive, and Myasthenia Gravis Foundation of America (MGFA) class II to IV.
- Patient with morbid obesity (Body Mass Index> or = 35 at inclusion visit).
- Signed informed consent form by patient him/herself and patient willing and able to comply with all study procedures.
Exclusion criteria
- Non-ambulant patients
- Patients with extreme cognitive disorders that limit their understanding of the exercises to be performed
- Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the upper or lower limbs
- A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to inclusion
- Patients who are participating in an interventional clinical trial
- Pregnant or breastfeeding women
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Following the qualification of the 95th centile of stride velocity (SV95C) as a primary digital endpoint in Duchenne muscular dystrophy (DMD), there is growing interest in extending such digital assessments to other neurological and metabolic diseases that impair movement. Traditional in-clinic functional tests (e.g., 6-minute walk test, 10-meter walk/run) provide only limited snapshots of motor ability and are influenced by external factors such as motivation and fatigue. Similarly, motor function scales and biomarkers, while useful, often lack objectivity or established clinical relevance. The ActiLiège-Adult study aims to address these limitations by leveraging the Syde® device, a wearable magneto-inertial sensor worn on the wrist and/or ankle, to continuously monitor motor activity in daily life. This device has been previously validated in DMD and other neuromuscular conditions and has been used in both interventional and natural history studies. This academic study will enroll 300 ambulant adult patients, including 220 with neurological diseases and 20 with obesity, with a minimum of 20 patients per disease type. Ambulation is defined as the ability to walk 10 meters unaided. Patients who lose ambulation during the study will continue to be followed with adapted assessments. Participants will be monitored for up to two years (six months for diseases affecting the neuromuscular junction). Standardized clinical assessments-including timed tests, motor function evaluations, and strength measurements-will be conducted at baseline and every six months. These will be compared with continuous data collected by the Syde® device. Additionally, patients will complete a Patient Global Impression of Change (PGI-C) questionnaire every six months. The study's goal is to generate robust, real-world data to support the development of objective, sensitive, and clinically meaningful digital endpoints for use in future therapeutic trials targeting movement disorders.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will wear the Syde device (two watch‑like movement sensors on the wrist and/or ankle) to record motor activity in daily life for up to two years (for diseases affecting the neuromuscular junction the device period is up to six months). They will attend clinic visits at baseline and every six months for standardized functional tests (timed walk tests, stair climb, rising from the floor), strength and upper‑limb assessments, and to complete a Patient Global Impression of Change questionnaire. If a participant loses the ability to walk during the study, they will continue to be followed with adapted assessments. The registry lists no invasive procedures (e.g., spinal tap or biopsies) as part of the study.
How the study is structured. This is a non-randomized, open-label diagnostic study in which participants wear the Syde® sensor at home and attend in-clinic functional tests every six months. Assignment is non-randomized and arranged in parallel groups by disease type. There is no masking (open-label). Follow-up is up to two years for most participants (shorter for some conditions as specified).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in Belgium. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on progressive supranuclear palsy
This trial is also listed on this site under hereditary spastic paraplegia, Pompe disease and spinocerebellar ataxia.
Important dates
- Study start
- Mar 29, 2024
- Primary completion
- December 2029 (estimated)
- Study completion
- December 2030 (estimated)
- Target enrollment
- 300 participants (estimated)
- Last updated on registry
- Aug 22, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Principal investigator
- Laurent Servais, Principal Investigator, Pediatrician
Centre Hospitalier Universitaire de Liege - Collaborators
- Centre Hospitalier Régional de la Citadelle
- SYSNAV
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Nicolas Bovy 📞 +3243218095 ✉ Nicolas.Bovy@citadelle.be
Participating sites (1)
- Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la CitadelleRecruiting
Liège, 4000 · Belgium
- Nicolas Bovy · +3243218095 · Nicolas.Bovy@citadelle.be
- Laurent Servais, MD
Terms used on this page · explanations by MedicalUpdates.ai
- observational study
- A study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
- natural history
- A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
- primary objective
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- endpoints
- Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- 6-minute walk test
- A test of how far a person can walk on a flat surface in six minutes. It is used to measure stamina and to track change over time.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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