Development and Validation of an Actimetric Protocol to Quantify Physical Activity and Sedentary … (NCT06943014) | Clinical Trial Compass
By InvitationNot Applicable
Development and Validation of an Actimetric Protocol to Quantify Physical Activity and Sedentary Behaviour in Post-stroke Subjects
Belgium200 participantsStarted 2025-07-10
Plain-language summary
The aim of this project is to develop an actimetry protocol based on a system of motion sensors, such as accelerometers and pressure insoles.
These sensors will be used to analyze arm and leg movements in individuals who have experienced a stroke. Throughout the study, the investigators will adjust certain parameters-such as sensor placement and measurement frequency-to optimize data quality.
They will also refine data analysis methods to better identify the types of movements performed (upper and lower limbs), estimate energy expenditure, and recognize different postures adopted by the participant (sitting, standing, etc.).
The goal of this protocol is to provide accurate measurements of physical activity and inactivity, both in controlled environments (such as a laboratory) and in real-life settings (outdoors or at home).
This study will allow us to validate the reliability of the actimetry protocol and assess how easy it is to use at home.
Who can participate
Age range
18 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:
* Age ≥ 18 years
* Stroke diagnosed by a neurologist and confirmed by medical imaging
* More than 14 days post-stroke
* Medically stable condition
* Hemiparesis with impaired locomotion: Functional Ambulation Classification (FAC) between 1 and 5
* Montreal Cognitive Assessment (MoCA) score \> 18/30
Exclusion Criteria:
* Inability to understand simple instructions
* Other neurological or musculoskeletal disorders limiting functional mobility
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
Actimetry protocol
Timeframe: By the completion of the home monitoring phase, expected around April 2027
Trial details
NCT IDNCT06943014
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain