Development and Validation of an Actimetric Protocol to Quantify Physical Activity and Sedentary Behaviour in Post-stroke Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Actimetry Protocol.
- Who it may be relevant to
- Registry conditions: Stroke, Chronic Stroke Patients, Stroke With Hemiparesis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Actimetry Protocol
Our goal is to develop an actimetry protocol using both accelerometers and pressure insoles to quantify physical activity, involving the upper and/or lower limbs, as well as sedentary behavior in post-stroke individuals. Recent studies have explored the use of validated accelerometer configurations designed for healthy individuals, applied to the post-stroke population to monitor their physical activity and sedentary behavior. However, although these protocols have been validated for healthy ind
Primary outcome measures
- Actimetry protocol [Time frame: By the completion of the home monitoring phase, expected around April 2027]
Secondary outcome measures (1)
- Validation, feasibility, and usability of the actimetry protocol across different environments [Time frame: By the completion of the home monitoring phase, expected around April 2027]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Belgium · 1 center
- Cliniques universitaires Saint-Luc — Brussels
Publications
- Macq L, Dehem S, Lejeune T, Otlet V. Quantifying Physical Activity Through Step Count Estimation Across Multiple Wearable Sensor Configurations: A Validation Study in Post-Stroke and Healthy Adults. NeuroRehabilitation. 2026 Jul 8:10538135261463255. doi: 10.1177/10538135261463255. Online ahead of print. PMID 42417037
Identifiers
NCT: NCT06943014 · 2025/11FEV/062