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Enrolling by invitation Not applicable

Development and Validation of an Actimetric Protocol to Quantify Physical Activity and Sedentary Behaviour in Post-stroke Subjects

NCT06943014 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2025-07-10
Last updated
2025-08-15

Condition(s) studied

StrokeChronic Stroke PatientsStroke With Hemiparesis

Investigational drug(s) / intervention(s)

Actimetry Protocol

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 individuals, they need to be adapted for post-stroke patients, who exhibit slower, asymmetric, and lower-amplitude movements compared to healthy subjects. This protocol could be valuable in both clinical practice and research, helping to optimize stroke rehabilitation and promote a healthy, active lifestyle.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Actimetry protocol — By the completion of the home monitoring phase, expected around April 2027
    Development of an actimetry protocol using accelerometers and pressure insoles for post-stroke subjects.

Trial sites (1)

FacilityCityRegionStatus
Cliniques universitaires Saint-Luc Brussels Belgium
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06943014 on ClinicalTrials.gov ↗ ← All trials in Belgium