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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Stroke Patients Nervous System Diseases Stroke With Hemiparesis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Actimetry Protocol

Device

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.

Other names: Accelerometry, Accelerometer

Primary outcomes

Actimetry protocol

Time frame: 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.

Secondary outcomes

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

Validation of an actimetry protocol in the post-stroke population in a controlled environment (laboratory), in an ecological setting (outdoor), and assessment of its feasibility and usability at home.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: ActiStroke

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Apr 24, 2025
Registry last updated: Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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