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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Not yet enrolling

Conditions: Stroke With Hemiparesis; Stroke; Chronic Stroke Patients

Treatments: Device: Actimetry Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06943014

2025/11FEV/062

Details and patient eligibility

About

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, we will adjust certain parameters-such as sensor placement and measurement frequency-to optimize data quality.

We 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Actimetry protocol

Experimental group

Description:

All participants follow the same actimetry-based monitoring protocol. There are no comparison groups or randomized interventions. Therefore, the study includes only one arm. Participants will wear motion sensors (accelerometers and pressure insoles) to quantify physical activity and sedentary behavior.

Treatment:

Device: Actimetry Protocol