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

NCT ID: NCT06943014

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2028-10-01

Brief 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.

Conditions

Stroke; Chronic Stroke Patients; Stroke With Hemiparesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Actimetry protocol

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.

Group Type: EXPERIMENTAL

Actimetry Protocol

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Accelerometry; Accelerometer

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry Lejeune

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Countries

Belgium

Other Identifiers

2025/11FEV/062

Identifier Type: -

Identifier Source: org_study_id