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

N/AEnrolling By InvitationNCT06943014

Cliniques universitaires Saint-Luc- Université Catholique de Louvain200 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Stroke Chronic Stroke Patients Stroke With Hemiparesis

Interventions

Actimetry ProtocolDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Actimetry protocol

Development of an actimetry protocol using accelerometers and pressure insoles for post-stroke subjects.

Time frame: By the completion of the home monitoring phase, expected around April 2027

Secondary Outcomes

Validation, feasibility, and usability of the actimetry protocol across different environments

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.