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

NCT06943014 | Enrolling By Invitation

• 1 other identifier: 2025/11FEV/062
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Physical activity monitoring; Stroke rehabilitation; Actimetry; Accelerometers; Pressure insoles; Energy expenditure estimation; Inactivity tracking; Actimetry to measure physical activity and sedentary behavior in stroke patients

Outcome Measures

Primary Outcomes (1)

• Actimetry protocol

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

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

Secondary Outcomes (1)

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

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

Study Arms (1)

Actimetry protocol

EXPERIMENTAL

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.

Device: Actimetry Protocol

Interventions

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.

Also known as: Accelerometry, Accelerometer

Actimetry protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to understand simple instructions
• Other neurological or musculoskeletal disorders limiting functional mobility

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Belgium

Location

MeSH Terms

Conditions

Stroke

Interventions

Accelerometry

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Thierry Lejeune

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 15, 2025

Record last verified: 2025-04

Locations

BE (1)