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

August 11, 2025 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Cliniques universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Other Names:
  • Accelerometry
  • Accelerometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
By the completion of the home monitoring phase, expected around April 2027

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
By the completion of the home monitoring phase, expected around April 2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Thierry Lejeune, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/11FEV/062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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