StrokeActiStrokeNCT06943014
Development and Validation of an Actimetric Protocol to Quantify Physical Activity and Sedentary Behaviour in Post-stroke Subjects
A study testing Actimetry Protocol in people with Stroke and Chronic Stroke Patients, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Chronic Stroke Patients, Stroke With Hemiparesis
- What is being tested?
- Actimetry Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jul 2025to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to understand simple instructions
- Other neurological or musculoskeletal disorders limiting functional mobility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- Actimetry Protocol
- 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
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actimetry ProtocolDevice
Also called Accelerometry, Accelerometer
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Actimetry Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actimetry protocol
Development of an actimetry protocol using accelerometers and pressure insoles for post-stroke subjects.
Measured: 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
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.
Measured: By the completion of the home monitoring phase, expected around April 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start10 Jul 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Lejeune, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943014
- Sponsor's protocol ID
- 2025/11FEV/062
- Acronym
- ActiStroke
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Macq L, Dehem S, Lejeune T, Otlet V. Quantifying Physical Activity Through Step Count Estimation Across Multiple Wearable Sensor Configurations: A Validation Study in Post-Stroke and Healthy Adults. NeuroRehabilitation. 2026 Jul 8:10538135261463255. doi: 10.1177/10538135261463255. Online ahead of print.
PubMed 42417037
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Actimetric Protocol to Quantify Physical Activity and Sedentary Behaviour in Post-stroke Subjects
- ClinicalTrials.gov ID
- NCT06943014
- Acronym / sponsor ID
- ActiStroke / 2025/11FEV/062
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Actimetry protocol | Experimental | Device: Actimetry ProtocolAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to understand simple instructions
- Other neurological or musculoskeletal disorders limiting functional mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actimetry ProtocolAlso: Accelerometry, AccelerometerOur 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. | Device | Actimetry protocol |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Derived from this study: PubMed 42417037Macq L, Dehem S, Lejeune T, Otlet V. Quantifying Physical Activity Through Step Count Estimation Across Multiple Wearable Sensor Configurations: A Validation Study in Post-Stroke and Healthy Adults. NeuroRehabilitation. 2026 Jul 8:10538135261463255. doi: 10.1177/10538135261463255. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thierry Lejeune principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actimetry Protocol in people with Stroke and Chronic Stroke Patients, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actimetry protocol (time frame: By the completion of the home monitoring phase, expected around April 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06943014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.