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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06943014
Acronym
ActiStroke
Enrollment
200
Registered
2025-04-24
Start date
2025-07-10
Completion date
2028-10-01
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stroke Patients, Stroke, 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

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.

Interventions

DEVICEActimetry 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.

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Actimetry protocolBy the completion of the home monitoring phase, expected around April 2027Development of an actimetry protocol using accelerometers and pressure insoles for post-stroke subjects.

Secondary

MeasureTime frameDescription
Validation, feasibility, and usability of the actimetry protocol across different environmentsBy the completion of the home monitoring phase, expected around April 2027Validation 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026