Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2025-01-07
2028-12-09
Brief Summary
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Interacting with a game designed to assess balance and movement, participants will perform tasks involving sitting balance, standing balance, and gait initiation. The game measures aspects like reaction time, movement accuracy, and postural control, providing detailed insights into recovery progress. These data will validate prediction models to support personalized care.
The study is non-invasive, does not interfere with usual care, and prioritizes patient safety. The investigators' ultimate goal is to enhance the understanding of recovery, leading to better care and improved quality of life for stroke survivors.
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Detailed Description
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At each time point, participants will perform standardized assessments targeting sitting balance, standing balance, and gait initiation. These assessments combine clinical scales (e.g., Fugl-Meyer Assessment for the lower limb, Berg Balance Scale, Functional Ambulation Categories) and biomechanical measurements collected using electromyography (EMG) sensors, inertial measurement units (IMUs), force plates, and a Kinect camera. EMG will provide detailed insights into muscle activation patterns, while IMUs (positioned on the sternum, pelvis, and non-paretic wrist) will measure acceleration and gyroscopic data to evaluate trunk movement and postural control. Force plates will provide data on weight distribution and stability, whereas the Kinect camera will capture posture and reaching accuracy data. An interactive assessment game will be used to evaluate task performance under various conditions, including anticipatory tasks (where the target location is known), reactive tasks (requiring quick adjustments to unpredictable targets), and cognitive-motor dual-task scenarios (involving decision-making under time pressure). Data from these assessments will provide detailed insights into recovery processes.
In addition to in-lab assessments, the study will also evaluate the relationship between laboratory-based measures and real-world functional activity. Participants will wear an activity monitor for three days following the longitudinal assessment sessions to measure real-world activity, including time spent sitting, standing, and walking. This approach allows the investigators to explore how improvements observed in the lab translate into functional recovery in daily life.
By combining clinical, biomechanical, and real-world data, the study seeks to address gaps in stroke recovery research, particularly the factors influencing recovery trajectories and how rehabilitation can be optimized. The findings are expected to enhance understanding of recovery patterns, inform individualized rehabilitation plans, and ultimately improve quality of life for stroke survivors.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients in the first 6 months after stroke
Participants in this study will be adults aged 18 years or older, following a supratentorial stroke, as defined by the World Health Organization (WHO). Inclusion will occur as soon as possible after hospital admission. Participants must be capable of providing informed consent, which may be written, verbal, or provided by proxy if necessary.
Exclusion criteria include the presence of other neurological or orthopedic disorders (e.g., Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis) that impair motor function, severe complicating comorbidities imposing health risks (e.g., cardiovascular instability), significant deficits in communication, memory, or understanding (defined by a score of less than 21 on the Montreal Cognitive Assessment (MoCA)), and insufficient knowledge of Dutch, French, German, or English.
Longitudinal prospective cohort study
Description: Patients after stroke who meet the in- and exclusion criteria will be examined up to 6 times during the first 6 months after their stroke.
Interventions
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Longitudinal prospective cohort study
Description: Patients after stroke who meet the in- and exclusion criteria will be examined up to 6 times during the first 6 months after their stroke.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of supratentorial stroke (as defined by the WHO)
* Able to provide written or verbal informed consent (written, verbal or by proxy)
Exclusion Criteria
* Severe complicating comorbidities imposing health risks (e.g., cardiovascular instability)
* Severe deficits in communication, memory or understanding (Montreal Cognitive Assessment test (MoCA) \< 21); and
* Insufficient knowledge of Dutch, French or English
18 Years
ALL
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Revalidatieziekenhuis InkendaaI
NETWORK
Vrije Universiteit Brussel
OTHER
Responsible Party
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Eva Swinnen
Assistant Professor
Locations
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Inkendaal rehabilitation hospital
Sint-Pieters-Leeuw, Brussels Capital, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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101136244_FOSTER
Identifier Type: -
Identifier Source: org_study_id
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