NCT06806761

Tracking Balance and Walking Recovery After Stroke

Mapping the Time Course of Recovery of Sitting and Standing Balance and Walking After Stroke

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Vrije Universiteit Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to understand how balance and walking abilities recover after a stroke, using innovative tools like an interactive assessment game. By observing patients over time, the investigators seek to identify recovery patterns that can improve rehabilitation strategies tailored to individual needs. 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.

Detailed description

During this longitudinal observational study, patients following a supratentorial stroke will be included as soon as possible after admission, provided they meet the inclusion criteria. Assessments will take place at fixed time points relative to stroke onset: baseline (as soon as possible after admission) and at 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge). The study aims to investigate recovery patterns in balance and walking (gait initiation) abilities, contributing to the validation of predictive models that support personalized rehabilitation strategies. 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

• Stroke

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-01-07
• Primary completion: 2028-12-09
• Completion: 2028-12-09
• First posted: 2025-02-04
• Last updated: 2025-02-27

Locations

1 site across 1 country: Belgium