Mapping the Time Course of Recovery of Sitting and Standing Balance and Walking After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postural control
研究概览
简要总结
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.
详细描述
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 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) and reactive tasks (requiring quick adjustments to unpredictable targets). 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged ≥18 years
- •Diagnosis of a supratentorial ischaemic or haemorrhagic stroke
- •Within the first eight weeks after stroke onset at the time of inclusion
- •Able to understand and perform the study procedures that are feasible at a given assessment time point, based on the advice of the treating therapist(s) and/or physician(s)
- •Written informed consent provided by the participant or, where applicable, by a legally authorised representative
排除标准
- •Neurological or orthopaedic comorbidities unrelated to stroke that significantly impair motor function
- •Severe medical conditions that could compromise safety during the assessments
- •Major deficits in communication, memory or understanding that prevent participation in the study procedures
- •Insufficient comprehension of Dutch, French, German or English
研究组 & 干预措施
Patients in the first 6 months after stroke
Participants will be adults aged 18 years or older who have experienced a supratentorial ischaemic or haemorrhagic stroke and are within eight weeks after stroke onset at inclusion. Inclusion will occur as soon as feasible after admission to the rehabilitation hospital. Participants must be able to understand and perform the study procedures feasible at each assessment, based on the advice of the treating therapist(s) and/or physician(s). Written informed consent will be obtained from the participant or, where applicable, a legally authorised representative. Exclusion criteria are neurological or orthopaedic comorbidities unrelated to stroke that significantly impair motor function, severe medical conditions that could compromise safety, major deficits in communication, memory or understanding that prevent participation, and insufficient comprehension of Dutch, French, German or English. Independent walking, standing balance and ability to perform the exergame tasks are not required.
干预措施: Longitudinal prospective cohort study (Other)
结局指标
主要结局
Postural control
时间窗: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Postural control during dynamic tasks (sitting, standing, gait initiation) measured using wearable sensors (e.g., IMUs) and other biomechanical measurement systems (e.g., force plates, Kinect cameras).
Weight distribution
时间窗: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Weight distribution during balance and movement tasks (standing, gait initiation) using force plates.
Movement coordination
时间窗: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Movement coordination assessed during functional motor tasks (sitting, standing, gait initiation) using wearable sensors (e.g., IMUs), force plates, and Kinect camera.
Neuromuscular activity
时间窗: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Neuromuscular activity evaluated during dynamic tasks (sitting, standing, gait initiation) using muscle activity measurement systems (e.g., EMG sensors).
次要结局
- Cognitive functioning(Baseline (screening))
- Reaction time(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Movement time(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Reaching or stepping accuracy(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Upper limb dynamics(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Daily activity monitoring(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Lower limb motor impairment(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Lower limb strength(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Dynamic sitting balance(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Dynamic standing balance(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Walking independence(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Walking performance(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Global disability(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Mental health(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
- Health-related quality of life(Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge))
研究者
Eva Swinnen
Assistant Professor
Vrije Universiteit Brussel