Stroke
Conditions
Keywords
stroke, balance, longitudinal, gait initiation
Brief 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 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.
Interventions
Description: Patients after stroke who meet the eligibility criteria will be assessed three to five times during the first six months after stroke, depending on the timing of inclusion.
Sponsors
Vrije Universiteit Brussel
Universitair Ziekenhuis Brussel
Revalidatieziekenhuis InkendaaI
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postural control | 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 | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reaction time | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | Time from target appearance to reaching/stepping movement initiation during sitting balance, standing balance, and gait initiation tasks, measured using the interactive assessment game and Kinect camera. |
| Movement time | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | Duration of the reaching/stepping movement from initiation to completion during sitting balance, standing balance, and gait initiation tasks, measured using the interactive assessment game and Kinect camera. |
| Reaching or stepping accuracy | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | Number of successful target reaches during sitting and standing balance tasks, and correct leg usage during gait initiation tasks, measured using the Kinect camera and the interactive assessment game. |
| Upper limb dynamics | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | Acceleration of upper limb movements during sitting and standing reaching tasks, measured using an IMU sensor on the wrist. |
| Daily activity monitoring | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | Measurement of time spent sitting, standing, and walking using the Activ8 sensor over a continuous 3-day monitoring period after each assessment. |
| Lower limb motor impairment | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | Fugl-Meyer Assessment-Lower Extremity (FMA-LE). Scores range from 0 to 34, with higher scores indicating better lower-limb motor function; a score of 34 indicates normal motor performance. |
| Lower limb strength | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | Motricity Index of the lower limb (MI-LL), ranging from 0 (complete paresis) to 100 (normal strength), with higher scores indicating greater lower-limb muscle strength. |
| Dynamic sitting balance | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | Trunk Impairment Scale (TIS), items D.1 till D.6. Scores ranging from 0 to 6 (no balance impairment present). |
| Dynamic standing balance | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | The Mini-BESTest and/or the Berg Balance Scale (BBS), depending on the Functional Ambulation Categories (FAC)-score. Scores ranging from 0 (severe balance deficits) to 28 (normal balance) and/or from 0 (severe balance deficits) to 56 (normal balance), respectively. |
| Walking independence | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | Functional Ambulation Categories (FAC)-score, ranging from 0 (not able to walk) to 5 (independent ambulator who can walk freely on any surface). |
| Walking performance | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | 10-meter walk test (10MWT), measuring the comfortable walking speed over a 10 meter walking distance. |
| Global disability | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | Modified Rankin Scale (mRS), both premorbid (pre-stroke) and baseline (post-stroke). Scores ranging from 0 (no symptoms) to 5 (severe disability). |
| Cognitive functioning | Baseline (screening) | Montreal Cognitive Assessment (MoCA), ranging from 0 to 30, will be administered at admission to assess global cognitive function. The score will be recorded as descriptive clinical information and will not be used as an eligibility cut-off. |
| Mental health | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | Hospital Anxiety and Depression Scale (HADS), with separate scores for anxiety and depression. Both subscale scores are ranging from 0 to 21. A total score is calculated by adding together all the values, with a total score ≥ 12 suggesting depression, whereas sub-scores of ≥ 8 suggest anxiety or depression. |
| Health-related quality of life | Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge) | 36-item Short Form survey (SF-36), ranging from 0 to 100, with higher scores defining a more favorable health state. |
Countries
Belgium
Contacts
CONTACTEva Swinnen
CONTACTMarc Degelaen
Outcome results
None listed