Tracking Balance and Walking Recovery After Stroke (FOSTER)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Longitudinal prospective cohort study

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Eva Swinnen; Phone Number: +32 (0)2 477 44 20; Email: eva.swinnen@vub.be
• Study Contact Backup: Name: Marc Degelaen; Email: marc.degelaen@vub.be

Study Locations

• Belgium
  • Brussels Capital
    • Sint-Pieters-Leeuw, Brussels Capital, Belgium, 1602
      • Recruiting
      • Inkendaal rehabilitation hospital
      • Contact: Marc Degelaen; Phone Number: +32 (0)2 531 51 11; Email: marc.degelaen@inkendaal.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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 included within eight weeks after stroke onset. They will be followed during the first six months after stroke.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Longitudinal prospective cohort study; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural control	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).	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Weight distribution	Weight distribution during balance and movement tasks (standing, gait initiation) using force plates.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Movement coordination	Movement coordination assessed during functional motor tasks (sitting, standing, gait initiation) using wearable sensors (e.g., IMUs), force plates, and Kinect camera.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Neuromuscular activity	Neuromuscular activity evaluated during dynamic tasks (sitting, standing, gait initiation) using muscle activity measurement systems (e.g., EMG sensors).	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction time	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.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Movement time	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.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Reaching or stepping accuracy	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.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Upper limb dynamics	Acceleration of upper limb movements during sitting and standing reaching tasks, measured using an IMU sensor on the wrist.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Daily activity monitoring	Measurement of time spent sitting, standing, and walking using the Activ8 sensor over a continuous 3-day monitoring period after each assessment.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Lower limb motor impairment	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.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Lower limb strength	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.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Dynamic sitting balance	Trunk Impairment Scale (TIS), items D.1 till D.6. Scores ranging from 0 to 6 (no balance impairment present).	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Dynamic standing balance	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.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Walking independence	Functional Ambulation Categories (FAC)-score, ranging from 0 (not able to walk) to 5 (independent ambulator who can walk freely on any surface).	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Walking performance	10-meter walk test (10MWT), measuring the comfortable walking speed over a 10 meter walking distance.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Global disability	Modified Rankin Scale (mRS), both premorbid (pre-stroke) and baseline (post-stroke). Scores ranging from 0 (no symptoms) to 5 (severe disability).	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Cognitive functioning	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.	Baseline (screening)
Mental health	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.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Health-related quality of life	36-item Short Form survey (SF-36), ranging from 0 to 100, with higher scores defining a more favorable health state.	Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Collaborators: Universitair Ziekenhuis Brussel; Revalidatieziekenhuis InkendaaI

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): December 9, 2028
• Study Completion (Estimated): December 9, 2028

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: stroke; balance; longitudinal; gait initiation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 101136244_FOSTER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study is part of the EU Horizon 2020 TARGET project, following its DMP to ensure data is handled ethically, legally, and sustainably in line with FAIR principles (Findability, Accessibility, Interoperability, Reusability). The plan ensures systematic organization, quality consistency via standardized procedures, and compliance with GDPR, national laws, and EU requirements. Personal data is processed securely, only when necessary for project objectives, with approvals and written consent from participants. Methods include interviews, surveys, workshops, and questionnaires. Data is stored with robust backup and preservation strategies to prevent loss and ensure future usability. Sharing is (currently) restricted to the consortium under a signed data transfer agreement, with external sharing undecided. Data not publicly available includes: third-party data without permission for public release, data compromising IP protection, and participant data that cannot be fully anonymized.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No