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StrokeFOSTERNCT06806761

Tracking Balance and Walking Recovery After Stroke

An observational study of Stroke, run by Vrije Universiteit Brussel at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Longitudinal prospective cohort study
How many people
100 participants
Where
1 siteBelgium
Study dates
7 Jan 2025to 9 Dec 2028
How long will I take part?
24 Weeks
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marc Degelaen contact

marc.degelaen@vub.be

Belgium1 site, 1 recruiting
  • Inkendaal rehabilitation hospital

    Sint-Pieters-Leeuw, Brussels Capital, 1602

    Marc Degelaen, +32 (0)2 531 51 11, marc.degelaen@inkendaal.be

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Conditions
Stroke
Being tested
Longitudinal prospective cohort study
Keywords
stroke, balance, longitudinal, gait initiation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Longitudinal prospective cohort studyOther

    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.

Study groups in NCT06806761
Study groupRoleWhat they receive
Patients in the first 6 months after strokeParticipants 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.
Receives: Other: Longitudinal prospective cohort study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  2. Weight distribution

    Weight distribution during balance and movement tasks (standing, gait initiation) using force plates.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  3. Movement coordination

    Movement coordination assessed during functional motor tasks (sitting, standing, gait initiation) using wearable sensors (e.g., IMUs), force plates, and Kinect camera.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  4. Neuromuscular activity

    Neuromuscular activity evaluated during dynamic tasks (sitting, standing, gait initiation) using muscle activity measurement systems (e.g., EMG sensors).

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

Secondary outcomes (15)
  1. 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.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  2. 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.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  3. 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.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  4. Upper limb dynamics

    Acceleration of upper limb movements during sitting and standing reaching tasks, measured using an IMU sensor on the wrist.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  5. 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.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  6. 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.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  7. 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.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  8. Dynamic sitting balance

    Trunk Impairment Scale (TIS), items D.1 till D.6. Scores ranging from 0 to 6 (no balance impairment present).

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  9. 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.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  10. 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).

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  11. Walking performance

    10-meter walk test (10MWT), measuring the comfortable walking speed over a 10 meter walking distance.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  12. Global disability

    Modified Rankin Scale (mRS), both premorbid (pre-stroke) and baseline (post-stroke). Scores ranging from 0 (no symptoms) to 5 (severe disability).

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  13. 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.

    Measured: Baseline (screening)

  14. 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.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

  15. 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.

    Measured: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start7 Jan 2025
  3. Primary completion9 Dec 2028 (estimated)
  4. Study completion9 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
24 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT06806761
Sponsor's protocol ID
101136244_FOSTER
Acronym
FOSTER
Status last verified
Jul 2026
First submitted
29 Nov 2024
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Moeyersons C, Embrechts E, Hanssen B, Firouzi M, De Raedt S, Omelina L, Dan B, Ortega-Martorell S, Jansen B, Degelaen M, Swinnen E; TARGET consortium. Mapping the longitudinal trajectories of postural control and functional activity after stroke using clinical and sensor-based assessments: protocol of the FOSTER prospective cohort study. BMJ Open. 2026 Aug 17;16(8):e121574. doi: 10.1136/bmjopen-2026-121574.

    PubMed 42608045

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Vrije Universiteit Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eva Swinnen (+32 (0)2 477 44 20, eva.swinnen@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postural control (time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06806761, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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