Tracking Balance and Walking Recovery After Stroke

NCT06806761 | Recruiting

• 1 other identifier: 101136244_FOSTER
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; balance; longitudinal; gait initiation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (15)

• 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)

Study Arms (1)

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

Interventions

Longitudinal prospective cohort study OTHER

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.

Patients in the first 6 months after stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult aged ≥18 years
• Diagnosis of a supratentorial ischaemic or haemorrhagic stroke
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universitair Ziekenhuis Brussel: collaborator
• Revalidatieziekenhuis InkendaaI: collaborator

Study Sites (1)

Inkendaal rehabilitation hospital

Sint-Pieters-Leeuw, Brussels Capital, 1602, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Eva Swinnen

CONTACT

+32 (0)2 477 44 20; eva.swinnen@vub.be

Marc Degelaen

CONTACT

marc.degelaen@vub.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: February 4, 2025
• Study Start: January 7, 2025
• Primary Completion (Estimated): December 9, 2028
• Study Completion (Estimated): December 9, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

BE (1)