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Recruiting NCT06806761

Tracking Balance and Walking Recovery After Stroke

Observational Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Longitudinal prospective cohort study.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Postural control [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Weight distribution [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Movement coordination [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Neuromuscular activity [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
Secondary outcome measures (12)
  • Reaction time [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Movement time [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Reaching or stepping accuracy [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Upper limb dynamics [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Daily activity monitoring [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Lower limb motor impairment [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Lower limb strength [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Dynamic sitting balance [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Dynamic standing balance [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Walking independence [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Walking performance [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]
  • Global disability [Time frame: Baseline, 5, 8, 12, and 24 weeks post-stroke (or until discharge)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Inkendaal rehabilitation hospital — Sint-Pieters-Leeuw

Identifiers

NCT: NCT06806761 · 101136244_FOSTER

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗