Clinical trial NCT06806761: Tracking Balance and Walking Recovery After Stroke
Official title: Mapping the Time Course of Recovery of Sitting and Standing Balance and Walking After Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: stroke
balance
longitudinal
gait initiation
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
name: Revalidatieziekenhuis InkendaaI
First posted: 2025-02-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the first 6 months after stroke: Participants in this study will be adults aged 18 years or older, following a supratentorial stroke, as defined by the World Health Organization (WHO).

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 3, 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), reactive tasks (requiring quick adjustments to unpredictable targets), and cognitive-motor dual-task scenarios (involving decision-making under time pressure). 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.

Eligibility criteria: Inclusion Criteria:

* Adult (≥ 18 years)
* Diagnosis of supratentorial stroke (as defined by the WHO)
* Able to provide written or verbal informed consent (written, verbal or by proxy)

Exclusion Criteria:

* Other neurological/orthopedic disorders (e.g., Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis) leading to impairments in motor function.
* Severe complicating comorbidities imposing health risks (e.g., cardiovascular instability)
* Severe deficits in communication, memory or understanding (Montreal Cognitive Assessment test (MoCA) \< 21); and
* Insufficient knowledge of Dutch, French or English

Primary outcomes:
measure: Postural control
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Weight distribution
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Movement coordination
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Neuromuscular activity
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Secondary outcomes:
measure: Reaction time
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Movement time
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Reaching or stepping accuracy
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Upper limb dynamics
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Error rate during dual-task performance
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Daily activity monitoring
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Lower limb motor impairment
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Lower limb strength
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Dynamic sitting balance
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Dynamic standing balance
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Walking independence
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Walking performance
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Daily life functioning
timeFrame: Baseline
measure: Activities of daily living
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Cognitive functioning
timeFrame: Baseline (screening)
measure: Mental health
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
measure: Health-related quality of life
timeFrame: Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)
Other outcomes:
Locations:
city: Sint-Pieters-Leeuw
country: Belgium
facility: Inkendaal rehabilitation hospital
state: Brussels
Study officials:
References: