Tracking Balance and Walking Recovery After Stroke

Recruiting

• Conditions: Stroke

• Registration Number: NCT06806761
• Lead Sponsor: Vrije Universiteit Brussel

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.

Study Timeline

• Study First Submitted: 2024-11-29
• Study Start: 2025-01-07
• Study First Submitted QC: 2025-01-28
• Status Verified: 2025-02
• Study First Posted: 2025-02-04
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-27
• Primary Completion: 2028-12-09
• Study Completion: 2028-12-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postural control	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	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).
Weight distribution	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	Weight distribution during balance and movement tasks (standing, gait initiation) using force plates.
Movement coordination	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	Movement coordination assessed during functional motor tasks (sitting, standing, gait initiation) using wearable sensors (e.g., IMUs), force plates, and Kinect camera.
Neuromuscular activity	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	Neuromuscular activity evaluated during dynamic tasks (sitting, standing, gait initiation) using muscle activity measurement systems (e.g., EMG sensors).

Secondary Outcome Measures

Name	Time	Method
Reaction time	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	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.
Movement time	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	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.
Reaching or stepping accuracy	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	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.
Upper limb dynamics	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	Acceleration of upper limb movements during sitting and standing reaching tasks, measured using an IMU sensor on the wrist.
Error rate during dual-task performance	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	Frequency of incorrect responses during Go/No-Go tasks integrated into sitting and standing tasks, measured using the interactive assessment game and Kinect camera.
Daily activity monitoring	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	Measurement of time spent sitting, standing, and walking using the Activ8 sensor over a continuous 3-day monitoring period after each assessment.
Lower limb motor impairment	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	Fugl-Meyer Assessment of the lower limb (FMA LL). Scores ranging from 0 to 34 (no motor impairment present).
Lower limb strength	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	Motricity Index of the lower limb (MI LL). Scores ranging from 0 (no movement) to 99 (normal power).
Dynamic sitting balance	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	Trunk Impairment Scale (TIS), items D.1 till D.6. Scores ranging from 0 to 6 (no balance impairment present).
Dynamic standing balance	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	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.
Walking independence	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	Functional Ambulation Categories (FAC)-score, ranging from 0 (not able to walk) to 5 (independent ambulator who can walk freely on any surface).
Walking performance	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	10-meter walk test (10MWT), measuring the comfortable and maximum walking speed over a 10 meter walking distance.
Daily life functioning	Baseline	Modified Ranking Scale (mRS), both premorbid (pre-stroke) and baseline (post-stroke). Scores ranging from 0 (no symptoms) to 5 (severe disability).
Activities of daily living	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	Functional Independence Measure (FIM), ranging from 18 (complete dependence/total assistance) to 126 (complete independence).
Cognitive functioning	Baseline (screening)	Montreal Cognitive Assessment (MoCA), ranging from 0 to 30. A score lower than or equal to 21 is suggesting that the patient is not able to take part in our study.
Mental health	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	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.
Health-related quality of life	Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)	36-item Short Form survey (SF-36), ranging from 0 to 100, with higher scores defining a more favorable health state.

Trial Locations

Locations (1)

Inkendaal rehabilitation hospital; 🇧🇪 Sint-Pieters-Leeuw, Brussels, Belgium