Tracking Balance and Walking Recovery After Stroke

NCT06806761 | Recruiting

• 1 other identifier: 101136244_FOSTER
• Study Type: observational
• Target: 120
• 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, 3, 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, 3, 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, 3, 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, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

Secondary Outcomes (17)

• Reaction time

  Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

• Movement time

  Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

• Reaching or stepping accuracy

  Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

• Upper limb dynamics

  Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

• Error rate during dual-task performance

  Baseline, 3, 5, 8, 12, and 24 weeks post-stroke (or until discharge)

Study Arms (1)

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). Inclusion will occur as soon as possible after hospital admission. Participants must be capable of providing informed consent, which may be written, verbal, or provided by proxy if necessary. Exclusion criteria include the presence of other neurological or orthopedic disorders (e.g., Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis) that impair motor function, severe complicating comorbidities imposing health risks (e.g., cardiovascular instability), significant deficits in communication, memory, or understanding (defined by a score of less than 21 on the Montreal Cognitive Assessment (MoCA)), and insufficient knowledge of Dutch, French, German, or English.

Other: Longitudinal prospective cohort study

Interventions

Longitudinal prospective cohort study OTHER

Description: Patients after stroke who meet the in- and exclusion criteria will be examined up to 6 times during the first 6 months after their stroke.

Patients in the first 6 months after stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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

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: February 27, 2025

Record last verified: 2025-02

Data Sharing

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

Locations

BE (1)