Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06187467

Longitudinal Multimodal Profiling of Balance and Gait In Stroke

Balance and gait recovery is a critical aspect of post-stroke motor rehabilitation. Researchers have effectively utilized EEG to investigate different aspects of lower limb motor control, however there are several technical challenges in the existing brain computer interface (BCI) motor profiling.

The study aims to test the EEG-BCI system to see if it's effective in understanding the balance and walking patterns of post-stroke populations.

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tan Tock Seng Hospital

Singapore

Location status: Recruiting

Location contact

Low Jaclyn

CONTACT

[email protected]

About this study

Brain Computer Interface represent a groundbreaking field at the crossroads of neuroscience and engineering, serving as a direct communication link between the human brain and computer system.

Despite advancements in BCI technology, the electrocortical oscillations during human walking remain relatively unexplored, providing an opportunity for pioneering investigations.

The research highlights the feasibility of using EEG to decode neural patterns associated with various functions and aims to contribute to existing knowledge by using advanced EEG-based techniques to predict balance and gait patterns with the ultimate goal of tailoring rehabilitation approaches to individual patient needs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First-ever clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors brain imaging
  • Age 21 to 85 years
  • At least ≥ 30 days post-stroke
  • Gait impairments related to stroke
  • Functional ambulation category -6 levels (Mehrholz et al, 2007): FAC ≥ 4, i.e. able to ambulate independently on level surface but requires supervision to negotiate (e.g. stairs, inclines, non-level surfaces).
  • Montreal Cognitive Assessment (MoCA) score > 21 (Nasreddine et al., 2005)
  • Able to understand study instructions and requirements

Exclusion criteria

  • Non-stroke related causes of gait impairment
  • Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, dialysis, unresolved cancers e.g.,), active seizures within 3 months
  • Anticipated life expectancy of < 6 months
  • On subcutaneous or oral anti-coagulation
  • Local factors potentially worsened by gait training: joint and muscle pains
  • Lower limb pain VAS >4/10, active lower limb fractures or arthritis, fixed leg contractures, severe peripheral vascular disease, organomegaly or aortic aneurysms
  • Active unhealed skin wounds or inflammatory skin conditions over trunk and lower limbs,
  • Severe visual impairment or visual neglect affecting navigation
  • Known allergy to EEG gel (Recoverix)
  • Presence of craniectomy skull defect
  • Resident of nursing home or overseas country which may compromise attendance at research site
  • Pregnant or lactating females

Treatment and study plan

Clinical and technological-aided assessments and questionnaires

Other

Assessments and questionnaires to quantify cortical and motor activities using portable EEG and lower limb sensors during dynamic balance and gait activities.

Primary outcomes

  1. EEG Activities

    Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

    To record EEG and EOG data from 64-Ch ActiCap EEG cap and electrode

  2. Goniometers

    Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

    7 sensors to measure 2-axis joint angles at bilateral Hip, Knee and Ankle

Secondary outcomes

  1. Fugl Meyer Assessment for Lower Limbs

    Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

    Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function

  2. Berg Balance Scale

    Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

    To assess functional balance

  3. Modified Clinical Test for Sensory Interaction in Balance

    Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

    Assess complex sensory system to assist in determining which sensory system the individual relies upon (visual, somatosensory, vestibul)

  4. 10-metre Walk Test

    Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

    To assess walking speed over a short distance

  5. 6-minute Walk Test

    Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)

    Determine the functional exercise capacity

Study contacts

Contact information is provided by the study sponsor or research team.

Low Ai Mei Jaclyn

CONTACT

[email protected]

68894580

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • Nanyang Technological University

Registry information

Official study title

Longitudinal Multimodal Profiling of Balance and Gait In Stroke Using EEG and Lower Limb Sensors: A Feasibility Study.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.