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Recruiting NCT06187467

Longitudinal Multimodal Profiling of Balance and Gait In 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: Clinical and technological-aided assessments and questionnaires.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 21 years — 85 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
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Clinical and technological-aided assessments and questionnaires
    Assessments and questionnaires to quantify cortical and motor activities using portable EEG and lower limb sensors during dynamic balance and gait activities.

Primary outcome measures

  • EEG Activities [Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)]
  • Goniometers [Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)]
Secondary outcome measures (5)
  • Fugl Meyer Assessment for Lower Limbs [Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)]
  • Berg Balance Scale [Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)]
  • Modified Clinical Test for Sensory Interaction in Balance [Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)]
  • 10-metre Walk Test [Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)]
  • 6-minute Walk Test [Time frame: Week 0 (baseline), 4 (1st follow-up assessment), 8 (last follow-up assessment)]

Eligibility criteria

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

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Singapore · 1 center
  • Tan Tock Seng Hospital — Singapore

Identifiers

NCT: NCT06187467 · DSRB 2023/00805

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗