Longitudinal Multimodal Profiling of Balance and Gait In Stroke
NCT ID: NCT06187467
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-07-01
2025-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
85 Years
ALL
No
Sponsors
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Nanyang Technological University
OTHER
Tan Tock Seng Hospital
OTHER
Responsible Party
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Principal Investigators
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Dr Wee Seng Kwee
Role: PRINCIPAL_INVESTIGATOR
Tan Tock Seng Hospital
Dr Karen Chua
Role: PRINCIPAL_INVESTIGATOR
Tan Tock Seng Hospital
Locations
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Tan Tock Seng Hospital
Singapore, Singapore, Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DSRB 2023/00805
Identifier Type: -
Identifier Source: org_study_id
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