Longitudinal Multimodal Profiling of Balance and Gait In Stroke

NCT ID: NCT06187467

Last Updated: 2025-04-11

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanyang Technological University

OTHER

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Low Ai Mei Jaclyn

Role: CONTACT

Facility Contacts

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Low Jaclyn

Role: primary

Other Identifiers

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DSRB 2023/00805

Identifier Type: -

Identifier Source: org_study_id

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