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Longitudinal Multimodal Profiling of Balance and Gait In Stroke

T

Tan Tock Seng Hospital

Status

Enrolling

Conditions

Stroke

Treatments

Other: Clinical and technological-aided assessments and questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT06187467
DSRB 2023/00805

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

21 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Low Ai Mei Jaclyn

Data sourced from clinicaltrials.gov

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