Status:

RECRUITING

Longitudinal Multimodal Profiling of Balance and Gait In Stroke

Lead Sponsor:

Tan Tock Seng Hospital

Collaborating Sponsors:

Nanyang Technological University

Conditions:

Stroke

Eligibility:

All Genders

21-85 years

Brief Summary

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 ther...

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. Despit...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2025

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06187467

Start Date

July 1 2024

End Date

October 1 2025

Last Update

April 11 2025

Active Locations (1)

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1

Tan Tock Seng Hospital

Singapore, Singapore, Singapore

Longitudinal Multimodal Profiling of Balance and Gait In Stroke | DecenTrialz