Understanding balance and walking patterns in stroke patients using EEG technology

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

This study is testing how brain activity relates to balance and walking in stroke patients to help improve their rehabilitation.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 21 Years to 85 Years
• Sex: All
• Sponsor: Tan Tock Seng Hospital (Academic / other)
• Locations: 1 site (Singapore, Singapore)
• Trial ID: NCT06187467 on ClinicalTrials.gov

What this trial studies

This observational study focuses on the recovery of balance and gait in individuals who have experienced a stroke. Researchers will utilize an Electroencephalographic (EEG) Brain Computer Interface (BCI) to analyze neural patterns associated with walking and balance. The aim is to address technical challenges in existing BCI systems and enhance understanding of motor control in post-stroke rehabilitation. By profiling these patterns, the study seeks to tailor rehabilitation strategies to better meet individual patient needs.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 85 who have experienced their first-ever stroke and have specific gait impairments.

Not a fit: Patients with non-stroke related causes of gait impairment or uncontrolled medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized rehabilitation approaches for stroke patients, improving their recovery outcomes.

How similar studies have performed: While the use of EEG in understanding motor control is promising, this specific approach using BCI for balance and gait profiling in stroke patients is relatively novel.

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

Where this trial is running

Singapore, Singapore

• Tan Tock Seng Hospital — Singapore, Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Dr Wee Seng Kwee — Tan Tock Seng Hospital
• Study coordinator: Low Ai Mei Jaclyn

Conditions Stroke; Electroencephalographic; Brain Computer Interfaces