NCT06187467 Longitudinal Multimodal Profiling of Balance and Gait In Stroke
| NCT ID | NCT06187467 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tan Tock Seng Hospital |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-07-01 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Dr Wee Seng Kwee
PRINCIPAL INVESTIGATOR
Tan Tock Seng Hospital
Frequently Asked Questions
Who can join the NCT06187467 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06187467 currently recruiting?
Yes, NCT06187467 is actively recruiting participants. Contact the research team at Jaclyn_AM_LOW@ttsh.com.sg for enrollment information.
Where is the NCT06187467 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06187467 clinical trial?
NCT06187467 is sponsored by Tan Tock Seng Hospital. The principal investigator is Dr Wee Seng Kwee at Tan Tock Seng Hospital. The trial plans to enroll 30 participants.
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