Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT06187467
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT06187467
Study Brief:
Protocol Section:
NCT06187467