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 @ 1:37 AM
Ignite Modification Date:
2025-12-25 @ 1:37 AM
NCT ID:
NCT04169594
Eligibility Criteria:
Inclusion Criteria for stroke patients:
* First ever chronic unilateral hemiparetic stroke subjects, with stroke diagnosed by a physician and confirmed via CT/MRI
* \>6 months post stroke
* ambulant with at most contact guard/standby supervision with/without walking aid during the study
* 10m Walk Test \>/=0.2m/s and 6min Walking test walking distance of \>/=50m without rest stop, with Functional Ambulation Category of \>/=4 ((Holden et al, 1994)
* AMT\>6
* able to understand study procedures and sign informed consent
* able to attend a single 2.5h session of research data collection.
Inclusion Criteria for amputee patients:
* First ever chronic unilateral transtibial amputee subjects
* intact residual limb
* \> 6 months post amputation
* ambulant with at most contact guard/standby supervision with/without walking aid during the study
* 10m Walk Test \>/=0.2m/s and 6min Walking test walking distance of \>/=50m without rest stop
* with Medicare K level of \>1
* AMT\>6
* able to understand study procedures and sign informed consent
* able to attend a single 2.5h session of research data collection.
Exclusion Criteria:
* Unstable recent cardiorespiratory conditions including uncontrolled hypertension/ hypotension, angina pectoris, myocardial infarction, active congestive cardiac failure, untreated cardiac arrhythmias (e.g. atrial fibrillation), untreated pulmonary embolism or deep vein thrombosis, presence of cardiac pacemaker.
* Functional status: severe aphasia or neglect (inability to obey 1 steps command), communication disorder precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
* End stage conditions such as medical instability or orthostatic insufficiency, organ, renal, liver, heart failure and life expectancy \<6 months or on haemodialysis.
* Pregnancy.
* Local limb conditions which could be exacerbated by research interventions such as open wounds, ulcers, stump pain or stump wounds/ulcers, neuromas in amputees, active arthritis or joint or limb pain.
* Skin conditions which could be worsened by application of adhesive skin markers such as uncontrolled eczema, psoriasis, fungal or bacterial infections etc.
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04169594
Study Brief:
Protocol Section:
NCT04169594