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:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT02898168
Eligibility Criteria:
Inclusion Criteria:
* 1\) Patients who agree to participate in this study and provide their informed consent
* 2\) Patients from 20 to 85 years old at the time of consent
* 3\) Patients of convalescent stoke (within 6 months of onset)
* 4\) Patients with a first episode of stroke, which type limited intracranial hemorrhage or ischemic stroke (excluding subarachnoid hemorrhage)
* 5\) Patients inpatients for the rehabilitation therapy
* 6\) Patients diagnosed 3 or 4 on Functional Ambulation Classification (FAC)
* 7\) Patients stable general condition(blood pressure, pulse, blood glucose level etc.)
* 8\) Patients with drop foot in walking
Exclusion Criteria:
* 1\) Patients due to severe heart disease
* 2\) Patients with previous gait disability, such as neurological disease
* 3\) Patients with previous orthopedic disease, such as knee osteoarthritis
* 4\) Patients with severe hepatic or renal dysfunction
* 5\) Patients with severe sensory disturbance or severe ataxia or severe higher brain dysfunction
* 6\) Patients correspond to contraindicated for the electrical stimulation (e.g. patients with a medical implant or implantable medical electrical equipment such as a cardiac pacemaker)
* 7\) Patients with severe skin disease
* 8\) Patients with any dose adjustment of antispasticity drugs (tizanidine hydrochloride, eperisone hydrochloride, baclofen, etc.) within 1month
* 9\) Patients whose impairment severities changed during the study period
* 10\) Patients taking the botulinum toxin formulation injection or the nerve block injection with phenol within 6months
* 11\) Patients with any lower limb treatment using FES or the robot suit within 1month
* 12\) Patients diagnosed not to use during the the WA trial operation period
* 13\) Patients who do not complete the WA trial operation for 7 days
* 14\) Patients joining any other clinical trials or studies with intervention
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT02898168
Study Brief:
Protocol Section:
NCT02898168