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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07448532
Eligibility Criteria:
Inclusion Criteria:
* Patient aged 18-85 years of age, who experienced stroke within ≤6 months.
* The Fugl-Meyer motor assessment of lower extremity (FMA-LE) was conducted by physiotherapist in the hospital, and score required to be ≥ 20 points.
* Participants possessed healthy nerves, neuromuscular junctions, muscles tissues, and a sufficient range of motion in dorsiflexor and plantarflexion.
* The subjects could walk independently on a treadmill for at least 2 min without without experiencing adverse reaction to FES.
* Patients who received more 24 scores on Mini Mental State Exam and could comprehend and follow the information researcher provides.
* No orthopedic diseases in upper and lower extremities.
* Patients with functional ambulation classification (FAC) score of 3 or 4 were included (FAC is a scale of 0-5, where 3 indicates supervision or standby guarding and 4 indicates independent on level surfaces.
* Patients with inadequate ankle dorsiflexion during the swing phase of gait.
* Patients with adequate minimal stability at the ankle during stance with stimulation.
Exclusion Criteria:
* Patients with cardiac pacemaker, those with skin lesions, who could not be treated due to spasticity within the last three months, and vestibular and cerebellar lesions or deaf- blindness were excluded.
* Patients with past or current epilepsy, uncontrolled seizure disorder, mental disorders and all neurological disorders except stroke.
* Patients with severe edema of lower extremities or patients of vascular disorders like deep vein thrombosis or thromboembolisms and severe atheroscelerosis of lower extremities.
* Subjects with any musculoskeletal dysfunction that would potentially affect gait and causes risk of falls.
* We excluded patients with pregnancy, plantar flexion contracture, and severe hemi-neglect.
* Subjects with hip or knee prostheses made of metal on the lower limb were excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07448532
Study Brief:
Protocol Section:
NCT07448532