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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT04650802
Eligibility Criteria:
Inclusion Criteria:
* adults (\>18 years of age) with unilateral ischemic or heamorrhagic supratentorial stroke
* at least 6 months post-onset
* impaired propulsion of the paretic leg during walking at a self-selected speed (≥ 8 percent propulsion asymmetry)
* ability to walk 10 meter without support or use of a walking aid (Functional Ambulatory Categories (FAC) 3-5)
* ability to walk for 5 consecutive minutes, with or without the use of a walking aid
* at least 10 degrees passive hip extension and able to stand plantigrade with extended knee
Exclusion Criteria:
* inability to move the body upward against gravity (calf muscle - Medical Research Council (MRC) scale \< 3)
* severe cognitive problems assessed with Mini-Mental State Examination (MMSE \< 24)
* depressed mood assessed with the Hospital Anxiety and Depression Score (HADS \> 7)
* persistent unilateral visuospatial neglect assessed with the Star Cancellation Test (score \< 44)
* any medical condition interfering with gait
* inability to understand verbal instructions
* inappropriate or unsafe fitting of the robotic gait trainer, due to severe lower limb spasticity (Modified Ashworth Scale (MAS) ≥ 3), severe lower limb contractures, body weight ≥ 140 kg, or skin problems at body sites where the harness or straps were to be fitted
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04650802
Study Brief:
Protocol Section:
NCT04650802