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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT06127602
Eligibility Criteria:
Inclusion Criteria:
* Age group: 18-90 years.
* Presence of hemiparesis.
* Onset of stroke (\> 6 months).
* Ability to walk at least for 2 minutes on the treadmill with or without ankle foot orthosis.
* Can understand and communicate in English.
* Cognitively and behaviorally capable of complying with the regimen (Mini-Mental State Examination \> 25/30).
* No history or recent use (i.e., past 6 weeks) of any Neuromuscular electrical stimulation device to leg muscles during walking (e.g., Bioness, Walkaide).
Exclusion Criteria:
* Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during rest, or 3) oxygen saturation (measured by pulse oximeter) \< 95% during rest.
* Body weight of more than 250 lbs.
* Spasticity (Ashworth scale \> 2).
* Loss of protective sensations on the paretic leg (indicated by inability to perceive the 5.07/10 g on Semmes-Weinstein Monofilament) or inability to feel the NMES.
* Severe osteoporosis (indicated by T score \< -2)
* Cognitive impairment (indicated by Mini-Mental State Exam score\<25)
* Global Aphasia (indicated by \<71% on the Mississippi Aphasia Screening Test).
* Subjects with Chedoke McMaster Leg Assessment Scale score (\> 4).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06127602
Study Brief:
Protocol Section:
NCT06127602