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 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT05436366
Eligibility Criteria:
Inclusion Criteria:
* For able-bodied individuals, the inclusion criterion is adults with no known neurological conditions or history of orthopedic injuries.
* For individuals after stroke, inclusion criteria include participants who are neurologically stable for \>6 months (and \>1 year post stroke) and have medical clearance to participate in the study (with the expectation that current medication will be maintained without change for at least 4 months); ability to ambulate with or without an assistive device at least 10 m; and unilateral ankle extensor spasticity (hemiparesis); and able to wear the robotic ankle device, provide written informed consent and follow instructions.
Exclusion Criteria:
* For able-bodied individuals, the exclusion criteria are motoneuron injury; a cardiac condition (history of myocardial infarct, pacemaker use); an unstable medical condition; and inability to provide written informed consent.
* For individuals after stroke, the exclusion criteria are are a cardiac condition (history of myocardial infarction or congestive heart failure, pacemaker use); motoneuron injury (i.e., the neurons that give rise to the axons innervating the muscles); ambulation velocity of \>1.2 m/s; a medically unstable condition (e.g., unstable angina, shortness of breath without exertion); musculoskeletal disorders that limit ambulation; and inability to provide informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05436366
Study Brief:
Protocol Section:
NCT05436366