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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT05135533
Eligibility Criteria:
Inclusion Criteria:
* At least six months since the onset of Ischemic or hemorrhagic stroke.
* Demonstrate residual paresis in the lower extremity (Fugl-Mayer lower extremity score \< 34).
* Are able to provide informed consent demonstrated by their ability to weigh the consequences of participating versus not participating in the study.
* Can walk at least 10 feet with and without assistive device.
* Functional Gait Assessment score \<22.
Exclusion Criteria:
* Pre-existing neurological disorders.
* Previous stroke affecting the other hemisphere .
* Severe arthritis or orthopedic problems that limit passive range of motion.
* Areas of recent bleeding or open wounds.
* Lack normal sensation on the tongue.
* Received treatment for cancer within the past year.
* Non-removable metal orthodontic devices.
* Oral health problems.
* Are sensitive to nickel, gold or copper.
* Chronic infectious diseases.
* Are pregnant.
* Have dementia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT05135533
Study Brief:
Protocol Section:
NCT05135533