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 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT03448159
Eligibility Criteria:
Inclusion Criteria:
1. 25 years of age or older
2. Days post stroke must be between 2 to 12 months when enrolled (i.e. day of consent)
3. Patient-reported hemiparesis of the lower extremity
Exclusion Criteria:
1. Patients with subarachnoid hemorrhage
2. Pre-morbid modified Rankin score \> 2
3. Substantial premorbid disability or pre-existing deficit or language comprehension deficit that could interfere with assessments
4. Diagnosis of major depressive disorder/anxiety disorder requiring antidepressant use within 6 weeks of enrolment
5. Taking neuroleptic drugs, benzodiazepines, monoamine oxidase inhibitors within 30 days of enrolment
6. Unstable serious medical condition (e.g., terminal cancer, renal or liver failure, congestive heart failure)
7. Resting blood pressure exceeding 180/100mmHg
8. Requires more than a one person assist for transfer
9. Planned surgery that would affect participation in the trial
10. Participating in another formal lower limbs exercise program more than one day per week
11. History of QT prolongation or concomitant use of clearly identified potential QT prolonging drugs, at the investigators discretion (e.g. amiodarone, bepridil, dysopyramide, dofetilide, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol, phenothiazines, pimozide, ziprasidone, TCAs, halofantrine, cisapride, and probucol)
12. History of glaucoma
13. Patients with a history of thrombocytopenia or clinically significant bleeding disorder or use of NSAID, ASA or other anticoagulants, at the investigators' discretion
14. History of convulsive disorders
15. Potential pregnancy (per screening algorithm)
16. Patients with an ongoing history of illicit drug use and/or alcohol abuse
17. Patient unwilling or unable to comply with trial requirements
18. Patient unable to understand English or communicate with the study team with staff support or translation services
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT03448159
Study Brief:
Protocol Section:
NCT03448159