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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT00721357
Eligibility Criteria:
Inclusion Criteria:
* age 18-80;
* stroke within past 6 months - 5 years;
* residual paresis in the lower extremity (LE) (Fugl-Meyer motor score \<34);
* ability to sit unsupported for 30 sec;
* ability to walk at least 10 ft with maximum 1 person assist;
* self selected 10 meter gait speed \< 0.8 m/s; and
* provision of informed consent.
Exclusion Criteria:
* Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking \< 200 meters;
* history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living;
* History of chronic obstructive pulmonary disease or oxygen dependence;
* Preexisting neurological disorders, dementia or previous stroke;
* History of major head trauma;
* Legal blindness or severe visual impairment;
* history of significant psychiatric illness;
* Life expectancy \<1 yr;
* Severe arthritis or orthopedic problems that limit passive range of motion (ROM);
* post-stroke depression (PHQ-9 10);
* History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months;
* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
* Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest;
* Previous or current enrollment in a clinical trial to enhance motor recovery;
* Presence of non-magnetic resonance (MR) compatible implants or devices, pregnancy or severe claustrophobia.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00721357
Study Brief:
Protocol Section:
NCT00721357