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 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT01970592
Eligibility Criteria:
Inclusion Criteria:
* age 50-70,
* stroke within the past 6 to 24 months,
* residual paresis in the lower extremity (Fugl-Meyer Lower Extremity motor score \<34),
* ability to walk without assistance and without an ankle foot orthotic (AFO) on the treadmill 30 seconds at speeds ranging from 0.3 - 0.8 m/s, and
* provision of informed consent.
* In addition, all subjects who meet criteria for the training portion must complete an exercise tolerance test and be cleared for participation by the study cardiologist.
Exclusion Criteria:
* Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking;
* rating on Modified Ashworth Scale 3 at the knee or ankle;
* limited lower extremity range of motion of the knee (passive flexion Range of Motion \[ROM\] \< 90); hip (inability to achieve neutral 0 hip extension); or ankle (inability to achieve 0 of active dorsiflexion);
* history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living (ADLs);
* History of chronic obstructive pulmonary disease (COPD) 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 other problems that limit passive ROM;
* post-stroke depression (PHQ-9 10),
* History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months;
* Uncontrolled diabetes with recent diabetic coma, or frequent insulin reactions;
* Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest;
* Previous or current enrollment in a trial to enhance motor recovery;
* Presence of non-magnetic resonance (MR) compatible implants, pregnancy or severe claustrophobia.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT01970592
Study Brief:
Protocol Section:
NCT01970592