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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT02132650
Eligibility Criteria:
Inclusion Criteria:
* occurrence of a single unilateral stroke within the previous 6-18 months (verified by MRI or CT from medical record)
* living in the community and able to travel to training and assessment sites
* approval of participation by primary care physician
* age 18 - 80 years
* lower extremity paresis indicated by Fugl-Meyer Assessment Score \< 30
* deficit in at least one "synergy" subcategory (II - IV) of the Fugl-Meyer Assessment
* self-selected 10m gait speed of 0.4 - 0.8 m/s (with or without an ankle/foot orthosis or cane)
* able to provide informed consent
* willingness to be randomized to either intervention group
* written approval by primary care physician
Exclusion Criteria:
neurological disorder or injury (other than stroke) such as Parkinson' s disease or spinal cord injury
* severe arthritis, such as awaiting joint replacement, that would interfere with study participation
* cardiovascular disease (congestive heart failure, significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, uncontrolled angina)
* myocardial infarction or major heart surgery in the previous year
* cancer requiring treatment in the past three years, except for nonmelanoma skin cancers and other cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
* lung disease requiring use of corticosteroids or supplemental oxygen
* renal disease requiring dialysis
* current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
* Mini-Mental State Examination (MMSE) score \<23
* major depression (Patient Health Questionnaire score \> 10)
* severe obesity (body mass index \> 35)
* uncontrolled hypertension (systolic \> 200 mmHg and/or diastolic \> 110 mmHg)
* uncontrolled diabetes with recent diabetic coma or frequent hypoglycemia
* bone fracture or joint replacement in the previous six months
* diagnosis of a terminal illness
* current participation in physical therapy or cardiopulmonary rehabilitation
* significant visual impairment affecting capability to gauge movement accuracy
* previous enrollment in a clinical trial for recovery of walking function
* current enrollment in any clinical trial
* planning to relocate out of the greater Gainesville FL area during the study period
* unable to communicate sufficiently with study personnel
* clinical judgment regarding safety or noncompliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02132650
Study Brief:
Protocol Section:
NCT02132650