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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT04625127
Eligibility Criteria:
Inclusion Criteria:
* Male and females of age between 18 to 85 year of age
* History of one-sided ischemic or hemorrhagic stroke
* Chronic: more than 6 months post-stroke (Aim 1 and Aim 2)
* Subacute: within 8 weeks post-stroke (Aim 1 and Aim 3)
* Residual functional impairment of a lower extremity as a result of the stroke
* Ability to walk at least 15 meters with or without assistive devices (FIM walk subsection, levels 6 and 7)
* Ability to walk 3 consecutive minutes (5 minutes for Aim 2) on a treadmill at a speed equal to or greater than 0.22 m/s (0.8 km/h or 0.5 mph) with or without hand support.
* Medical clearance received from treating physician to participate in the gait training program proposed in the study
Exclusion Criteria:
* Severe aphasia limiting the ability to express needs or discomfort verbally or non-verbally
* Cognitive impairment limiting the ability to understand and follow instructions (as assessed by a score \<23 on the Mini Mental State Examination)
* Previous diagnosis of neurological diseases other than stroke
* Recent history of lower extremity fractures (\<12 months ago), unhealed wounds
* Current indication for isolation precautions (e.g. MRSA, VRE, C. difficile, and others)
* Severe visual impairments (as assessed by the NIH Stroke Scale Visual Field subscale. score \>0)
* Hemispatial neglect (as assessed by the Line Bisection Test)
* Subjects diagnosed with a medical condition that would interfere with their participation in regular sustained exercise (such as a severe pulmonary and/or cardiovascular condition)
* For Aim 2: currently participating in a gait training intervention (PT or research)
* Adults with impaired decision-making capacity
* Women who are pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04625127
Study Brief:
Protocol Section:
NCT04625127