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 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT01558232
Eligibility Criteria:
Inclusion Criteria:
* Single stroke with residual unilateral lower-extremity weakness
* Subacute post-stroke period (\>3 and \<12 months)
* Eligible to participate to lower extremity physical therapy
* Age 40 years or greater
* Able to ambulate at least 10 meters
* Able to ambulate without a leg brace
* Ambulation speed less than 0.8 meters/second
* Minimum to moderate assist for transfer or ambulation by physical therapist evaluation
* Subject must understand the nature of the study and provide written informed consent prior to enrollment.
* Subject must be willing and able to attend all study sessions
Exclusion Criteria:
* Medically unstable
* Age younger than 40 years
* Acute post-stroke (\< 3 months)
* Chronic post-stroke (\> 12 months)
* Status-post multiple strokes
* Status-post traumatic brain injury
* Ambulation speed greater than 0.8 meters/second
* Currently using a Knee-Ankle-Foot Orthosis (KAFO)
* Not eligible for lower extremity physical therapy
* Concomitant degenerative neurological conditions
* Not able to ambulate at least 10 meters without assistance
* Greater than moderate assist during transfer or ambulation by physical therapist evaluation
* Unable to ambulate without a leg brace
* Unable to follow instructions, complete follow-up, or provide informed consent.
* Currently enrolled in another investigational device or drug trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT01558232
Study Brief:
Protocol Section:
NCT01558232