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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02892760
Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 65 years
* Diagnosis of hemiparesis or hemiplegia following stroke
* Presence of abnormal walking pattern
* Poor knee control during stance phase
* Cognitive ability to (or care provider) manage daily charging of battery
* Cognitive ability to follow commands
* Hip flexor muscle strength grade 3 or greater or the ability to perform reciprocal gait using compensatory patterns
Exclusion Criteria:
* Weight \> 275 lbs. (Includes body weight and weight of heaviest object carried)
* Less than 2° of ankle motion
* Severe spasticity of the quadriceps (MAS \>3) and/or uncontrolled spasticity of the quadriceps
* Severe spasticity of other lower limb muscles (MAS \>3)
* Fixed genuvalgum exceeding 10° beyond anatomic neutral valgum
* Any fixed genuvarum exceeding anatomic neutral varum.
* Hip or knee flexion contractures greater than 10°
* Presence of chronic obstructive pulmonary disease (COPD)
* Chronic heart failure - New York Heart Association (NYHA) stages 3 and 4
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02892760
Study Brief:
Protocol Section:
NCT02892760