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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT06923293
Eligibility Criteria:
Inclusion Criteria:
* Have a lower limb injury greater than a year ago.
* Be 18-80 years old.
* Be able to stand for 30 minutes.
* Have enough range of motion in my ankle to comfortably wear the AFO.
* Be able to follow directions and commands.
* Be willing and able to give informed consent.
* Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.
Exclusion Criteria:
* Have any joint or muscle tightness that would limit my movement while walking with the AFO.
* Have any medical issue that prevents me from supporting my weight and walking (e.g. orthopedic injuries, pain, severe spasticity).
* Have any medical issues that affect my unaffected side.
* Have skin issues that would prevent wearing the device.
* Have a pre-existing condition that caused exercise intolerance. (Documented uncontrolled hypertension, coronary artery disease, abnormal heart rate or rhythm, or congestive heart failure).
* Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
* Have nervous system issues that affect my movement (for example Parkinson's disease, multiple sclerosis).
* Have additional orthopedic issues that interfere with my walking or limit my range of motion in my legs.
* Have any other medical conditions that my doctor or physical therapist feels would affect my ability to use the device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06923293
Study Brief:
Protocol Section:
NCT06923293