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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT05765435
Eligibility Criteria:
Inclusion Criteria:
1. Persons with knee osteoarthritis between the ages of 22 and 75
2. Ability to walk a duration of 30 minutes per walking session (with or without an assistive device), for three days per week
3. Able to tolerate the device for up to 1 hour per lab session
4. No recent change in medication or exacerbation of symptoms over the last 60 days
5. Radiographic KOA Kellgren and Lawrence grade 2 or 3 or physician diagnosed mild or moderate KOA if radiographic imaging is not available
6. No hyaluronic acid or cortisone injection into knees in previous 12 months
Exclusion Criteria:
1. Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation
2. Absent sensation in the impacted or more impacted leg
3. Inadequate response to stimulation, as defined as inability to achieve muscle contraction or tolerate stimulation
4. Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized
5. Use of FES devices in the past year
6. Demand-type cardiac pacemaker or defibrillator
7. Malignant tumor in the impacted or more impacted leg
8. Existing thrombosis in the impacted or more impacted leg
9. Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation
10. History of knee replacement surgery
11. History of other types of arthritis
12. History of neurological disease
13. History of seizures or diagnosed with epilepsy/seizures
14. Current pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
75 Years
Study:
NCT05765435
Study Brief:
Protocol Section:
NCT05765435