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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT04323969
Eligibility Criteria:
Inclusion Criteria:
* Be 50 years of age or greater
* Exhibit signs of tibiofemoral OA (a score of ≥ 2 on the Kellgren and Lawrence (KL) grading scale) predominantly in the medial compartment,
* Self-reported knee pain ≥ 3 / 10 on a numerical rating scale of pain (NRS; 0 = "no pain" and 10 = "worst pain imaginable") during most days of the previous month
* Are comfortable walking intermittently for 30 minutes
* Fit into the available sizes of sensorized shoes (sizes spanning US women's 5 to men's 13)
* Exhibit at least a 5% reduction in knee adduction moment impulse for 10 degrees of change to foot rotation measured during a screening appointment.
Exclusion Criteria:
* Any knee surgery or intraarticular injections within the past 6 months
* A history of joint replacement surgery or high tibial osteotomy
* Current or recent (within 6 weeks) corticosteroid injections
* Use of a gait aid
* Currently on a wait list for joint replacement surgery or high tibial osteotomy
* Any inflammatory arthritic condition
* Any other conditions that may affect normal gait or participation in an aerobic exercise program
* Cannot attend all required appointments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04323969
Study Brief:
Protocol Section:
NCT04323969