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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT07031518
Eligibility Criteria:
Inclusion Criteria:
* Patients with bi- or unilateral Knee Osteoarthritis as confirmed by a qualified rheumatologist/orthopaedist or rehabilitation doctor and having had at least one X-ray or MRI for diagnosis confirmation with Kellgren-Lawrence grade minimum 1
* WOMAC 3.1 total score at screening indicating mild, moderate, or severe symptoms in the past 48 hours
* BMI below 35.0 kg/m2
Exclusion Criteria:
* Patients with significant cognitive disorders, limiting the understanding of the exercises to be performed or the presence of apparent communication difficulties hindering the correct collection of data.
* Unable to walk independently (10 meters without any type of external help)
* History of any joint replacement surgery.
* Currently undergoing or had corticosteroid injections within the past 3 weeks.
* Underwent knee surgery in the past 6 months.
* Expecting joint replacement surgery or arthroscopy within 3 months.
* Pregnant women or women planning to become pregnant during the study
* Presence of any other conditions than osteoarthritis (musculoskeletal or neurological) that may affect normal gait. OA in other joints is not considered as an exclusion criterion as long as OAK is the most significant cause of walking impairment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT07031518
Study Brief:
Protocol Section:
NCT07031518