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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT07198750
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 60
* Clinical and radiological diagnosis of knee OA grade I-IV
* Pain ≥ 3 on Numeric Analog Scale for \>6 months
* Can walk (with/without aid)
* Cognitive ability to follow instructions
* Signed informed consent
* Availability for 9 treatment sessions and home exercise Exclusion Criteria
* Prior total knee arthroplasty (unilateral or bilateral)
* Neurological disorders affecting motor function or cognition (e.g., Parkinson's disease, stroke, moderate to severe dementia)
* Active inflammatory rheumatic diseases (e.g., rheumatoid arthritis, lupus)
* Presence of pacemakers, implantable defibrillators, or metallic implants near the treatment area
* Current use of other physical therapy modalities for pain (e.g., electrotherapy, ultrasound, TENS) outside the study protocol
* Participation in another clinical trial within the past 3 months
* Current use of NSAIDs or systemic/local corticosteroids (including intra-articular injections)
* Open wounds or active infections at the treatment site
* Decompensated cardiac conditions or medical contraindication to exercise
* Vestibular disorders that affect balance and interfere with functional assessments
* Uncorrected visual impairment interfering with gait or balance (visual acuity worse than 20/60 in the better eye, assessed by Snellen chart)
Withdrawal Criteria:
* Participants who complete fewer than 7 out of the 9 planned intervention sessions (i.e., less than 80% adherence)
* Occurrence of serious adverse events related to the intervention that contraindicate continuation
* Repeated non-compliance with the home exercise program, documented in at least two consecutive weekly follow-up reports
* Voluntary withdrawal of consent at any time during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT07198750
Study Brief:
Protocol Section:
NCT07198750