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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT01528566
Eligibility Criteria:
Inclusion Criteria:
1. Age 60 years or order;
2. A MMSE score of 18-28;
3. Diagnosis of knee OA based on medical history reviewed with elders or family members/staff and confirmation from the physician/APN;
4. Self-report of knee OA pain ≥ 2 on the VDS, or pain score ≥ 3 on the WOMAC pain subscale;
5. Ability to speak English;
6. Physician's/APN's permission to participate;
7. No regular exercise program in the past month;
8. Ambulation without assistance from staff or a walking device for 50 meters; and
9. Ability to stand and maintain balance for 1 minute without a walking device
Exclusion Criteria:
1. Uncorrectable moderate or severe hearing or vision deficits;
2. Parkinson's disease;
3. Cancer pain;
4. Chronic pain conditions, such as rheumatoid arthritis, fibromyalgia, or severe low back pain;
5. Diabetic neuropathy;
6. Arthroscopic surgery or total knee- or hip-replacement surgery in the past 6 months;
7. Fractures in the past 6 months;
8. Major psychiatric disorder or positive screen for depressive symptoms (GDS-15 score ≥ 5) without taking medication;
9. History of falls in the past 3 months; or
10. Vertigo in the past month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01528566
Study Brief:
Protocol Section:
NCT01528566